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FTR#1189 The Oswald Institute of Virology, Part 8: Covid-19 and The American Deep State, Part 2 (The Cover-Up Obviates the Conspiracy)

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FTR #1189 This pro­gram was record­ed in one, 60-minute seg­ment.

Intro­duc­tion: This pro­gram con­tin­ues our series ana­lyz­ing the Wuhan Insti­tute of Virol­o­gy as hav­ing been set up to take the fall for the Covid-19 pan­dem­ic, which–in our con­sid­ered opinion–is a covert oper­a­tion by the U.S. as part of the full-court press against Chi­na.

Under­scor­ing a point of analy­sis from pre­vi­ous broad­casts, we note that, of para­mount impor­tance in this con­text, is the fact that ANY virus can be made in a lab­o­ra­to­ry, from scratch as is being done for the SARS-CoV­‑2 (Covid-19) virus.

Ralph Baric–who did the gain-of-func­tion mod­i­fi­ca­tion on the Horse­shoe Bat coro­n­avirus, has been select­ed to engi­neer the Covid-19.

Note what might be termed a “viro­log­ic Juras­sic Park” man­i­fes­ta­tion: ” . . . . The tech­nol­o­gy imme­di­ate­ly cre­at­ed bio-weapon wor­ries. . . . Researchers at the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion (CDC) drove that point home in 2005 when they res­ur­rect­ed the influen­za virus that killed tens of mil­lions in 1918–1919. . . .

Cen­tral to the inquiry about a lab­o­ra­to­ry gen­e­sis for the virus is Ralph Bar­ic. We note that:

  1. Bar­ic’s mod­i­fi­ca­tion of a horse­shoe bat virus to make it more infec­tious (in col­lab­o­ra­tion with Shi Zhengli and in an Eco­Health Alliance affil­i­at­ed project) took place in North Car­oli­na, not Wuhan. “. . . . Crit­ics have jumped on this paper as evi­dence that Shi was con­duct­ing “gain of func­tion” exper­i­ments that could have cre­at­ed a super­bug, but Shi denies it. The research cit­ed in the paper was con­duct­ed in North Car­oli­na.
  2. Bar­ic has been using relat­ed tech­niques to text remde­sivir (in 2017) and the Mod­er­na vac­cine. This places him in a milieu inex­tri­ca­bly linked to the mil­i­tary and pre-dat­ing the pan­dem­ic. ” . . . . Using a sim­i­lar tech­nique, in 2017, Baric’s lab showed that remde­sivir — cur­rent­ly the only licensed drug for treat­ing covid — could be use­ful in fight­ing coro­n­avirus infec­tions. Bar­ic also helped test the Mod­er­na covid vac­cine and a lead­ing new drug can­di­date against covid. . . .”

Next, we present analy­sis of a very impor­tant, albeit slant­ed Van­i­ty Fair arti­cle:

  1. Pom­peo State Depart­ment offi­cials pur­su­ing the lab-leak hypoth­e­sis were told to cov­er it up lest it shed light on U.S. gov­ern­ment fund­ing of research at the “Oswald Insti­tute of Virol­o­gy!”: ” . . . . In one State Depart­ment meet­ing, offi­cials seek­ing to demand trans­paren­cy from the Chi­nese gov­ern­ment say they were explic­it­ly told by col­leagues not to explore the Wuhan Insti­tute of Virology’s gain-of-func­tion research, because it would bring unwel­come atten­tion to U.S. gov­ern­ment fund­ing of it. . . . . In an inter­nal memo obtained by Van­i­ty Fair, Thomas DiNan­no, for­mer act­ing assis­tant sec­re­tary of the State Department’s Bureau of Arms Con­trol, Ver­i­fi­ca­tion, and Com­pli­ance, wrote that. . .  staff from two bureaus . . . “warned” lead­ers with­in his bureau ‘not to pur­sue an inves­ti­ga­tion into the ori­gin of COVID-19’ because it would ‘open a can of worms’ if it con­tin­ued.’ . . . . As the group probed the lab-leak sce­nario, among oth­er pos­si­bil­i­ties, its mem­bers were repeat­ed­ly advised not to open a ‘Pandora’s box,’ said four for­mer State Depart­ment offi­cials inter­viewed by Van­i­ty Fair. . . .”
  2. Set­ting the ortho­doxy in ear­ly 2020 with a Lancet arti­cle rul­ing out a lab­o­ra­to­ry ori­gin for the virus was Peter Daszak, with approval from Ralph Bar­ic: ” . . . . It soon emerged, based on emails obtained by a Free­dom of Infor­ma­tion group called U.S. Right to Know, that Daszak had not only signed but orga­nized the influ­en­tial Lancet state­ment, with the inten­tion of con­ceal­ing his role and cre­at­ing the impres­sion of sci­en­tif­ic una­nim­i­ty. . . .”
  3. ” . . . . In late March, for­mer Cen­ters for Dis­ease Con­trol direc­tor Robert Red­field received death threats from fel­low sci­en­tists after telling CNN that he believed COVID-19 had orig­i­nat­ed in a lab. . . . ”
  4. Matthew Pot­tinger, a Chi­na hawk in the Trump admin­is­tra­tion, head­ed up a team to inves­ti­gate the Wuhan lab leak hypoth­e­sis. Note that the gain-of-func­tion milieu in the U.S. nation­al secu­ri­ty estab­lish­ment was a retard­ing fac­tor in the inquiry: ” . . . . By then, Matthew Pot­tinger had approved a COVID-19 ori­gins team, run by the NSC direc­torate that over­saw issues relat­ed to weapons of mass destruc­tion. A long­time Asia expert and for­mer jour­nal­ist, Pot­tinger pur­pose­ful­ly kept the team small . . . . In addi­tion, many lead­ing experts had either received or approved fund­ing for gain-of-func­tion research. Their ‘con­flict­ed’ sta­tus, said Pot­tinger, ‘played a pro­found role in mud­dy­ing the waters and con­t­a­m­i­nat­ing the shot at hav­ing an impar­tial inquiry.’  . . . .” 
  5. Note that Lawrence Liv­er­more sci­en­tists were involved with the gen­e­sis of the “Chi­na did it” hypoth­e­sis, after alleged­ly being alert­ed by a for­eign source to look into their own files. ” . . . . An intel­li­gence ana­lyst work­ing with David Ash­er sift­ed through clas­si­fied chan­nels and turned up a report that out­lined why the lab-leak hypoth­e­sis was plau­si­ble. It had been writ­ten in May by researchers at the Lawrence Liv­er­more Nation­al Lab­o­ra­to­ry, which per­forms nation­al secu­ri­ty research for the Depart­ment of Ener­gy. But it appeared to have been buried with­in the clas­si­fied col­lec­tions sys­tem. . . .”
  6. Note, also, that Chris Ford, a Chi­na hawk, was work­ing to sup­press the Wuhan lab leak hypoth­e­sis: ” . . . . Their frus­tra­tion crest­ed in Decem­ber, when they final­ly briefed Chris Ford, act­ing under­sec­re­tary for Arms Con­trol and Inter­na­tion­al Secu­ri­ty. He seemed so hos­tile to their probe that they viewed him as a blink­ered func­tionary bent on white­wash­ing China’s malfea­sance. But Ford, who had years of expe­ri­ence in nuclear non­pro­lif­er­a­tion, had long been a Chi­na hawk. . . .”
  7. The “Chi­na did it/Wuhan lab leak” hypoth­e­sis sur­vived from the Trump admin­is­tra­tion and Mike Pom­peo’s State Depart­ment to the Biden admin­is­tra­tion: ” . . . . The state­ment with­stood ‘aggres­sive sus­pi­cion,’ as one for­mer State Depart­ment offi­cial said, and the Biden admin­is­tra­tion has not walked it back. ‘I was very pleased to see Pompeo’s state­ment come through,’ said Chris Ford, who per­son­al­ly signed off on a draft of the fact sheet before leav­ing the State Depart­ment. ‘I was so relieved that they were using real report­ing that had been vet­ted and cleared.’ . . . .”
  8. Avril Haines, whom we have cit­ed in this series as a key par­tic­i­pant in the Deep State shep­herd­ing of the “Lab-Leak Hypoth­e­sis,” looms large in the inquiry into the per­pet­u­a­tion of this pro­pa­gan­da meme: ” . . . . Inside the U.S. gov­ern­ment, mean­while, the lab-leak hypoth­e­sis had sur­vived the tran­si­tion from Trump to Biden. On April 15, Direc­tor of Nation­al Intel­li­gence Avril Haines told the House Intel­li­gence Com­mit­tee that two ‘plau­si­ble the­o­ries’ were being weighed: a lab acci­dent or nat­ur­al emer­gence. . . .”
  9. The arti­cle con­cludes with the inter­est­ing use of the term “cut-out” to describe the Eco­Health Alliance. The term gen­er­al­ly refers to an intel­li­gence-com­mu­ni­ty front orga­ni­za­tion. Is the author hint­ing at more? Did her edi­tor take infor­ma­tion out? ” . . . . The Unit­ed States deserves a healthy share of blame as well. Thanks to their unprece­dent­ed track record of men­dac­i­ty and race-bait­ing, Trump and his allies had less than zero cred­i­bil­i­ty. And the prac­tice of fund­ing risky research via cutouts like Eco­Health Alliance enmeshed lead­ing virol­o­gists in con­flicts of inter­est at the exact moment their exper­tise was most des­per­ate­ly need­ed. . . .”

We con­clude with two impor­tant points from an arti­cle used ear­li­er in the pro­gram.

  1. Shi Zhengli has not­ed that open­ing up the WIV’s records is unac­cept­able: ” . . . . That demand is ‘def­i­nite­ly not accept­able,’ respond­ed Shi Zhengli, who directs the Cen­ter for Emerg­ing Infec­tious Dis­eases at the Wuhan Insti­tute. ‘Who can pro­vide evi­dence that does not exist?’ she told MIT Tech­nol­o­gy Review. Shi has said that thou­sands of attempts to hack its com­put­er sys­tems forced the insti­tute to close its data­base. . . .”
  2. The U.S. would not be accept­able to such a propo­si­tion, if the Chi­nese demand­ed access to Ft. Det­rick (part of which was shut down by the CDC in ear­ly August of 2019 on the eve of the pan­dem­ic). A com­menter also not­ed the Rocky Moun­tain lab in his analy­sis, which we not­ed was one of the areas where Willy Burgdor­fer appears to have worked on the devel­op­ment of Lyme Dis­ease.) ” . . . . If a dis­ease had emerged from the U.S. and the Chi­nese blamed the Pen­ta­gon and demand­ed access to the data, ‘what would we say?’ [Dr. Ger­ald] Keusch asked. ‘Would we throw out the red car­pet, ‘Come on over to Fort Det­rick and the Rocky Moun­tain Lab?’ We’d have done exact­ly what the Chi­nese did, which is say, ‘Screw you!’’ . . . .”

1a. Under­scor­ing a point of analy­sis from pre­vi­ous broad­casts, we note that, of para­mount impor­tance in this con­text, is the fact that ANY virus can be made in a lab­o­ra­to­ry, from scratch as is being done for the SARS-CoV­‑2 (Covid-19) virus.

Ralph Baric–who did the gain-of-func­tion mod­i­fi­ca­tion on the Horse­shoe Bat coro­n­avirus, has been select­ed to engi­neer the Covid-19.

Note what might be termed a “viro­log­ic Juras­sic Park” man­i­fes­ta­tion: ” . . . . The tech­nol­o­gy imme­di­ate­ly cre­at­ed bio-weapon wor­ries. . . . Researchers at the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion (CDC) drove that point home in 2005 when they res­ur­rect­ed the influen­za virus that killed tens of mil­lions in 1918–1919. . . .

“Biol­o­gists rush to re-cre­ate the Chi­na coro­n­avirus from its DNA code” by Anto­nio Regal­a­do; MIT Tech­nol­o­gy Review; 02/15/2020

The world is watch­ing with alarm as Chi­na strug­gles to con­tain a dan­ger­ous new virus, now being called SARS-CoV­‑2. It has quar­an­tined entire cities, and the US has put a blan­ket ban on trav­ellers who’ve been there. Health offi­cials are scram­bling to under­stand how the virus is trans­mit­ted and how to treat patients.

But in one Uni­ver­si­ty of North Car­oli­na lab, there’s a dif­fer­ent race. Researchers are try­ing to cre­ate a copy of the virus. From scratch.

Led by Ralph Bar­ic, an expert in coronaviruses—which get their name from the crown-shaped spike they use to enter human cells—the North Car­oli­na team expects to recre­ate the virus start­ing only from com­put­er read­outs of its genet­ic sequence post­ed online by Chi­nese labs last month.

The remark­able abil­i­ty to “boot up” virus­es from genet­ic instruc­tions is made pos­si­ble by com­pa­nies that man­u­fac­ture cus­tom DNA mol­e­cules, such as Inte­grat­ed DNA Tech­nol­o­gy, Twist Bio­science, and Atum. By order­ing the right genes, which cost a few thou­sand dol­lars, and then stitch­ing them togeth­er to cre­ate a copy of the coro­n­avirus genome, it’s pos­si­ble to inject the genet­ic mate­r­i­al into cells and jump-start the virus to life.

The abil­i­ty to make a lethal virus from mail-order DNA was first demon­strat­ed 20 years ago. It’s enough of a bioter­ror­ism con­cern that com­pa­nies care­ful­ly mon­i­tor who is order­ing which genes. . . . The tech­nol­o­gy imme­di­ate­ly cre­at­ed bio-weapon wor­ries. . . . Researchers at the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion (CDC) drove that point home in 2005 when they res­ur­rect­ed the influen­za virus that killed tens of mil­lions in 1918–1919. . . .

1b. Cen­tral to the inquiry about a lab­o­ra­to­ry gen­e­sis for the virus is Ralph Bar­ic. We note that:

  1. Bar­ic’s mod­i­fi­ca­tion of a horse­shoe bat virus to make it more infec­tious (in col­lab­o­ra­tion with Shi Zhengli and in an Eco­Health Alliance affil­i­at­ed project) took place in North Car­oli­na, not Wuhan. “. . . . Crit­ics have jumped on this paper as evi­dence that Shi was con­duct­ing “gain of func­tion” exper­i­ments that could have cre­at­ed a super­bug, but Shi denies it. The research cit­ed in the paper was con­duct­ed in North Car­oli­na. . . .”
  2. Bar­ic has been using relat­ed tech­niques to text remde­sivir (in 2017) and the Mod­er­na vac­cine. This places him in a milieu inex­tri­ca­bly linked to the mil­i­tary and pre-dat­ing the pan­dem­ic. ” . . . . Using a sim­i­lar tech­nique, in 2017, Baric’s lab showed that remde­sivir — cur­rent­ly the only licensed drug for treat­ing covid — could be use­ful in fight­ing coro­n­avirus infec­tions. Bar­ic also helped test the Mod­er­na covid vac­cine and a lead­ing new drug can­di­date against covid. . . .”

“To the Bat Cave: In Search of Covid’s Ori­gins, Sci­en­tists Reignite Polar­iz­ing Debate on Wuhan ‘Lab        Leak’” by Arthur Allen; KHN; 05/19/2021

. . . . Crit­ics have jumped on this paper as evi­dence that Shi was con­duct­ing “gain of func­tion” exper­i­ments that could have cre­at­ed a super­bug, but Shi denies it. The research cit­ed in the paper was con­duct­ed in North Car­oli­na.

Using a sim­i­lar tech­nique, in 2017, Baric’s lab showed that remde­sivir — cur­rent­ly the only licensed drug for treat­ing covid — could be use­ful in fight­ing coro­n­avirus infec­tions. Bar­ic also helped test the Mod­er­na covid vac­cine and a lead­ing new drug can­di­date against covid.

Research into covid-like virus­es is vital, Bar­ic said. “A ter­ri­ble truth,” he said, “is that mil­lions of coro­n­avirus­es exist in ani­mal reser­voirs, like bats, and unfor­tu­nate­ly many appear poised for rapid trans­mis­sion between species.”

Bar­ic told KHN he does not believe covid result­ed from gain-of-func­tion research. But he signed the Sci­ence let­ter call­ing for a more thor­ough inves­ti­ga­tion of his Chi­nese col­leagues’ lab­o­ra­to­ry, he said in an email, because while he “per­son­al­ly believe[s] in the nat­ur­al ori­gin hypoth­e­sis,” WHO should arrange for a rig­or­ous, open inves­ti­ga­tion. . . .

. . . . The more than $50 mil­lion Eco­Health Alliance had received in U.S. fund­ing since 2007 includes con­tracts and grants from two NIH insti­tutes, the Nation­al Sci­ence Foun­da­tion and the U.S. Agency for Inter­na­tion­al Devel­op­ment, as well as Pen­ta­gon funds to look for organ­isms that could be fash­ioned into bioter­ror weapons. . . .

. . . . Scal­ing the Wall of Secre­cy

U.S.-China ten­sions will make it very dif­fi­cult to con­clude any such study, sci­en­tists on both sides of the issue sug­gest. With their anti-Chi­na rhetoric, Trump and his aides “could not have made it more dif­fi­cult to get coop­er­a­tion,” said Dr. Ger­ald Keusch, asso­ciate direc­tor of the Nation­al Emerg­ing Infec­tious Dis­eases Lab­o­ra­to­ry Insti­tute at Boston Uni­ver­si­ty. If a dis­ease had emerged from the U.S. and the Chi­nese blamed the Pen­ta­gon and demand­ed access to the data, “what would we say?” Keusch asked. “Would we throw out the red car­pet, ‘Come on over to Fort Det­rick and the Rocky Moun­tain Lab?’ We’d have done exact­ly what the Chi­nese did, which is say, ‘Screw you!’”

3. Next, we present analy­sis of a very impor­tant, albeit slant­ed Van­i­ty Fair arti­cle:

  1. Pom­peo State Depart­ment offi­cials pur­su­ing the lab-leak hypoth­e­sis were told to cov­er it up lest it shed light on U.S. gov­ern­ment fund­ing of research at the “Oswald Insti­tute of Virol­o­gy!”: ” . . . . In one State Depart­ment meet­ing, offi­cials seek­ing to demand trans­paren­cy from the Chi­nese gov­ern­ment say they were explic­it­ly told by col­leagues not to explore the Wuhan Insti­tute of Virology’s gain-of-func­tion research, because it would bring unwel­come atten­tion to U.S. gov­ern­ment fund­ing of it. . . . . In an inter­nal memo obtained by Van­i­ty Fair, Thomas DiNan­no, for­mer act­ing assis­tant sec­re­tary of the State Department’s Bureau of Arms Con­trol, Ver­i­fi­ca­tion, and Com­pli­ance, wrote that. . .  staff from two bureaus . . . “warned” lead­ers with­in his bureau ‘not to pur­sue an inves­ti­ga­tion into the ori­gin of COVID-19’ because it would ‘open a can of worms’ if it con­tin­ued.’ . . . . As the group probed the lab-leak sce­nario, among oth­er pos­si­bil­i­ties, its mem­bers were repeat­ed­ly advised not to open a ‘Pandora’s box,’ said four for­mer State Depart­ment offi­cials inter­viewed by Van­i­ty Fair. . . .”
  2. Set­ting the ortho­doxy in ear­ly 2020 with a Lancet arti­cle rul­ing out a lab­o­ra­to­ry ori­gin for the virus was Peter Daszak, with approval from Ralph Bar­ic: ” . . . . It soon emerged, based on emails obtained by a Free­dom of Infor­ma­tion group called U.S. Right to Know, that Daszak had not only signed but orga­nized the influ­en­tial Lancet state­ment, with the inten­tion of con­ceal­ing his role and cre­at­ing the impres­sion of sci­en­tif­ic una­nim­i­ty. . . .”
  3. ” . . . . In late March, for­mer Cen­ters for Dis­ease Con­trol direc­tor Robert Red­field received death threats from fel­low sci­en­tists after telling CNN that he believed COVID-19 had orig­i­nat­ed in a lab. . . . ”
  4. Matthew Pot­tinger, a Chi­na hawk in the Trump admin­is­tra­tion, head­ed up a team to inves­ti­gate the Wuhan lab leak hypoth­e­sis. Note that the gain-of-func­tion milieu in the U.S. nation­al secu­ri­ty estab­lish­ment was a retard­ing fac­tor in the inquiry: ” . . . . By then, Matthew Pot­tinger had approved a COVID-19 ori­gins team, run by the NSC direc­torate that over­saw issues relat­ed to weapons of mass destruc­tion. A long­time Asia expert and for­mer jour­nal­ist, Pot­tinger pur­pose­ful­ly kept the team small . . . . In addi­tion, many lead­ing experts had either received or approved fund­ing for gain-of-func­tion research. Their ‘con­flict­ed’ sta­tus, said Pot­tinger, ‘played a pro­found role in mud­dy­ing the waters and con­t­a­m­i­nat­ing the shot at hav­ing an impar­tial inquiry.’  . . . .” 
  5. Note that Lawrence Liv­er­more sci­en­tists were involved with the gen­e­sis of the “Chi­na did it” hypoth­e­sis, after alleged­ly being alert­ed by a for­eign source to look into their own files. ” . . . . An intel­li­gence ana­lyst work­ing with David Ash­er sift­ed through clas­si­fied chan­nels and turned up a report that out­lined why the lab-leak hypoth­e­sis was plau­si­ble. It had been writ­ten in May by researchers at the Lawrence Liv­er­more Nation­al Lab­o­ra­to­ry, which per­forms nation­al secu­ri­ty research for the Depart­ment of Ener­gy. But it appeared to have been buried with­in the clas­si­fied col­lec­tions sys­tem. . . .”
  6. Note, also, that Chris Ford, a Chi­na hawk, was work­ing to sup­press the Wuhan lab leak hypoth­e­sis: ” . . . . Their frus­tra­tion crest­ed in Decem­ber, when they final­ly briefed Chris Ford, act­ing under­sec­re­tary for Arms Con­trol and Inter­na­tion­al Secu­ri­ty. He seemed so hos­tile to their probe that they viewed him as a blink­ered func­tionary bent on white­wash­ing China’s malfea­sance. But Ford, who had years of expe­ri­ence in nuclear non­pro­lif­er­a­tion, had long been a Chi­na hawk. . . .”
  7. The “Chi­na did it/Wuhan lab leak” hypoth­e­sis sur­vived from the Trump admin­is­tra­tion and Mike Pom­peo’s State Depart­ment to the Biden admin­is­tra­tion: ” . . . .. . . . The state­ment with­stood ‘aggres­sive sus­pi­cion,’ as one for­mer State Depart­ment offi­cial said, and the Biden admin­is­tra­tion has not walked it back. ‘I was very pleased to see Pompeo’s state­ment come through,’ said Chris Ford, who per­son­al­ly signed off on a draft of the fact sheet before leav­ing the State Depart­ment. ‘I was so relieved that they were using real report­ing that had been vet­ted and cleared.’ . . . .”
  8. Avril Haines, whom we have cit­ed in this series as a key par­tic­i­pant in the Deep State shep­herd­ing of the “Lab-Leak Hypoth­e­sis,” looms large in the inquiry into the per­pet­u­a­tion of this pro­pa­gan­da meme: ” . . . . Inside the U.S. gov­ern­ment, mean­while, the lab-leak hypoth­e­sis had sur­vived the tran­si­tion from Trump to Biden. On April 15, Direc­tor of Nation­al Intel­li­gence Avril Haines told the House Intel­li­gence Com­mit­tee that two ‘plau­si­ble the­o­ries’ were being weighed: a lab acci­dent or nat­ur­al emer­gence. . . .”
  9. The arti­cle con­cludes with the inter­est­ing use of the term “cut-out” to describe the Eco­Health Alliance. The term gen­er­al­ly refers to an intel­li­gence-com­mu­ni­ty front orga­ni­za­tion. Is the author hint­ing at more? Did her edi­tor take infor­ma­tion out? ” . . . . The Unit­ed States deserves a healthy share of blame as well. Thanks to their unprece­dent­ed track record of men­dac­i­ty and race-bait­ing, Trump and his allies had less than zero cred­i­bil­i­ty. And the prac­tice of fund­ing risky research via cutouts like Eco­Health Alliance enmeshed lead­ing virol­o­gists in con­flicts of inter­est at the exact moment their exper­tise was most des­per­ate­ly need­ed. . . .”

“The Lab-Leak The­o­ry: Inside the Fight to Uncov­er Covid-19’s Ori­gins” by Kather­ine Eban; Van­i­ty Fair; 6/3/2021.

. . . . At times, it seemed the only oth­er peo­ple enter­tain­ing the lab-leak the­o­ry were crack­pots or polit­i­cal hacks hop­ing to wield COVID-19 as a cud­gel against Chi­na. Pres­i­dent Don­ald Trump’s for­mer polit­i­cal advis­er Steve Ban­non, for instance, joined forces with an exiled Chi­nese bil­lion­aire named Guo Wen­gui to fuel claims that Chi­na had devel­oped the dis­ease as a bioweapon and pur­pose­ful­ly unleashed it on the world. As proof, they parad­ed a Hong Kong sci­en­tist around right-wing media out­lets until her man­i­fest lack of exper­tise doomed the cha­rade. . . .

. . . . On Feb­ru­ary 19, 2020, The Lancet, among the most respect­ed and influ­en­tial med­ical jour­nals in the world, pub­lished a state­ment that round­ly reject­ed the lab-leak hypoth­e­sis, effec­tive­ly cast­ing it as a xeno­pho­bic cousin to cli­mate change denial­ism and anti-vaxxism. Signed by 27 sci­en­tists, the state­ment expressed “sol­i­dar­i­ty with all sci­en­tists and health pro­fes­sion­als in Chi­na” and assert­ed: “We stand togeth­er to strong­ly con­demn con­spir­a­cy the­o­ries sug­gest­ing that COVID-19 does not have a nat­ur­al ori­gin.”

The Lancet state­ment effec­tive­ly end­ed the debate over COVID-19’s ori­gins before it began. To Gilles Dema­neuf, fol­low­ing along from the side­lines, it was as if it had been “nailed to the church doors,” estab­lish­ing the nat­ur­al ori­gin the­o­ry as ortho­doxy. “Every­one had to fol­low it. Every­one was intim­i­dat­ed. That set the tone.” . . . . 

. . . . It soon emerged, based on emails obtained by a Free­dom of Infor­ma­tion group called U.S. Right to Know, that Daszak had not only signed but orga­nized the influ­en­tial Lancet state­ment, with the inten­tion of con­ceal­ing his role and cre­at­ing the impres­sion of sci­en­tif­ic una­nim­i­ty.

Under the sub­ject line, “No need for you to sign the “State­ment” Ralph!!,” he wrote to two sci­en­tists, includ­ing UNC’s Dr. Ralph Bar­ic, who had col­lab­o­rat­ed with Shi Zhengli on the gain-of-func­tion study that cre­at­ed a coro­n­avirus capa­ble of infect­ing human cells: “you, me and him should not sign this state­ment, so it has some dis­tance from us and there­fore doesn’t work in a coun­ter­pro­duc­tive way.” Daszak added, “We’ll then put it out in a way that doesn’t link it back to our col­lab­o­ra­tion so we max­i­mize an inde­pen­dent voice.”

Bar­ic agreed, writ­ing back, “Oth­er­wise it looks self-serv­ing and we lose impact.” . . . .

. . . . A months long Van­i­ty Fair inves­ti­ga­tion, inter­views with more than 40 peo­ple, and a review of hun­dreds of pages of U.S. gov­ern­ment doc­u­ments, includ­ing inter­nal mem­os, meet­ing min­utes, and email cor­re­spon­dence, found that con­flicts of inter­est, stem­ming in part from large gov­ern­ment grants sup­port­ing con­tro­ver­sial virol­o­gy research, ham­pered the U.S. inves­ti­ga­tion into COVID-19’s ori­gin at every step.In one State Depart­ment meet­ing, offi­cials seek­ing to demand trans­paren­cy from the Chi­nese gov­ern­ment say they were explic­it­ly told by col­leagues not to explore the Wuhan Insti­tute of Virology’s gain-of-func­tion research, because it would bring unwel­come atten­tion to U.S. gov­ern­ment fund­ing of it.

In an inter­nal memo obtained by Van­i­ty Fair, Thomas DiNan­no, for­mer act­ing assis­tant sec­re­tary of the State Department’s Bureau of Arms Con­trol, Ver­i­fi­ca­tion, and Com­pli­ance, wrote that staff from two bureaus, his own and the Bureau of Inter­na­tion­al Secu­ri­ty and Non­pro­lif­er­a­tion, “warned” lead­ers with­in his bureau “not to pur­sue an inves­ti­ga­tion into the ori­gin of COVID-19” because it would “‘open a can of worms’ if it con­tin­ued.” . . . . 

. . . . But for most of the past year, the lab-leak sce­nario was treat­ed not sim­ply as unlike­ly or even inac­cu­rate but as moral­ly out-of-bounds. In late March, for­mer Cen­ters for Dis­ease Con­trol direc­tor Robert Red­field received death threats from fel­low sci­en­tists after telling CNN that he believed COVID-19 had orig­i­nat­ed in a lab. . . . 

. . . . In the words of David Fei­th, for­mer deputy assis­tant sec­re­tary of state in the East Asia bureau, “The sto­ry of why parts of the U.S. gov­ern­ment were not as curi­ous as many of us think they should have been is a huge­ly impor­tant one.” . . . .

. . . . By then, Matthew Pot­tinger had approved a COVID-19 ori­gins team, run by the NSC direc­torate that over­saw issues relat­ed to weapons of mass destruc­tion. A long­time Asia expert and for­mer jour­nal­ist, Pot­tinger pur­pose­ful­ly kept the team small, because there were so many peo­ple with­in the gov­ern­ment “whol­ly dis­count­ing the pos­si­bil­i­ty of a lab leak, who were pre­dis­posed that it was impos­si­ble,” said Pot­tinger. In addi­tion, many lead­ing experts had either received or approved fund­ing for gain-of-func­tion research. Their “con­flict­ed” sta­tus, said Pot­tinger, “played a pro­found role in mud­dy­ing the waters and con­t­a­m­i­nat­ing the shot at hav­ing an impar­tial inquiry.”  . . . . 

. . . . Believ­ing they had uncov­ered impor­tant evi­dence in favor of the lab-leak hypoth­e­sis, the NSC inves­ti­ga­tors began reach­ing out to oth­er agen­cies. That’s when the ham­mer came down. “We were dis­missed,” said Antho­ny Rug­giero, the NSC’s senior direc­tor for coun­ter­pro­lif­er­a­tion and biode­fense. “The response was very neg­a­tive.” . . . .

. . . . By the sum­mer of 2020, Gilles Dema­neuf was spend­ing up to four hours a day research­ing the ori­gins of COVID-19, join­ing Zoom meet­ings before dawn with Euro­pean col­lab­o­ra­tors and not sleep­ing much. He began to receive anony­mous calls and notice strange activ­i­ty on his com­put­er, which he attrib­uted to Chi­nese gov­ern­ment sur­veil­lance. “We are being mon­i­tored for sure,” he says. He moved his work to the encrypt­ed plat­forms Sig­nal and Pro­ton­Mail. . . .

. . . . As offi­cials at the meet­ing dis­cussed what they could share with the pub­lic, they were advised by Christo­pher Park, the direc­tor of the State Department’s Bio­log­i­cal Pol­i­cy Staff in the Bureau of Inter­na­tion­al Secu­ri­ty and Non­pro­lif­er­a­tion, not to say any­thing that would point to the U.S. government’s own role in gain-of-func­tion research, accord­ing to doc­u­men­ta­tion of the meet­ing obtained by Van­i­ty Fair.

Only two oth­er labs in the world, in Galve­ston, Texas and Chapel Hill, North Car­oli­na, were doing sim­i­lar research. “It’s not a dozen cities,” Dr. Richard Ebright said. “It’s three places.” 

Some of the atten­dees were “absolute­ly floored,” said an offi­cial famil­iar with the pro­ceed­ings. That some­one in the U.S. gov­ern­ment could “make an argu­ment that is so naked­ly against trans­paren­cy, in light of the unfold­ing cat­a­stro­phe, was…shocking and dis­turb­ing.”

Park, who in 2017 had been involved in lift­ing a U.S. gov­ern­ment mora­to­ri­um on fund­ing for gain-of-func­tion research, was not the only offi­cial to warn the State Depart­ment inves­ti­ga­tors against dig­ging in sen­si­tive places. As the group probed the lab-leak sce­nario, among oth­er pos­si­bil­i­ties, its mem­bers were repeat­ed­ly advised not to open a “Pandora’s box,” said four for­mer State Depart­ment offi­cials inter­viewed by Van­i­ty Fair. The admo­ni­tions “smelled like a cov­er-up,” said Thomas DiNan­no, “and I wasn’t going to be part of it.” . . . . 

. . . . In the first year of the Trump admin­is­tra­tion, the mora­to­ri­um was lift­ed and replaced with a review sys­tem called the HHS P3CO Frame­work (for Poten­tial Pan­dem­ic Pathogen Care and Over­sight). It put the onus for ensur­ing the safe­ty of any such research on the fed­er­al depart­ment or agency fund­ing it. This left the review process shroud­ed in secre­cy. “The names of review­ers are not released, and the details of the exper­i­ments to be con­sid­ered are large­ly secret,” said the Har­vard epi­demi­ol­o­gist Dr. Marc Lip­sitch, whose advo­ca­cy against gain-of-func­tion research helped prompt the mora­to­ri­um. (An NIH spokesper­son told Van­i­ty Fair that “infor­ma­tion about indi­vid­ual unfund­ed appli­ca­tions is not pub­lic to pre­serve con­fi­den­tial­i­ty and pro­tect sen­si­tive infor­ma­tion, pre­lim­i­nary data, and intel­lec­tu­al prop­er­ty.”)

Inside the NIH, which fund­ed such research, the P3CO frame­work was large­ly met with shrugs and eye rolls, said a long­time agency offi­cial: “If you ban gain-of-func­tion research, you ban all of virol­o­gy.” He added, “Ever since the mora­to­ri­um, everyone’s gone wink-wink and just done gain-of-func­tion research any­way.” . . . .

. . . . By the sum­mer of 2020, the State Department’s COVID-19 ori­gins inves­ti­ga­tion had gone cold. Offi­cials in the Bureau of Arms Con­trol, Ver­i­fi­ca­tion, and Com­pli­ance went back to their nor­mal work: sur­veilling the world for bio­log­i­cal threats. “We weren’t look­ing for Wuhan,” said Thomas DiNan­no. That fall, the State Depart­ment team got a tip from a for­eign source: Key infor­ma­tion was like­ly sit­ting in the U.S. intel­li­gence community’s own files, unan­a­lyzed. In Novem­ber, that lead turned up clas­si­fied infor­ma­tion that was “absolute­ly arrest­ing and shock­ing,” said a for­mer State Depart­ment offi­cial. Three researchers at the Wuhan Insti­tute of Virol­o­gy, all con­nect­ed with gain-of-func­tion research on coro­n­avirus­es, had fall­en ill in Novem­ber 2019 and appeared to have vis­it­ed the hos­pi­tal with symp­toms sim­i­lar to COVID-19, three gov­ern­ment offi­cials told Van­i­ty Fair.

While it is not clear what had sick­ened them, “these were not the jan­i­tors,” said the for­mer State Depart­ment offi­cial. “They were active researchers. The dates were among the absolute most arrest­ing part of the pic­ture, because they are smack where they would be if this was the ori­gin.” The reac­tion inside the State Depart­ment was, “Holy shit,” one for­mer senior offi­cial recalled. “We should prob­a­bly tell our boss­es.” The inves­ti­ga­tion roared back to life.

An intel­li­gence ana­lyst work­ing with David Ash­er sift­ed through clas­si­fied chan­nels and turned up a report that out­lined why the lab-leak hypoth­e­sis was plau­si­ble. It had been writ­ten in May by researchers at the Lawrence Liv­er­more Nation­al Lab­o­ra­to­ry, which per­forms nation­al secu­ri­ty research for the Depart­ment of Ener­gy. But it appeared to have been buried with­in the clas­si­fied col­lec­tions sys­tem.

Now the offi­cials were begin­ning to sus­pect that some­one was actu­al­ly hid­ing mate­ri­als sup­port­ive of a lab-leak expla­na­tion. “Why did my con­trac­tor have to pore through doc­u­ments?” DiNan­no won­dered. Their sus­pi­cion inten­si­fied when Depart­ment of Ener­gy offi­cials over­see­ing the Lawrence Liv­er­more lab unsuc­cess­ful­ly tried to block the State Depart­ment inves­ti­ga­tors from talk­ing to the report’s authors.

Their frus­tra­tion crest­ed in Decem­ber, when they final­ly briefed Chris Ford, act­ing under­sec­re­tary for Arms Con­trol and Inter­na­tion­al Secu­ri­ty. He seemed so hos­tile to their probe that they viewed him as a blink­ered func­tionary bent on white­wash­ing China’s malfea­sance. But Ford, who had years of expe­ri­ence in nuclear non­pro­lif­er­a­tion, had long been a Chi­na hawk. Ford told Van­i­ty Fair that he saw his job as pro­tect­ing the integri­ty of any inquiry into COVID-19’s ori­gins that fell under his purview. Going with “stuff that makes us look like the crack­pot brigade” would back­fire, he believed.

There was anoth­er rea­son for his hos­til­i­ty. He’d already heard about the inves­ti­ga­tion from inter­a­gency col­leagues, rather than from the team itself, and the secre­cy left him with a “spidey sense” that the process was a form of “creepy free­lanc­ing.” He won­dered: Had some­one launched an unac­count­able inves­ti­ga­tion with the goal of achiev­ing a desired result?

He was not the only one with con­cerns. As one senior gov­ern­ment offi­cial with knowl­edge of the State Department’s inves­ti­ga­tion said, “They were writ­ing this for cer­tain cus­tomers in the Trump admin­is­tra­tion. We asked for the report­ing behind the state­ments that were made. It took for­ev­er. Then you’d read the report, it would have this ref­er­ence to a tweet and a date. It was not some­thing you could go back and find.”

After lis­ten­ing to the inves­ti­ga­tors’ find­ings, a tech­ni­cal expert in one of the State Department’s bioweapons offices “thought they were bonkers,” Ford recalled.

The State Depart­ment team, for its part, believed that Ford was the one try­ing to impose a pre­con­ceived con­clu­sion: that COVID-19 had a nat­ur­al ori­gin. A week lat­er, one of them attend­ed the meet­ing where Christo­pher Park, who worked under Ford, advised those present not to draw atten­tion to U.S. fund­ing of gain-of-func­tion research. . . .

. . . . The state­ment with­stood “aggres­sive sus­pi­cion,” as one for­mer State Depart­ment offi­cial said, and the Biden admin­is­tra­tion has not walked it back. “I was very pleased to see Pompeo’s state­ment come through,” said Chris Ford, who per­son­al­ly signed off on a draft of the fact sheet before leav­ing the State Depart­ment. “I was so relieved that they were using real report­ing that had been vet­ted and cleared.” . . . .

Inside the U.S. gov­ern­ment, mean­while, the lab-leak hypoth­e­sis had sur­vived the tran­si­tion from Trump to Biden. On April 15, Direc­tor of Nation­al Intel­li­gence Avril Haines told the House Intel­li­gence Com­mit­tee that two “plau­si­ble the­o­ries” were being weighed: a lab acci­dent or nat­ur­al emer­gence. . . .

. . . . Chi­na obvi­ous­ly bears respon­si­bil­i­ty for stonewalling inves­ti­ga­tors. Whether it did so out of sheer author­i­tar­i­an habit or because it had a lab leak to hide is, and may always be, unknown.

The Unit­ed States deserves a healthy share of blame as well. Thanks to their unprece­dent­ed track record of men­dac­i­ty and race-bait­ing, Trump and his allies had less than zero cred­i­bil­i­ty. And the prac­tice of fund­ing risky research via cutouts like Eco­Health Alliance enmeshed lead­ing virol­o­gists in con­flicts of inter­est at the exact moment their exper­tise was most des­per­ate­ly need­ed.

4. We con­clude with two impor­tant points from an arti­cle used ear­li­er in the pro­gram.

  1. Shi Zhengli has not­ed that open­ing up the WIV’s records is unac­cept­able: ” . . . . That demand is ‘def­i­nite­ly not accept­able,’ respond­ed Shi Zhengli, who directs the Cen­ter for Emerg­ing Infec­tious Dis­eases at the Wuhan Insti­tute. ‘Who can pro­vide evi­dence that does not exist?’ she told MIT Tech­nol­o­gy Review. Shi has said that thou­sands of attempts to hack its com­put­er sys­tems forced the insti­tute to close its data­base. . . .”
  2. The U.S. would not be accept­able to such a propo­si­tion, if the Chi­nese demand­ed access to Ft. Det­rick (part of which was shut down by the CDC in ear­ly August of 2019 on the eve of the pan­dem­ic). A com­menter also not­ed the Rocky Moun­tain lab in his analy­sis, which we not­ed was one of the areas where Willy Burgdor­fer appears to have worked on the devel­op­ment of Lyme Dis­ease. ” . . . . If a dis­ease had emerged from the U.S. and the Chi­nese blamed the Pen­ta­gon and demand­ed access to the data, ‘what would we say?’ [Dr. Ger­ald] Keusch asked. ‘Would we throw out the red car­pet, ‘Come on over to Fort Det­rick and the Rocky Moun­tain Lab?’ We’d have done exact­ly what the Chi­nese did, which is say, ‘Screw you!’’ . . . .”

“To the Bat Cave: In Search of Covid’s Ori­gins, Sci­en­tists Reignite Polar­iz­ing Debate on Wuhan ‘Lab        Leak’” by Arthur Allen; KHN; 05/19/2021

. . . . The more than $50 mil­lion Eco­Health Alliance had received in U.S. fund­ing since 2007 includes con­tracts and grants from two NIH insti­tutes, the Nation­al Sci­ence Foun­da­tion and the U.S. Agency for Inter­na­tion­al Devel­op­ment, as well as Pen­ta­gon funds to look for organ­isms that could be fash­ioned into bioter­ror weapons. . . .

On Fri­day, 18 virus and immunol­o­gy experts pub­lished a let­ter in the jour­nal Sci­ence demand­ing a deep­er dive. “The­o­ries of acci­den­tal release from a lab and zoonot­ic spillover both remain viable,” they said, adding that the Wuhan Insti­tute should open its records. One of the sig­na­to­ries was a North Car­oli­na virol­o­gist who has worked direct­ly with the Wuhan Institute’s top sci­en­tists.

. . . . That demand is “def­i­nite­ly not accept­able,” respond­ed Shi Zhengli, who directs the Cen­ter for Emerg­ing Infec­tious Dis­eases at the Wuhan Insti­tute. “Who can pro­vide evi­dence that does not exist?” she told MIT Tech­nol­o­gy Review. Shi has said that thou­sands of attempts to hack its com­put­er sys­tems forced the insti­tute to close its data­base. . . .

. . . . Scal­ing the Wall of Secre­cy

U.S.-China ten­sions will make it very dif­fi­cult to con­clude any such study, sci­en­tists on both sides of the issue sug­gest. With their anti-Chi­na rhetoric, Trump and his aides “could not have made it more dif­fi­cult to get coop­er­a­tion,” said Dr. Ger­ald Keusch, asso­ciate direc­tor of the Nation­al Emerg­ing Infec­tious Dis­eases Lab­o­ra­to­ry Insti­tute at Boston Uni­ver­si­ty. If a dis­ease had emerged from the U.S. and the Chi­nese blamed the Pen­ta­gon and demand­ed access to the data, “what would we say?” Keusch asked. “Would we throw out the red car­pet, ‘Come on over to Fort Det­rick and the Rocky Moun­tain Lab?’ We’d have done exact­ly what the Chi­nese did, which is say, ‘Screw you!’”

Discussion

10 comments for “FTR#1189 The Oswald Institute of Virology, Part 8: Covid-19 and The American Deep State, Part 2 (The Cover-Up Obviates the Conspiracy)”

  1. As usu­al, bril­liant research, com­men­tary and analy­sis — Dave Emory is a nation­al trea­sure

    Posted by ALAN Kernoff | June 19, 2021, 10:57 am
  2. Thanks so much for the kind words!

    Posted by Dave Emory | June 19, 2021, 6:00 pm
  3. Here’s a sto­ry with intrigu­ing impli­ca­tions: Peter Daszak just recused him­self from the Lancet’s inquiry into the ori­gins of the coro­n­avirus pan­dem­ic. While there’s no short­age of rea­sons for why Daszak should have recused him­self and nev­er been on the com­mis­sion in the first place, no rea­son for the recusal was giv­en. The com­mis­sion web­site sim­ply states that Daszak has recused him­self.

    So was this move a gen­uine attempt at avoid a con­flict of inter­est? Or was this mere­ly intend­ed to avoid the appear­ance of a con­flict of inter­est? Well, as we’re also going to see, the Lancet has also updat­ed the con­flict-of-inter­est state­ments that were pub­lished in the Feb 2020 let­ter pub­lished in the Lancet by Daszak and numer­ous oth­er top virol­o­gist dis­miss­ing the pos­si­bil­i­ty of a lab leak. So it isn’t just Daszak doing the retroac­tive recus­ing here:

    The Tele­graph

    UK sci­en­tist at cen­tre of debate over ori­gin of Covid pan­dem­ic ‘recus­es him­self’ from inquiry

    Dr Peter Daszak has left inves­ti­ga­tion into coro­n­avirus emer­gence after con­cerns raised over links with Chi­nese lab­o­ra­to­ry

    By Anne Gul­land, Glob­al Health Secu­ri­ty Deputy Edi­tor
    22 June 2021 • 12:55pm

    A British-born sci­en­tist who was part of the World Health Organ­i­sa­tion team inves­ti­gat­ing the ori­gins of the pan­dem­ic has been recused from an inquiry led by a lead­ing med­ical jour­nal into how Covid emerged.

    Dr Peter Daszak, pres­i­dent of the US-based Eco­Health Alliance, has “recused him­self” from the Lancet com­mis­sion into the ori­gins of the pan­dem­ic after con­cerns were raised over his links with the Wuhan Insti­tute of Virol­o­gy — the organ­i­sa­tion con­duct­ing research into bat virus­es in the city where the pan­dem­ic first emerged.

    On the commission’s web­site it states that Dr Daszak has “recused him­self from Com­mis­sion work on the ori­gins of the pan­dem­icbut gives no fur­ther infor­ma­tion.

    The debate into how the virus has emerged has grown increas­ing­ly fraught, with some say­ing the “lab leak the­o­ry” was dis­missed by the sci­en­tif­ic com­mu­ni­ty too ear­ly on. Last month US pres­i­dent Joe Biden ordered US intel­li­gence agen­cies to “redou­ble” efforts to inves­ti­gate the pan­demic’s ori­gins, includ­ing the the­o­ry it came from the lab.

    In Feb­ru­ary 2020 Dr Daszak, who has strong­ly con­demned any sug­ges­tion that the virus came from the insti­tute, co-authored a let­ter pub­lished in the Lancet with 26 oth­er experts “in sup­port of sci­en­tists, pub­lic health pro­fes­sion­als and med­ical pro­fes­sion­als com­bat­ing Covid-19 in Chi­na”.

    The let­ter stat­ed: “The rapid, open, and trans­par­ent shar­ing of data on this out­break is now being threat­ened by rumours and mis­in­for­ma­tion around its ori­gins. We stand togeth­er to strong­ly con­demn con­spir­a­cy the­o­ries sug­gest­ing that Covid-19 does not have a nat­ur­al ori­gin.”

    At the time of the let­ter the authors declared no com­pet­ing inter­ests but in a state­ment pub­lished on its web­site on Mon­day the Lancet said: “Some read­ers have ques­tioned the valid­i­ty of this dis­clo­sure, par­tic­u­lar­ly as it relates to one of the authors, Peter Daszak.”

    Dr Daszak has worked close­ly with Shi Zhengli, known as “bat­woman”, who leads work into bat virus­es at the insti­tute. And the Eco­Health Alliance, which has been a world leader in the hunt for ani­mal virus­es, has chan­neled some of its fund­ing towards the insti­tute, which involved col­lect­ing sam­ples from bats and peo­ple at risk of infec­tion from bat virus­es.

    That grant was stopped in April 2020 on the orders of then pres­i­dent Don­ald Trump but was rein­stat­ed lat­er in the year.

    In his updat­ed state­ment of com­pet­ing inter­ests Dr Daszak says his organ­i­sa­tion col­lab­o­rates with a range of uni­ver­si­ties and gov­ern­men­tal health and envi­ron­men­tal sci­ence organ­i­sa­tions in Chi­na.

    He says that nei­ther the Eco­Health Alliance nor he per­son­al­ly receive fund­ing from the Chi­nese gov­ern­ment.

    Before he recused him­self from the Lancet com­mis­sion, which is sup­port­ed by the Unit­ed Nations Sus­tain­able Devel­op­ment Solu­tions Net­work, Dr Daszak was one of a 12-strong inter­na­tion­al team look­ing at the ori­gins of the pan­dem­ic and how future out­breaks could be pre­vent­ed.

    In a doc­u­ment set­ting out its terms of ref­er­ence the team said it would look at mul­ti­ple hypothe­ses into the ori­gins, includ­ing whether the virus was bio­engi­neered in the Wuhan lab or whether it escaped acci­den­tal­ly.

    Ear­li­er this year, Dr Daszak vis­it­ed Chi­na as part of the joint WHO-Chi­na inves­ti­ga­tion into how the coro­n­avirus emerged. That inves­ti­ga­tion con­clud­ed that while a lab­o­ra­to­ry leak was a pos­si­bil­i­ty it was extreme­ly unlike­ly and the virus was most like­ly to have been passed from bats via an “inter­me­di­ate ani­mal host” to humans before spark­ing an “explo­sive out­break” in Wuhan.

    How­ev­er, WHO direc­tor gen­er­al Dr Tedros Adhanom Ghe­breye­sus said all the­o­ries remained on the table and called for fur­ther inves­ti­ga­tion. These plans are still being drawn up.

    ...

    ————–

    “UK sci­en­tist at cen­tre of debate over ori­gin of Covid pan­dem­ic ‘recus­es him­self’ from inquiry” by Anne Gul­land; The Tele­graph; 06/22/2021

    “On the commission’s web­site it states that Dr Daszak has “recused him­self from Com­mis­sion work on the ori­gins of the pan­dem­icbut gives no fur­ther infor­ma­tion.

    The com­mis­sion does­n’t tell us why Daszak recused him­self. But it’s not exact­ly a mys­tery. Espe­cial­ly when the Lancet simul­ta­ne­ous­ly updates the con­flict-of-inter­est state­ment on the Feb­ru­ary 2020 let­ter pub­lished in the Lancet where Daszak and oth­ers dis­missed the pos­si­bil­i­ty of a lab leak:

    ...
    In Feb­ru­ary 2020 Dr Daszak, who has strong­ly con­demned any sug­ges­tion that the virus came from the insti­tute, co-authored a let­ter pub­lished in the Lancet with 26 oth­er experts “in sup­port of sci­en­tists, pub­lic health pro­fes­sion­als and med­ical pro­fes­sion­als com­bat­ing Covid-19 in Chi­na”.

    The let­ter stat­ed: “The rapid, open, and trans­par­ent shar­ing of data on this out­break is now being threat­ened by rumours and mis­in­for­ma­tion around its ori­gins. We stand togeth­er to strong­ly con­demn con­spir­a­cy the­o­ries sug­gest­ing that Covid-19 does not have a nat­ur­al ori­gin.”

    At the time of the let­ter the authors declared no com­pet­ing inter­ests but in a state­ment pub­lished on its web­site on Mon­day the Lancet said: “Some read­ers have ques­tioned the valid­i­ty of this dis­clo­sure, par­tic­u­lar­ly as it relates to one of the authors, Peter Daszak.”
    ...

    Now here’s an excerpt with a bit more on what the Lancet pub­lished with this updat­ed con­flict-of-inter­est dis­clo­sure for that Feb­ru­ary 2020 let­ter. While the updat­ed state­ment on Dasza­k’s con­flicts-of-inter­est don’t explic­it­ly men­tion the Wuhan Insti­tute of Virol­o­gy, it does point out that the Eco­Health Alliance worked in Chi­na “assess­ing the risk of viral spillover across the wildlife-live­stock-human inter­face, and includes behav­iour­al and sero­log­i­cal sur­veys of peo­ple, and eco­log­i­cal and viro­log­i­cal analy­ses of ani­mals” and that this work involved “the pro­duc­tion of a small num­ber of recom­bi­nant bat coro­n­avirus­es to analyse cell entry and oth­er char­ac­ter­is­tics of bat coro­n­avirus­es for which only the genet­ic sequences are avail­able.” So Dasza­k’s con­flict-of-inter­est state­ment was updat­ed to include his orga­ni­za­tion’s work cre­at­ing recom­bi­nant bat coro­n­avirus­es in part­ner­ship with Chi­nese researchers, which is a pret­ty big update to a con­flict-of-inter­est state­ment for a let­ter dis­miss­ing the pos­si­bil­i­ty of a lab leak:

    Times High­er Edu­ca­tion

    Under-fire Lancet admits con­flict of inter­est on lab-leak let­ter
    After crit­i­cism that it failed to declare Peter Daszak’s work with the Wuhan Insti­tute of Virol­o­gy, jour­nal has also ‘recused’ zool­o­gist from its coro­n­avirus ori­gins task­force

    David Matthews
    June 22, 2021

    The Lancet has added a com­pet­ing inter­ests state­ment to a now infa­mous let­ter pub­lished in Feb­ru­ary 2020 that crit­ics argue sti­fled ear­ly debate about the ori­gins of coro­n­avirus with­out suf­fi­cient inves­ti­ga­tion or evi­dence.

    The let­ter, organ­ised and signed by the British zool­o­gist Peter Daszak, con­demned “con­spir­a­cy the­o­ries sug­gest­ing that Covid-19 does not have a nat­ur­al ori­gin”, seem­ing­ly rul­ing out the prospect of a lab leak right at the begin­ning of the pan­dem­ic.

    But the lab leak the­o­ry, once pushed to the mar­gins of main­stream dis­course, is now seri­ous­ly enter­tained by a num­ber of lead­ing sci­en­tists, although defin­i­tive proof of any one expla­na­tion is still lack­ing.

    Crit­i­cism of The Lancet has focused on its fail­ure to declare in the orig­i­nal let­ter that Dr Daszak had for years fund­ed and worked with the lab at the cen­tre of the leak the­o­ry – the Wuhan Insti­tute of Virol­o­gy. This link, in the eyes of crit­ics, could make Dr Daszak par­tial­ly cul­pa­ble if the lab leak hypoth­e­sis was true.

    Instead, the 27 let­ter sig­na­to­ries declared at the time that they had “no com­pet­ing inter­ests”.

    Now, the jour­nal has added an adden­dum to the let­ter, acknowl­edg­ing that “some read­ers have ques­tioned the valid­i­ty of this dis­clo­sure, par­tic­u­lar­ly as it relates to one of the authors, Peter Daszak”.

    “There may be dif­fer­ences in opin­ion as to what con­sti­tutes a com­pet­ing inter­est,” an expla­na­tion from the jour­nal says. “Trans­par­ent report­ing allows read­ers to make judge­ments about these inter­ests. Read­ers, in turn, have their own inter­ests that could influ­ence their eval­u­a­tion of the work in ques­tion. With these facts in mind, The Lancet invit­ed the 27 authors of the let­ter to re-eval­u­ate their com­pet­ing inter­ests.”

    The jour­nal then pub­lish­es a lengthy com­pet­ing inter­est state­ment about Dr Daszak, which does not explic­it­ly men­tion his work with the Wuhan Insti­tute of Virol­o­gy.

    But it does acknowl­edge that the Eco­Health Alliance, the research fun­der that Dr Daszak leads, worked in Chi­na “assess­ing the risk of viral spillover across the wildlife-live­stock-human inter­face, and includes behav­iour­al and sero­log­i­cal sur­veys of peo­ple, and eco­log­i­cal and viro­log­i­cal analy­ses of ani­mals”.

    “This work includes the iden­ti­fi­ca­tion of viral sequences in bat sam­ples, and has result­ed in the iso­la­tion of three bat Sars-relat­ed coro­n­avirus­es that are now used as reagents to test ther­a­peu­tics and vac­cines,” the dis­clo­sure says. “It also includes the pro­duc­tion of a small num­ber of recom­bi­nant bat coro­n­avirus­es to analyse cell entry and oth­er char­ac­ter­is­tics of bat coro­n­avirus­es for which only the genet­ic sequences are avail­able.”

    ...

    “Too lit­tle too late,” tweet­ed Ali­na Chan, a mol­e­c­u­lar biol­o­gist at the Broad Insti­tute of MIT and Har­vard.

    Dr Daszak has also been “recused” from the journal’s team of experts inves­ti­gat­ing the ori­gins of the pan­dem­ic, it emerged. Ear­li­er this month, he was chair of the body.

    ————

    “Under-fire Lancet admits con­flict of inter­est on lab-leak let­ter” by David Matthews; Times High­er Edu­ca­tion; 06/22/2021

    “Crit­i­cism of The Lancet has focused on its fail­ure to declare in the orig­i­nal let­ter that Dr Daszak had for years fund­ed and worked with the lab at the cen­tre of the leak the­o­ry – the Wuhan Insti­tute of Virol­o­gy. This link, in the eyes of crit­ics, could make Dr Daszak par­tial­ly cul­pa­ble if the lab leak hypoth­e­sis was true.

    Yeah, it’s about as big a con­flict as you could get with a con­flict-of-inter­est state­ment on a lab leak the­o­ry: if it turns out the the­o­ry is true, the peo­ple assert­ing it can’t pos­si­bly be true — and yet are engaged in recom­bi­nant viral work with bat coro­n­avirus­es — could them­selves be par­tial­ly cul­pa­ble:

    ...
    Now, the jour­nal has added an adden­dum to the let­ter, acknowl­edg­ing that “some read­ers have ques­tioned the valid­i­ty of this dis­clo­sure, par­tic­u­lar­ly as it relates to one of the authors, Peter Daszak”.

    “There may be dif­fer­ences in opin­ion as to what con­sti­tutes a com­pet­ing inter­est,” an expla­na­tion from the jour­nal says. “Trans­par­ent report­ing allows read­ers to make judge­ments about these inter­ests. Read­ers, in turn, have their own inter­ests that could influ­ence their eval­u­a­tion of the work in ques­tion. With these facts in mind, The Lancet invit­ed the 27 authors of the let­ter to re-eval­u­ate their com­pet­ing inter­ests.”

    The jour­nal then pub­lish­es a lengthy com­pet­ing inter­est state­ment about Dr Daszak, which does not explic­it­ly men­tion his work with the Wuhan Insti­tute of Virol­o­gy.

    But it does acknowl­edge that the Eco­Health Alliance, the research fun­der that Dr Daszak leads, worked in Chi­na “assess­ing the risk of viral spillover across the wildlife-live­stock-human inter­face, and includes behav­iour­al and sero­log­i­cal sur­veys of peo­ple, and eco­log­i­cal and viro­log­i­cal analy­ses of ani­mals”.

    “This work includes the iden­ti­fi­ca­tion of viral sequences in bat sam­ples, and has result­ed in the iso­la­tion of three bat Sars-relat­ed coro­n­avirus­es that are now used as reagents to test ther­a­peu­tics and vac­cines,” the dis­clo­sure says. “It also includes the pro­duc­tion of a small num­ber of recom­bi­nant bat coro­n­avirus­es to analyse cell entry and oth­er char­ac­ter­is­tics of bat coro­n­avirus­es for which only the genet­ic sequences are avail­able.”
    ...

    So we’ll see what, if any, impact the recusal of Daszak from the Lancet com­mis­sion on the ori­gins of the virus actu­al­ly has on that com­mis­sion’s work. On the one hand, it’s not hard to cyn­i­cal­ly view this move as an attempt to pre­emp­tive­ly address crit­i­cisms for the con­clu­sion by the com­mis­sion of a nat­ur­al ori­gin. On the oth­er hand, that’s quite an update to Dasza­k’s con­flict-of-inter­est state­ment that includ­ed the Eco­Health Alliance’s work on recom­bi­nant bat coro­n­avirus work. But on the oth­er oth­er hand, it was an update that was basi­cal­ly irrefutable and unavoid­able. Inter­pret­ing the belat­ed acknowl­edge­ment of the irrefutable can be a tricky task.

    Posted by Pterrafractyl | June 23, 2021, 3:38 pm
  4. With the annu­al Davos meet­ing of glob­al elites cur­rent­ly under­way we’re get­ting our expect­ed del­uge of updates on all the dif­fer­ent things that are being dis­cussed at the con­fer­ence. And that brings us to a tru­ly chill­ing three para­graph report on one of the top­ics dis­cussed. Accord­ing to Anna van Pouke, the head 0f glob­al health care at KPMG, there’s a new threat to civ­i­liza­tion even larg­er than nuclear weapons. Although it’s not exact­ly a new threat: the threat of hack­ers manip­u­lat­ing the genom­ic exper­i­ments tak­ing place inside research lab. A nuclear bomb is “noth­ing” com­pared to the threat posed by this genom­ic research lab hack­ing, accord­ing to van Pouke.

    And that’s more or less all we know about van Pouke’s warn­ings at Davos. Cyber­se­cu­ri­ty at biore­search facil­i­ties should be a top pri­or­i­ty. But the sce­nario von Pouke is describ­ing does at least sound tech­ni­cal­ly plau­si­ble in the era of made-to-order virus­es and oth­er snip­pets of DNA and RNA: if the genom­ic sequences being gen­er­at­ed for research pur­pos­es are spec­i­fied in the soft­ware run­ning the genom­ic syn­the­sis equip­ment, there’s noth­ing the­o­ret­i­cal­ly stop­ping a hack­er from insert­ing the genom­ic sequences of high­ly dan­ger­ous virus­es in place of the intend­ed sequence. Heck, some­one could trick a lab into recre­at­ing small pox if they so intend­ed.

    Also don’t for­get the oth­er major con­text of this warn­ing: the fact that just about every sin­gle major com­pa­ny on the plan­et has had their net­works pen­e­trat­ed in Solar­Winds and/or Microsoft Exchange Mega-hacks of 2021. The notion that hack­ers have access to the direct com­put­er net­works run­ning these facil­i­ties is far from fan­ci­ful. On the con­trary, it’s a safe bet bio­log­i­cal research and pro­duc­tion facil­i­ties around the world are indeed thor­ough hacked at this point.

    That’s the con­text of this warn­ing: it simul­ta­ne­ous­ly seemed kind of out of the blue, but also very nec­es­sary. So while this part of the Davos report was just three para­graphs, they were some extreme­ly omi­nous para­graphs:

    Bloomberg News

    Ukraine Says Rus­sia Peace Talks Going ‘Nowhere’: Davos Update

    May 25, 2022, 1:16 AM CDT
    Updat­ed on May 25, 2022, 11:24 AM CDT

    Ukraine For­eign Min­is­ter Dmytro Kule­ba said peace nego­ti­a­tions with Rus­sia are going “nowhere” and com­pared Moscow’s offen­sive in the east­ern Don­bas region to a World War II bat­tle.

    “Tanks, artillery, com­bat heli­copters, air attacks, mul­ti­ple-launch rock­et sys­tems, every­thing is involved,” Kule­ba said dur­ing a Q&A at the World Eco­nom­ic Forum in Davos. “When you are con­duct­ing an oper­a­tion like this you basi­cal­ly say no to nego­ti­a­tions.”

    The con­flict in Ukraine has over­shad­owed the first in-per­son Davos meet­ing in two years. Surg­ing infla­tion, food short­ages, cli­mate change and migra­tion risks have also been high on the agen­da, prompt­ing a series of dire warn­ings about threats to the glob­al eco­nom­ic out­look.

    On the final day of the meet­ing on Thurs­day, Ger­man Chan­cel­lor Olaf Scholz deliv­ers a speech and Iran’s For­eign Min­is­ter Hos­sein Amir-Abdol­lahi­an takes part in a one-on-one dis­cus­sion. Bloomberg TV has inter­views with the Unit­ed Arab Emi­rates’ trade min­is­ter and chief exec­u­tive offi­cers from Rio Tin­to Plc, Fideli­ty Inter­na­tion­al and Mod­er­na Inc.

    ...

    Genome Manip­u­la­tion ‘New Nuclear Threat’ (12 p.m.)

    Bioter­ror­ists using cyber attacks to tar­get nation­al genome projects pose a big­ger threat than a nuclear strike, the glob­al head of health­care at KPMG LLP has warned. Were mali­cious hack­ers able to infil­trate gene edit­ing exper­i­ments and manip­u­late a virus, the con­se­quences would be worse than the Covid-19 pan­dem­ic, KPMG International’s Anna van Pouke said in an inter­view.

    “Imag­ine that there is some­one who finds out how to manip­u­late a genome,” she said. “We had a mutat­ed virus. We don’t know where it mutat­ed, whether it was in a mar­ket or a research lab in Chi­na, but you know what it did to the world,” she said.

    “Just imag­ine if we have sev­er­al cas­es even more severe than that because of genome manip­u­la­tion in med­ica­tion, com­ing from a lab,” van Pouke said. “If some­one hacks the genome project with mali­cious inten­tions — a nuclear bomb is noth­ing com­pared to that. We need to have cyber secu­ri­ty work­ing very hard.”

    ...

    ———–

    “Ukraine Says Rus­sia Peace Talks Going ‘Nowhere’: Davos Update”; Bloomberg News; 05/25/2022

    ““Just imag­ine if we have sev­er­al cas­es even more severe than that because of genome manip­u­la­tion in med­ica­tion, com­ing from a lab,” van Pouke said. “If some­one hacks the genome project with mali­cious inten­tions — a nuclear bomb is noth­ing com­pared to that. We need to have cyber secu­ri­ty work­ing very hard.””

    Keep in mind one of the obvi­ous appli­ca­tions of these warn­ings: if indeed a nov­el virus is dis­cov­ered to have been leaked from a lab, they can poten­tial­ly claim they were hacked! They did­n’t actu­al­ly intend on cre­at­ing those virus­es that escaped from the lab. The mali­cious hack­ers did it, fram­ing this inno­cent lab! And yes, such a sce­nario lab-hack might tech­ni­cal­ly be plau­si­ble for cer­tain kinds of research, but it’s sure hard not to notice now this dou­bles as a won­der­ful catch all excuse to deflect blame from a gen­uine lab leak.

    But giv­en that we’re now in an era of mRNA vac­cines — with mRNA ther­a­peu­tics pre­sum­ably on the way after the vac­cines have been deemed safe enough for rou­tine use — it’s also impor­tant to real­ize that if we’re talk­ing about dis­as­ter sce­nar­ios involv­ing the hack­ing of equip­ment where genom­ic sequences are gen­er­at­ed, the poten­tial risks don’t just involve hack­ers hit­ting research facil­i­ties or the release of new con­ta­gious virus­es. Imag­ine hack­ers affect­ing the con­tent of mRNA vac­cines. The mRNA vac­cines the US gov­ern­ment is push­ing on vir­tu­al­ly every­one in the US at the moment now that the gov­ern­ment has warned the pub­lic away from tak­ing the non-mRNA J&J vac­cine for high­ly ques­tion­able rea­sons. Imag­ine the machines cre­at­ing those batch­es get­ting hacked. Beyond the imme­di­ate poten­tial to cause seri­ous dis­ease, don’t for­get that mRNA can poten­tial­ly be used to deliv­er per­ma­nent changes into the genome via the use of CRISPR tech­nol­o­gy. In oth­er words, while you could hack the mRNA vac­cine sup­ply to effec­tive­ly kill off large num­bers of peo­ple or cause seri­ous dis­ease, you could also use it to qui­et­ly intro­duce per­ma­nent genet­ic alter­na­tions in large swathes of the a pop­u­la­tion. Alter­ations no one nec­es­sar­i­ly has to ever dis­cov­er. And alter­na­tions that could poten­tial­ly be tar­get­ed at spe­cif­ic pop­u­la­tions if its known where the vac­cine batch­es are going to be sent.

    So let’s hope the issue of cyber­se­cu­ri­ty in bio­log­i­cal facil­i­ties is indeed being tak­en very seri­ous­ly. There real­ly is abun­dant rea­son for gen­uine con­cern about this kind of sce­nario. But at this point we had also bet­ter hope that this warn­ing at Davos was­n’t the kind of vague warn­ing about secu­ri­ty con­cerns com­pa­nies ini­tial­ly send out to cush­ion the blow when they even­tu­al­ly dis­close all their cus­tomer accounts were hacked.

    Posted by Pterrafractyl | May 25, 2022, 2:15 pm
  5. Well that was great to hear. From a rather inter­est­ing source: A call for a new inde­pen­dent inquiry into the ori­gins of the SARS-CoV­‑2 virus was pub­lished last week in the Pro­ceed­ings of the Nation­al Acad­e­my of Sci­ences (PNAS). The piece suc­cinct­ly but effec­tive­ly lays out the estab­lished rela­tion­ships between the Wuhan Insti­tute of Virol­o­gy (WIV) and its many US-based col­lab­o­ra­tors — the Eco­Health Alliance (EHA), Ralph Bar­ic’s lab at the Uni­ver­si­ty of North Car­oli­na Chapel Hill (UNC), the Uni­ver­si­ty of Cal­i­for­nia at Davis (UCD), the NIH, the Defense Threat Reduc­tion Agency (DTRA), and USAID — and makes the sim­ple obser­va­tion that there’s been no indi­ca­tion at all that the US intel­li­gence com­mu­ni­ty’s pri­or inves­ti­ga­tions into the ori­gins of the virus have seri­ous­ly con­sid­ered the pos­si­bil­i­ty that the virus emerged on the US side of this years long inter­na­tion­al col­lab­o­ra­tion.

    The piece calls for the release of all rel­e­vant mate­ri­als — lab man­u­als, emails, etc — from these US col­lab­o­ra­tors to inde­pen­dent inves­ti­ga­tors for a real inde­pen­dent inves­ti­ga­tion. They go on to sug­gest a tight­ly focused sci­ence-based bipar­ti­san Con­gres­sion­al inquiry with full inves­tiga­tive pow­ers as an exam­ple of the kind of body that could car­ry it out.

    The piece also points out a now leaked 2018 grant pro­pos­al sub­mit­ted to DARPA by this col­lab­o­ra­tion that would have involved putting new furin cleav­age sites (FCSs) in coro­n­avirus­es. DARPA claims it did­n’t fund the grant, but it cer­tain­ly shows intent and abil­i­ty.

    The piece also reminds us of how SARS-CoV­‑2 is the only known virus in the beta­coro­n­avirus sub­fam­i­ly, which has long been one of the more sus­pi­cious coin­ci­dences that the zoonot­ic the­o­ry of ori­gin relies on. Also recall how Mod­er­na filed a patent in Feb­ru­ary of 2020 for a uni­ver­sal beta­coro­n­avirus vac­cine that in the­o­ry could cov­er all oth­er coro­n­avirus­es oth­er than SARS-CoV­‑2. So when we learn about that 2018 DARPA grant pro­pos­al by this inter­na­tion­al col­lab­o­ra­tion to insert dif­fer­ent FCSs into coro­n­avirus­es, it’s worth ask­ing if any of that ulti­mate­ly went into Mod­er­na’s pre-COVID-19 beta­coro­n­avirus vac­cine research.

    Here’s the some­what sur­pris­ing, but not actu­al­ly all that sur­pris­ing part: it’s writ­ten by two pro­fes­sors from Colom­bia Uni­ver­si­ty. Niel L. Har­ri­son and Jef­frey D. Sachs. Yep, Jef­frey Sachs is one of the authors of this damn­ing piece call­ing for the mas­sive release of infor­ma­tion on the US’s coro­n­avirus research efforts for inde­pen­dent inves­ti­ga­tors.

    On one lev­el, this isn’t at all sur­pris­ing to see Sachs author­ing this. Recall how Sachs was tasked with lead­ing the Lancet’s inves­ti­ga­tion into the ori­gins of the pan­dem­ic and end­ed up lit­er­al­ly dis­band­ing it over the mas­sive con­flicts of inter­est it demon­strat­ed in appoint­ing Peter Daszak of the Eco­Health Alliance to join him on the inves­tiga­tive com­mis­sion. If he was will­ing to dis­band the Lancet’s inves­ti­ga­tion it’s all that sur­pris­ing to see this let­ter pub­lished.

    Still, it’s pret­ty remark­able just how damn­ing this piece is giv­en that Sachs is some­one in a posi­tion to bring real pub­lic atten­tion to this top­ic. They real­ly do make a com­pelling case for an inde­pen­dent inves­ti­ga­tion, and who is in a bet­ter posi­tion than Sachs to make this case pub­licly after he dis­band­ed his Lancet Com­mis­sion over these kinds of con­cerns? That’s all part of what is going to make this a sto­ry to watch. This has been a grow­ing unde­ni­able scan­dal just sit­ting out there wait­ing for some­one to draw atten­tion to it, and Sachs appears to try­ing to do exact­ly that:

    PNAS

    A call for an inde­pen­dent inquiry into the ori­gin of the SARS-CoV­‑2 virus

    Neil L. Har­ri­son and Jef­frey D. Sachs
    May 19, 2022
    119 (21) e2202769119
    https://doi.org/10.1073/pnas.2202769119

    Since the iden­ti­fi­ca­tion of the­SARS-CoV­‑2 in Wuhan, Chi­na, in Jan­u­ary 2020 (1), the ori­gin of the virus has been a top­ic of intense sci­en­tif­ic debate and pub­lic spec­u­la­tion. The two main hypothe­ses are that the virus emerged from human expo­sure to an infect­ed ani­mal [“zoono­sis” (2)] or that it emerged in a research-relat­ed inci­dent (3). The inves­ti­ga­tion into the ori­gin of the virus has been made dif­fi­cult by the lack of key evi­dence from the ear­li­est days of the outbreak—there’s no doubt that greater trans­paren­cy on the part of Chi­nese author­i­ties would be enor­mous­ly help­ful. Nev­er­the­less, we argue here that there is much impor­tant infor­ma­tion that can be gleaned from US-based research insti­tu­tions, infor­ma­tion not yet made avail­able for inde­pen­dent, trans­par­ent, and sci­en­tif­ic scruti­ny.

    The data avail­able with­in the Unit­ed States would explic­it­ly include, but are not lim­it­ed to, viral sequences gath­ered and held as part of the PREDICT project and oth­er fund­ed pro­grams, as well as sequenc­ing data and lab­o­ra­to­ry note­books from US lab­o­ra­to­ries. We call on US gov­ern­ment sci­en­tif­ic agen­cies, most notably the NIH, to sup­port a full, inde­pen­dent, and trans­par­ent inves­ti­ga­tion of the ori­gins of SARS-CoV­‑2. This should take place, for exam­ple, with­in a tight­ly focused sci­ence-based bipar­ti­san Con­gres­sion­al inquiry with full inves­tiga­tive pow­ers, which would be able to ask impor­tant questions—but avoid mis­guid­ed witch-hunts gov­erned more by pol­i­tics than by sci­ence.

    Essen­tial US Inves­ti­ga­tions

    The US intel­li­gence com­mu­ni­ty (IC) was tasked, in 2021 by Pres­i­dent Joe Biden (4), with inves­ti­gat­ing the ori­gin of the virus. In their sum­ma­ry pub­lic state­ment, the IC writes that “all agen­cies assess that two hypothe­ses are plau­si­ble: nat­ur­al expo­sure to an infect­ed ani­mal and a lab­o­ra­to­ry-asso­ci­at­ed inci­dent” (4). The IC fur­ther writes that “China’s coop­er­a­tion most like­ly would be need­ed to reach a con­clu­sive assess­ment of the ori­gins of COVID-19 [coro­n­avirus dis­ease 2019].” Of course, such coop­er­a­tion is high­ly war­rant­ed and should be pur­sued by the US Gov­ern­ment and the US sci­en­tif­ic com­mu­ni­ty. Yet, as out­lined below, much could be learned by inves­ti­gat­ing US-sup­port­ed and US-based work that was under­way in col­lab­o­ra­tion with Wuhan-based insti­tu­tions, includ­ing the Wuhan Insti­tute of Virol­o­gy (WIV), Chi­na. It is still not clear whether the IC inves­ti­gat­ed these US-sup­port­ed and US-based activ­i­ties. If it did, it has yet to make any of its find­ings avail­able to the US sci­en­tif­ic com­mu­ni­ty for inde­pen­dent and trans­par­ent analy­sis and assess­ment. If, on the oth­er hand, the IC did not inves­ti­gate these US-sup­port­ed and US-based activ­i­ties, then it has fall­en far short of con­duct­ing a com­pre­hen­sive inves­ti­ga­tion.

    This lack of an inde­pen­dent and trans­par­ent US-based sci­en­tif­ic inves­ti­ga­tion has had four high­ly adverse con­se­quences. First, pub­lic trust in the abil­i­ty of US sci­en­tif­ic insti­tu­tions to gov­ern the activ­i­ties of US sci­ence in a respon­si­ble man­ner has been shak­en. Sec­ond, the inves­ti­ga­tion of the ori­gin of SARS-CoV­‑2 has become politi­cized with­in the US Con­gress (5); as a result, the incep­tion of an inde­pen­dent and trans­par­ent inves­ti­ga­tion has been obstruct­ed and delayed. Third, US researchers with deep knowl­edge of the pos­si­bil­i­ties of a lab­o­ra­to­ry-asso­ci­at­ed inci­dent have not been enabled to share their exper­tise effec­tive­ly. Fourth, the fail­ure of NIH, one of the main fun­ders of the US–China col­lab­o­ra­tive work, to facil­i­tate the inves­ti­ga­tion into the ori­gins of SARS-CoV­‑2 (4) has fos­tered dis­trust regard­ing US biode­fense research activ­i­ties.

    Much of the work on SARS-like CoVs per­formed in Wuhan was part of an active and high­ly col­lab­o­ra­tive US–China sci­en­tif­ic research pro­gram fund­ed by the US Gov­ern­ment (NIH, Defense Threat Reduc­tion Agency [DTRA], and US Agency for Inter­na­tion­al Devel­op­ment [USAID]), coor­di­nat­ed by researchers at Eco­Health Alliance (EHA), but involv­ing researchers at sev­er­al oth­er US insti­tu­tions. For this rea­son, it is impor­tant that US insti­tu­tions be trans­par­ent about any knowl­edge of the detailed activ­i­ties that were under­way in Wuhan and in the Unit­ed States. The evi­dence may also sug­gest that research insti­tu­tions in oth­er coun­tries were involved, and those too should be asked to sub­mit rel­e­vant infor­ma­tion (e.g., with respect to unpub­lished sequences).

    Par­tic­i­pat­ing US insti­tu­tions include the EHA, the Uni­ver­si­ty of North Car­oli­na (UNC), the Uni­ver­si­ty of Cal­i­for­nia at Davis (UCD), the NIH, and the USAID. Under a series of NIH grants and USAID con­tracts, EHA coor­di­nat­ed the col­lec­tion of SARS-like bat CoVs from the field in south­west Chi­na and south­east Asia, the sequenc­ing of these virus­es, the archiv­ing of these sequences (involv­ing UCD), and the analy­sis and manip­u­la­tion of these virus­es (notably at UNC). A broad spec­trum of coro­n­avirus research work was done not only in Wuhan (includ­ing groups at Wuhan Uni­ver­si­ty and the Wuhan CDC, as well as WIV) but also in the Unit­ed States. The exact details of the field­work and lab­o­ra­to­ry work of the EHA-WIV-UNC part­ner­ship, and the engage­ment of oth­er insti­tu­tions in the Unit­ed States and Chi­na, has not been dis­closed for inde­pen­dent analy­sis. The pre­cise nature of the exper­i­ments that were con­duct­ed, includ­ing the full array of virus­es col­lect­ed from the field and the sub­se­quent sequenc­ing and manip­u­la­tion of those virus­es, remains unknown.

    EHA, UNC, NIH, USAID, and oth­er research part­ners have failed to dis­close their activ­i­ties to the US sci­en­tif­ic com­mu­ni­ty and the US pub­lic, instead declar­ing that they were not involved in any exper­i­ments that could have result­ed in the emer­gence of SARS-CoV­‑2. The NIH has specif­i­cal­ly stat­ed (6) that there is a sig­nif­i­cant evo­lu­tion­ary dis­tance between the pub­lished viral sequences and that of SARS-CoV­‑2 and that the pan­dem­ic virus could not have result­ed from the work spon­sored by NIH. Of course, this state­ment is only as good as the lim­it­ed data on which it is based, and ver­i­fi­ca­tion of this claim is depen­dent on gain­ing access to any oth­er unpub­lished viral sequences that are deposit­ed in rel­e­vant US and Chi­nese data­bas­es (7,8). On May 11, 2022, Act­ing NIH Direc­tor Lawrence Tabak tes­ti­fied before Con­gress that sev­er­al such sequences in a US data­base were removed from pub­lic view, and that this was done at the request of both Chi­nese and US inves­ti­ga­tors.

    Blan­ket denials from the NIH are no longer good enough. Although the NIH and USAID have stren­u­ous­ly resist­ed full dis­clo­sure of the details of the EHA-WIV-UNC work pro­gram, sev­er­al doc­u­ments leaked to the pub­lic or released through the Free­dom of Infor­ma­tion Act (FOIA) have raised con­cerns. These research pro­pos­als make clear that the EHA-WIV-UNC col­lab­o­ra­tion was involved in the col­lec­tion of a large num­ber of so-far undoc­u­ment­ed SARS-like virus­es and was engaged in their manip­u­la­tion with­in bio­log­i­cal safe­ty lev­el (BSL)-2 and BSL‑3 lab­o­ra­to­ry facil­i­ties, rais­ing con­cerns that an air­borne virus might have infect­ed a lab­o­ra­to­ry work­er (9). A vari­ety of sce­nar­ios have been dis­cussed by oth­ers, includ­ing an infec­tion that involved a nat­ur­al virus col­lect­ed from the field or per­haps an engi­neered virus manip­u­lat­ed in one of the lab­o­ra­to­ries (3).

    Over­looked Details

    Spe­cial con­cerns sur­round the pres­ence of an unusu­al furin cleav­age site (FCS) in SARS-CoV­‑2 (10) that aug­ments the path­o­genic­i­ty and trans­mis­si­bil­i­ty of the virus rel­a­tive to relat­ed virus­es like SARS-CoV­‑1 (11, 12). SARS-CoV­‑2 is, to date, the only iden­ti­fied mem­ber of the sub­genus sar­be­covirus that con­tains an FCS, although these are present in oth­er coro­n­avirus­es (13, 14). A por­tion of the sequence of the spike pro­tein of some of these virus­es is illus­trat­ed in the align­ment shown in Fig. 1, illus­trat­ing the unusu­al nature of the FCS and its appar­ent inser­tion in SARS-CoV­‑2 (15). From the first weeks after the genome sequence of SARS-CoV­‑2 became avail­able, researchers have com­ment­ed on the unex­pect­ed pres­ence of the FCS with­in SARS-CoV‑2—the impli­ca­tion being that SARS-CoV­‑2 might be a prod­uct of lab­o­ra­to­ry manip­u­la­tion. In a review piece argu­ing against this pos­si­bil­i­ty, it was assert­ed that the amino acid sequence of the FCS in SARS-CoV­‑2 is an unusu­al, non­stan­dard sequence for an FCS and that nobody in a lab­o­ra­to­ry would design such a nov­el FCS (13).

    [see fig­ure]
    Fig. 1.

    In fact, the asser­tion that the FCS in SARS-CoV­‑2 has an unusu­al, non­stan­dard amino acid sequence is false. The amino acid sequence of the FCS in SARS-CoV­‑2 also exists in the human ENaC a sub­unit (16), where it is known to be func­tion­al and has been exten­sive­ly stud­ied (17, 18). The FCS of human ENaC a has the amino acid sequence RRAR’SVAS (Fig. 2), an eight–amino-acid sequence that is per­fect­ly iden­ti­cal with the FCS of SARS-CoV­‑2 (16). ENaC is an epithe­lial sodi­um chan­nel, expressed on the api­cal sur­face of epithe­lial cells in the kid­ney, colon, and air­ways (19, 20), that plays a crit­i­cal role in con­trol­ling flu­id exchange. The ENaC a sub­unit has a func­tion­al FCS (17, 18) that is essen­tial for ion chan­nel func­tion (19) and has been char­ac­ter­ized in a vari­ety of species. The FCS sequence of human ENaC a (20) is iden­ti­cal in chim­panzee, bonobo, orang­utan, and goril­la (SI Appen­dix , Fig. 1), but diverges in all oth­er species, even pri­mates, except one. (The one non-human non-great ape species with the same sequence is Pip­istrel­lus kuh­lii, a bat species found in Europe and West­ern Asia; oth­er bat species, includ­ing Rhi­nolo­phus fer­rume­quinem, have a dif­fer­ent FCS sequence in ENaC a [RKAR’SAAS]).

    [see fig­ure 2]
    Fig. 2.

    One con­se­quence of this “mol­e­c­u­lar mim­ic­ry” between the FCS of SARS CoV‑2 spike and the FCS of human ENaC is com­pe­ti­tion for host furin in the lumen of the Gol­gi appa­ra­tus, where the SARS-CoV­‑2 spike is processed. This results in a decrease in human ENaC expres­sion (21). A decrease in human ENaC expres­sion com­pro­mis­es air­way func­tion and has been impli­cat­ed as a con­tribut­ing fac­tor in the patho­gen­e­sis of COVID-19 (22). Anoth­er con­se­quence of this aston­ish­ing mol­e­c­u­lar mim­ic­ry is evi­denced by appar­ent cross-reac­tiv­i­ty with human ENaC of anti­bod­ies from COVID-19 patients, with the high­est lev­els of cross-react­ing anti­bod­ies direct­ed against this epi­tope being asso­ci­at­ed with most severe dis­ease (23).

    We do not know whether the inser­tion of the FCS was the result of nat­ur­al evo­lu­tion (2, 13)—per­haps via a recom­bi­na­tion event in an inter­me­di­ate mam­mal or a human (13, 24)—or was the result of a delib­er­ate intro­duc­tion of the FCS into a SARS-like virus as part of a lab­o­ra­to­ry exper­i­ment. We do know that the inser­tion of such FCS sequences into SARS-like virus­es was a spe­cif­ic goal of work pro­posed by the EHA-WIV-UNC part­ner­ship with­in a 2018 grant pro­pos­al (“DEFUSE”) that was sub­mit­ted to the US Defense Advanced Research Projects Agency (DARPA) (25). The 2018 pro­pos­al to DARPA was not fund­ed, but we do not know whether some of the pro­posed work was sub­se­quent­ly car­ried out in 2018 or 2019, per­haps using anoth­er source of fund­ing.

    We also know that that this research team would be famil­iar with sev­er­al pre­vi­ous exper­i­ments involv­ing the suc­cess­ful inser­tion of an FCS sequence into SARS-CoV­‑1 (26) and oth­er coro­n­avirus­es, and they had a lot of expe­ri­ence in con­struc­tion of chimeric SARS-like virus­es (2729). In addi­tion, the research team would also have some famil­iar­i­ty with the FCS sequence and the FCS-depen­dent acti­va­tion mech­a­nism of human ENaC a (19), which was exten­sive­ly char­ac­ter­ized at UNC (17, 18). For a research team assess­ing the pan­dem­ic poten­tial of SARS-relat­ed coro­n­avirus­es, the FCS of human ENaC—an FCS known to be effi­cient­ly cleaved by host furin present in the tar­get loca­tion (epithe­lial cells) of an impor­tant tar­get organ (lung), of the tar­get organ­ism (human)—might be a ratio­nal, if not obvi­ous, choice of FCS to intro­duce into a virus to alter its infec­tiv­i­ty, in line with oth­er work per­formed pre­vi­ous­ly.

    Of course, the mol­e­c­u­lar mim­ic­ry of ENaC with­in the SARS-CoV­‑2 spike pro­tein might be a mere coin­ci­dence, although one with a very low prob­a­bil­i­ty. The exact FCS sequence present in SARS-CoV­‑2 has recent­ly been intro­duced into the spike pro­tein of SARS-CoV­‑1 in the lab­o­ra­to­ry, in an ele­gant series of exper­i­ments (12, 30), with pre­dictable con­se­quences in terms of enhanced viral trans­mis­si­bil­i­ty and path­o­genic­i­ty. Obvi­ous­ly, the cre­ation of such SARS‑1/2 “chimeras” is an area of some con­cern for those respon­si­ble for present and future reg­u­la­tion of this area of biol­o­gy. [Note that these exper­i­ments in ref. 30 were done in the con­text of a safe “pseudo­typed” virus and thus posed no dan­ger of pro­duc­ing or releas­ing a nov­el pathogen.] These sim­ple exper­i­ments show that the intro­duc­tion of the 12 nucleotides that con­sti­tute the FCS inser­tion in SARS-CoV­‑2 would not be dif­fi­cult to achieve in a lab. It would there­fore seem rea­son­able to ask that elec­tron­ic com­mu­ni­ca­tions and oth­er rel­e­vant data from US groups should be made avail­able for scruti­ny.

    Seek­ing Trans­paren­cy

    To date, the fed­er­al gov­ern­ment, includ­ing the NIH, has not done enough to pro­mote pub­lic trust and trans­paren­cy in the sci­ence sur­round­ing SARS-CoV­‑2. A steady trick­le of dis­qui­et­ing infor­ma­tion has cast a dark­en­ing cloud over the agency. The NIH could say more about the pos­si­ble role of its grantees in the emer­gence of SARS-CoV­‑2, yet the agency has failed to reveal to the pub­lic the pos­si­bil­i­ty that SARS-CoV­‑2 emerged from a research-asso­ci­at­ed event, even though sev­er­al researchers raised that con­cern on Feb­ru­ary 1, 2020, in a phone con­ver­sa­tion that was doc­u­ment­ed by email (5). Those emails were released to the pub­lic only through FOIA, and they sug­gest that the NIH lead­er­ship took an ear­ly and active role in pro­mot­ing the “zoonot­ic hypoth­e­sis” and the rejec­tion of the lab­o­ra­to­ry-asso­ci­at­ed hypoth­e­sis (5). The NIH has resist­ed the release of impor­tant evi­dence, such as the grant pro­pos­als and project reports of EHA, and has con­tin­ued to redact mate­ri­als released under FOIA, includ­ing a remark­able 290-page redac­tion in a recent FOIA release.

    Infor­ma­tion now held by the research team head­ed by EHA (7), as well as the com­mu­ni­ca­tions of that research team with US research fund­ing agen­cies, includ­ing NIH, USAID, DARPA, DTRA, and the Depart­ment of Home­land Secu­ri­ty, could shed con­sid­er­able light on the exper­i­ments under­tak­en by the US-fund­ed research team and on the pos­si­ble rela­tion­ship, if any, between those exper­i­ments and the emer­gence of SARS-CoV­‑2. We do not assert that lab­o­ra­to­ry manip­u­la­tion was involved in the emer­gence of SARS-CoV­‑2, although it is appar­ent that it could have been. How­ev­er, we do assert that there has been no inde­pen­dent and trans­par­ent sci­en­tif­ic scruti­ny to date of the full scope of the US-based evi­dence.

    The rel­e­vant US-based evi­dence would include the fol­low­ing infor­ma­tion: lab­o­ra­to­ry note­books, virus data­bas­es, elec­tron­ic media (emails, oth­er com­mu­ni­ca­tions), bio­log­i­cal sam­ples, viral sequences gath­ered and held as part of the PREDICT project (7) and oth­er fund­ed pro­grams, and inter­views of the EHA-led research team by inde­pen­dent researchers, togeth­er with a full record of US agency involve­ment in fund­ing the research on SARS-like virus­es, espe­cial­ly with regard to projects in col­lab­o­ra­tion with Wuhan-based insti­tu­tions. We sug­gest that a bipar­ti­san inquiry should also fol­low up on the ten­ta­tive con­clu­sion of the IC (4) that the ini­tial out­break in Wuhan may have occurred no lat­er than Novem­ber 2019 and that there­fore the virus was cir­cu­lat­ing before the clus­ter of known clin­i­cal cas­es in Decem­ber. The IC did not reveal the evi­dence for this state­ment, nor when parts of the US Gov­ern­ment or US-based researchers first became aware of a poten­tial new out­break. Any avail­able infor­ma­tion and knowl­edge of the ear­li­est days of the out­break, includ­ing viral sequences (8), could shed con­sid­er­able light on the ori­gins ques­tion.

    ...

    ———-

    “A call for an inde­pen­dent inquiry into the ori­gin of the SARS-CoV­‑2 virus” by Neil L. Har­ri­son and Jef­frey D. Sachs; PNAS; 05/19/2022

    “The US intel­li­gence com­mu­ni­ty (IC) was tasked, in 2021 by Pres­i­dent Joe Biden (4), with inves­ti­gat­ing the ori­gin of the virus. In their sum­ma­ry pub­lic state­ment, the IC writes that “all agen­cies assess that two hypothe­ses are plau­si­ble: nat­ur­al expo­sure to an infect­ed ani­mal and a lab­o­ra­to­ry-asso­ci­at­ed inci­dent” (4). The IC fur­ther writes that “China’s coop­er­a­tion most like­ly would be need­ed to reach a con­clu­sive assess­ment of the ori­gins of COVID-19 [coro­n­avirus dis­ease 2019].” Of course, such coop­er­a­tion is high­ly war­rant­ed and should be pur­sued by the US Gov­ern­ment and the US sci­en­tif­ic com­mu­ni­ty. Yet, as out­lined below, much could be learned by inves­ti­gat­ing US-sup­port­ed and US-based work that was under­way in col­lab­o­ra­tion with Wuhan-based insti­tu­tions, includ­ing the Wuhan Insti­tute of Virol­o­gy (WIV), Chi­na. It is still not clear whether the IC inves­ti­gat­ed these US-sup­port­ed and US-based activ­i­ties. If it did, it has yet to make any of its find­ings avail­able to the US sci­en­tif­ic com­mu­ni­ty for inde­pen­dent and trans­par­ent analy­sis and assess­ment. If, on the oth­er hand, the IC did not inves­ti­gate these US-sup­port­ed and US-based activ­i­ties, then it has fall­en far short of con­duct­ing a com­pre­hen­sive inves­ti­ga­tion.

    Did the US intel­li­gence com­mu­ni­ty even inves­ti­gate the pos­si­bil­i­ty as to whether or not these US-based research pro­gram played a role in the pan­dem­ic? That remains unclear to this day. Which more or less tells us the answer.

    There’s also the ques­tion of how the intel­li­gence com­mu­ni­ty arrived at the con­clu­sions it even­tu­al­ly made from its inves­ti­ga­tion. In par­tic­u­lar, the con­clu­sion that the ini­tial out­break in Wuhan may have occurred no lat­er than Novem­ber 2019 and there­fore the virus was already cir­cu­lat­ing before the known clin­i­cal clus­ters in Decem­ber. No evi­dence for this has ever been giv­en just as no infor­ma­tion has been giv­en about when the US gov­ern­ment and researchers first became aware of a poten­tial new out­break. It’s a pret­ty notable omis­sion:

    ...
    The rel­e­vant US-based evi­dence would include the fol­low­ing infor­ma­tion: lab­o­ra­to­ry note­books, virus data­bas­es, elec­tron­ic media (emails, oth­er com­mu­ni­ca­tions), bio­log­i­cal sam­ples, viral sequences gath­ered and held as part of the PREDICT project (7) and oth­er fund­ed pro­grams, and inter­views of the EHA-led research team by inde­pen­dent researchers, togeth­er with a full record of US agency involve­ment in fund­ing the research on SARS-like virus­es, espe­cial­ly with regard to projects in col­lab­o­ra­tion with Wuhan-based insti­tu­tions. We sug­gest that a bipar­ti­san inquiry should also fol­low up on the ten­ta­tive con­clu­sion of the IC (4) that the ini­tial out­break in Wuhan may have occurred no lat­er than Novem­ber 2019 and that there­fore the virus was cir­cu­lat­ing before the clus­ter of known clin­i­cal cas­es in Decem­ber. The IC did not reveal the evi­dence for this state­ment, nor when parts of the US Gov­ern­ment or US-based researchers first became aware of a poten­tial new out­break. Any avail­able infor­ma­tion and knowl­edge of the ear­li­est days of the out­break, includ­ing viral sequences (8), could shed con­sid­er­able light on the ori­gins ques­tion.
    ...

    Then they point out how the US-based coro­n­avirus research was more or less exact­ly the kind of research that should prompt fears of a COVID-like lab release. Except we can’t say that for sure because the details about the kind of work that was done by the WIV’s US col­lab­o­ra­tors has­n’t been pub­licly dis­closed either. But that lack of pub­lic dis­clo­sure does­n’t mean we know noth­ing about the nature of the research being done in the US as part of this inter­na­tion­al col­lab­o­ra­tion. The research pro­pos­als were released as a result of FOIA requests, reveal­ing that it was­n’t just the WIV engaged in coro­n­avirus research under BSL‑2 and BSL‑3 con­di­tions. The EHA-WIV-UNC side of this inter­na­tion­al col­lab­o­ra­tion was also involved in the col­lec­tion of a large num­ber of so-far undoc­u­ment­ed SARS-like virus­es and was engaged in their manip­u­la­tion under BSL‑2 and BSL‑3 con­di­tions:

    ...
    Par­tic­i­pat­ing US insti­tu­tions include the EHA, the Uni­ver­si­ty of North Car­oli­na (UNC), the Uni­ver­si­ty of Cal­i­for­nia at Davis (UCD), the NIH, and the USAID. Under a series of NIH grants and USAID con­tracts, EHA coor­di­nat­ed the col­lec­tion of SARS-like bat CoVs from the field in south­west Chi­na and south­east Asia, the sequenc­ing of these virus­es, the archiv­ing of these sequences (involv­ing UCD), and the analy­sis and manip­u­la­tion of these virus­es (notably at UNC). A broad spec­trum of coro­n­avirus research work was done not only in Wuhan (includ­ing groups at Wuhan Uni­ver­si­ty and the Wuhan CDC, as well as WIV) but also in the Unit­ed States. The exact details of the field­work and lab­o­ra­to­ry work of the EHA-WIV-UNC part­ner­ship, and the engage­ment of oth­er insti­tu­tions in the Unit­ed States and Chi­na, has not been dis­closed for inde­pen­dent analy­sis. The pre­cise nature of the exper­i­ments that were con­duct­ed, includ­ing the full array of virus­es col­lect­ed from the field and the sub­se­quent sequenc­ing and manip­u­la­tion of those virus­es, remains unknown.

    EHA, UNC, NIH, USAID, and oth­er research part­ners have failed to dis­close their activ­i­ties to the US sci­en­tif­ic com­mu­ni­ty and the US pub­lic, instead declar­ing that they were not involved in any exper­i­ments that could have result­ed in the emer­gence of SARS-CoV­‑2. The NIH has specif­i­cal­ly stat­ed (6) that there is a sig­nif­i­cant evo­lu­tion­ary dis­tance between the pub­lished viral sequences and that of SARS-CoV­‑2 and that the pan­dem­ic virus could not have result­ed from the work spon­sored by NIH. Of course, this state­ment is only as good as the lim­it­ed data on which it is based, and ver­i­fi­ca­tion of this claim is depen­dent on gain­ing access to any oth­er unpub­lished viral sequences that are deposit­ed in rel­e­vant US and Chi­nese data­bas­es (7,8). On May 11, 2022, Act­ing NIH Direc­tor Lawrence Tabak tes­ti­fied before Con­gress that sev­er­al such sequences in a US data­base were removed from pub­lic view, and that this was done at the request of both Chi­nese and US inves­ti­ga­tors.

    Blan­ket denials from the NIH are no longer good enough. Although the NIH and USAID have stren­u­ous­ly resist­ed full dis­clo­sure of the details of the EHA-WIV-UNC work pro­gram, sev­er­al doc­u­ments leaked to the pub­lic or released through the Free­dom of Infor­ma­tion Act (FOIA) have raised con­cerns. These research pro­pos­als make clear that the EHA-WIV-UNC col­lab­o­ra­tion was involved in the col­lec­tion of a large num­ber of so-far undoc­u­ment­ed SARS-like virus­es and was engaged in their manip­u­la­tion with­in bio­log­i­cal safe­ty lev­el (BSL)-2 and BSL‑3 lab­o­ra­to­ry facil­i­ties, rais­ing con­cerns that an air­borne virus might have infect­ed a lab­o­ra­to­ry work­er (9). A vari­ety of sce­nar­ios have been dis­cussed by oth­ers, includ­ing an infec­tion that involved a nat­ur­al virus col­lect­ed from the field or per­haps an engi­neered virus manip­u­lat­ed in one of the lab­o­ra­to­ries (3).
    ...

    They go on to note the remark­able coin­ci­dence of SARS-CoV­‑2 just hap­pen­ing to con­tain a canon­i­cal human furin cleav­age site (FCS), mak­ing the virus high­ly adapt­ed at infect­ing human air­ways. As they note, while this FCS has been found in oth­er coro­n­avirus­es, SARS-CoV­‑2 is the only iden­ti­fied mem­ber of its viral fam­i­ly — the sub­genus sar­be­covirus — that con­tains it. But the coin­ci­dence is more remark­able when we fac­tor in that the Eco­Health Alliance-WIV-UNC col­lab­o­ra­tion sub­mit­ted a grant pro­pos­al to DARPA in 2018 that would have involved research insert­ing FCSs into coro­n­avirus­es. The grant was turned down, but it demon­strates intent:

    ...
    Spe­cial con­cerns sur­round the pres­ence of an unusu­al furin cleav­age site (FCS) in SARS-CoV­‑2 (10) that aug­ments the path­o­genic­i­ty and trans­mis­si­bil­i­ty of the virus rel­a­tive to relat­ed virus­es like SARS-CoV­‑1 (11, 12). SARS-CoV­‑2 is, to date, the only iden­ti­fied mem­ber of the sub­genus sar­be­covirus that con­tains an FCS, although these are present in oth­er coro­n­avirus­es (13, 14). A por­tion of the sequence of the spike pro­tein of some of these virus­es is illus­trat­ed in the align­ment shown in Fig. 1, illus­trat­ing the unusu­al nature of the FCS and its appar­ent inser­tion in SARS-CoV­‑2 (15). From the first weeks after the genome sequence of SARS-CoV­‑2 became avail­able, researchers have com­ment­ed on the unex­pect­ed pres­ence of the FCS with­in SARS-CoV‑2—the impli­ca­tion being that SARS-CoV­‑2 might be a prod­uct of lab­o­ra­to­ry manip­u­la­tion. In a review piece argu­ing against this pos­si­bil­i­ty, it was assert­ed that the amino acid sequence of the FCS in SARS-CoV­‑2 is an unusu­al, non­stan­dard sequence for an FCS and that nobody in a lab­o­ra­to­ry would design such a nov­el FCS (13).

    ...

    We do not know whether the inser­tion of the FCS was the result of nat­ur­al evo­lu­tion (2, 13)—per­haps via a recom­bi­na­tion event in an inter­me­di­ate mam­mal or a human (13, 24)—or was the result of a delib­er­ate intro­duc­tion of the FCS into a SARS-like virus as part of a lab­o­ra­to­ry exper­i­ment. We do know that the inser­tion of such FCS sequences into SARS-like virus­es was a spe­cif­ic goal of work pro­posed by the EHA-WIV-UNC part­ner­ship with­in a 2018 grant pro­pos­al (“DEFUSE”) that was sub­mit­ted to the US Defense Advanced Research Projects Agency (DARPA) (25). The 2018 pro­pos­al to DARPA was not fund­ed, but we do not know whether some of the pro­posed work was sub­se­quent­ly car­ried out in 2018 or 2019, per­haps using anoth­er source of fund­ing.

    We also know that that this research team would be famil­iar with sev­er­al pre­vi­ous exper­i­ments involv­ing the suc­cess­ful inser­tion of an FCS sequence into SARS-CoV­‑1 (26) and oth­er coro­n­avirus­es, and they had a lot of expe­ri­ence in con­struc­tion of chimeric SARS-like virus­es (2729). In addi­tion, the research team would also have some famil­iar­i­ty with the FCS sequence and the FCS-depen­dent acti­va­tion mech­a­nism of human ENaC a (19), which was exten­sive­ly char­ac­ter­ized at UNC (17, 18). For a research team assess­ing the pan­dem­ic poten­tial of SARS-relat­ed coro­n­avirus­es, the FCS of human ENaC—an FCS known to be effi­cient­ly cleaved by host furin present in the tar­get loca­tion (epithe­lial cells) of an impor­tant tar­get organ (lung), of the tar­get organ­ism (human)—might be a ratio­nal, if not obvi­ous, choice of FCS to intro­duce into a virus to alter its infec­tiv­i­ty, in line with oth­er work per­formed pre­vi­ous­ly.
    ...

    Final­ly, there was the FOIA release that showed NIH lead­er­ship took active steps to ensure the ini­tial gov­ern­ment line on the nature of this virus was that it was zoonot­ic in ori­gin, despite emails from Feb 1, 2020, show­ing con­cerns expressed by sev­er­al researchers that it could have been released from a lab:

    ...
    To date, the fed­er­al gov­ern­ment, includ­ing the NIH, has not done enough to pro­mote pub­lic trust and trans­paren­cy in the sci­ence sur­round­ing SARS-CoV­‑2. A steady trick­le of dis­qui­et­ing infor­ma­tion has cast a dark­en­ing cloud over the agency. The NIH could say more about the pos­si­ble role of its grantees in the emer­gence of SARS-CoV­‑2, yet the agency has failed to reveal to the pub­lic the pos­si­bil­i­ty that SARS-CoV­‑2 emerged from a research-asso­ci­at­ed event, even though sev­er­al researchers raised that con­cern on Feb­ru­ary 1, 2020, in a phone con­ver­sa­tion that was doc­u­ment­ed by email (5). Those emails were released to the pub­lic only through FOIA, and they sug­gest that the NIH lead­er­ship took an ear­ly and active role in pro­mot­ing the “zoonot­ic hypoth­e­sis” and the rejec­tion of the lab­o­ra­to­ry-asso­ci­at­ed hypoth­e­sis (5). The NIH has resist­ed the release of impor­tant evi­dence, such as the grant pro­pos­als and project reports of EHA, and has con­tin­ued to redact mate­ri­als released under FOIA, includ­ing a remark­able 290-page redac­tion in a recent FOIA release.
    ...

    So what’s going on here? Is Sachs going to con­tin­ue press­ing this and actu­al­ly raise enough hell to make an inde­pen­dent inquiry hap­pen? If so, wow.

    Or per­haps we’re being set up for some sort of lim­it­ed hang­out. But even in that case, with all the dirt already hang­ing out there, it’s hard to see how lim­it­ed a hang­out it could be. For exam­ple, there’s no way of deny­ing that 2018 DARPA grant pro­pos­al to con­duct what appear to be gain-of-func­tion research on coro­n­avirus­es. Whether DARPA approved the grant is kind of beside the point. Now, since the doc­u­ments show­ing this 2018 grant pro­pos­al were appar­ent­ly leaked anony­mous­ly, it’s pos­si­ble the doc­u­ments aren’t authen­tic. But as we can see in the fol­low­ing arti­cle from back in Sep­tem­ber, 2021, when this these doc­u­ments were first leaked, no one appeared to be con­test­ing its authen­tic­i­ty either:

    Newsweek

    DARPA Denies Fund­ing Wuhan Insti­tute of Virol­o­gy Amid Alleged Doc­u­ment Leak

    By Ed Browne On 9/22/21 at 11:46 AM EDT

    DARPA, the U.S. advanced research projects agency, has denied fund­ing research activ­i­ty at the Wuhan Insti­tute of Virol­o­gy (WIV) after a group released doc­u­ments alleged­ly detail­ing a coro­n­avirus research pro­pos­al.

    Newsweek can­not con­firm the verac­i­ty of the DRASTIC group or the exis­tence of the Project DEFUSE doc­u­ments described. The group says the doc­u­ments were pro­vid­ed anony­mous­ly.

    DRASTIC is a group of activists who say they are work­ing towards solv­ing the “rid­dle” of the ori­gins of the SARS-CoV­‑2 virus that is behind the COVID pan­dem­ic. They say they were giv­en doc­u­ments by an anony­mous source which detail some­thing called “Project DEFUSE.”

    Accord­ing to what appear to be fund­ing pro­pos­al excerpts pub­lished by DRASTIC, Project DEFUSE aimed to reduce the threat of bat-borne coro­n­avirus­es through research and was head­ed by Peter Daszak, pres­i­dent of the U.S.-based research orga­ni­za­tion Eco­Health Alliance (EHA). It would have run between 2018 and 2022.

    DRASTIC states the research pro­pos­al would have involved “advanced and dan­ger­ous” research into bat coro­n­avirus­es in coop­er­a­tion with the WIV and oth­er facil­i­ties, and said the research would qual­i­fy as Gain of Func­tion (GoF)—a process that can be used to make virus­es more dan­ger­ous so that humans can inves­ti­gate them and improve under­stand­ing.

    How­ev­er, DRASTIC said the doc­u­ments showed that DARPA reject­ed the DEFUSE pro­pos­al in part because of GoF con­cerns. DRASTIC did not pub­licly release the actu­al doc­u­ment it said it had seen.

    In a state­ment to Newsweek, DARPA denied fund­ing any activ­i­ty asso­ci­at­ed with EHA or the WIV. A spokesman said: “In accor­dance with U.S. Fed­er­al Acqui­si­tion Reg­u­la­tions, we are not at lib­er­ty to divulge who may have or may not have not sub­mit­ted a pro­pos­al in response to any of the agen­cy’s solic­i­ta­tions. Fur­ther, infor­ma­tion con­tained with­in bids is con­sid­ered pro­pri­etary and can only be released by the bid­der.

    “That being said, DARPA has nev­er fund­ed direct­ly, nor indi­rect­ly as a sub­con­trac­tor, any activ­i­ty or researcher asso­ci­at­ed with the Eco­Health Alliance or Wuhan Insti­tute of Virol­o­gy.”

    Newsweek has con­tact­ed Peter Daszak and EHA for com­ment. Newsweek has also con­tact­ed UNC-Chapel Hill, Duke-Nation­al Uni­ver­si­ty in Sin­ga­pore, the USGS Nation­al Wildlife Health Cen­ter (NWHC) and Palo Alto Research Cen­ter (PARC), which DRASTIC says are also men­tioned in the doc­u­ments, for com­ment. Newsweek was unable to con­tact the WIV.

    GoF research into coro­n­avirus­es has been a hot top­ic recent­ly, since many are con­cerned that SARS-CoV­‑2 could have been acci­den­tal­ly leaked from a lab, spark­ing the pan­dem­ic.

    The Nation­al Insti­tutes of Health (NIH), for instance, has already denied approv­ing grants that would have sup­port­ed GoF research on coro­n­avirus­es.

    Inves­ti­ga­tion into the ori­gin of SARS-CoV­‑2 is ongo­ing. In August, Pres­i­dent Joe Biden received a report from the intel­li­gence com­mu­ni­ty into the mat­ter that came back incon­clu­sive. He had ordered the report back in May in the hope of get­ting clos­er to a con­clu­sion.

    ...

    ———-

    “DARPA Denies Fund­ing Wuhan Insti­tute of Virol­o­gy Amid Alleged Doc­u­ment Leak” By Ed Browne; Newsweek; 09/22/2021

    “DRASTIC states the research pro­pos­al would have involved “advanced and dan­ger­ous” research into bat coro­n­avirus­es in coop­er­a­tion with the WIV and oth­er facil­i­ties, and said the research would qual­i­fy as Gain of Func­tion (GoF)—a process that can be used to make virus­es more dan­ger­ous so that humans can inves­ti­gate them and improve under­stand­ing.”

    The grant pro­pos­al was basi­cal­ly gain-of-func­tion research on coro­n­avirus­es. That was the assess­ment of DRASTIC, the group that received the grant from an anony­mous source. And note how the grant was for research to be con­duct­ed between 2018 and 2022. So they were ready to go with this gain-of-func­tion research imme­di­ate­ly. Which, of course, implies they were already con­duct­ing this kind of research, at least for pilot fea­si­bil­i­ty projects. They just want­ed DARPA to fund the scaled up ver­sion of the research:

    ...
    Accord­ing to what appear to be fund­ing pro­pos­al excerpts pub­lished by DRASTIC, Project DEFUSE aimed to reduce the threat of bat-borne coro­n­avirus­es through research and was head­ed by Peter Daszak, pres­i­dent of the U.S.-based research orga­ni­za­tion Eco­Health Alliance (EHA). It would have run between 2018 and 2022.
    ...

    And note the range of US research insti­tu­tions involved: UNC-Chapel Hill, Duke-Nation­al Uni­ver­si­ty in Sin­ga­pore, the USGS Nation­al Wildlife Health Cen­ter (NWHC) and Palo Alto Research Cen­ter (PARC). That’s a lot of pub­lic and pri­vate US insti­tu­tions involved with this gain-of-func­tion coro­n­avirus research grant pro­pos­al:

    ...
    Newsweek has con­tact­ed Peter Daszak and EHA for com­ment. Newsweek has also con­tact­ed UNC-Chapel Hill, Duke-Nation­al Uni­ver­si­ty in Sin­ga­pore, the USGS Nation­al Wildlife Health Cen­ter (NWHC) and Palo Alto Research Cen­ter (PARC), which DRASTIC says are also men­tioned in the doc­u­ments, for com­ment. Newsweek was unable to con­tact the WIV.
    ...

    So good luck to Jef­frey Sachs in his appar­ent quest to see an inde­pen­dent inves­ti­ga­tion of the ori­gins of the pan­dem­ic that includes an exam­i­na­tion of this entire inter­na­tion­al research net­work involved with pre-pan­dem­ic coro­n­avirus gain-of-func­tion research. It’s hard to imag­ine all of the rel­e­vant evi­dence to be released for a real inde­pen­dent inves­ti­ga­tion. But it’s not quite as unthink­able as before. Let’s hope this isn’t all part of a lim­it­ed hang­out.

    Posted by Pterrafractyl | May 27, 2022, 8:19 am
  6. The dan­gers involved with ‘gain-of-func­tion’ research has been a hot top over the last cou­ple of years fol­low­ing the COVID-19. But it’s not a new top­ic. ‘Gain-of-func­tion’ research has been going on for decades. And as the fol­low­ing fas­ci­nat­ing piece pub­lished by organ­ic food activist Alex­is Baden-May­er lays out, the his­to­ry of gain-of-func­tion research is much more direct­ly relat­ed to con­tem­po­rary gain-of-func­tion research than is per­haps rec­og­nized. As Baden-May­er describes, the US gov­ern­ment has been fund­ing ‘gain-of-func­tion’ research on avian flu virus­es going back the ear­ly 1990. And the two researchers who have long led the US gov­ern­men­t’s ‘gain-of-func­tion’ research into avian flu were none oth­er than the Ron Fouch­i­er at the Eras­mus Med­ical Cen­ter in Rot­ter­dam, the Nether­lands, and Yoshi­hi­ro Kawao­ka at the Uni­ver­si­ty of Wis­con­sin-Madi­son and the Uni­ver­si­ty of Tokyo. So when Kawao­ka and Fouch­i­er pub­lished their now noto­ri­ous 2011 study show­ing how they could eas­i­ly dri­ve the muta­tion of the dead­ly H5N1 avian flu to spread between fer­rets using sim­ple pas­sag­ing tech­niques, this was after years of gov­ern­ment fund­ed efforts.

    Although the US gov­ern­ment has­n’t been the only enti­ty financ­ing this. For exam­ple, when Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases (NIAID) direc­tor Antho­ny Fau­ci ini­tial­ly com­mis­sioned Fouch­i­er and Kawaoka’s ‘gain-of-func­tion’ stud­ies in 2006, that effort was paid for, in part, by the Bill & Melin­da Gates Foun­da­tion. Recall how Bill Gates has been influ­enc­ing inter­na­tion­al vac­cine devel­op­ment efforts for years. And as we got to see at the start of the COVID-19 pan­dem­ic, Gates’s vac­cine ‘phil­an­thropy’ does­n’t just involve financ­ing the vac­cine devel­op research but also demands that the world main­tain intel­lec­tu­al prop­er­ty rights regimes that ensure monop­oly sta­tus is main­tained even in the face of a glob­al pan­dem­ic. When WHO came out with its Covid-19 Tech­nol­o­gy Access Pool (C‑TAP) — designed to ensure all coun­tries could access new vac­cines as soon as they are avail­able — Gates came out with his own COVID-19 ACT-Accel­er­a­tor — designed to ensure the main­te­nance of the glob­al intel­lec­tu­al prop­er­ty monop­oly sys­tem for vac­cines remains intact. And in the end, Gates won and his mod­el was ulti­mate­ly adopt­ed.

    But Fouch­i­er and Kawao­ka aren’t the only researchers involved with mod­i­fy­ing avian flu. When the avian flu out­break of 1997 hap­pened in Hong Kong, the jump from bird to humans was seen as so improb­a­bly that sci­en­tists first sus­pect­ed con­t­a­m­i­na­tion from Kennedy Shortridge’s lab at the Uni­ver­si­ty of Hong Kong. Short­ridge was the head of the WHO’s ref­er­ence lab­o­ra­to­ry there. And it turns out Short­ridge’s research had some inter­est­ing ties to gov­ern­ment-fund­ed the work Fouch­i­er and Kawao­ka had been doing on avian flu since 1990. Kawaoka’s men­tor, Robert G. Web­ster, is a close col­league of Short­ridge, co-pub­lish­ing with Short­ridge and spend­ing three months each year at Short­ridge’s lab. Web­ster also hap­pens to be one of the first gain-of-func­tion sci­en­tists, pub­lish­ing a suc­cess­ful cre­ation of a recom­bi­nant virus in 1973.

    Short­ridge and Web­ster were both, in turn, men­tored by none oth­er than Sir Mac­far­lane Bur­net. Recall how Bur­net, Australia’s top post-WWII micro­bi­ol­o­gist, actu­al­ly advo­cat­ed for the use of bio­log­i­cal war­fare on South­east Asian coun­tries. And the rea­son­ing he used for why it would be ‘safe’ for Aus­tralia to do so with­out risk­ing blow­back is the fact that Australia’s cli­mate is tem­per­ate com­pared to its trop­i­cal neigh­bors. And that’s real­ly the big his­toric arc to note here: the men­tors for Fouch­i­er and Kawao­ka — the two sci­en­tists lead­ing the mod­ern efforts to devel­op weaponized ver­sion of avian flu capa­ble of infect­ing humans — were them­selves men­tored by gain-of-0func­tion pio­neers Web­ster and Short­ridge, who were men­tored by Sir Mac­far­lane Bur­net, a major fig­ure in the his­to­ry of bio­log­i­cal war­fare. But while Bur­net made no bones about his desire to unleash bioweapons against Aus­trali­a’s trop­i­cal neigh­bors, con­tem­po­rary ‘gain-of-func­tion’ research is all giv­en the veneer of pure­ly aca­d­e­m­ic or ‘defen­sive’ uses.

    And that brings us to the oth­er part of Baden-May­er­s’s piece: giv­en the trou­bling but well doc­u­ment­ed his­to­ry sur­round­ing gain-of-func­tion research mak­ing avian virus­es capa­ble of infect­ing humans, what are we to make of Rus­si­a’s claims about Pen­ta­gon-fund­ed Ukrain­ian bio­labs work­ing on avian flu gain-of-func­tion research. And as Baden-May­er lays out, not only are Rus­si­a’s claims based on pub­licly avail­able evi­dence that the US gov­ern­ment does­n’t refute, but that evi­dence ties direct­ly back to this his­to­ry of US-fund­ed avian flu research. Beyond that, it turns out these same US-fund­ed enti­ties oper­at­ing in Ukraine were also direct­ly involved with the joint inter­na­tion­al col­lab­o­ra­tion between the Eco­Health Alliance and the Wuhan Insti­tute of Virol­o­gy (WIV) in the study of nov­el coro­n­avirus­es. Yep.

    Some of that US-fund­ed bio­log­i­cal research in Ukraine goes back to 2008, when the firm Black & Veatch first got what even­tu­al­ly become $208.5 mil­lion in Pen­ta­gon con­tracts to design, con­struct and equip 11 bio-labs in Ukraine. Anoth­er firm involved with these US-fund­ed efforts in Ukraine is Metabio­ta, which has received enor­mous atten­tion in right-wing cir­cles for the invest­ment it received by an invest­ment firm affil­i­at­ed with Hunter Biden. As we’re going to see, Metabio­ta basi­cal­ly emerged as a for-prof­it ver­sion of an ear­li­er non-prof­it ini­tia­tive, the Glob­al Viral Fore­cast­ing Ini­tia­tive (GVFI), which was fund­ed with at least $5.5 mil­lion in 2008 as part of a $30 mil­lion effort by Google to finance virus hunt­ing and gain-of-func­tion efforts. GVFI’s oth­er fun­ders includ­ed the Skoll Foun­da­tion, the Bill & Melin­da Gates Foun­da­tion, Mer­ck Research Lab­o­ra­to­ries and the US Depart­ment of Defense. It soon became the for-prof­it Metabio­ta. So while a firm asso­ci­at­ed with Hunter Biden is indeed a Metabio­ta investor, there are a lot of oth­er very inter­est­ing enti­ties involved it its cre­ation.

    It also turns out that Metabio­ta was was part of the USAID-fund­ed PREDICT team hunt­ing virus­es in Chi­na in 2013 when they found what it now believed to be the clos­est known rel­a­tive of SARS-CoV­‑2, the RaTG13 bat virus. PREDICT also got its ini­tial fund­ing from Google. So if there’s ever a real inves­ti­ga­tion into the ori­gins of the COVID-19 pan­dem­ic, an inves­ti­ga­tion of Metabio­ta’s work coro­n­avirus research efforts has to be part of it.

    And that’s all just a taste of what’s con­tained in this fas­ci­nat­ing piece that attempts to answer the ques­tions about what has been going on in the US-fund­ed bio­labs in Ukraine with pub­licly avail­able infor­ma­tion all point­ing back towards that dis­turb­ing his­to­ry where bio­log­i­cal war­fare research was allowed to con­tin­ue under a ‘gain-of-func­tion’ cloak:

    Organ­ic Con­sumers Asso­ci­a­tion

    Is Bird Flu Being Weaponized?

    by Alex­is Baden-May­er
    April 22, 2022

    There’s been a lot of talk about the con­flict in Ukraine caus­ing the release of dan­ger­ous pathogens, includ­ing high­ly path­o­gen­ic avian influen­za (H5N1), from U.S. fund­ed bio­labs.

    This isn’t the first time that H5N1 bioweapons fears have gripped Ukraine. In 2009, when a flu broke out in Ukraine (the offi­cial sto­ry is that it was H1N1), rumors cir­cu­lat­ed that it was H5N1, spread via vac­cines or aer­i­al spray­ing.

    Mak­ing the whole H5N1 saga even sketch­i­er is its ori­gin sto­ry in the late 1990s. The emer­gence of the virus in 1997 in Hong Kong was eeri­ly pre­dict­ed by Kennedy Short­ridge, the sci­en­tist who would dis­cov­er it. H5N1 didn’t infect humans until Short­ridge and his col­leagues had been study­ing its human infec­tion poten­tial in their labs for sev­er­al years. At the time, the nat­ur­al leap of a flu direct­ly from poul­try to humans was so improb­a­ble that sci­en­tists first sus­pect­ed that it was the result of con­t­a­m­i­na­tion from Shortridge’s lab. The 1997 H5N1 out­break in Hong Kong was the first flu to be diag­nosed by PCR test.

    Does this sce­nario sound famil­iar?

    ...

    In this arti­cle, I lay out the evi­dence that:

    1. Fau­ci and Gates fund­ed the weaponiza­tion of H5N1.

    2. Fauci’s H5N1 research is ongo­ing and is being done all over the world, includ­ing in Pen­ta­gon-fund­ed bio­labs in Ukraine.

    3. Some of the scari­est, most scan­dal-plagued cor­po­ra­tions on the plan­et are involved in the Ukraine bio­labs, from our Mil­lions Against Mon­san­to neme­sis Bay­er to the likes of Bat­telle, Metabio­ta and South­ern Research, biode­fense con­trac­tors var­i­ous­ly linked to the Biden fam­i­ly, the ori­gins of COVID-19 and the 2001 anthrax attacks.

    4. The U.S. has already autho­rized and stock­piled a human H5N1 vac­cine.

    Chris­t­ian West­brook at IceAgeFarmer.com is warn­ing that bird flu will be the next human pan­dem­ic and that the cat­a­stro­phe is being engi­neered to ush­er in the post-meat/­post-farmer world that Bill Gates aspires to. I sin­cere­ly hope he’s wrong, but it’s hard to be opti­mistic when peo­ple like Robert Red­field, who was CDC direc­tor under Trump and is known for his sus­pi­cion that COVID-19 orig­i­nat­ed in a lab, are com­ing out of the wood­work to make the same eerie pre­dic­tion.

    Fau­ci & Gates Fund­ed the Weaponiza­tion of H5N1

    Fau­ci and Gates fig­ured out how to get sci­en­tists to par­tic­i­pate in bio­log­i­cal weapons research with a clean con­science:

    They pay them to...

    1. Believe pan­demics are caused by pathogens that don’t infect humans.

    2. Use genet­ic engi­neer­ing and syn­thet­ic biol­o­gy to “pre­dict” how those pathogens will infect humans.

    In his 2006 piece, “The Sci­ence: How a Human Pan­dem­ic Could Start,” Scott Dow­ell, wrote:

    “While rare instances of H5N1 pass­ing from per­son to per­son have been doc­u­ment­ed, there is no indi­ca­tion that it can do so effi­cient­ly. That could change. … A series of muta­tions or a sin­gle genet­ic reas­sort­ment event (a type of gene swap­ping among virus­es) could enable H5N1 to spread effi­cient­ly among humans, trig­ger­ing a pan­dem­ic. … H5N1 may evolve into some­thing that’s eas­i­ly spread through cough­ing, sneez­ing, or con­tact with con­t­a­m­i­nat­ed hands.”

    In his wis­dom, Fau­ci decid­ed to see if he could make that hap­pen in a lab.

    As direc­tor of the Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases (NIAID), Fau­ci com­mis­sioned two gain-of-func­tion research teams with grants titled “Pan­dem­ic Poten­tial of H5N1 Influen­za Virus­es” and “Under­stand­ing the Emer­gence of High­ly Path­o­gen­ic Avian Influen­za Virus­es.

    Gates chipped in, too, with grants 48339 and OPPGH5383 from the Bill & Melin­da Gates Foun­da­tion. (Ice Age Farmer’s West­brook found a lot more doc­u­men­ta­tion of Gates’ fund­ing of gain-of-func­tion research to make high­ly path­o­gen­ic avian influen­za even more path­o­gen­ic and trans­mis­si­ble.)

    The sci­en­tists Fau­ci chose to lead the H5N1 teams, Ron Fouch­i­er at the Eras­mus Med­ical Cen­ter in Rot­ter­dam, the Nether­lands, and Yoshi­hi­ro Kawao­ka at the Uni­ver­si­ty of Wis­con­sin-Madi­son and the Uni­ver­si­ty of Tokyo, were sci­en­tists Fau­ci had fund­ed since 1990 under grants with titles includ­ing “Influen­za Virus Assem­bly.”

    In Feb­ru­ary 2006, Fau­ci con­vened a one-day in-house “NIAID Influen­za Research Sum­mit” to iden­ti­fy influen­za research pri­or­i­ties. In Sep­tem­ber, he opened up the top­ic to a 35-mem­ber “Blue Rib­bon Pan­el on Influen­za Research” that includ­ed Fouch­i­er and Kawao­ka. The Blue Rib­bon panel’s report doesn’t men­tion gain-of-func­tion exper­i­ments, but Fau­ci gave them grants to do just that.

    Fouch­i­er and Kawaoka’s now infa­mous gain-of-func­tion research showed that, through lab manip­u­la­tion, H5N1 could be altered to become high­ly trans­mis­si­ble among humans via air­borne infec­tion.

    Did Fau­ci & Gates’ Weaponized H5N1 End Up In Ukraine?

    In this video from IceAge Farmer, Chris­t­ian West­brook talks about Russia’s claim that the U.S. fund­ed Ukraine exper­i­ments with engi­neered strains of bird flu that could kill 50 per­cent of human­i­ty:

    [see video]

    Russia’s accu­sa­tion was pre­sent­ed to the Unit­ed Nations:

    [see video]

    Russia’s infor­ma­tion on U.S. fund­ing of pathogen research in Ukraine was gleaned from pub­lic sources. Rob­bie Mar­tin of Media Roots Radio has com­piled the doc­u­men­ta­tion in a search­able data­base housed by Our Hid­den His­to­ry. Mar­tin did a great pod­cast on the sub­ject, “Is the US Mak­ing Bioweapons Under the Guise of ‘Biode­fense’ in Ukraine & Else­where? w/ Gum­by

    As Igor Kir­illov, the head of the Nuclear, Bio­log­i­cal, and Chem­i­cal Pro­tec­tion Troops of the Russ­ian Armed Forces, has report­ed, the Pen­ta­gon-fund­ed pathogens projects in Ukraine were labeled UP for Ukraine Project and giv­en num­bers start­ing with UP‑1.

    Cur­rent­ly, the project lead for U.S.-funded H5N1 research in Ukraine (the Pentagon’s Defense Threat Reduc­tion Agency (DTRA) refers to it as UP‑4 or Ukraine Project 4) is Denys Muzy­ka. (The link goes to his pub­li­ca­tions on Google Schol­ar.)

    This is all very well doc­u­ment­ed and the U.S. has­n’t denied it (although it insists it is in full com­pli­ance with the Bio­log­i­cal Weapons Con­ven­tion):

    [see video]

    Ukraine is a hub for Pen­ta­gon bio­lab fund­ing, and biotech & phar­ma­ceu­ti­cal com­pa­nies are going where the gov­ern­ment con­tracts are. Our Mil­lions Against Mon­san­to neme­sis Bay­er is sidling up to the trough, too.

    The DA is pan­ick­ing Ukraine BIOLABS- crest­ed for dis­tri­b­u­tion world­wide weaponised Coro­na Virus Anthrax H5N1 diph­the­ria Ebo­la & loads more Putin reports to Secu­ri­ty coun­cil today USA fund­ing Hunter Biden involve­ment Metabio­ta — South Africa is AWAKE pic.twitter.com/wKPkNIFofb— The Chron­i­cler (@TheChronicler13) March 11, 2022

    A series of bioweapons scan­dals that pre­date the cur­rent cri­sis reveal that the U.S. has been fund­ing H5N1 research in Ukraine for many years.

    Begin­ning in 2018, Dilyana Gay­tandzhie­va of Arm­sWatch pub­lished a series of reports on U.S.-funded bio­labs, reveal­ing that defense con­trac­tor Black & Veatch got a total of $208.5 mil­lion in Pen­ta­gon con­tracts to design, con­struct and equip 11 bio-labs in Ukraine in 2008, 2012 and 2020. The com­pa­ny com­plet­ed Ukraine’s first Bio-Safe­ty Lev­el 3 (BSL‑3) lab­o­ra­to­ry in 2010. Black & Veatch also main­tains the Pentagon’s sys­tems in Ukraine for the “con­trol and account­ing of bio­log­i­cal mate­ri­als in lab­o­ra­to­ries” and the “ear­ly detec­tion of a dis­ease out­break and assist[ance] in an effec­tive response.”

    Gay­tandzhie­va was also the first to report Metabiota’s Pen­ta­gon con­tracts to research pathogens in Ukraine.

    Metabio­ta received a Pen­ta­gon con­tract worth up to $23.9 mil­lion that includ­ed a 2014 line item allo­cat­ing $307,091 for “Ukraine Research Projects.”. As men­tioned above, Rus­sia claimed that the U.S. labeled its Ukraine bio­lab projects as UP for Ukraine Project and gave them num­bers. This match­es the way Amer­i­can sci­en­tists work­ing on these projects refer to them, but they call them “Metabio­ta Ukraine Projects.” For exam­ple, there’s this ref­er­ence to “Metabio­ta UP‑8” on LinkedIn.

    Black & Veatch and Metabio­ta co-lead the Defense Threat Reduc­tion Agency’s so-called Sci­ence Writ­ers Men­tor­ship Pro­gram (SWMP) in Ukraine, begun in 2016. That’s how the Pen­ta­gon puts one degree of sep­a­ra­tion between itself and Ukrain­ian sci­en­tists. The sci­en­tists put a dis­claimer on their pub­lished research that says that their research isn’t fund­ed by DTRA but their pub­li­ca­tions are, through the SWMP.

    For exam­ple, the authors of “Phy­lo­ge­net­ic Analy­sis of H5N8 High­ly Path­o­gen­ic Avian Influen­za Virus­es in Ukraine, 2016–2017” thank “Greg Glass [pro­gram direc­tor for DTRA’s Coop­er­a­tive Bio­log­i­cal Engage­ment Pro­gram (CBEP) in Ukraine] and the sci­en­tif­ic staff at BV/Metabiota (Kyiv, Ukraine) for crit­i­cal read­ing and assis­tance with prepa­ra­tion of the arti­cle.” They also thank the “Sci­ence Writ­ers Men­tor­ship Pro­gram (SWMP) for their sup­port in pro­vid­ing resources for writ­ing this man­u­script.” Then, they claim that “DTRA/CBEP did not direct­ly sup­port the research described here­in.” They leave out the fact that they work in lab­o­ra­to­ries designed, built and equipped by the Pen­ta­gon. But, their most reveal­ing acknowl­edg­ment is to the Cen­ter of Excel­lence for Influen­za Research and Sur­veil­lance (CEIRS).

    CEIRS fund­ing comes from Fau­ci.

    As Gay­tandzhie­va report­ed in “Poten­tial pan­dem­ic bird flu mod­i­fied to be more dan­ger­ous in new risky NIH research,” CEIRS is one of Fauci’s fund­ing streams for research that could start a human bird flu Plan­dem­ic.

    The I.I. Mech­nikov Anti-Plague Sci­en­tif­ic Research Insti­tute of Ukraine is Fauci’s region­al CEIRS hub.

    Is the Mech­nikov Insti­tute being set up as the next Wuhan Insti­tute of Virol­o­gy?

    The Sur­pris­ing Links Between the Ori­gins of COVID-19, Ukraine Bio­labs and the 2001 Anthrax Attacks

    In addi­tion to Black & Veatch, Fauci’s Cen­ter of Excel­lence for Influen­za Research and Sur­veil­lance, and Metabio­ta, there are two oth­er notable U.S. orga­ni­za­tions work­ing in the Pen­ta­gon-fund­ed bio­labs in Ukraine: South­ern Research and Bat­telle.

    South­ern Research has had Pen­ta­gon projects in Ukraine since 2008 and a Ukraine office since 2010. It has received $688.5 mil­lion in gov­ern­ment fund­ing since 2001.

    Accord­ing to this LinkedIn pro­file, Bat­telle is also oper­at­ing Ukraine bio­labs, run­ning Pen­ta­gon-fund­ed “projects in Virol­o­gy, Bac­te­ri­ol­o­gy, Decon­t­a­m­i­na­tion, Aerosol sci­ence, BSL‑2/3 lab­o­ra­to­ry activ­i­ties, CONOP, Data Ana­lyt­ics and Mol­e­c­u­lar Biol­o­gy.”

    Infa­mous bio­log­i­cal weapons defense con­trac­tor Bat­telle is run­ning Pen­ta­gon bio­labs in Ukraine… pic.twitter.com/ItLIoCLZXx— Alex­is Baden-May­er (@AlexisBadenMaye) April 11, 2022

    Bat­telle, Metabio­ta and South­ern Research’s involve­ment con­nects U.S.-funded pathogens research in Ukraine to two very hot top­ics: 1) the Biden family’s eco­nom­ic inter­ests in Ukraine; and 2) the truth about COVID-19, as well a much old­er inci­dent that shouldn’t be mem­o­ry-holed: the 2001 anthrax attacks.

    [see video]

    The above video from the Reese Report, ties it all togeth­er, but here are a few addi­tion­al details, as well as infor­ma­tion about how Metabio­ta, Eco­Health Alliance, South­ern Research and Bat­telle link back to the 2001 anthrax attacks.

    Metabio­ta was part of the PREDICT team hunt­ing virus­es in Chi­na in 2013 when they found what it now believed to be the clos­est known rel­a­tive of SARS-CoV­‑2, a bat virus named RaTG13. PREDICT is a USAID project, fund­ed by U.S. tax dol­lars, but it got its start at Google.org.

    In 2008, Google.org com­mit­ted $30 mil­lion to virus hunt­ing and gain-of-func­tion research on poten­tial pan­dem­ic pathogens through a project it called Pre­dict and Pre­vent. At least $5.5 mil­lion of that went to Dr. Nathan Wolfe’s non-prof­it Glob­al Viral Fore­cast­ing Ini­tia­tive, which was soon to become the for-prof­it Metabio­ta. Oth­er GVFI fun­ders at the time includ­ed the Skoll Foun­da­tion, which also gave $5.5 mil­lion, the Bill & Melin­da Gates Foun­da­tion, Mer­ck Research Lab­o­ra­to­ries and the US Depart­ment of Defense.

    When the GVFI became the for-prof­it Metabio­ta, Google Ven­tures con­tin­ued to invest. In addi­tion, it cre­at­ed a busi­ness part­ner­ship with Metabio­ta, “offer­ing its big-data exper­tise to help the com­pa­ny serve its customers–insurers, gov­ern­ment agen­cies and oth­er organizations–by offer­ing them fore­cast­ing and risk-man­age­ment tools.” In oth­er words, they sell pan­dem­ic insur­ance.

    Google’s Pre­dict and Pre­vent was a prof­itable invest­ment. The com­pa­ny par­layed the $30 mil­lion it bun­dled through its non-prof­it Google.org, into hun­dreds of mil­lions in gov­ern­ment grants for its part­ners in the pan­dem­ic indus­tri­al com­plex, includ­ing $99.5 mil­lion for its for-prof­it part­ner Metabio­ta since 2008.

    Now that Metabio­ta has got­ten caught up in the COVID ori­gins scan­dal, its orig­i­nal investors, Eric Schmidt of Google, Jef­frey Skoll of EBay, Rajiv Shah of The Rock­e­feller Foun­da­tion (for­mer­ly USAID direc­tor, Bill & Melin­da Gates Foun­da­tion) chipped in to fund the COVID Com­mis­sion Plan­ning Group, a white-wash led by Philip Zelikow who gave us the 9–11 Com­mis­sion cov­er-up.

    One of Metabiota’s PREDICT part­ners is Eco­Health Alliance, whose sci­ence and pol­i­cy advi­sor, David Franz, pro­duced the anthrax used in the 2001 attacks while work­ing for South­ern Research and part­ner­ing with sci­en­tists at Bat­telle.

    Franz, a for­mer com­man­der of the U.S. Army Med­ical Research Insti­tute of Infec­tious Dis­eases went from Fort Det­rick to work­ing at South­ern Research for the Pentagon’s Defense Advanced Research Projects Agency (DARPA), which from 1999–2001 con­tract­ed with Advanced Biosys­tems for microen­cap­su­lat­ed anthrax. Franz’s South­ern Research was a sub­con­trac­tor on that project. His part­ners, Advanced Biosys­tems’ Ken Alibek, a for­mer Sovi­et bioweapons sci­en­tist, and Charles L. Bai­ley, anoth­er for­mer Fort Det­rick com­man­der, filed a patent on the sil­i­con microen­cap­su­la­tion tech­nol­o­gy in 2001. In their 2012 arti­cle in the peer-reviewed Jour­nal of Bioter­ror­ism & Biode­fense, “Evi­dence for the Source of the 2001 Attack Anthrax,” Mar­tin E. Hugh-Jones, Bar­bara Hatch Rosen­berg and Stu­art Jacob­sen link the foren­sic evi­dence from the attack anthrax to the Alibek, Bai­ley and Franz’s microen­cap­su­la­tion tech­niques. The trio like­ly engi­neered the attack anthrax in Battelle’s West Jef­fer­son, Ohio, facil­i­ty. As Whit­ney Webb has report­ed, the Pen­ta­gon con­tract­ed with Bat­telle to “cre­ate the genet­i­cal­ly-mod­i­fied anthrax, a task that was over­seen by Battelle’s then-pro­gram man­ag­er for all things bioweapons, Ken Alibek.”

    The 2009 Ukraine Flu Pan­ic

    One of the many phar­ma­ceu­ti­cal com­pa­nies work­ing under U.S. gov­ern­ment con­tracts at Ukraine bio­labs is the phar­ma­ceu­ti­cal com­pa­ny Bax­ter.

    In 2009, after the com­pa­ny near­ly sparked an H5N1 pan­dem­ic, rumors cir­cu­lat­ed that Bax­ter caused the flu out­break that swept Ukraine lat­er the same year.

    In ear­ly Feb­ru­ary 2009, Bax­ter acci­den­tal­ly com­bined the high­ly path­o­gen­ic avian influen­za with an H3N2 flu that com­mon­ly infects humans. The mis­take occurred in Baxter’s Aus­tri­an lab­o­ra­to­ries, and the dead­ly chimera was dis­trib­uted to sub­con­trac­tors in the Czech Repub­lic, Slove­nia and Ger­many. The con­t­a­m­i­na­tion was discovered—and human lives were spared—when what they called an “exper­i­men­tal virus mate­r­i­al” killed fer­rets in a test con­duct­ed by researchers who believed they were work­ing with a com­mon sea­son­al flu. Bax­ter nev­er explained what hap­pened.

    An H1N1 swine flu pan­dem­ic began the next month, March 2009. The U.S. gov­ern­ment gave Bax­ter con­tracts to pro­duce swine flu vac­cines despite the H5N1 con­t­a­m­i­na­tion inci­dent. “Coin­ci­den­tal­ly,” Bax­ter had filed a patent on its H1N1 vac­cine on August 28, 2008.

    When the swine flu hit Ukraine in Octo­ber 2009, the recent Bax­ter H5N1 scan­dal and their lab­o­ra­to­ries in Kyiv caused rumors to cir­cu­late that it was actu­al­ly H5N1 spread via vac­cines or aer­i­al spray­ing.

    ...

    The Curi­ous Ori­gin of H5N1

    The first human H5N1 out­break occurred in Hong Kong in 1997, the year of what the British call the “Hong Kong han­dover,” when sov­er­eign­ty over Hong Kong was trans­ferred from the U.K. to Chi­na.

    It was dur­ing this “polit­i­cal­ly sen­si­tive” year that Kennedy Short­ridge, an Aus­tralian sci­en­tist who was the direc­tor of the World Health Orga­ni­za­tion’s ref­er­ence lab­o­ra­to­ry at the Uni­ver­si­ty of Hong Kong, con­firmed human cas­es of high­ly path­o­gen­ic bird flu.

    Shortridge’s col­league Yuen Kwok-Yung attend­ed to the H5N1 patients and devised a rapid diag­nos­tic test known as RT-PCR to ana­lyze res­pi­ra­to­ry secre­tions from these patients. As they pub­lished in the Lancet, this was the first time that a pure­ly avian virus had been iso­lat­ed from peo­ple with a res­pi­ra­to­ry dis­ease and the first time that a PCR test was used for rapid diag­no­sis of such patients in a clin­i­cal set­ting.

    The 1997 Hong Kong H5N1 virus was unique in every respect.

    Time mag­a­zine report­ed, “On the H gene at a point called the cleav­age site, [was] found a tell­tale muta­tion, the same kind of muta­tion found in oth­er high­ly path­o­gen­ic avian virus­es. …The virus … had regions that were iden­ti­cal to por­tions of [an] avian virus that struck Penn­syl­va­nia [chick­ens] in 1983.”

    The L.A. Times report­ed, “The H5 piece came from a virus in a goose. The N1 piece came from a sec­ond virus in a quail. The remain­ing flu genes came from a third virus, also in quail.”

    Short­ridge had been study­ing how avian influen­za virus­es spread to humans since 1975. Pri­or to dis­cov­er­ing H5N1, Short­ridge eeri­ly pre­dict­ed its emer­gence. As Frank Ching report­ed in Bird Flu, SARS and Beyond”:

    As ear­ly as 1982, Short­ridge had labeled south­ern Chi­na, where humans and domes­tic ani­mals lived in close prox­im­i­ty, “an epi­cen­ter for the ori­gin of pan­demics.” Ten years lat­er, he called south­ern Chi­na a “virus soup” and warned that pan­dem­ic influen­za was a zoono­sis, that is, it could be trans­mit­ted from ani­mals to humans and, in 1995, he warned that influen­za in south­ern Chi­na could not prop­er­ly be called an “emerg­ing” infec­tion because it was con­stant­ly lurk­ing. “Elu­sive might be more apt,” he wrote.

    An exam­ple of Shortridge’s pen­chant for such pre­dic­tions is his 1995 Lancet arti­cle “The next pan­dem­ic influen­za virus?” Curi­ous­ly, H5N1 emerged two years lat­er, in 1997, in the same city where Short­ridge worked, Hong Kong.

    At the time, the nat­ur­al leap of a flu direct­ly from poul­try to humans was thought to be so unlike­ly that sci­en­tists first sus­pect­ed con­t­a­m­i­na­tion from Shortridge’s lab was the cause of the high­ly improb­a­ble H5N1 diag­no­sis.

    How would that con­t­a­m­i­na­tion hap­pen unless Short­ridge hadn’t already been work­ing with H5N1 in the lab?

    Time mag­a­zine report­ed, “In an ear­li­er study, con­duct­ed with great dis­cre­tion, his lab had found that res­i­dents of rur­al Hong Kong had anti­bod­ies to all the known bird-flu virus­es.”

    H5N1 didn’t cause dis­ease humans until this poten­tial had been stud­ied in a lab for sev­er­al years.

    Fau­ci had been fund­ing Kawao­ka and Fouchier’s efforts to get bird flu to leap to humans since 1990 and their work was con­nect­ed to what Short­ridge was doing in Hong Kong. For sev­en years pri­or to the first human H5N1 out­break in 1997, Fau­ci had been fund­ing Kawaoka’s gain-of-func­tion bird flu research at St. Jude Children’s Research Hos­pi­tal and Kawaoka’s men­tor there, Robert G. Web­ster, was work­ing and pub­lish­ing with Short­ridge. Every year, Web­ster spent three months work­ing with Short­ridge at the Uni­ver­si­ty of Hong Kong, accord­ing to this pro­file of Web­ster which men­tions Kawao­ka as his pro­tege.

    The most eerie con­nec­tion between Short­ridge and Webster’s labs is that the clos­est known rel­a­tive of the 1997 Hong Kong H5N1 was the avian virus that struck Penn­syl­va­nia chick­ens in 1983—that Yoshi­hi­ro Kawao­ka had stud­ied. Accord­ing to Time mag­a­zine:

    Web­ster assigned a young sci­en­tist, Yoshi­hi­ro Kawao­ka, to try to fig­ure out how the [1983] virus trans­formed itself into such a “hot” pathogen. Kawao­ka, now a pro­fes­sor of virol­o­gy at the Uni­ver­si­ty of Wis­con­sin, Madi­son, com­pared the genet­ic struc­ture of virus­es from the first and sec­ond waves and found only a sin­gle, extreme­ly sub­tle change in the H gene. The two virus­es dif­fered by just one nucleotide–one of 1,700 nucleotides that made up the gene.

    In 1997, Fau­ci reward­ed Short­ridge and Webster’s team for the H5N1 out­break by cre­at­ing and fund­ing the St. Jude Cen­ter of Excel­lence for Influen­za Research and Sur­veil­lance which con­tin­ues to oper­ate today in the U.S., Cana­da, Bangladesh, Chi­na, Colom­bia, and Egypt.

    Web­ster was one of the first gain-of-func­tion sci­en­tists, pub­lish­ing a suc­cess­ful cre­ation of a recom­bi­nant virus in 1973. As Lyle Fearn­ley writes in “Wild Goose Chase”:

    For an influen­za pan­dem­ic to arise, a new form of the virus is nec­es­sary, one able to escape the immune respons­es cul­ti­vat­ed by human pop­u­la­tions dur­ing pre­vi­ous flu out­breaks. The Amer­i­can Robert Web­ster had pre­vi­ous­ly shown that such new virus­es can be exper­i­men­tal­ly pro­duced in the lab­o­ra­to­ry: tak­ing virus­es derived from dif­fer­ent species, he co-infect­ed a sin­gle ani­mal host, a process that Web­ster and his coau­thors observed had encour­aged the two virus­es to swap genet­ic mate­r­i­al and cre­ate “recom­bi­nant” forms.

    There’s also a con­nec­tion to Fouch­i­er, through his men­tor at the Eras­mus Med­ical Cen­ter in Rot­ter­dam, the Nether­lands, Jan De Jong, also a col­league and col­lab­o­ra­tor of Short­ridge and Webster’s.

    Kawaoka’s col­league and men­tor Robert G. Web­ster and Fouchier’s col­league and men­tor Jan De Jong were the first sci­en­tists out­side of Hong Kong to receive sam­ples of the 1997 H5N1 flu from Shortridge’s lab.

    De Jong is often cred­it­ed with being the one who iden­ti­fied the 1997 Hong Kong flu as H5N1, but he did so with “a pan­el of reagents to every type of flu strain yet known” that had been brought from Webster’s lab in Mem­phis to the Nation­al Influen­za Cen­tre in Rot­ter­dam.

    Kawao­ka and Fouch­i­er are of post-Bio­log­i­cal Weapons Con­ven­tion era where the weaponiza­tion of pathogens is euphemisti­cal­ly called “gain-of-func­tion” research, but their old­er col­leagues, De Jong, Short­ridge and Web­ster came of age pri­or to 1972 and their men­tors were of the pre-Bio­log­i­cal Weapons Con­ven­tion era when virol­o­gists know­ing­ly and open­ly engi­neered virus­es for mil­i­tary pur­pos­es.

    Short­ridge and Web­ster were trained by Frank Mac­far­lane Bur­net who served on the Aus­tralian Depart­ment of Defence’s New Weapons and Equip­ment Devel­op­ment Com­mit­tee in the 1940s and 50s. The Fed­er­a­tion of Amer­i­can Sci­en­tists lists some of the most chill­ing things Bur­net rec­om­mend­ed:

    ...

    ———–

    “Is Bird Flu Being Weaponized?” by Alex­is Baden-May­er; Organ­ic Con­sumers Asso­ci­a­tion; 04/22/2022

    “Kawao­ka and Fouch­i­er are of post-Bio­log­i­cal Weapons Con­ven­tion era where the weaponiza­tion of pathogens is euphemisti­cal­ly called “gain-of-func­tion” research, but their old­er col­leagues, De Jong, Short­ridge and Web­ster came of age pri­or to 1972 and their men­tors were of the pre-Bio­log­i­cal Weapons Con­ven­tion era when virol­o­gists know­ing­ly and open­ly engi­neered virus­es for mil­i­tary pur­pos­es.”

    A tran­si­tion from overt for­mal bio­log­i­cal war­fare research pre-1972 to covert ‘gain-of-func­tion’ research for ‘defen­sive’ rea­sons fol­low­ing the Bio­log­i­cal Weapons Con­ven­tion. It’s that his­toric arc that omi­nous­ly guides us in this look at the kind of Pen­ta­gon-fund­ed bio­log­i­cal research that has been car­ried out in Ukraine over the past decade. We can’t make sep­a­rate the whole Metabio­ta sto­ry from the broad­er sto­ry of how bio­log­i­cal war­fare was giv­en a pub­lic mask in the form of ‘gain-of-func­tion’ research.

    And the two researchers who have long led the US gov­ern­men­t’s ‘gain-of-func­tion’ research into avian flu were none oth­er than the Ron Fouch­i­er at the Eras­mus Med­ical Cen­ter in Rot­ter­dam, the Nether­lands, and Yoshi­hi­ro Kawao­ka at the Uni­ver­si­ty of Wis­con­sin-Madi­son and the Uni­ver­si­ty of Tokyo. So when Kawao­ka and Fouch­i­er pub­lished their now noto­ri­ous 2011 study show­ing how they could eas­i­ly dri­ve the muta­tion of the dead­ly H5N1 avian flu to spread between fer­rets using sim­ple pas­sag­ing tech­niques, they were fol­low­ing in a long tra­di­tion of bio­log­i­cal war­fare research. A tra­di­tion they were direct­ly trained in by their men­tors.

    And as the piece describes, that now infa­mous research that result­ed in the cre­ation of a ver­sion of H5N1 that could infect fer­rets — and there­fore like­ly humans too — was com­mis­sioned in 2006 under an NIAID project. Bill Gates was even involved. It’s all why Russ­ian claims about weaponized bird flu virus­es being cre­at­ed in labs Ukraine aren’t some dark fan­ta­sy. This kind of research is extreme­ly well doc­u­ment­ed and already high­ly con­tro­ver­sial:

    ...
    As direc­tor of the Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases (NIAID), Fau­ci com­mis­sioned two gain-of-func­tion research teams with grants titled “Pan­dem­ic Poten­tial of H5N1 Influen­za Virus­es” and “Under­stand­ing the Emer­gence of High­ly Path­o­gen­ic Avian Influen­za Virus­es.

    Gates chipped in, too, with grants 48339 and OPPGH5383 from the Bill & Melin­da Gates Foun­da­tion. (Ice Age Farmer’s West­brook found a lot more doc­u­men­ta­tion of Gates’ fund­ing of gain-of-func­tion research to make high­ly path­o­gen­ic avian influen­za even more path­o­gen­ic and trans­mis­si­ble.)

    The sci­en­tists Fau­ci chose to lead the H5N1 teams, Ron Fouch­i­er at the Eras­mus Med­ical Cen­ter in Rot­ter­dam, the Nether­lands, and Yoshi­hi­ro Kawao­ka at the Uni­ver­si­ty of Wis­con­sin-Madi­son and the Uni­ver­si­ty of Tokyo, were sci­en­tists Fau­ci had fund­ed since 1990 under grants with titles includ­ing “Influen­za Virus Assem­bly.”

    ...

    Fouch­i­er and Kawaoka’s now infa­mous gain-of-func­tion research showed that, through lab manip­u­la­tion, H5N1 could be altered to become high­ly trans­mis­si­ble among humans via air­borne infec­tion.
    ...

    But Fouch­i­er and Kawao­ka did­n’t start their gov­ern­ment-fund­ed avian flu gain-of-func­tion efforts in 2006. They had been doing it since 1990. Research that was direct­ly relat­ed to the avian flu research tak­ing place in Kennedy Short­ridge’s lab in Hong Kong. Short­ridge was direct­ly involved in the ini­tial iden­ti­fi­ca­tion of the first known instance of avian flu infect­ing humans: the 1997 H5N1 Hong Kong out­break. It turns out Kawaoka’s men­tor, Robert G. Web­ster, was work­ing and pub­lish­ing with Short­ridge through­out the 90s and spent three months each year with Short­ridge at the Uni­ver­si­ty of Hong Kong. Web­ster was one of the first gain-of-func­tion sci­en­tists, pub­lish­ing a suc­cess­ful cre­ation of a recom­bi­nant virus in 1973. So sev­en years before the first known instance of avian flu jump­ing to humans, we had gov­ern­ment fund­ed research into learn­ing how to make that hap­pen. And one of the fig­ures involved, Web­ster, is one of the pio­neers of gain-of-func­tion tech­niques. It’s the kind of his­to­ry that reminds us that not only has this kind of research been hap­pen­ing for years, but we’re also still fair­ly new at it. The pio­neers cur­rent lead­ers in the field were trained by the pio­neers in the field:

    ...
    The first human H5N1 out­break occurred in Hong Kong in 1997, the year of what the British call the “Hong Kong han­dover,” when sov­er­eign­ty over Hong Kong was trans­ferred from the U.K. to Chi­na.

    It was dur­ing this “polit­i­cal­ly sen­si­tive” year that Kennedy Short­ridge, an Aus­tralian sci­en­tist who was the direc­tor of the World Health Orga­ni­za­tion’s ref­er­ence lab­o­ra­to­ry at the Uni­ver­si­ty of Hong Kong, con­firmed human cas­es of high­ly path­o­gen­ic bird flu.

    Shortridge’s col­league Yuen Kwok-Yung attend­ed to the H5N1 patients and devised a rapid diag­nos­tic test known as RT-PCR to ana­lyze res­pi­ra­to­ry secre­tions from these patients. As they pub­lished in the Lancet, this was the first time that a pure­ly avian virus had been iso­lat­ed from peo­ple with a res­pi­ra­to­ry dis­ease and the first time that a PCR test was used for rapid diag­no­sis of such patients in a clin­i­cal set­ting.

    ...

    Time mag­a­zine report­ed, “On the H gene at a point called the cleav­age site, [was] found a tell­tale muta­tion, the same kind of muta­tion found in oth­er high­ly path­o­gen­ic avian virus­es. …The virus … had regions that were iden­ti­cal to por­tions of [an] avian virus that struck Penn­syl­va­nia [chick­ens] in 1983.”

    ...

    At the time, the nat­ur­al leap of a flu direct­ly from poul­try to humans was thought to be so unlike­ly that sci­en­tists first sus­pect­ed con­t­a­m­i­na­tion from Shortridge’s lab was the cause of the high­ly improb­a­ble H5N1 diag­no­sis.

    ...

    Fau­ci had been fund­ing Kawao­ka and Fouchier’s efforts to get bird flu to leap to humans since 1990 and their work was con­nect­ed to what Short­ridge was doing in Hong Kong. For sev­en years pri­or to the first human H5N1 out­break in 1997, Fau­ci had been fund­ing Kawaoka’s gain-of-func­tion bird flu research at St. Jude Children’s Research Hos­pi­tal and Kawaoka’s men­tor there, Robert G. Web­ster, was work­ing and pub­lish­ing with Short­ridge. Every year, Web­ster spent three months work­ing with Short­ridge at the Uni­ver­si­ty of Hong Kong, accord­ing to this pro­file of Web­ster which men­tions Kawao­ka as his pro­tege.

    ...

    Web­ster was one of the first gain-of-func­tion sci­en­tists, pub­lish­ing a suc­cess­ful cre­ation of a recom­bi­nant virus in 1973. As Lyle Fearn­ley writes in “Wild Goose Chase”:

    ...

    There’s also a con­nec­tion to Fouch­i­er, through his men­tor at the Eras­mus Med­ical Cen­ter in Rot­ter­dam, the Nether­lands, Jan De Jong, also a col­league and col­lab­o­ra­tor of Short­ridge and Webster’s.
    ...

    And then we get to the chill­ing his­toric tie back to the bio­log­i­cal war­fare norms of the 1940s and 50s: both Short­ridge and Web­ster were trained by none oth­er than Frank Mac­far­lane Bur­net:

    ...
    Short­ridge and Web­ster were trained by Frank Mac­far­lane Bur­net who served on the Aus­tralian Depart­ment of Defence’s New Weapons and Equip­ment Devel­op­ment Com­mit­tee in the 1940s and 50s. The Fed­er­a­tion of Amer­i­can Sci­en­tists lists some of the most chill­ing things Bur­net rec­om­mend­ed:
    ...

    And that all brings us to the the ques­tion of what kind of research has the Pen­ta­gon been financ­ing in Ukraine. Rus­sia has basi­cal­ly be assert­ing that Ukraine has become the Pen­tagons new loca­tion of choice for avian flu gain-of-func­tion research. Claims based on pub­lic sources and claims that US gov­ern­ment has­n’t denied. So it’s impor­tant to keep in mind anoth­er aspect of the US’s gain-of-func­tion research that was a direct result of the infa­mous 2011–2012 fer­ret pas­sag­ing exper­i­ments: The NIH’s 2014 three-year ban on new gain-of-func­tion research imposed as a result of the out­cry over Fluchier’s and Kawaoka’s dan­ger­ous stud­ies. And while that ban was lift­ed by the Trump admin­is­tra­tion in 2017, it under­scores one of the key dynam­ics we should keep in mind in with this top­ic: this kind of research is so dan­ger­ous it might get banned. At least banned in some coun­tries. Hav­ing research like this take place in Ukraine (or at the WIV in Wuhan) solves a lot of these pub­lic rela­tions prob­lems:

    ...
    Russia’s infor­ma­tion on U.S. fund­ing of pathogen research in Ukraine was gleaned from pub­lic sources. Rob­bie Mar­tin of Media Roots Radio has com­piled the doc­u­men­ta­tion in a search­able data­base housed by Our Hid­den His­to­ry. Mar­tin did a great pod­cast on the sub­ject, “Is the US Mak­ing Bioweapons Under the Guise of ‘Biode­fense’ in Ukraine & Else­where? w/ Gum­by

    ...

    Cur­rent­ly, the project lead for U.S.-funded H5N1 research in Ukraine (the Pentagon’s Defense Threat Reduc­tion Agency (DTRA) refers to it as UP‑4 or Ukraine Project 4) is Denys Muzy­ka. (The link goes to his pub­li­ca­tions on Google Schol­ar.)

    This is all very well doc­u­ment­ed and the U.S. has­n’t denied it (although it insists it is in full com­pli­ance with the Bio­log­i­cal Weapons Con­ven­tion):
    ...

    Then there’s the tim­ing of when the US began invest­ing in this biore­search col­lab­o­ra­tion in Ukraine: Black & Veatch got a total of $208.5 mil­lion in Pen­ta­gon con­tracts to design, con­struct and equip 11 bio-labs in Ukraine in 2008, 2012 and 2020, com­plet­ing Ukraine’s first Bio-Safe­ty Lev­el 3 (BSL‑3) lab­o­ra­to­ry in 2010. So this rela­tion­ship start­ed back in 2008, when the NIAID was still fund­ing Fouch­ier’s and Kawaoka’s gain-of-func­tion research on H5N1 and before all the pub­lic out­cry over their pub­li­ca­tions on that research in 2011–2012:

    ...
    Begin­ning in 2018, Dilyana Gay­tandzhie­va of Arm­sWatch pub­lished a series of reports on U.S.-funded bio­labs, reveal­ing that defense con­trac­tor Black & Veatch got a total of $208.5 mil­lion in Pen­ta­gon con­tracts to design, con­struct and equip 11 bio-labs in Ukraine in 2008, 2012 and 2020. The com­pa­ny com­plet­ed Ukraine’s first Bio-Safe­ty Lev­el 3 (BSL‑3) lab­o­ra­to­ry in 2010. Black & Veatch also main­tains the Pentagon’s sys­tems in Ukraine for the “con­trol and account­ing of bio­log­i­cal mate­ri­als in lab­o­ra­to­ries” and the “ear­ly detec­tion of a dis­ease out­break and assist[ance] in an effec­tive response.”
    ...

    Also note how Metabio­ta’s Pen­ta­gon con­tract for research into Ukraine includes $307,091 mil­lion for “Ukraine Research Projects” in 2014. For starters, the fact that this hap­pened in 2014 sug­gests these new projects were being approved by the new­ly installed post-Maid­an gov­ern­ment that was heav­i­ly depen­dent on US mil­i­tary sup­port as the coun­try descend­ed into civ­il war. But also keep in mind that it was 2014 when the NIH paused new fund­ing for gain-of-func­tion research fol­low­ing the pub­lic out­cry over Fouch­ier’s and Kawaoka’s exper­i­ments. The tim­ing of that 2014 Metabio­ta Ukrain­ian work sure was con­ve­nient. Con­ve­nient both in terms of the NIH gain-of-func­tion pause but also con­ve­nient in that the Ukrain­ian gov­ern­ment was prob­a­bly the most recep­tive its ever been towards pla­cat­ing US requests for oth­er­wise con­tro­ver­sial projects:

    ...
    Gay­tandzhie­va was also the first to report Metabiota’s Pen­ta­gon con­tracts to research pathogens in Ukraine.

    Metabio­ta received a Pen­ta­gon con­tract worth up to $23.9 mil­lion that includ­ed a 2014 line item allo­cat­ing $307,091 for “Ukraine Research Projects.”. As men­tioned above, Rus­sia claimed that the U.S. labeled its Ukraine bio­lab projects as UP for Ukraine Project and gave them num­bers. This match­es the way Amer­i­can sci­en­tists work­ing on these projects refer to them, but they call them “Metabio­ta Ukraine Projects.” For exam­ple, there’s this ref­er­ence to “Metabio­ta UP‑8” on LinkedIn.
    ...

    Also note how the DRTA isn’t the only US agency fund­ing these research efforts in Ukraine led by Black & Veatch and Metabio­ta. The Cen­ter of Excel­lence for Influen­za Research and Sur­veil­lance (CEIRS) — part of the NIAID — is also involved:

    ...
    Black & Veatch and Metabio­ta co-lead the Defense Threat Reduc­tion Agency’s so-called Sci­ence Writ­ers Men­tor­ship Pro­gram (SWMP) in Ukraine, begun in 2016. That’s how the Pen­ta­gon puts one degree of sep­a­ra­tion between itself and Ukrain­ian sci­en­tists. The sci­en­tists put a dis­claimer on their pub­lished research that says that their research isn’t fund­ed by DTRA but their pub­li­ca­tions are, through the SWMP.

    For exam­ple, the authors of “Phy­lo­ge­net­ic Analy­sis of H5N8 High­ly Path­o­gen­ic Avian Influen­za Virus­es in Ukraine, 2016–2017thank “Greg Glass [pro­gram direc­tor for DTRA’s Coop­er­a­tive Bio­log­i­cal Engage­ment Pro­gram (CBEP) in Ukraine] and the sci­en­tif­ic staff at BV/Metabiota (Kyiv, Ukraine) for crit­i­cal read­ing and assis­tance with prepa­ra­tion of the arti­cle.” They also thank the “Sci­ence Writ­ers Men­tor­ship Pro­gram (SWMP) for their sup­port in pro­vid­ing resources for writ­ing this man­u­script.” Then, they claim that “DTRA/CBEP did not direct­ly sup­port the research described here­in.” They leave out the fact that they work in lab­o­ra­to­ries designed, built and equipped by the Pen­ta­gon. But, their most reveal­ing acknowl­edg­ment is to the Cen­ter of Excel­lence for Influen­za Research and Sur­veil­lance (CEIRS).
    ...

    But the US-fund­ed bio­log­i­cal research efforts in Ukraine aren’t just being led by Black & Veatch and Metabio­ta. South­ern Research and Bat­telle are also involved. The piece links to a short Youtube video by Greg Reese where those con­nec­tions are laid out. Note that Greg Reese sad­ly made that video as a part of InfoWars, mean­ing it effec­tive­ly has neg­a­tive cred­i­bil­i­ty. But that’s part of why the pub­lic nature of the evi­dence of all of this is so impor­tant to keep in mind: whether we’re talk­ing about garbage sources like InfoWars or obvi­ous­ly biased sources like the Russ­ian ambas­sador, the evi­dence for this is based on pub­licly avail­able infor­ma­tion:

    ...
    In addi­tion to Black & Veatch, Fauci’s Cen­ter of Excel­lence for Influen­za Research and Sur­veil­lance, and Metabio­ta, there are two oth­er notable U.S. orga­ni­za­tions work­ing in the Pen­ta­gon-fund­ed bio­labs in Ukraine: South­ern Research and Bat­telle.

    South­ern Research has had Pen­ta­gon projects in Ukraine since 2008 and a Ukraine office since 2010. It has received $688.5 mil­lion in gov­ern­ment fund­ing since 2001.

    Accord­ing to this LinkedIn pro­file, Bat­telle is also oper­at­ing Ukraine bio­labs, run­ning Pen­ta­gon-fund­ed “projects in Virol­o­gy, Bac­te­ri­ol­o­gy, Decon­t­a­m­i­na­tion, Aerosol sci­ence, BSL‑2/3 lab­o­ra­to­ry activ­i­ties, CONOP, Data Ana­lyt­ics and Mol­e­c­u­lar Biol­o­gy.”

    ...

    Bat­telle, Metabio­ta and South­ern Research’s involve­ment con­nects U.S.-funded pathogens research in Ukraine to two very hot top­ics: 1) the Biden family’s eco­nom­ic inter­ests in Ukraine; and 2) the truth about COVID-19, as well a much old­er inci­dent that shouldn’t be mem­o­ry-holed: the 2001 anthrax attacks.

    [see video]

    The above video from the Reese Report, ties it all togeth­er, but here are a few addi­tion­al details, as well as infor­ma­tion about how Metabio­ta, Eco­Health Alliance, South­ern Research and Bat­telle link back to the 2001 anthrax attacks.
    ...

    Then we get to the fas­ci­nat­ing ties con­nect­ing Metabio­ta to the ori­gins of COVID019: it turns out the com­pa­ny was part of the PREDICT team hunt­ing virus­es in Chi­na in 2013 when they found the RaTG13 virus. Recall how we’ve now learned that Shi Zhengli’s lab at the WIV has not only start­ed sequenc­ing the RaTG13 viral genome back in 2017, but they pub­lished some of that work in a PhD dis­seartion that became part of a 2017 pub­lished paper co-authored with Peter Daszak of the Eco­Health Alliance. So when we learn that Metabio­ta was involved with the efforts to obtain that ini­tial RaTG13 sam­ple back in 2013, we also have to ask if they were involved with all of the sub­se­quent research we now know took place.

    But it’s also impor­tant to keep in mind that Metabio­ta was orig­i­nal­ly fund­ed by Google, with addi­tion funds com­ing from the Skoll Foun­da­tion, the Bill & Melin­da Gates Foun­da­tion, Mer­ck Research Lab­o­ra­to­ries and the US Depart­ment of Defense. And this group of Metabio­ta investors just hap­pened to finance the COVID Com­mis­sion Plan­ning Group, head­ed by 9/11 cov­er-up artist Philip Zelikow. So when we hear Jef­frey Sachs slam­ming the COVID Com­mis­sion inves­ti­ga­tion for being rid­dled with con­flicts of inter­est, that’s part of what he’s talk­ing about:

    ...
    Metabio­ta was part of the PREDICT team hunt­ing virus­es in Chi­na in 2013 when they found what it now believed to be the clos­est known rel­a­tive of SARS-CoV­‑2, a bat virus named RaTG13. PREDICT is a USAID project, fund­ed by U.S. tax dol­lars, but it got its start at Google.org.

    In 2008, Google.org com­mit­ted $30 mil­lion to virus hunt­ing and gain-of-func­tion research on poten­tial pan­dem­ic pathogens through a project it called Pre­dict and Pre­vent. At least $5.5 mil­lion of that went to Dr. Nathan Wolfe’s non-prof­it Glob­al Viral Fore­cast­ing Ini­tia­tive, which was soon to become the for-prof­it Metabio­ta. Oth­er GVFI fun­ders at the time includ­ed the Skoll Foun­da­tion, which also gave $5.5 mil­lion, the Bill & Melin­da Gates Foun­da­tion, Mer­ck Research Lab­o­ra­to­ries and the US Depart­ment of Defense.

    ...

    Now that Metabio­ta has got­ten caught up in the COVID ori­gins scan­dal, its orig­i­nal investors, Eric Schmidt of Google, Jef­frey Skoll of EBay, Rajiv Shah of The Rock­e­feller Foun­da­tion (for­mer­ly USAID direc­tor, Bill & Melin­da Gates Foun­da­tion) chipped in to fund the COVID Com­mis­sion Plan­ning Group, a white-wash led by Philip Zelikow who gave us the 9–11 Com­mis­sion cov­er-up.
    ...

    Anoth­er very inter­est­ing fig­ure in all of this is David Franz, a sci­ence and pol­i­cy advi­sor for the Eco­Health Alliance. As we’ve seen, Franz is a for­mer com­man­der of Fort Det­rick. Franz went on to work at South­ern Research on DARPA relat­ed work involv­ing the weaponiza­tion of anthrax. Anthrax that inves­ti­ga­tors have foren­si­cal­ly tied back to the 2001 anthrax attacks. It’s the kind of resume that sug­gests Franz isn’t lack­ing in expe­ri­ence involv­ing high­ly sen­si­tive secret biowar­fare pro­grams:

    ...
    One of Metabiota’s PREDICT part­ners is Eco­Health Alliance, whose sci­ence and pol­i­cy advi­sor, David Franz, pro­duced the anthrax used in the 2001 attacks while work­ing for South­ern Research and part­ner­ing with sci­en­tists at Bat­telle.

    Franz, a for­mer com­man­der of the U.S. Army Med­ical Research Insti­tute of Infec­tious Dis­eases went from Fort Det­rick to work­ing at South­ern Research for the Pentagon’s Defense Advanced Research Projects Agency (DARPA), which from 1999–2001 con­tract­ed with Advanced Biosys­tems for microen­cap­su­lat­ed anthrax. Franz’s South­ern Research was a sub­con­trac­tor on that project. His part­ners, Advanced Biosys­tems’ Ken Alibek, a for­mer Sovi­et bioweapons sci­en­tist, and Charles L. Bai­ley, anoth­er for­mer Fort Det­rick com­man­der, filed a patent on the sil­i­con microen­cap­su­la­tion tech­nol­o­gy in 2001. In their 2012 arti­cle in the peer-reviewed Jour­nal of Bioter­ror­ism & Biode­fense, “Evi­dence for the Source of the 2001 Attack Anthrax,” Mar­tin E. Hugh-Jones, Bar­bara Hatch Rosen­berg and Stu­art Jacob­sen link the foren­sic evi­dence from the attack anthrax to the Alibek, Bai­ley and Franz’s microen­cap­su­la­tion tech­niques. The trio like­ly engi­neered the attack anthrax in Battelle’s West Jef­fer­son, Ohio, facil­i­ty. As Whit­ney Webb has report­ed, the Pen­ta­gon con­tract­ed with Bat­telle to “cre­ate the genet­i­cal­ly-mod­i­fied anthrax, a task that was over­seen by Battelle’s then-pro­gram man­ag­er for all things bioweapons, Ken Alibek.”
    ...

    Again, all of this analy­sis was based on pub­licly avail­able infor­ma­tion. We cer­tain­ly need to ask more ques­tions about the nature of this cov­er bio­log­i­cal research activ­i­ty. But we don’t have to ask if it’s hap­pen­ing. It’s def­i­nite­ly hap­pen­ing and has been for decades. Includ­ing years of Pen­ta­gon fund­ed research in Ukraine. The ques­tion at this point is where the research involv­ing gain-of-func­tion research involv­ing the weaponiza­tion of avian flu is tak­ing place. Ukraine? Some­where else? We don’t know. But we can be very con­fi­dent, based on pub­licly avail­able infor­ma­tion, that it’s hap­pen­ing. And has been for quite a while in a lot of dif­fer­ent coun­tries.

    Posted by Pterrafractyl | May 31, 2022, 5:30 pm
  7. This could become a very inter­est­ing law­suit: Mod­er­na is get­ting extra greedy again. In a new­ly filed law­suit, Mod­er­na asserts that the Pfizer/BioNTech mRNA coro­n­avirus vac­cines are infring­ing on Mod­er­na’s patents. On one lev­el it’s not par­tic­u­lar­ly sur­pris­ing. But what’s rather eye­brow-rais­ing in this law­suit is the time­frame of Mod­er­na’s claims. The com­pa­ny is argu­ing that Pfiz­er’s vac­cine basi­cal­ly copied work Mod­er­na had already done on coro­n­avirus vac­cines involv­ing human tri­als going back to 2015 and 2016. Beyond that, Mod­er­na asserts the the full-sequence coro­n­avirus spike pro­tein used in Pfiz­er’s vac­cine was devel­oped by Mod­er­na years before the pan­dem­ic. So this is poten­tial­ly the kind of law­suit that could end up reveal­ing all sorts of infor­ma­tion about the nature of Mod­er­na’s pre-pan­dem­ic coro­n­avirus-relat­ed research.

    And per­haps the biggest set of ques­tions that might be answered in this law­suit involve Mod­er­na’s pos­si­ble col­lab­o­ra­tive role in the broad­er US-gov­ern­ment-fund­ed gain-of-func­tion research being lead by the Eco­HealthAl­liance in col­lab­o­ra­tion with labs around the world like Shi Zhengli’s lab at the Wuhan Insti­tute of Virol­o­gy (WIV) and Ralph Bar­ic’s lab at UNC Chapel Hill. As we’ve seen, Ralph Bar­ic was work­ing on devel­op­ing coro­n­avirus ther­a­peu­tics back in 2017 using gain-of-func­tion-cre­at­ed coro­n­avirus­es in col­lab­o­ra­tion with Shi Zhengli’s lab at the WIV. And Bar­ic also helped test the Mod­er­na covid vac­cine in 2020. So was Mod­er­na — which was fund­ed by DARPA — at all involved in this oth­er NIH-fund­ed coro­n­avirus-relat­ed gain-of-func­tion work? The cir­cum­stan­tial evi­dence sure points in that direc­tion.

    And then there’s the part of the law­suit claim­ing that Pfiz­er effec­tive­ly stole the full-sequence coro­n­avirus spike pro­tein sequence Mod­er­na had worked out years ear­li­er. This is a some­what con­fus­ing part of the law­suit since, as we’ve been told, it was the SARs-CoV­‑2 spike pro­tein sequence that was at the heart of the mRNA COVID vac­cine devel­oped in record-break­ing time back in Jan­u­ary of 2020. So what is Mod­er­na talk­ing about when claim­ing that it already devel­oped a coro­n­avirus spike pro­tein years ear­li­er. Well, recall how Mod­er­na was crit­i­cized back in 2020 over its deci­sion to file a patent in Feb 2020 for a “Beta­coro­n­avirus vac­cine” — a broad-spec­trum vac­cine designed for non-COVID coro­n­avirus­es — with­out acknowl­edg­ing the US gov­ern­ments role in that research. Pfizer/BioNTech filed a patent for a sim­i­lar “uni­ver­sal coro­n­avirus vac­cine” back in June. So odds are that’s what Mod­er­na is refer­ring to when it claims to have devel­oped a coro­n­avirus spike pro­tein sequence years before the pan­dem­ic. But, again, that just rais­es the obvi­ous ques­tion: was Mod­er­na part of the whole Eco­HealthAl­liance gain-of-func­tion research on coro­n­avirus­es back in their 2015–2016 peri­od? Don’t for­get that gain-of-func­tion research was tech­ni­cal­ly banned in the US from 2014 until the Trump admin­is­tra­tion lift­ed it in 2017. Also recall how Bar­ic’s gain-of-func­tion work that was start­ed before the mora­to­ri­um was put into place was allowed to con­tin­ue under a spe­cial exemp­tion. So if Mod­er­na’s coro­n­avirus vac­cine devel­op involved the use of any virus­es being gen­er­at­ed by Bar­ic under and exemp­tion to the gain-of-func­tion mora­to­ri­um, that would obvi­ous­ly be a very sen­si­tive area of research.

    There’s anoth­er facet of this sto­ry to keep in mind: recall that fas­ci­nat­ing Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics — which require numer­ous shots over years — to mRNA vac­cines. It was seen as as dis­ap­point­ment by indus­try observers and sign that Mod­er­na was run­ning into undis­closed set­backs involv­ing side effects trig­gered by the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA. But as we saw, Mod­er­na was insist­ing at the time that it was expe­ri­enc­ing no such set backs. And yet observers were just forced to take their word because the com­pa­ny was being so secre­tive and releas­ing almost no infor­ma­tion about its inter­nal tri­als. There is no men­tion of coro­n­avirus-relat­ed research at all in that arti­cle, while there is men­tion of work on things like a Zika virus vac­cine. And yet, in the new law­suit, Mod­er­na claims it suc­cess­ful­ly car­ried out human tri­als on a coro­n­avirus vac­cine as far back as 2015. It would seem that Mod­er­na’s coro­n­avirus-relat­ed vac­cine research was being kept under wraps dur­ing this peri­od.

    So while it has long appeared that Mod­er­na’s secre­cy dur­ing this peri­od was like­ly dri­ven by a desire to cov­er up side effects-relat­ed set­backs, we also have to ask if the extreme secre­cy around its work dur­ing this peri­od was dri­ven in part by the con­tro­ver­sial nature of devel­op­ing coro­n­avirus vac­cines using gain-of-func­tion coro­n­avirus­es gen­er­at­ed by the Eco­HealthAl­liance net­work. We don’t know for sure that Mod­er­na was doing that, but boy is the cir­cum­stan­tial evi­dence point­ing in that direc­tion. Will any still-secret research from that peri­od get released as part of this law­suit? Let’s hope so:

    The New York Times

    Mod­er­na Sues Pfiz­er and BioN­Tech Over Covid Vac­cine

    The law­suit, filed Fri­day, claims that the com­pa­nies’ Covid vac­cine vio­lat­ed Moderna’s mRNA patents.

    By Jen­ny Gross and Rebec­ca Rob­bins

    Aug. 26, 2022 Updat­ed 11:49 a.m. ET

    The vac­cine man­u­fac­tur­er Mod­er­na sued Pfiz­er and BioN­Tech on Fri­day, claim­ing that its rivals’ Covid-19 shot vio­lates its patents pro­tect­ing its ground­break­ing tech­nol­o­gy.

    Mod­er­na said in a state­ment that Pfiz­er and BioN­Tech infringed on patents filed between 2010 and 2016 that cov­ered its mRNA tech­nol­o­gy. Mod­er­na, which is based in Cam­bridge, Mass., sued in U.S. Dis­trict Court in Mass­a­chu­setts and the Region­al Court of Düs­sel­dorf in Ger­many, where BioN­Tech is based.

    Christo­pher Rid­ley, a spokesman for Mod­er­na, said the com­pa­ny did not have an esti­mate for the amount of dam­ages it was seek­ing.

    Pfiz­er and its devel­op­ment part­ner BioN­Tech were “sur­prised by the lit­i­ga­tion,” said Jer­i­ca Pitts, a spokes­woman for Pfiz­er. She added that the com­pa­nies “remain con­fi­dent in our intel­lec­tu­al prop­er­ty sup­port­ing the Pfizer/BioNTech vac­cine and will vig­or­ous­ly defend against the alle­ga­tions of the law­suit.”

    Mes­sen­ger RNA, or mRNA, is the genet­ic script that car­ries DNA instruc­tions to each cell’s pro­tein-mak­ing machin­ery and has been used in the pro­duc­tion of coro­n­avirus vac­cines.

    “We are fil­ing these law­suits to pro­tect the inno­v­a­tive mRNA tech­nol­o­gy plat­form that we pio­neered, invest­ed bil­lions of dol­lars in cre­at­ing, and patent­ed dur­ing the decade pre­ced­ing the Covid-19 pan­dem­ic,” said Stéphane Ban­cel, Moderna’s chief exec­u­tive. “This foun­da­tion­al plat­form, which we began build­ing in 2010, along with our patent­ed work on coro­n­avirus­es in 2015 and 2016, enabled us to pro­duce a safe and high­ly effec­tive Covid-19 vac­cine in record time after the pan­dem­ic struck.”

    Mod­er­na, which received close to $10 bil­lion in tax­pay­er fund­ing to devel­op the vac­cine, test it and pro­vide dos­es to the fed­er­al gov­ern­ment, had said in fall 2020 that it would not enforce its Covid-relat­ed patents while the pan­dem­ic con­tin­ued. But on March 7, the com­pa­ny said that said that it was updat­ing its pledge, since vac­cine sup­ply was no longer an issue out­side the poor­est coun­tries. It said it expect­ed man­u­fac­tur­ers out­side the 92 poor­est coun­tries to respect the company’s intel­lec­tu­al prop­er­ty. At the time, it also said that it was expand­ing its patent pledge to nev­er enforce Covid patents for 92 low- and mid­dle-income coun­tries.

    Mod­er­na said on Fri­day that it was not seek­ing dam­ages for activ­i­ties before March 8 and that none of the patents relate to intel­lec­tu­al prop­er­ty gen­er­at­ed dur­ing Moderna’s col­lab­o­ra­tion with the Nation­al Insti­tutes of Health on Covid-19, which it said began only after patent­ed tech­nolo­gies were proven suc­cess­ful in 2015 and 2016.

    Mod­er­na said that Pfiz­er copied two fea­tures of its patent­ed tech­nol­o­gy. First, Pfiz­er took four vac­cine can­di­dates into clin­i­cal test­ing, but ulti­mate­ly pro­ceed­ed with a vac­cine with the same mRNA tech­nol­o­gy as the Mod­er­na vac­cine. Mod­er­na said it was the first com­pa­ny to val­i­date this tech­nol­o­gy in human tri­als in 2015, and that nei­ther Pfiz­er nor BioN­Tech had its lev­el of expe­ri­ence in devel­op­ing mRNA vac­cines for infec­tious dis­eases.

    Sec­ond, Mod­er­na claims that Pfiz­er and BioN­Tech copied its full-length spike pro­tein for­mu­la­tion for a coro­n­avirus, which Mod­er­na had cre­at­ed years before Covid-19 emerged. Coro­n­avirus­es refer to a large fam­i­ly of virus­es that cause mild to mod­er­ate upper res­pi­ra­to­ry tract ill­ness­es, accord­ing to the N.I.H. The more seri­ous ones include SARS, MERS and Covid-19.

    Mod­er­na said it was not seek­ing to remove Pfiz­er and BioNTech’s vac­cines from the mar­ket, and was not ask­ing for an injunc­tion to pre­vent their future sale, giv­en the need for access to coro­n­avirus vac­cines.

    ...

    ————

    “Mod­er­na Sues Pfiz­er and BioN­Tech Over Covid Vac­cine” By Jen­ny Gross and Rebec­ca Rob­bins; The New York Times; 08/26/2022

    ““We are fil­ing these law­suits to pro­tect the inno­v­a­tive mRNA tech­nol­o­gy plat­form that we pio­neered, invest­ed bil­lions of dol­lars in cre­at­ing, and patent­ed dur­ing the decade pre­ced­ing the Covid-19 pan­dem­ic,” said Stéphane Ban­cel, Moderna’s chief exec­u­tive. “This foun­da­tion­al plat­form, which we began build­ing in 2010, along with our patent­ed work on coro­n­avirus­es in 2015 and 2016, enabled us to pro­duce a safe and high­ly effec­tive Covid-19 vac­cine in record time after the pan­dem­ic struck.””

    A law­suit based on Mod­er­na’s coro­n­avirus vac­cine work from 2015 and 2016. This could be quite an inter­est­ing law­suit. How much are we going to learn about that ear­ly coro­n­avirus vac­cine research? A lot, hope­ful­ly. Because at this point we still don’t actu­al­ly know all that much about Mod­er­na’s pre-COVID work on vac­cines, let alone coro­n­avirus vac­cines. Was this work in con­junc­tion with the Eco­HealthAl­liance’s pre-COVID coro­n­avirus gain-of-func­tion research? As we’ve seen, Ralph Bar­ic was work­ing on devel­op­ing coro­n­avirus ther­a­peu­tics back in 2017 using gain-of-func­tion-cre­at­ed coro­n­avirus­es in col­lab­o­ra­tion with Shi Zhengli’s lab at the WIV. And Bar­ic also helped test the Mod­er­na covid vac­cine in 2020. So was Bar­ic or any­one else involved in the coro­n­avirus gain-of-func­tion research dur­ing this pre-pan­dem­ic peri­od also work­ing with Mod­er­na on theri coro­n­avirus vac­cines? Hope­ful­ly we’ll be get­ting some more info on that as this law­suit plays out. Because at this point, the main detail that we know about Mod­er­na’s pre-pan­dem­ic coro­n­avirus vac­cine research is that the com­pa­ny got bil­lions in tax pay­er mon­ey to car­ry it out. And yet, accord­ing to Mod­er­na, none of the patent dis­putes in this law­suit involve work that was done post-COVID. This was all pre-COVID work. In fact, Mod­er­na assert that it first val­i­dat­ed the tech­nol­o­gy in human tri­als in 2015. It sure sounds like Mod­er­na was engaged in a lot of pre-COVD coro­n­avirus vac­cine research, includ­ing human tri­als of coro­n­avirus vac­cines:

    ...
    Mod­er­na, which received close to $10 bil­lion in tax­pay­er fund­ing to devel­op the vac­cine, test it and pro­vide dos­es to the fed­er­al gov­ern­ment, had said in fall 2020 that it would not enforce its Covid-relat­ed patents while the pan­dem­ic con­tin­ued. But on March 7, the com­pa­ny said that said that it was updat­ing its pledge, since vac­cine sup­ply was no longer an issue out­side the poor­est coun­tries. It said it expect­ed man­u­fac­tur­ers out­side the 92 poor­est coun­tries to respect the company’s intel­lec­tu­al prop­er­ty. At the time, it also said that it was expand­ing its patent pledge to nev­er enforce Covid patents for 92 low- and mid­dle-income coun­tries.

    Mod­er­na said on Fri­day that it was not seek­ing dam­ages for activ­i­ties before March 8 and that none of the patents relate to intel­lec­tu­al prop­er­ty gen­er­at­ed dur­ing Moderna’s col­lab­o­ra­tion with the Nation­al Insti­tutes of Health on Covid-19, which it said began only after patent­ed tech­nolo­gies were proven suc­cess­ful in 2015 and 2016.

    Mod­er­na said that Pfiz­er copied two fea­tures of its patent­ed tech­nol­o­gy. First, Pfiz­er took four vac­cine can­di­dates into clin­i­cal test­ing, but ulti­mate­ly pro­ceed­ed with a vac­cine with the same mRNA tech­nol­o­gy as the Mod­er­na vac­cine. Mod­er­na said it was the first com­pa­ny to val­i­date this tech­nol­o­gy in human tri­als in 2015, and that nei­ther Pfiz­er nor BioN­Tech had its lev­el of expe­ri­ence in devel­op­ing mRNA vac­cines for infec­tious dis­eases.
    ...

    And that brings us to the fol­low­ing very inter­est­ing detail in Mod­er­na’s com­plaint: the com­pa­ny is also assert­ing that Pfiz­er and BioN­Tech copied Mod­er­na’s full-length spike pro­tein for­mu­la­tion for a coro­n­avirus, which Mod­ern claims to have cre­at­ed years before the emer­gence of COVID-19. So what exact­ly is Mod­er­na claim­ing here? Recall how the shar­ing of the genet­ic sequence of SAR-CoV­‑2 by Chi­nese researchers with the glob­al com­mu­ni­ty allowed for Mod­er­na to and its NIH col­lab­o­ra­tors to design the vac­cine in just two days with just that spike pro­tein sequence infor­ma­tion. So if Mod­er­na is suing Pfiz­er over the theft of a coro­n­avirus spike pro­tein sequence devel­oped years ear­li­er, we have to ask whether or not this part of the law­suit is relat­ed to the “uni­ver­sal coro­n­avirus” vac­cine Pfiz­er and BioN­Tech start­ed test­ing back in June. Recall how Mod­er­na caught flack back in August of 2020 after it filed patents relat­ed to the coro­n­avirus vac­cine that did­n’t dis­close the bil­lions in dol­lars in DARPA mon­ey, includ­ing DARPA involve­ment in the devel­op­ment of a broad spec­turm “Beta­coro­n­avirus” vac­cine that Mod­er­na had filed a patent for in Feb­ru­ary 2020. And that, again, returns us to ques­tions regard­ing Mod­er­na’s involve­ment with the pre-pan­dem­ic gain-of-func­tion coro­n­avirus research car­ried out by the Eco­Health Alliance and col­lab­o­ra­tors like the WIV. Because as we’ve seen, the cre­ation of a broad-spec­trum coro­n­avirus vac­cine was part of the pre-pan­dem­ic work done by the Eco­HealthAl­liance, the WIV, and Ralph Bar­ic’s lab at UNC Chapel Hill. So was Mod­er­na involved in that broad-spec­trum coro­n­avirus vac­cine research? It sure sounds like it:

    ...
    Sec­ond, Mod­er­na claims that Pfiz­er and BioN­Tech copied its full-length spike pro­tein for­mu­la­tion for a coro­n­avirus, which Mod­er­na had cre­at­ed years before Covid-19 emerged. Coro­n­avirus­es refer to a large fam­i­ly of virus­es that cause mild to mod­er­ate upper res­pi­ra­to­ry tract ill­ness­es, accord­ing to the N.I.H. The more seri­ous ones include SARS, MERS and Covid-19.
    ...

    So with that intrigu­ing law­suit in mind, here’s a quick look back at some of that impor­tant Sep­tem­ber 2016 STAT News arti­cle that describes Mod­er­na’s deci­sion to shift its focus from mRNA ther­a­peu­tics to vac­cines. As we’ve seen, the move was seen as a dis­ap­point­ment by some in the com­pa­ny since vac­cines have far less prof­it poten­tial than ther­a­peu­tics that involve reg­u­lar injec­tions for years. But was we also saw, it was the fact that vac­cines require as lit­tle as one dose that made this shift a tempt­ing choice for Mod­er­na because that would reduce the poten­tial for side-effects asso­ci­at­ed with mRNA ther­a­py. At least that was what oth­ers in the indus­try sug­gest­ed was behind Mod­er­na’s deci­sion. But Mod­er­na insist­ed at the time that side effects were not at all a fac­tor. And yet, as the arti­cle point­ed out, every­one was forced to take Mod­er­na at its word because the com­pa­ny was­n’t releas­ing any of its research results. That’s all part of what could make this law­suit very inter­est­ing giv­en that its focused on inno­va­tions Mod­er­na alleged­ly made dur­ing this exact peri­od:

    STAT News

    Ego, ambi­tion, and tur­moil: Inside one of biotech’s most secre­tive star­tups

    By Dami­an Garde
    Sept. 13, 2016

    ...

    A strate­gic shift to less ambi­tious tar­gets

    With a pub­lic list­ing come required dis­clo­sures, and many are eager to see what Moderna’s been keep­ing under wraps all these years.

    Out­siders and com­peti­tors, look­ing only at Moderna’s pub­lic state­ments, have not­ed a shift in strat­e­gy that might sig­nal undis­closed set­backs.

    From the start, Mod­er­na her­ald­ed its abil­i­ty to pro­duce pro­teins with­in cells, which could open up a world of ther­a­peu­tic tar­gets unreach­able by con­ven­tion­al drugs. The most rev­o­lu­tion­ary treat­ments, which could chal­lenge the multi­bil­lion-dol­lar mar­ket for pro­tein ther­a­py, would involve repeat­ed dos­es of mRNA over many years, so a patient’s body con­tin­ued to pro­duce pro­teins to keep dis­ease at bay.

    But Moderna’s first human tri­als aren’t so ambi­tious, focus­ing instead on the crowd­ed field of vac­cines, where the com­pa­ny has only been work­ing since 2014.

    First are the two vac­cine tri­als for undis­closed infec­tious dis­eases. Com­ing next is a one-time treat­ment for heart fail­ure, devel­oped in part­ner­ship with AstraZeneca, fol­lowed by anoth­er exper­i­men­tal vac­cine, for Zika virus, which sev­er­al oth­er phar­ma com­pa­nies are also work­ing to devel­op. And after that, Mod­er­na is plan­ning a human tri­al of a per­son­al­ized can­cer vac­cine using mRNA, some­thing it just came up with last year.

    The choice to pri­or­i­tize vac­cines came as a dis­ap­point­ment to many in the com­pa­ny, accord­ing to a for­mer man­ag­er. The plan had been to rad­i­cal­ly dis­rupt the biotech indus­try, the man­ag­er said, so “why would you start with a clin­i­cal pro­gram that has very lim­it­ed upside and lots of com­pe­ti­tion?”

    The answer could be the chal­lenge of ensur­ing drug safe­ty, out­siders said.

    Deliv­ery — actu­al­ly get­ting RNA into cells — has long bedev­iled the whole field. On their own, RNA mol­e­cules have a hard time reach­ing their tar­gets. They work bet­ter if they’re wrapped up in a deliv­ery mech­a­nism, such as nanopar­ti­cles made of lipids. But those nanopar­ti­cles can lead to dan­ger­ous side effects, espe­cial­ly if a patient has to take repeat­ed dos­es over months or years.

    Novar­tis aban­doned the relat­ed realm of RNA inter­fer­ence over con­cerns about tox­i­c­i­ty, as did Mer­ck and Roche.

    Moderna’s most advanced com­peti­tors, Cure­Vac and BioN­Tech, have acknowl­edged the same chal­lenge with mRNA. Each is prin­ci­pal­ly focused on vac­cines for infec­tious dis­ease and can­cer, which the com­pa­nies believe can be attacked with just a few dos­es of mRNA. And each has already test­ed its tech­nol­o­gy on hun­dreds of patients.

    “I would say that mRNA is bet­ter suit­ed for dis­eases where treat­ment for short dura­tion is suf­fi­cient­ly cura­tive, so the tox­i­c­i­ties caused by deliv­ery mate­ri­als are less like­ly to occur,” said Katal­in Karikó, a pio­neer in the field who serves as a vice pres­i­dent at BioN­Tech.

    That makes vac­cines the low­est hang­ing fruit in mRNA, said Franz-Wern­er Haas, CureVac’s chief cor­po­rate offi­cer. “From our point of view, it’s obvi­ous why [Mod­er­na] start­ed there,” he said.

    Mod­er­na said it pri­or­i­tized vac­cines because they pre­sent­ed the fastest path to human tri­als, not because of set­backs with oth­er projects. “The notion that [Mod­er­na] ran into dif­fi­cul­ties isn’t borne in real­i­ty,” said Afeyan.

    But this is where Moderna’s secre­cy comes into play: Until there’s pub­lished data, only the com­pa­ny and its part­ners know what the data show. Every­one out­side is left guess­ing — and, in some cas­es, wor­ry­ing that Mod­er­na won’t live up to its hype.

    “Frankly, I hope that there’s real sub­stance and I hope they solve those chal­lenges, because it’s not going to be good for the broad­er biotech indus­try in gen­er­al if this thing implodes,” said one investor not involved with Mod­er­na.

    ...

    ———–

    “Ego, ambi­tion, and tur­moil: Inside one of biotech’s most secre­tive star­tups” by Dami­an Garde; STAT News; 09/13/2016

    “Out­siders and com­peti­tors, look­ing only at Moderna’s pub­lic state­ments, have not­ed a shift in strat­e­gy that might sig­nal undis­closed set­backs.”

    Was Mod­er­na expe­ri­enc­ing undis­closed set­backs involv­ing side-effects when it made the deci­sion to piv­ot away from mRNA ther­a­peu­tics to vac­cines? That’s what indus­try insid­ers were strong­ly spec­u­lat­ing back in 2016. But it was pure spec­u­la­tion because the com­pa­ny was­n’t releas­ing any info. For exam­ple, there’s no men­tion of coro­n­avirus­es in that entire arti­cle. And yet, now, Mod­er­na is insist­ing that it had already devel­oped coro­n­avirus vac­cines by this peri­od. But Mod­er­na insist­ed at the time that it was­n’t hid­ing any set backs. Was the high­ly con­tro­ver­sial nature of gain-of-func­tion research — which was still banned in the US in 2016 — at all a fac­tor in Mod­er­na’s extreme secre­tive­ness dur­ing this time?

    ...
    The choice to pri­or­i­tize vac­cines came as a dis­ap­point­ment to many in the com­pa­ny, accord­ing to a for­mer man­ag­er. The plan had been to rad­i­cal­ly dis­rupt the biotech indus­try, the man­ag­er said, so “why would you start with a clin­i­cal pro­gram that has very lim­it­ed upside and lots of com­pe­ti­tion?”

    The answer could be the chal­lenge of ensur­ing drug safe­ty, out­siders said.

    Deliv­ery — actu­al­ly get­ting RNA into cells — has long bedev­iled the whole field. On their own, RNA mol­e­cules have a hard time reach­ing their tar­gets. They work bet­ter if they’re wrapped up in a deliv­ery mech­a­nism, such as nanopar­ti­cles made of lipids. But those nanopar­ti­cles can lead to dan­ger­ous side effects, espe­cial­ly if a patient has to take repeat­ed dos­es over months or years.

    ...

    That makes vac­cines the low­est hang­ing fruit in mRNA, said Franz-Wern­er Haas, CureVac’s chief cor­po­rate offi­cer. “From our point of view, it’s obvi­ous why [Mod­er­na] start­ed there,” he said.

    Mod­er­na said it pri­or­i­tized vac­cines because they pre­sent­ed the fastest path to human tri­als, not because of set­backs with oth­er projects. “The notion that [Mod­er­na] ran into dif­fi­cul­ties isn’t borne in real­i­ty,” said Afeyan.

    But this is where Moderna’s secre­cy comes into play: Until there’s pub­lished data, only the com­pa­ny and its part­ners know what the data show. Every­one out­side is left guess­ing — and, in some cas­es, wor­ry­ing that Mod­er­na won’t live up to its hype.
    ...

    Mod­er­na’s claims that it chose vac­cines because they pre­sent­ed the fastest path to human tri­als is a rather inter­est­ing claim giv­en the noto­ri­ous­ly dif­fi­cult vac­cine approval process. But the com­pa­ny may have been sin­cere in one key respect: if it was work­ing with DARPA on cre­at­ing a broad-spec­trum coro­n­avirus vac­cine, it’s pret­ty rea­son­able to assume that Mod­er­na was have had an easy time get­ting approval for human tri­als. In oth­er words, the deci­sion to shift to vac­cine research may have been dri­ven, in part, by the desires of its main part­ner: the US gov­ern­ment. DARPA want­ed a coro­n­avirus vac­cine and Mod­er­na was clear­ly the com­pa­ny of choice for mak­ing that a real­i­ty.

    And that’s also part of what’s going to make this law­suit very inter­est­ing to play out. Mod­er­na is appar­ent­ly suing over patents it devel­oped dur­ing its most­ly-still-secret DARPA col­lab­o­ra­tion. A col­lab­o­ra­tion that just might be direct­ly relat­ed to the most­ly-still-secret US-gov­ern­ment-financed inter­na­tion­al col­lab­o­ra­tion ded­i­cat­ed to mak­ing and study­ing nov­el coro­n­avirus­es. Law­suit have a ten­den­cy to unin­ten­tion­al­ly reveal secrets. And there are clear­ly an abun­dance of secrets still wait­ing to be revealed about Mod­er­na’s coro­n­avirus vac­cine research. Mod­er­na is mak­ing quite a few claims in this law­suit. Let’s hope their forced to actu­al­ly prove them.

    Posted by Pterrafractyl | August 26, 2022, 3:49 pm
  8. Fol­low­ing up on that fas­ci­nat­ing law­suit filed last week by Mod­er­na against Pfizer/BioNTech, here’s an arti­cle that adds an impor­tant detail regard­ing Mod­er­na’s asser­tion that Pfizer/BioNTech copied the work on a beta­coro­n­avirus vac­cine that Mod­er­na had car­ried out years ear­li­er back in 2015–2016: Mod­er­na is also assert­ing in its law­suit that the com­pa­ny invent­ed the very idea of using mRNA vac­cines for the beta­coro­n­avirus fam­i­ly of virus­es. It’s the kind of claim that rais­es the ques­tion of how cen­tral coro­n­avirus­es were to Mod­er­na’s ini­tial vac­cine work, which only fur­thers adds to ques­tions about the role of the US gov­ern­ment in that ear­ly phase of Mod­er­na’s vac­cine research and whether or not Mod­er­na was qui­et­ly involved with the gain-of-func­tion work on coro­n­avirus­es tak­ing place dur­ing this peri­od with the Eco­HealthAl­liance.

    First, recall how Mod­er­na was crit­i­cized back in 2020 over its deci­sion to file a patent in Feb 2020 for a “Beta­coro­n­avirus vac­cine” — a broad-spec­trum vac­cine designed for non-COVID coro­n­avirus­es — with­out acknowl­edg­ing the US gov­ern­ments role in that research. The NIH sued Mod­er­na in response to that patent fil­ing, argu­ing that the spike pro­tein sequence was devel­oped as part of Mod­er­na’s joint pre-pan­dem­ic work withe NIH on beta­coro­n­avirus vac­cines. So right out of the gate we have have to ask: was the US gov­ern­ment at all involved with Mod­er­na’s ini­tial plans to devel­op beta­coro­n­avirus mRNA vac­cines? If so, it sounds like Mod­er­na is back to its old tricks of try­ing to claim exclu­sive patent rights over US gov­ern­ment-fund­ed research.

    But let’s also not for­get that the ear­ly coro­n­avirus research done by Mod­er­na was large­ly kept a secret up until now. Recall that impor­tant Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics — which require numer­ous shots over years — to mRNA vac­cines. As we saw, there was no men­tion at all of coro­n­avirus vac­cine devel­op­ment in that arti­cle. They men­tioned a Zika virus vac­cine, but noth­ing about coro­n­avirus­es and observers not­ed how the com­pa­ny was oper­at­ing in extreme secre­cy. So the idea that Mod­er­na real­ly was work­ing on coro­n­avirus vac­cines dur­ing this peri­od would actu­al­ly be kind of con­sis­tent with the com­pa­ny’s extreme secre­cy dur­ing this period...especially if it involved con­tro­ver­sial gain-of-func­tion work on nov­el coro­n­avirus­es. But that also makes any asser­tions that Mod­er­na exclu­sive­ly devel­oped the idea of using mRNA vac­cines for beta­coro­n­avirus­es on its own, with­out any US gov­ern­ment input, all the more dif­fi­cult to believe. And that rais­es the grim ques­tion regard­ing the pos­si­bil­i­ty that Mod­er­na is once again try­ing to make exclu­sive claims to patents that real­ly should be shared with the gov­ern­ment: would the US gov­ern­ment risk chal­leng­ing Mod­er­na’s claims if that also meant risk­ing the expo­sure of con­tro­ver­sial gain-of-func­tion mRNA coro­n­avirus vac­cine exper­i­ments that the world still large­ly does­n’t know about? It’s the kind of ques­tion that may have fig­ured sig­nif­i­cant­ly in Mod­er­na’s deci­sion to wage this law­suit.

    But there’s anoth­er rea­son we should sus­pect Mod­er­na might be try­ing to exclu­sive­ly claim patent rights to some­thing that was joint­ly devel­oped with US gov­ern­ment researchers: at the heart of Mod­er­na’s law­suit is the claim that Pfiz­er stole the inno­va­tion of using a mod­i­fied ribonu­cleotide, 1‑methylpseudouridine, in its mRNA for­mu­la­tions. Pfiz­er points to its own patent involv­ing 1‑methylpseudouridine filed six years ear­li­er. And yet, as we’ve seen, the NIH asserts that its researchers devel­oped those tech­niques as part of the NIH’s ear­ly vac­cine work and cit­ed a 2017 pub­li­ca­tion that involved anal­o­gous chem­i­cal mod­i­fi­ca­tions that sta­bi­lized a MERS spike pro­tein. So this law­suit with Pfiz­er appears to dou­ble down on Mod­er­na’s patent dis­putes with the NIH. And as we saw, if Mod­er­na won that patent fight, it would poten­tial­ly be able to block a broad array of poten­tial com­peti­tors for all sorts of vac­cines for years to come around the world, includ­ing in devel­op­ing coun­tries. Mod­er­na wants it all, and it just might get it if this law­suit suc­ceeds:

    Sci­ence

    Sci­en­tists ques­tion Mod­er­na inven­tion claim in COVID-19 vac­cine dis­pute
    Com­pa­ny sues rivals Pfiz­er and BioN­Tech over mRNA tech­nol­o­gy

    By Jon Cohen
    29 Aug 2022 1:10 p.m.

    One of the three inven­tions claimed by Mod­er­na in a legal bat­tle that has erupt­ed over the mes­sen­ger RNA (mRNA) vac­cines against COVID-19 was actu­al­ly patent­ed years ear­li­er by two uni­ver­si­ty sci­en­tists.

    In a com­plaint filed on 26 August in a U.S. dis­trict court in Mass­a­chu­setts, Mod­er­na accus­es Pfiz­er and its part­ner BioN­Tech of “co-opt­ing Moderna’s patent­ed inven­tions” cov­er­ing dif­fer­ent aspects of the two COVID-19 vac­cines, which have already earned the com­pa­nies bil­lions of dol­lars. Both vac­cines rely on mRNA that codes for the spike pro­tein of SARS-CoV­‑2.

    BioN­Tech issued a state­ment insist­ing its COVID-19 vac­cine work was “orig­i­nal” and said it “will vig­or­ous­ly defend against all alle­ga­tions of patent infringe­ment.” In a state­ment to Sci­ence, Pfiz­er said it had “not yet ful­ly reviewed the com­plaint but we are sur­prised by the lit­i­ga­tion,” adding that the com­pa­ny is “con­fi­dent in our intel­lec­tu­al prop­er­ty sup­port­ing the Pfizer/BioNTech vac­cine.”

    The two vac­cines were the first autho­rized for COVID-19 in the Unit­ed States and the first to show the mRNA plat­form worked, for any pathogen, in peo­ple. Mod­er­na said in 2020 it would not enforce patent claims while the pan­dem­ic was ongo­ing. Jacob Sherkow, a patent attor­ney at the Uni­ver­si­ty of Illi­nois Col­lege of Law, sus­pects the com­pa­ny has changed its tune because it and Pfiz­er-BioN­Tech will soon have new mar­kets for for­mu­la­tions of their vac­cines that tar­get coro­n­avirus vari­ants. Reg­u­la­tors are expect­ed to autho­rize these updat­ed vac­cines short­ly. Mod­er­na and Pfiz­er-BioN­Tech ini­tial­ly sold most of their dos­es to the U.S. gov­ern­ment but are now sell­ing the shots glob­al­ly on the open mar­ket, with even larg­er prof­its at stake. Moderna’s fil­ing “makes sense now that these are goods,” Sherkow says.

    At the heart of Moderna’s patent infringe­ment claim are the steps that opened the door for mRNA as a vac­cine. Drew Weiss­man and Katal­in Karikó, both at the Uni­ver­si­ty of Penn­syl­va­nia (Karikó now also works for BioN­Tech), pub­lished the fun­da­men­tal dis­cov­ery in 2005: They showed that alter­ing one of the fun­da­men­tal build­ing blocks of mRNA, the nucleotide uri­dine, made the mol­e­cule less tox­ic and also more capa­ble of dodg­ing immune destruc­tion.

    Mod­er­na, which was found­ed to devel­op med­i­cines based on mRNA, has a patent for a spe­cif­ic mod­i­fi­ca­tion known as 1‑methylpseudouridine. “Moderna’s sci­en­tists made the ground­break­ing dis­cov­ery that replac­ing uri­dine in the mRNA mol­e­cule with 1‑methylpseudouridine result­ed in sur­pris­ing­ly supe­ri­or pro­tein production—a sev­er­al­fold increase over chem­i­cal­ly-mod­i­fied mRNAs stud­ied before—with a sig­nif­i­cant­ly reduced immune response against the mRNA itself,” the com­plaint argues. “This work became the foun­da­tion of Moderna’s mRNA plat­form.”

    Weiss­man and Karikó not­ed in sep­a­rate emails to Sci­ence that they have an issued patent, filed 6 years ear­li­er than Moderna’s, that explic­it­ly includes the 1‑methylpseudouridine mod­i­fi­ca­tion. Moderna’s attor­neys and press office did not respond to Sci­ence’s request for com­ment. Kevin Noo­nan, a patent attor­ney in Chica­go who spe­cial­izes in biotech­nol­o­gy, says their 1‑methylpseudouridine claim like­ly will be weak­ened, but not com­plete­ly inval­i­dat­ed, by the ear­li­er patent.

    Moderna’s com­plaint alleges two oth­er patent/intellectual prop­er­ty infringe­ments. The com­pa­ny “fur­ther dis­cov­ered that pack­ag­ing that chem­i­cal­ly-mod­i­fied mRNA in a lipid nanopar­ti­cle for­mu­la­tion allowed for the effi­cient deliv­ery of the mRNA to cells,” it says. Mod­er­na also claims it invent­ed the spe­cif­ic use of mRNA vac­cines to pro­tect against beta­coro­n­avirus­es, the genus that includes SARS-CoV­‑2. Noo­nan, who knows the details of these claims, char­ac­ter­izes them as “incred­i­bly broad.”

    Indus­try watch­ers say that in try­ing to bol­ster its claims, Mod­er­na is like­ly eye­ing prof­its from future mRNA vac­cines. “Our mis­sion to cre­ate a new gen­er­a­tion of trans­for­ma­tive med­i­cines for patients by deliv­er­ing on the promise of mRNA sci­ence can­not be achieved with­out a patent sys­tem that rewards and pro­tects inno­va­tion,” Mod­er­na CEO Stéphane Ban­cel said in a press release announc­ing the law­suit.

    ...

    ————

    “Sci­en­tists ques­tion Mod­er­na inven­tion claim in COVID-19 vac­cine dis­pute” by Jon Cohen; Sci­ence; 08/29/2022

    “Moderna’s com­plaint alleges two oth­er patent/intellectual prop­er­ty infringe­ments. The com­pa­ny “fur­ther dis­cov­ered that pack­ag­ing that chem­i­cal­ly-mod­i­fied mRNA in a lipid nanopar­ti­cle for­mu­la­tion allowed for the effi­cient deliv­ery of the mRNA to cells,” it says. Mod­er­na also claims it invent­ed the spe­cif­ic use of mRNA vac­cines to pro­tect against beta­coro­n­avirus­es, the genus that includes SARS-CoV­‑2. Noo­nan, who knows the details of these claims, char­ac­ter­izes them as “incred­i­bly broad.”

    Yes, Mod­er­na is assert­ing that it invent­ed the spe­cif­ic use of using mRNA vac­cines to pro­tect against beta­coro­n­avirus­es. That’s quite a claim. The kind of claim that sug­gests Mod­er­na had coro­n­avirus­es in mind very ear­ly on. Don’t for­get the com­pa­ny was only start­ed in 2010. Now claim­ing it was val­i­dat­ing coro­n­avirus vac­cines with human tri­als in 2015.

    But then there’s the claims at the heart of the law­suit: that Pfiz­er stole Mod­er­na’s approach of using a mod­i­fied ribonu­cleotide, 1‑methylpseudouridine, which plays a key role in help­ing in reduc­ing the immune response to the mRNA while increas­ing pro­tein pro­duc­tion. The catch with this claim is that Pfiz­er issued its own patents involv­ing 1‑methylpseudouridine six years ear­li­er:

    ...
    At the heart of Moderna’s patent infringe­ment claim are the steps that opened the door for mRNA as a vac­cine. Drew Weiss­man and Katal­in Karikó, both at the Uni­ver­si­ty of Penn­syl­va­nia (Karikó now also works for BioN­Tech), pub­lished the fun­da­men­tal dis­cov­ery in 2005: They showed that alter­ing one of the fun­da­men­tal build­ing blocks of mRNA, the nucleotide uri­dine, made the mol­e­cule less tox­ic and also more capa­ble of dodg­ing immune destruc­tion.

    Mod­er­na, which was found­ed to devel­op med­i­cines based on mRNA, has a patent for a spe­cif­ic mod­i­fi­ca­tion known as 1‑methylpseudouridine. “Moderna’s sci­en­tists made the ground­break­ing dis­cov­ery that replac­ing uri­dine in the mRNA mol­e­cule with 1‑methylpseudouridine result­ed in sur­pris­ing­ly supe­ri­or pro­tein production—a sev­er­al­fold increase over chem­i­cal­ly-mod­i­fied mRNAs stud­ied before—with a sig­nif­i­cant­ly reduced immune response against the mRNA itself,” the com­plaint argues. “This work became the foun­da­tion of Moderna’s mRNA plat­form.”

    Weiss­man and Karikó not­ed in sep­a­rate emails to Sci­ence that they have an issued patent, filed 6 years ear­li­er than Moderna’s, that explic­it­ly includes the 1‑methylpseudouridine mod­i­fi­ca­tion. Moderna’s attor­neys and press office did not respond to Sci­ence’s request for com­ment. Kevin Noo­nan, a patent attor­ney in Chica­go who spe­cial­izes in biotech­nol­o­gy, says their 1‑methylpseudouridine claim like­ly will be weak­ened, but not com­plete­ly inval­i­dat­ed, by the ear­li­er patent.

    ...

    Is Mod­er­na mak­ing a BS legal claim? Per­haps, but it looks like it’s basi­cal­ly the same kind of BS Mod­er­na has been try­ing to pull with the NIH about the devel­op­ment of ribonu­cleotide mod­i­fi­ca­tions for mRNA vac­cines. With the end result being that only Mod­er­na will be allowed to cre­ate new mRNA-based vac­cines around the world for the dura­tion of these patents. Don’t for­get that these patent fights have glob­al impli­ca­tions. That’s what Mod­er­na fight­ing for. Glob­al intel­lec­tu­al prop­er­ty cap­ture of mRNA vac­cines for years to come. It’s quite a prize. A prize so tempt­ing that Mod­er­na appears to be flirt­ing with the prospect of hav­ing to share with the world — or at least the courts — all sorts of details about its ear­ly coro­n­avirus vac­cine work in order to get that prize. So let’s hope the glob­al pub­lic final­ly gets a chance to learn those details. Details like when exact­ly did Mod­er­na decide to devel­op coro­n­avirus vac­cines and how much of that work was car­ried out in part­ner­ship with gov­ern­ment researchers? It’s the least we can ask if we’re going to let Mod­er­na steal exclu­sive rights on the devel­op­ment of new mRNA vac­cines for decades to come.

    Posted by Pterrafractyl | August 31, 2022, 3:53 pm
  9. This should be inter­est­ing: The NIH recent­ly announced its ter­mi­nat­ing the Eco­Health Alliance’s grant. Not the whole grant. Just the sub-award doled out to the Wuhan Insti­tute of Virol­o­gy (WIV). The Eco­Health Alliance is still free to rework a new grant with­out the WIV.

    That’s the news we got last week, with the NIH stat­ing that it was cut­ting the sub-award to the WIV “for fail­ure to meet award terms and con­di­tions requir­ing pro­vi­sion of records to NIH upon request.” Specif­i­cal­ly, the NIH is tak­ing action because Eco­Health did not include terms and con­di­tions on its sub-award to the WIV, includ­ing a require­ment that Eco­Health Alliance be allowed access to the institute’s records and finan­cial state­ments. “NIH has deter­mined that [Wuhan Insti­tute of Virology’s] refusal to pro­vide the request­ed records, and [EcoHealth’s] fail­ure to include the required terms in [the] sub­award agree­ment rep­re­sent mate­r­i­al fail­ures to com­ply with the terms of award.” In oth­er words, the NIH is play­ing dumb and tak­ing the stand that it had no idea what was going on inside the WIV.

    Now, as the fol­low­ing arti­cle notes, this comes rough­ly a year after the NIH chid­ed the WIV were not pro­vid­ing notice that the exper­i­ments tak­ing place at the WIV involv­ing chimeric coro­n­avirus­es on human­ized mice result­ed in virus­es that repli­cat­ed much faster (up to 10,000 times faster) than the unmod­i­fied virus­es and results in greater weight loss in the mice. The NIH should have been imme­di­ate­ly informed and the exper­i­ments should have been halt­ed under the rules of the con­tract. We’re told that this nev­er hap­pened. And yet, as The Inter­cept report­ed last Sep­tem­ber based on doc­u­ments obtained through the Free­dom of Infor­ma­tion Act, the NIH was ful­ly informed about these exper­i­ments back in May of 2018 basi­cal­ly came up with excus­es for why the exper­i­ments should be allowed to con­tin­ue. One excuse involved cit­ing a 2017 paper pub­lished by Shi Zhengli’s lab show­ing chimeric virus­es repli­cat­ed at slow­er rates than mod­i­fied virus­es. The NIH appeared to view the cre­ation of less aggres­sive virus­es as a tech­ni­cal rea­son for con­clud­ing these these were not gain-of-func­tion exper­i­ments.

    And yet, as those FOIA doc­u­ments show, the Eco­Health Alliance sent the NIH a report in 2018 cit­ing the 10k-fold high­er viral load in these chimeric virus­es at ear­ly time points in these exper­i­ments. So how did the NIH con­clude that these weren’t exam­ples of gain-of-func­tion exper­i­ments? By point­ing to sim­i­lar viral loads by the end of the exper­i­ment. So even though the chimeric virus­es caus­es mas­sive dif­fer­ences in viral loads ear­ly on, it was­n’t gain-of-func­tion because it was evened out in the end. And the fact the the mice infect­ed with the chimeric virus­es lost more weight was appar­ent­ly just ignored. It’s an exam­ple of high­ly moti­vat­ed rea­son­ing. And the moti­va­tion was to keep these exper­i­ments going. If that required defin­ing them as non-gain-of-func­tion, so be it.

    Also keep in mind that we still don’t ful­ly under­stand the nature of the NIH’s work with Mod­er­na in the cre­ation of coro­n­avirus mRNA vac­cines. But we do know Mod­er­na claims it con­duct­ed human vac­cine tri­als on coro­n­avirus­es as ear­ly as 2015. So when we’re look­ing at the high­ly moti­vat­ed deci­sion-mak­ing by the NIH sur­round­ing these Eco­Health Alliance exper­i­ments, keep in mind that those Mod­er­na coro­n­avirus vac­cine exper­i­ments may have been part of that moti­va­tion.

    That’s all part of the con­text of the ter­mi­na­tion of the WIV’s sub-con­tract in the Eco­Health Alliance’s grant: the grant is going to con­tin­ue. Just not the the WIV col­lab­o­ra­tion. Instead, it appears that the WIV is being set up as the fall guy for all the gain-of-func­tion work while every­one else plays dumb. Which is, of course, a recipe for just con­tin­u­ing the same mod­el of research but with a new fall guy:

    Bul­letin of the Atom­ic Sci­en­tists

    NIH to ter­mi­nate part of Eco­Health Alliance grant after its Wuhan part­ners refuse to deliv­er infor­ma­tion on coro­n­avirus stud­ies

    By Matt Field | August 24, 2022

    The Nation­al Insti­tute of Health (NIH) is par­tial­ly ter­mi­nat­ing a grant to a non­prof­it that worked exten­sive­ly with the Wuhan Insti­tute of Virol­o­gy on bat coro­n­avirus research. In let­ters post­ed by Repub­li­cans on the House Over­sight Com­mit­tee this month, an NIH offi­cial said Eco­Health Alliance had not been able to hand over lab note­books and oth­er records from its Wuhan part­ner that relate to con­tro­ver­sial exper­i­ments involv­ing mod­i­fied bat virus­es, despite mul­ti­ple requests.

    In an Aug. 19 let­ter to Ken­tucky Rep James Com­er, the top Repub­li­can mem­ber of the US House Over­sight Com­mit­tee, Michael Lauer, the deputy direc­tor of extra­mur­al research at NIH, said the agency had informed Eco­Health that it was ter­mi­nat­ing the sub-award to the Wuhan Insti­tute of Virol­o­gy “for fail­ure to meet award terms and con­di­tions requir­ing pro­vi­sion of records to NIH upon request.”

    The ter­mi­na­tion notice comes after the NIH chid­ed Eco­Health last fall for not imme­di­ate­ly noti­fy­ing the agency after its exper­i­ments showed mod­i­fied coro­n­avirus­es repli­cat­ed at a faster rate in exper­i­men­tal mice than an unmod­i­fied virus. The agency then asked for lab note­books and oth­er files per­tain­ing to the exper­i­ments, and Eco­Health report­ed that it would relay the request to the Wuhan Insti­tute of Virol­o­gy. Accord­ing to the new NIH let­ters, the Wuhan insti­tute nev­er deliv­ered.

    “NIH has request­ed on two occa­sions that [Eco­Health] pro­vide NIH the lab­o­ra­to­ry note­books and orig­i­nal elec­tron­ic files from the research con­duct­ed at [the Wuhan Insti­tute of Virol­o­gy]. To date, [the insti­tute] has not pro­vid­ed these records,” Lauer told Com­er. NIH ver­i­fied to the Bul­letin that the let­ters were authen­tic.

    A let­ter from NIH to Eco­Health staff, also dat­ed Aug. 19, said the NIH is tak­ing action because Eco­Health did not include terms and con­di­tions on its sub-award to the Wuhan Insti­tute of Virol­o­gy, includ­ing a require­ment that Eco­Health Alliance be allowed access to the institute’s records and finan­cial state­ments. “NIH has deter­mined that [Wuhan Insti­tute of Virology’s] refusal to pro­vide the request­ed records, and [EcoHealth’s] fail­ure to include the required terms in [the] sub­award agree­ment rep­re­sent mate­r­i­al fail­ures to com­ply with the terms of award,” the let­ter said.

    Between June 2017 and May 2019, sci­en­tists work­ing on EcoHealth’s grant test­ed genet­i­cal­ly engi­neered coro­n­avirus­es with the back­bone of one virus and the spike proteins—which bind to host cells—of anoth­er on mice that expressed human cell recep­tors. In one case, the NIH report­ed last fall, one of the chimeric virus­es caused mice to become “sick­er.” Eco­Health reports show that in the infec­tion exper­i­ments, con­duct­ed in years four and five of the grant, chimeric virus­es repli­cat­ed faster in mice lungs and killed a high­er per­cent­age of mice than the unmod­i­fied virus. Last fall, the NIH said that Eco­Health was sup­posed to report the increased viral growth to the agency “imme­di­ate­ly” to assess whether fur­ther biosafe­ty mea­sures were nec­es­sary.

    The NIH said the Wuhan institute’s exper­i­ments under the Eco­Health grant involved virus­es that were too genet­i­cal­ly dis­tant to have evolved to become SARS-CoV­‑2, the virus that caus­es COVID-19. But some crit­ics of so-called gain-of-func­tion experimentation—in which pathogens are enhanced in way that makes them, say, more transmissible—have said last fall’s rev­e­la­tions point to risky research projects being under­tak­en at the lab­o­ra­to­ry in Wuhan, the city where the first report­ed cas­es of COVID were report­ed. Research pub­lished recent­ly in Sci­ence points to the pan­dem­ic hav­ing sprung from a seafood mar­ket in the city where ani­mals that could have har­bored coro­n­avirus infec­tions were kept. That researchers has served as a new focus of con­tro­ver­sy, as researchers argue over whether it does or does not great­ly reduce (or even elim­i­nate) the pos­si­bil­i­ty that the COVID-19 pan­dem­ic start­ed with the leak of a virus from a lab­o­ra­to­ry in Wuhan.

    ...

    Accord­ing to the new NIH let­ters, Eco­Health can work with Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases to revise the grants with­out involv­ing the Wuhan Insti­tute of Virol­o­gy. If that is not pos­si­ble, the NIH will ask that the grant be “bilat­er­al­ly ter­mi­nat­ed.” Should a reworked grant be pos­si­ble, the agency will add new terms to it, includ­ing increased NIH over­sight over Eco­Health for at least three years and increased report­ing require­ments for the non­prof­it. The non­prof­it will also be required to vis­it its sub-awardees every six months to ensure com­pli­ance with the grant.

    ————-

    “NIH to ter­mi­nate part of Eco­Health Alliance grant after its Wuhan part­ners refuse to deliv­er infor­ma­tion on coro­n­avirus stud­ies” By Matt Field; Bul­letin of the Atom­ic Sci­en­tists; 08/24/2022

    “A let­ter from NIH to Eco­Health staff, also dat­ed Aug. 19, said the NIH is tak­ing action because Eco­Health did not include terms and con­di­tions on its sub-award to the Wuhan Insti­tute of Virol­o­gy, includ­ing a require­ment that Eco­Health Alliance be allowed access to the institute’s records and finan­cial state­ments. “NIH has deter­mined that [Wuhan Insti­tute of Virology’s] refusal to pro­vide the request­ed records, and [EcoHealth’s] fail­ure to include the required terms in [the] sub­award agree­ment rep­re­sent mate­r­i­al fail­ures to com­ply with the terms of award,” the let­ter said.”

    The Eco­Health Alliance’s sub-con­tract with the WIV did­n’t include terms that allowed access to the insti­tute’s records and finan­cial state­ments. That’s the stat­ed rea­son the NIH game for ter­mi­nat­ing Eco­Health Alliances grant. But it’s not a com­plete ter­mi­na­tion. It sounds like it’s just that sub-grant to the WIV that’s get­ting ter­mi­nat­ed:

    ...
    In an Aug. 19 let­ter to Ken­tucky Rep James Com­er, the top Repub­li­can mem­ber of the US House Over­sight Com­mit­tee, Michael Lauer, the deputy direc­tor of extra­mur­al research at NIH, said the agency had informed Eco­Health that it was ter­mi­nat­ing the sub-award to the Wuhan Insti­tute of Virol­o­gy “for fail­ure to meet award terms and con­di­tions requir­ing pro­vi­sion of records to NIH upon request.”

    And as the arti­cle notes, this ter­mi­na­tion notice comes rough­ly a year after the NIH chid­ed the Eco­Health Alliance for not imme­di­ate­ly noti­fy­ing the agency about exper­i­ments involv­ing the cre­ation of mod­i­fied coro­n­avirus­es that repli­cat­ed at a faster rate in exper­i­ment (human­ized) mice. In oth­er words, The Eco­Health Alliance did­n’t imme­di­ate­ly noti­fy the NIH of what amounts to gain-of-func­tion exper­i­ments:

    ...
    The ter­mi­na­tion notice comes after the NIH chid­ed Eco­Health last fall for not imme­di­ate­ly noti­fy­ing the agency after its exper­i­ments showed mod­i­fied coro­n­avirus­es repli­cat­ed at a faster rate in exper­i­men­tal mice than an unmod­i­fied virus. The agency then asked for lab note­books and oth­er files per­tain­ing to the exper­i­ments, and Eco­Health report­ed that it would relay the request to the Wuhan Insti­tute of Virol­o­gy. Accord­ing to the new NIH let­ters, the Wuhan insti­tute nev­er deliv­ered.

    “NIH has request­ed on two occa­sions that [Eco­Health] pro­vide NIH the lab­o­ra­to­ry note­books and orig­i­nal elec­tron­ic files from the research con­duct­ed at [the Wuhan Insti­tute of Virol­o­gy]. To date, [the insti­tute] has not pro­vid­ed these records,” Lauer told Com­er. NIH ver­i­fied to the Bul­letin that the let­ters were authen­tic.

    ...

    Between June 2017 and May 2019, sci­en­tists work­ing on EcoHealth’s grant test­ed genet­i­cal­ly engi­neered coro­n­avirus­es with the back­bone of one virus and the spike proteins—which bind to host cells—of anoth­er on mice that expressed human cell recep­tors. In one case, the NIH report­ed last fall, one of the chimeric virus­es caused mice to become “sick­er.” Eco­Health reports show that in the infec­tion exper­i­ments, con­duct­ed in years four and five of the grant, chimeric virus­es repli­cat­ed faster in mice lungs and killed a high­er per­cent­age of mice than the unmod­i­fied virus. Last fall, the NIH said that Eco­Health was sup­posed to report the increased viral growth to the agency “imme­di­ate­ly” to assess whether fur­ther biosafe­ty mea­sures were nec­es­sary.
    ...

    Impor­tant­ly, it does­n’t at all sound like the Eco­Health Alliance’s over­all NIH-fund­ed work is end­ing. It’s just not going to con­tin­ue with the WIV. And that’s what all the ques­tions from crit­ics about what oth­er risky research might be going on at the WIV miss­ing one of the biggest pieces of this whole sto­ry: it’s not like this kind of research is just tak­ing place at the WIV:

    ...
    The NIH said the Wuhan institute’s exper­i­ments under the Eco­Health grant involved virus­es that were too genet­i­cal­ly dis­tant to have evolved to become SARS-CoV­‑2, the virus that caus­es COVID-19. But some crit­ics of so-called gain-of-func­tion experimentation—in which pathogens are enhanced in way that makes them, say, more transmissible—have said last fall’s rev­e­la­tions point to risky research projects being under­tak­en at the lab­o­ra­to­ry in Wuhan, the city where the first report­ed cas­es of COVID were report­ed. Research pub­lished recent­ly in Sci­ence points to the pan­dem­ic hav­ing sprung from a seafood mar­ket in the city where ani­mals that could have har­bored coro­n­avirus infec­tions were kept. That researchers has served as a new focus of con­tro­ver­sy, as researchers argue over whether it does or does not great­ly reduce (or even elim­i­nate) the pos­si­bil­i­ty that the COVID-19 pan­dem­ic start­ed with the leak of a virus from a lab­o­ra­to­ry in Wuhan.

    ...

    Accord­ing to the new NIH let­ters, Eco­Health can work with Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases to revise the grants with­out involv­ing the Wuhan Insti­tute of Virol­o­gy. If that is not pos­si­ble, the NIH will ask that the grant be “bilat­er­al­ly ter­mi­nat­ed.” Should a reworked grant be pos­si­ble, the agency will add new terms to it, includ­ing increased NIH over­sight over Eco­Health for at least three years and increased report­ing require­ments for the non­prof­it. The non­prof­it will also be required to vis­it its sub-awardees every six months to ensure com­pli­ance with the grant.
    ...

    As we can see, the nar­ra­tive we’re get­ting now appears to be that the NIH did­n’t know about all this gain-of-func­tion research tak­ing place under the Eco­Health Alliance’s grant because the Eco­Health Alliance was­n’t shar­ing that info and because the WIV has­n’t been forth­com­ing with access to to its inter­nal research. Again, that’s the nar­ra­tive. So it’s worth tak­ing a look at that report from The Inter­cept last year about the NIH’s ‘chid­ing’ of the Eco­Health Alliance. As the arti­cle makes clear, not only was the NIH thor­ough­ly informed about the gain-of-func­tion nature of these exper­i­ments back in 2018, but it appeared to go out of its way to come up with excus­es for why the research should be allowed to con­tin­ue. Excus­es that come down to high­ly tech­ni­cal quib­bles over whether or not gain-of-func­tion research should real­ly be con­sid­ered gain-of-func­tion:

    The Inter­cept

    NIH Doc­u­ments Pro­vide New Evi­dence U.S. Fund­ed Gain-of-Func­tion Research in Wuhan
    U.S.-funded exper­i­ment in Chi­na posed biosafe­ty risks but did not cause Covid-19 pan­dem­ic, sci­en­tists say.

    Sharon Lern­er, Mara Hvis­ten­dahl, Maia Hib­bett
    Sep­tem­ber 9 2021, 8:03 p.m.

    Doc­u­ments obtained by The Inter­cept con­tain new evi­dence that the Wuhan Insti­tute of Virol­o­gy and the near­by Wuhan Uni­ver­si­ty Cen­ter for Ani­mal Exper­i­ment, along with their col­lab­o­ra­tor, the U.S.-based non­prof­it Eco­Health Alliance, have engaged in what the U.S. gov­ern­ment defines as “gain-of-func­tion research of con­cern,” inten­tion­al­ly mak­ing virus­es more path­o­gen­ic or trans­mis­si­ble in order to study them, despite stip­u­la­tions from a U.S. fund­ing agency that the mon­ey not be used for that pur­pose.

    Grant mon­ey for the con­tro­ver­sial exper­i­ment came from the Nation­al Insti­tutes of Health’s Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases, which is head­ed by Antho­ny Fau­ci. The award to Eco­Health Alliance, a research orga­ni­za­tion which stud­ies the spread of virus­es from ani­mals to humans, includ­ed sub­awards to Wuhan Insti­tute of Virol­o­gy and East Chi­na Nor­mal Uni­ver­si­ty. The prin­ci­pal inves­ti­ga­tor on the grant is Eco­Health Alliance Pres­i­dent Peter Daszak, who has been a key voice in the search for Covid-19’s ori­gins.

    Sci­en­tists unan­i­mous­ly told The Inter­cept that the exper­i­ment, which involved infect­ing genet­i­cal­ly engi­neered mice with “chimeric” hybrid virus­es, could not have direct­ly sparked the pan­dem­ic. None of the virus­es list­ed in the write-ups of the exper­i­ment are relat­ed to the virus that caus­es Covid-19, SARS-CoV­‑2, close­ly enough to have evolved into it. Still, sev­er­al sci­en­tists said the new infor­ma­tion, which the NIH released after it was sued by The Inter­cept, points to biosafe­ty con­cerns, high­light­ing a gen­er­al lack of over­sight for research on pathogens and rais­ing ques­tions about what oth­er infor­ma­tion has not been pub­licly dis­closed.

    “As a virol­o­gist, I per­son­al­ly think cre­at­ing chimeras of SARS-relat­ed bat coro­n­avirus­es that are thought to pose high risk to humans entails unac­cept­able risks,” said Jesse Bloom, who stud­ies the evo­lu­tion of virus­es at the Fred Hutchin­son Can­cer Research Cen­ter. Severe acute res­pi­ra­to­ry syn­drome, or SARS, is a dis­ease caused, like Covid-19, by an air­borne coro­n­avirus.

    The exper­i­ment also rais­es ques­tions about asser­tions from Fau­ci and NIH Direc­tor Fran­cis Collins that NIH-fund­ed projects at the Wuhan Insti­tute of Virol­o­gy did not involve gain-of-func­tion research. In May, Fau­ci tes­ti­fied before Con­gress: “The NIH has not ever and does not now fund gain-of-func­tion research in the Wuhan Insti­tute of Virol­o­gy.” The doc­u­ments do not estab­lish whether Fau­ci was direct­ly aware of the work.

    Sci­en­tists work­ing under a 2014 NIH grant to the Eco­Health Alliance to study bat coro­n­avirus­es com­bined the genet­ic mate­r­i­al from a “par­ent” coro­n­avirus known as WIV1 with oth­er virus­es. They twice sub­mit­ted sum­maries of their work that showed that, when in the lungs of genet­i­cal­ly engi­neered mice, three altered bat coro­n­avirus­es at times repro­duced far more quick­ly than the orig­i­nal virus on which they were based. The altered virus­es were also some­what more path­o­gen­ic, with one caus­ing the mice to lose sig­nif­i­cant weight. The researchers report­ed, “These results demon­strate vary­ing path­o­genic­i­ty of SARSr-CoVs with dif­fer­ent spike pro­teins in human­ized mice.”

    But the terms of the grant clear­ly stip­u­lat­ed that the fund­ing could not be used for gain-of-func­tion exper­i­ments. The grant con­di­tions also required the researchers to imme­di­ate­ly report poten­tial­ly dan­ger­ous results and stop their exper­i­ments pend­ing fur­ther NIH review. Accord­ing to both the Eco­Health Alliance and NIH, the results were report­ed to the agency, but NIH deter­mined that rules designed to restrict gain-of-func­tion research did not apply.

    The Inter­cept con­sult­ed 11 sci­en­tists who are virol­o­gists or work in adja­cent fields and hold a range of views on both the ethics of gain-of-func­tion research and the Covid-19 ori­gins search. Sev­en said that the work appears to meet NIH’s cri­te­ria for gain-of-func­tion research.

    One said that the exper­i­ment “absolute­ly does not meet the bar” for gain-of-func­tion research. “You can’t pre­dict that these virus­es would be more path­o­gen­ic, or even path­o­gen­ic at all in peo­ple,” said Angela Ras­mussen, a virol­o­gist with the Vac­cine and Infec­tious Dis­ease Orga­ni­za­tion at the Uni­ver­si­ty of Saskatchewan. “They also did not study trans­mis­si­bil­i­ty at all in these exper­i­ments,” mean­ing that the sci­en­tists did not look at whether the virus­es could spread across a pop­u­la­tion.

    Three experts said that, while they did not have enough knowl­edge of U.S. poli­cies to com­ment on whether the research met NIH cri­te­ria, the exper­i­ment involv­ing human­ized mice was unnec­es­sar­i­ly risky.

    One virol­o­gist, Vin­cent Racaniel­lo, a pro­fes­sor of micro­bi­ol­o­gy and immunol­o­gy at Colum­bia Uni­ver­si­ty, said while he con­sid­ered the mouse exper­i­ment described in the doc­u­ment to clear­ly fall into the gain-of-func­tion cat­e­go­ry, he didn’t see it as prob­lem­at­ic. “You can do some kinds of gain-of-func­tion research that then has unfore­seen con­se­quences and may be a prob­lem, but that’s not the case here,” said Racaniel­lo.

    Robert Kessler, com­mu­ni­ca­tions man­ag­er for Eco­Health Alliance, denied that the work on the human­ized mice met the def­i­n­i­tion of gain-of-func­tion research. Kessler insist­ed that bat virus­es are not poten­tial pan­dem­ic pathogens because, he said, “a bat virus is not known to be able to infect humans.” The pro­pos­al jus­ti­fied the work on WIV1 by explain­ing that it is “not a select agent” — refer­ring to a list of close­ly mon­i­tored tox­ins and bio­log­i­cal agents that have the poten­tial to pose a severe threat to pub­lic health — and “has not been shown to cause human infec­tions, and has not been shown to be trans­mis­si­ble between humans.”

    But the group’s bat coro­n­avirus research was focused on the very threat that bat virus­es pose to peo­ple. Kessler did acknowl­edge that, while the orig­i­nal bat coro­n­avirus in the exper­i­ment did not spread among humans, the research was designed to gauge how bat coro­n­avirus­es could evolve to infect humans.

    All but two of the sci­en­tists con­sult­ed agreed that, what­ev­er title it is giv­en, the new­ly pub­lic exper­i­ment raised seri­ous con­cerns about the safe­ty and over­sight of fed­er­al­ly fund­ed research. “In my point of view, the debate about the def­i­n­i­tion of ‘gain-of-func­tion’ has been too much focused on tech­ni­cal aspects,” said Jacques van Helden, a pro­fes­sor of bioin­for­mat­ics at Aix-Mar­seille Uni­ver­sité. “The real ques­tion is whether or not research has the poten­tial to cre­ate or facil­i­tate the selec­tion of virus­es that might infect humans.” The exper­i­ments described in the pro­pos­al clear­ly do have that poten­tial, he said.

    NIH spokesper­son Eliz­a­beth Deatrick said that the agency had con­sid­ered the research — and decid­ed not to restrict it under its own rules. “In 2016, NIAID deter­mined that the work was not sub­ject to the Gain-of-Func­tion (GoF) research fund­ing pause and the sub­se­quent HHS P3CO Frame­work,” Deatrick wrote, refer­ring to cri­te­ria put in place in 2017 to guide the agency’s fund­ing deci­sions about research that involves, or is rea­son­ably antic­i­pat­ed to involve, poten­tial pan­dem­ic pathogens.

    ...

    In a heat­ed exchange in July, Repub­li­can Sen. Rand Paul accused Fau­ci of lying when he claimed that NIH did not fund gain-of-func­tion research at the Wuhan Insti­tute of Virol­o­gy.

    Experts now say that the doc­u­ments sup­port the con­tention that NIH fund­ed gain-of-func­tion work, though not in the spe­cif­ic instance where Paul alleged it. “There’s no ques­tion,” said Racaniel­lo, of Colum­bia Uni­ver­si­ty, who point­ed to the decreased weight of the mice infect­ed with the chimeric virus­es that was described in the research sum­maries sent to NIH. “From the weight loss, it’s gain of func­tion. Tony Fau­ci is wrong say­ing it’s not.”

    But the doc­u­ments do not prove Paul’s claim that Fau­ci was lying, as they do not make clear whether Fau­ci read them. Nor do they in any way sup­port Paul’s alle­ga­tion that Fau­ci was “respon­si­ble for 4 mil­lion peo­ple around the world dying of a pan­dem­ic” — or that any­one inten­tion­al­ly caused Covid-19. What is clear is that pro­gram offi­cers at NIAID, the agency that Fau­ci over­sees, did know about the research.

    A para­graph describ­ing the research, as well as two fig­ures illus­trat­ing its results, were includ­ed in both a 2018 progress report on the bat coro­n­avirus grant and an appli­ca­tion for its 2019 renew­al. And NIH con­firmed that it reviewed them.

    “NIH has nev­er approved any research that would make a coro­n­avirus more dan­ger­ous to humans,” the agency said in a state­ment, echo­ing remarks by Collins, the NIH direc­tor, post­ed to its web­site in May. “The research we sup­port­ed in Chi­na, where coro­n­avirus­es are preva­lent, sought to under­stand the behav­ior of coro­n­avirus­es cir­cu­lat­ing in bats that have the poten­tial to cause wide­spread dis­ease.” Sim­i­lar research fund­ed by NIH had aid­ed in the devel­op­ment of vac­cines against the coro­n­avirus, the state­ment con­tin­ued.

    ...

    Shift­ing Def­i­n­i­tions, Grow­ing Viral Load

    The human­ized mouse exper­i­ment fits with the over­all goal of the $3.1 mil­lion grant, which was titled “Under­stand­ing the Risk of Bat Coro­n­avirus Emer­gence” and aimed at pre­vent­ing a pan­dem­ic by pre­dict­ing the cir­cum­stances under which a bat coro­n­avirus could evolve to infect humans. The researchers took an ambi­tious three-pronged approach: screen­ing peo­ple with high expo­sure to wildlife, math­e­mat­i­cal mod­el­ing, and lab exper­i­ments on virus­es. Peter Daszak, the Eco­Health Alliance pres­i­dent, has worked close­ly with sci­en­tists in Chi­na for years, and rough­ly $750,000 of the grant was allo­cat­ed for the Wuhan Insti­tute of Virol­o­gy. An addi­tion­al near­ly $300,000 went to East Chi­na Nor­mal Uni­ver­si­ty, where researchers did field sam­pling.

    In a 2005, Daszak’s team showed that the first SARS virus orig­i­nat­ed in bats. Mid­dle East res­pi­ra­to­ry syn­drome, or MERS, is caused by a coro­n­avirus that emerged in 2012 and also believed to come from bats, which are now a prime tar­get for virol­o­gists try­ing to under­stand and com­bat emerg­ing dis­eases. Daszak has long main­tained that his research is crit­i­cal to pre­vent­ing out­breaks.

    But the research on the bat virus­es in Wuhan showed that infect­ing live ani­mals with altered virus­es can have unpre­dictable con­se­quences. A report to NIH on the project’s progress in the year end­ing in May 2018 described sci­en­tists cre­at­ing new coro­n­avirus­es by chang­ing parts of WIV1 and expos­ing genet­i­cal­ly engi­neered mice to the new chimeric virus­es. Research pub­lished in 2017 in the jour­nal PLOS Pathogen showed that, in cells in a lab­o­ra­to­ry, sim­i­lar chimeric virus­es repro­duced less effec­tive­ly than the orig­i­nal. NIH cit­ed that research as one of the rea­sons the mora­to­ri­um on gain-of-func­tion research of con­cern didn’t apply to this exper­i­ment. “It was a loss of func­tion, not a gain of func­tion,” the email from NIH explained. (NIH also point­ed out that the changes to the chimeric virus­es “would not be antic­i­pat­ed to increase vir­u­lence or trans­mis­si­bil­i­ty in humans.”)

    Inside the lungs of the human­ized mice, how­ev­er, the nov­el virus­es appear to have repro­duced far more quick­ly than the orig­i­nal virus that was used to cre­ate them, accord­ing to a bar graph shown in the doc­u­ments. The viral load in the lung tis­sue of the mice was, at cer­tain points, up to 10,000 times high­er in the mice infect­ed with the altered virus­es than in those infect­ed with WIV1. Accord­ing to Deatrick, the NIH spokesper­son, the dif­fer­ence in the rates of viral repro­duc­tion — which were par­tic­u­lar­ly pro­nounced two and four days after the mice were infect­ed with the virus — didn’t amount to gain of func­tion because, by the end of the exper­i­ment, the amount of virus pro­duced by the par­ent and chimeric strains evened out. “Viral titers were equiv­a­lent by the end of the exper­i­men­tal time-course,” Deatrick wrote. The email also said, “NIH sup­ports this type of research to bet­ter under­stand the char­ac­ter­is­tics of ani­mal virus­es that have the poten­tial to spill over to humans and cause wide­spread dis­ease.”

    Sci­en­tists The Inter­cept con­sult­ed expressed dif­fer­ing views on whether the increase in viral load could be trans­lat­ed to an increase in trans­mis­si­bil­i­ty, which relies on the virus’s abil­i­ty to repli­cate. To some, the jump in viral load indi­cat­ed that the mod­i­fied RNA virus could repli­cate far more rapid­ly than the orig­i­nal in the lungs of the mice, like­ly lead­ing to increased path­o­genic­i­ty and spread. Ras­mussen, of the Vac­cine and Infec­tious Dis­ease Orga­ni­za­tion, point­ed out that viral load is not iden­ti­cal to repro­duc­tion rate, not­ing: “This shows the chimeric virus­es repli­cat­ed a lit­tle faster, but that tells us exact­ly noth­ing about trans­mis­si­bil­i­ty. Fur­ther­more, WIV1 caught up by the end of the exper­i­ment. We see dif­fer­ences in the rate of viral repli­ca­tion all the time, but it is often not direct­ly cor­re­lat­ed with path­o­genic­i­ty.”

    Anoth­er fig­ure in the doc­u­ments sug­gests that at least one of the altered virus­es not only enhanced viral repro­duc­tion, but also caused the human­ized mice to lose more weight than those exposed to the orig­i­nal virus — a mea­sure of the sever­i­ty of ill­ness.

    NIH requires the increase in viral repro­duc­tion to be imme­di­ate­ly report­ed, accord­ing to a note in the Notice of Award the agency issued in July 2016. “No funds are pro­vid­ed and no funds can be used to sup­port gain-of-func­tion research cov­ered under the Octo­ber 17, 2014 White House Announce­ment,” the note said. If any new MERS-like or SARS-like chimeras show “enhanced virus growth greater than 1 log over the parental back­bone strain,” the note con­tin­ued, the researchers were instruct­ed to stop all exper­i­ments with the virus­es and send the data to NIAID grant spe­cial­ists, as well as to the Wuhan Insti­tute of Virol­o­gy biosafe­ty com­mit­tee. The enhanced growth of the chimeric coro­n­avirus­es in the human­ized mice was, at one point, up to 4 log greater — or 10,000 times — the rate of the orig­i­nal virus. But there are no indi­ca­tions the research was stopped.

    In fact, the bat coro­n­avirus grant was renewed for a five-year peri­od in 2019, although the Trump admin­is­tra­tion sus­pend­ed fund­ing in April 2020 amid the Covid-19 pan­dem­ic and spi­ral­ing con­cerns about its ori­gins. (Fund­ing was lat­er rein­stat­ed but under strict con­di­tions that Daszak said were impos­si­ble for his group to meet.)

    Kessler, Eco­Health Alliance’s com­mu­ni­ca­tions man­ag­er, also point­ed to the fact that the grant was renewed in 2019 — after Eco­Health Alliance had twice sub­mit­ted doc­u­ments detail­ing the exper­i­ment — as evi­dence that the orga­ni­za­tion did noth­ing wrong. “If there had been any vio­la­tions, they would not have done so,” he said.

    Long His­to­ry of Con­tro­ver­sy

    The prac­tice of mak­ing chimeric virus­es in order to study how they might become more con­ta­gious was under scruti­ny long before the pan­dem­ic. Pro­po­nents of such gain-of-func­tion research argued that it can help virol­o­gists bet­ter under­stand and defend against nat­ur­al out­breaks. But crit­ics said that they were unrea­son­ably dan­ger­ous.

    In Octo­ber 2014, the fed­er­al gov­ern­ment put a mora­to­ri­um on fund­ing gain-of-func­tion research on poten­tial pan­dem­ic pathogens that could be “rea­son­ably antic­i­pat­ed” to lead to spread in humans, as out­lined in a 2017 guid­ance from the Depart­ment of Health and Human Ser­vices. In Decem­ber 2017, the mora­to­ri­um was lift­ed and replaced with new guide­lines for over­sight of research using poten­tial pan­dem­ic pathogens. The grantees report­ed that the human­ized mouse exper­i­ment was done between June 2017 and May 2018. Gain-of-func­tion research was thrust into the spot­light again in 2020, amid spec­u­la­tion that the Wuhan Insti­tute of Virol­o­gy had con­duct­ed such research and that it was some­how linked to the pan­dem­ic.

    While the new infor­ma­tion about the research on human­ized mice does not pro­vide the “smok­ing gun” for pro­po­nents of what has become known as the “lab leak the­o­ry,” it lends the hypoth­e­sis cre­dence, accord­ing to Stu­art New­man, a pro­fes­sor of cell biol­o­gy who directs the devel­op­men­tal biol­o­gy lab­o­ra­to­ry at New York Med­ical Col­lege. “Mak­ing chimeric coro­n­avirus­es, mix­ing and match­ing RBDs [a part of the virus that allows it to attach to recep­tors] and spike pro­teins is exact­ly the sce­nario imag­ined by many lab-leak sce­nario pro­po­nents,” said New­man. “The fact that this was an estab­lished research par­a­digm in the Wuhan lab … def­i­nite­ly makes the lab­o­ra­to­ry ori­gin more plau­si­ble.”

    The doc­u­ments about the research were released by NIH after The Inter­cept sub­mit­ted a Free­dom of Infor­ma­tion Act request in Sep­tem­ber 2020, lat­er suing to have it ful­filled. The request sought copies of these and oth­er grant pro­pos­als that Daszak sub­mit­ted to the agency, as well as the agency’s com­mu­ni­ca­tions about the pro­pos­als. NIH orig­i­nal­ly denied The Intercept’s request on the grounds that releas­ing Daszak’s pro­pos­als would under­mine an ongo­ing inves­ti­ga­tion. Coun­sel for the agency lat­er admit­ted that NIH had not reviewed many of the records before mak­ing that asser­tion.

    ...

    ———–

    “NIH Doc­u­ments Pro­vide New Evi­dence U.S. Fund­ed Gain-of-Func­tion Research in Wuhan” by Sharon Lern­er, Mara Hvis­ten­dahl, Maia Hib­bett; The Inter­cept; 09/09/2021

    “All but two of the sci­en­tists con­sult­ed agreed that, what­ev­er title it is giv­en, the new­ly pub­lic exper­i­ment raised seri­ous con­cerns about the safe­ty and over­sight of fed­er­al­ly fund­ed research. “In my point of view, the debate about the def­i­n­i­tion of ‘gain-of-func­tion’ has been too much focused on tech­ni­cal aspects,” said Jacques van Helden, a pro­fes­sor of bioin­for­mat­ics at Aix-Mar­seille Uni­ver­sité. “The real ques­tion is whether or not research has the poten­tial to cre­ate or facil­i­tate the selec­tion of virus­es that might infect humans.” The exper­i­ments described in the pro­pos­al clear­ly do have that poten­tial, he said.”

    A high­ly tech­ni­cal quib­ble. That’s what the debate over whether or not the Eco­Health Alliance’s research con­sti­tut­ed gain-of-func­tion research devolved into. A tech­ni­cal quib­ble over whether or not research involv­ing the cre­ation of chimeric virus­es and test­ing them on human­ized mice fell under the tech­ni­cal def­i­n­i­tion of “gain-of-func­tion.” And a quib­ble that’s real­ly only being had at all thanks to the NIH’s release of doc­u­ments request­ed under the Free­dom of Infor­ma­tion Act. Doc­u­ments that the NIH ini­tial­ly tried to avoid releas­ing on bogus claims of an inves­ti­ga­tion into the Eco­Health Alliance that nev­er real­ly hap­pened. That’s all part of the con­text of the recent deci­sion to rescind the WIV-sub award in the Eco­Health Alliance’s con­tract: that deci­sion to ter­mi­nat­ed the WIV sub-award came after an inves­ti­ga­tion that nev­er real­ly appeared to be gen­uine­ly run in the first place:

    ...
    The doc­u­ments about the research were released by NIH after The Inter­cept sub­mit­ted a Free­dom of Infor­ma­tion Act request in Sep­tem­ber 2020, lat­er suing to have it ful­filled. The request sought copies of these and oth­er grant pro­pos­als that Daszak sub­mit­ted to the agency, as well as the agency’s com­mu­ni­ca­tions about the pro­pos­als. NIH orig­i­nal­ly denied The Intercept’s request on the grounds that releas­ing Daszak’s pro­pos­als would under­mine an ongo­ing inves­ti­ga­tion. Coun­sel for the agency lat­er admit­ted that NIH had not reviewed many of the records before mak­ing that asser­tion.
    ...

    And yet, as we saw, that tech­ni­cal quib­ble over whether or not the exper­i­ments con­sti­tut­ed gain-of-func­tion work appears to also large­ly be a dis­trac­tions from the the fact that even the NIH was­n’t fol­low­ing its own rules when it came to this grant. Rule like how the research was to be imme­di­ate­ly report­ed and halt­ed if the virus­es demon­strat­ed an enhanced abil­i­ty to repro­duce. And yet it appears to the Eco­Health Alliance did indeed issue reports that the chimeric virus­es being gen­er­at­ed under the grant were demon­strat­ed high­er rates of repro­duc­tion. Beyond that, they also report­ed signs that the virus was more path­o­gen­ic (caus­ing increased weight loss), and yet the research was nev­er halt­ed and the NIH ulti­mate­ly con­clud­ed that the gain-of-func­tion restric­tions did not apply. In oth­er words, the NIH was giv­ing a thumbs up to the cre­ation of chimeric virus­es at the WIV the entire time:

    ...
    Grant mon­ey for the con­tro­ver­sial exper­i­ment came from the Nation­al Insti­tutes of Health’s Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases, which is head­ed by Antho­ny Fau­ci. The award to Eco­Health Alliance, a research orga­ni­za­tion which stud­ies the spread of virus­es from ani­mals to humans, includ­ed sub­awards to Wuhan Insti­tute of Virol­o­gy and East Chi­na Nor­mal Uni­ver­si­ty. The prin­ci­pal inves­ti­ga­tor on the grant is Eco­Health Alliance Pres­i­dent Peter Daszak, who has been a key voice in the search for Covid-19’s ori­gins.

    ...

    Sci­en­tists work­ing under a 2014 NIH grant to the Eco­Health Alliance to study bat coro­n­avirus­es com­bined the genet­ic mate­r­i­al from a “par­ent” coro­n­avirus known as WIV1 with oth­er virus­es. They twice sub­mit­ted sum­maries of their work that showed that, when in the lungs of genet­i­cal­ly engi­neered mice, three altered bat coro­n­avirus­es at times repro­duced far more quick­ly than the orig­i­nal virus on which they were based. The altered virus­es were also some­what more path­o­gen­ic, with one caus­ing the mice to lose sig­nif­i­cant weight. The researchers report­ed, “These results demon­strate vary­ing path­o­genic­i­ty of SARSr-CoVs with dif­fer­ent spike pro­teins in human­ized mice.”

    But the terms of the grant clear­ly stip­u­lat­ed that the fund­ing could not be used for gain-of-func­tion exper­i­ments. The grant con­di­tions also required the researchers to imme­di­ate­ly report poten­tial­ly dan­ger­ous results and stop their exper­i­ments pend­ing fur­ther NIH review. Accord­ing to both the Eco­Health Alliance and NIH, the results were report­ed to the agency, but NIH deter­mined that rules designed to restrict gain-of-func­tion research did not apply.
    ...

    And regard­ing the demands for the WIV’s note­books, keep in mind that a lot of the this research was pub­lished. That’s a pret­ty good sign of what that grant mon­ey was going towards. And here’s where we get to one of the absurd tech­ni­cal quib­bles that was used to give this research a waiv­er under the NIH’s gain-of-func­tion ban put in place in 2014: The 2017 research pub­lished by Shi Zhengli’s lab showed the chimeric virus­es repro­duced less effec­tive­ly than the orig­i­nal virus­es. The NIH cit­ed the research as a rea­son the gain-of-func­tion mora­to­ri­um — which was­n’t lift­ed until Decem­ber 2017 — as one of the rea­sons the mora­to­ri­um should­n’t apply to the research. And yet, report­ed data from these human­ized mouse exper­i­ments indi­cat­ed that the chimeric virus had viral loads that were up to 10,000 times high­er than the native virus at dif­fer­ent points in the incu­ba­tion peri­od! So how on earth did the NIH con­clude that the research was­n’t cre­at­ing virus­es with enhanced path­o­genic­i­ty? By point­ing to the viral loads at the end of the incu­ba­tion peri­od, which weren’t sig­nif­i­cant­ly dif­fer­ent. It’s the kind of tech­ni­cal quib­ble that shows how almost any exper­i­ment can be deemed not-gain-of-func­tion as long as you try hard enough to find a loop­hole:

    ...
    But the research on the bat virus­es in Wuhan showed that infect­ing live ani­mals with altered virus­es can have unpre­dictable con­se­quences. A report to NIH on the project’s progress in the year end­ing in May 2018 described sci­en­tists cre­at­ing new coro­n­avirus­es by chang­ing parts of WIV1 and expos­ing genet­i­cal­ly engi­neered mice to the new chimeric virus­es. Research pub­lished in 2017 in the jour­nal PLOS Pathogen showed that, in cells in a lab­o­ra­to­ry, sim­i­lar chimeric virus­es repro­duced less effec­tive­ly than the orig­i­nal. NIH cit­ed that research as one of the rea­sons the mora­to­ri­um on gain-of-func­tion research of con­cern didn’t apply to this exper­i­ment. “It was a loss of func­tion, not a gain of func­tion,” the email from NIH explained. (NIH also point­ed out that the changes to the chimeric virus­es “would not be antic­i­pat­ed to increase vir­u­lence or trans­mis­si­bil­i­ty in humans.”)

    Inside the lungs of the human­ized mice, how­ev­er, the nov­el virus­es appear to have repro­duced far more quick­ly than the orig­i­nal virus that was used to cre­ate them, accord­ing to a bar graph shown in the doc­u­ments. The viral load in the lung tis­sue of the mice was, at cer­tain points, up to 10,000 times high­er in the mice infect­ed with the altered virus­es than in those infect­ed with WIV1. Accord­ing to Deatrick, the NIH spokesper­son, the dif­fer­ence in the rates of viral repro­duc­tion — which were par­tic­u­lar­ly pro­nounced two and four days after the mice were infect­ed with the virus — didn’t amount to gain of func­tion because, by the end of the exper­i­ment, the amount of virus pro­duced by the par­ent and chimeric strains evened out. “Viral titers were equiv­a­lent by the end of the exper­i­men­tal time-course,” Deatrick wrote. The email also said, “NIH sup­ports this type of research to bet­ter under­stand the char­ac­ter­is­tics of ani­mal virus­es that have the poten­tial to spill over to humans and cause wide­spread dis­ease.”

    Sci­en­tists The Inter­cept con­sult­ed expressed dif­fer­ing views on whether the increase in viral load could be trans­lat­ed to an increase in trans­mis­si­bil­i­ty, which relies on the virus’s abil­i­ty to repli­cate. To some, the jump in viral load indi­cat­ed that the mod­i­fied RNA virus could repli­cate far more rapid­ly than the orig­i­nal in the lungs of the mice, like­ly lead­ing to increased path­o­genic­i­ty and spread. Ras­mussen, of the Vac­cine and Infec­tious Dis­ease Orga­ni­za­tion, point­ed out that viral load is not iden­ti­cal to repro­duc­tion rate, not­ing: “This shows the chimeric virus­es repli­cat­ed a lit­tle faster, but that tells us exact­ly noth­ing about trans­mis­si­bil­i­ty. Fur­ther­more, WIV1 caught up by the end of the exper­i­ment. We see dif­fer­ences in the rate of viral repli­ca­tion all the time, but it is often not direct­ly cor­re­lat­ed with path­o­genic­i­ty.”
    ...

    Beyond that, these same chimeric virus­es demon­strat­ed an abil­i­ty to induce greater weight loss, an unam­bigu­ous sign of greater path­o­genic­i­ty. This was all part of the data sub­mit­ted by the Eco­Health Alliance to the NIH in 2018. And the exper­i­ments were nev­er stopped:

    ...
    Anoth­er fig­ure in the doc­u­ments sug­gests that at least one of the altered virus­es not only enhanced viral repro­duc­tion, but also caused the human­ized mice to lose more weight than those exposed to the orig­i­nal virus — a mea­sure of the sever­i­ty of ill­ness.

    NIH requires the increase in viral repro­duc­tion to be imme­di­ate­ly report­ed, accord­ing to a note in the Notice of Award the agency issued in July 2016. “No funds are pro­vid­ed and no funds can be used to sup­port gain-of-func­tion research cov­ered under the Octo­ber 17, 2014 White House Announce­ment,” the note said. If any new MERS-like or SARS-like chimeras show “enhanced virus growth greater than 1 log over the parental back­bone strain,” the note con­tin­ued, the researchers were instruct­ed to stop all exper­i­ments with the virus­es and send the data to NIAID grant spe­cial­ists, as well as to the Wuhan Insti­tute of Virol­o­gy biosafe­ty com­mit­tee. The enhanced growth of the chimeric coro­n­avirus­es in the human­ized mice was, at one point, up to 4 log greater — or 10,000 times — the rate of the orig­i­nal virus. But there are no indi­ca­tions the research was stopped.

    In fact, the bat coro­n­avirus grant was renewed for a five-year peri­od in 2019, although the Trump admin­is­tra­tion sus­pend­ed fund­ing in April 2020 amid the Covid-19 pan­dem­ic and spi­ral­ing con­cerns about its ori­gins. (Fund­ing was lat­er rein­stat­ed but under strict con­di­tions that Daszak said were impos­si­ble for his group to meet.)

    Kessler, Eco­Health Alliance’s com­mu­ni­ca­tions man­ag­er, also point­ed to the fact that the grant was renewed in 2019 — after Eco­Health Alliance had twice sub­mit­ted doc­u­ments detail­ing the exper­i­ment — as evi­dence that the orga­ni­za­tion did noth­ing wrong. “If there had been any vio­la­tions, they would not have done so,” he said.
    ...

    Keep in part of the conun­drum the NIH found itself in when mak­ing these gain-of-func­tion deter­mi­na­tions: the mora­to­ri­um was­n’t lift­ed until Decem­ber 2017, and yet the research on those human­ized mice was done between June 1017 and May 2018. It start­ed while the mora­to­ri­um was still in place:

    ...
    In Octo­ber 2014, the fed­er­al gov­ern­ment put a mora­to­ri­um on fund­ing gain-of-func­tion research on poten­tial pan­dem­ic pathogens that could be “rea­son­ably antic­i­pat­ed” to lead to spread in humans, as out­lined in a 2017 guid­ance from the Depart­ment of Health and Human Ser­vices. In Decem­ber 2017, the mora­to­ri­um was lift­ed and replaced with new guide­lines for over­sight of research using poten­tial pan­dem­ic pathogens. The grantees report­ed that the human­ized mouse exper­i­ment was done between June 2017 and May 2018. Gain-of-func­tion research was thrust into the spot­light again in 2020, amid spec­u­la­tion that the Wuhan Insti­tute of Virol­o­gy had con­duct­ed such research and that it was some­how linked to the pan­dem­ic.

    While the new infor­ma­tion about the research on human­ized mice does not pro­vide the “smok­ing gun” for pro­po­nents of what has become known as the “lab leak the­o­ry,” it lends the hypoth­e­sis cre­dence, accord­ing to Stu­art New­man, a pro­fes­sor of cell biol­o­gy who directs the devel­op­men­tal biol­o­gy lab­o­ra­to­ry at New York Med­ical Col­lege. “Mak­ing chimeric coro­n­avirus­es, mix­ing and match­ing RBDs [a part of the virus that allows it to attach to recep­tors] and spike pro­teins is exact­ly the sce­nario imag­ined by many lab-leak sce­nario pro­po­nents,” said New­man. “The fact that this was an estab­lished research par­a­digm in the Wuhan lab … def­i­nite­ly makes the lab­o­ra­to­ry ori­gin more plau­si­ble.”
    ...

    And note the utter­ly disin­gen­u­ous rea­son­ing issued by the Eco­Health Alliance itself in defin­ing its work as not falling under the gain-of-func­tion mora­to­ri­um: They argue that their work did­n’t have any pan­dem­ic poten­tial because “a bat virus is not known to be able to infect humans.” This is such an absurd state­ment on so many lev­els it’s hard to know where to be begin:

    ...
    Robert Kessler, com­mu­ni­ca­tions man­ag­er for Eco­Health Alliance, denied that the work on the human­ized mice met the def­i­n­i­tion of gain-of-func­tion research. Kessler insist­ed that bat virus­es are not poten­tial pan­dem­ic pathogens because, he said, “a bat virus is not known to be able to infect humans.” The pro­pos­al jus­ti­fied the work on WIV1 by explain­ing that it is “not a select agent” — refer­ring to a list of close­ly mon­i­tored tox­ins and bio­log­i­cal agents that have the poten­tial to pose a severe threat to pub­lic health — and “has not been shown to cause human infec­tions, and has not been shown to be trans­mis­si­ble between humans.”

    But the group’s bat coro­n­avirus research was focused on the very threat that bat virus­es pose to peo­ple. Kessler did acknowl­edge that, while the orig­i­nal bat coro­n­avirus in the exper­i­ment did not spread among humans, the research was designed to gauge how bat coro­n­avirus­es could evolve to infect humans.

    ...

    NIH spokesper­son Eliz­a­beth Deatrick said that the agency had con­sid­ered the research — and decid­ed not to restrict it under its own rules. “In 2016, NIAID deter­mined that the work was not sub­ject to the Gain-of-Func­tion (GoF) research fund­ing pause and the sub­se­quent HHS P3CO Frame­work,” Deatrick wrote, refer­ring to cri­te­ria put in place in 2017 to guide the agency’s fund­ing deci­sions about research that involves, or is rea­son­ably antic­i­pat­ed to involve, poten­tial pan­dem­ic pathogens.

    ...

    In a 2005, Daszak’s team showed that the first SARS virus orig­i­nat­ed in bats. Mid­dle East res­pi­ra­to­ry syn­drome, or MERS, is caused by a coro­n­avirus that emerged in 2012 and also believed to come from bats, which are now a prime tar­get for virol­o­gists try­ing to under­stand and com­bat emerg­ing dis­eases. Daszak has long main­tained that his research is crit­i­cal to pre­vent­ing out­breaks.
    ...

    Final­ly, note the scope of the NIH’s grants to the WIV dur­ing this peri­od: rough­ly $750,000. So that’s pre­sum­ably what the Eco­Health Alliance just lost with the now-ter­mi­nat­ed sub-award:

    ...
    The human­ized mouse exper­i­ment fits with the over­all goal of the $3.1 mil­lion grant, which was titled “Under­stand­ing the Risk of Bat Coro­n­avirus Emer­gence” and aimed at pre­vent­ing a pan­dem­ic by pre­dict­ing the cir­cum­stances under which a bat coro­n­avirus could evolve to infect humans. The researchers took an ambi­tious three-pronged approach: screen­ing peo­ple with high expo­sure to wildlife, math­e­mat­i­cal mod­el­ing, and lab exper­i­ments on virus­es. Peter Daszak, the Eco­Health Alliance pres­i­dent, has worked close­ly with sci­en­tists in Chi­na for years, and rough­ly $750,000 of the grant was allo­cat­ed for the Wuhan Insti­tute of Virol­o­gy. An addi­tion­al near­ly $300,000 went to East Chi­na Nor­mal Uni­ver­si­ty, where researchers did field sam­pling.
    ...

    How long before the Eco­Health Alliance reworks its grant to con­tin­ue this research? It looks like that’s just a mat­ter of time. But a far more inter­est­ing ques­tion is who is going to be the next fall guy? We’ll see, but if you’re an aca­d­e­m­ic virol­o­gist work­ing in say, Rus­sia or Iran, and the Eco­Health Alliance approach­es you with an excit­ing col­lab­o­ra­tion, it might be worth tak­ing a pass.

    Posted by Pterrafractyl | September 3, 2022, 4:18 pm
  10. Here’s a trou­bling update on the next round of mRNA COVID vac­cine boost­ers slat­ed for roll out this fall: the FDA has decid­ed to approve the lat­est mRNA boost­ers based exclu­sive­ly on mouse data.

    The ratio­nale for the deci­sion appears to be root­ed, in part, in a per­ceived need to have vac­cines tai­lored for the BA.4 and BA.5 Omi­cron sub­vari­ants that large­ly over­tak­en all of the oth­er vari­ants in the ongo­ing pan­dem­ic. That last boost­er for which human clin­i­cal tri­als were com­plet­ed, the BA.1 vari­ant, was basi­cal­ly replaced by BA.4 and BA.5 this sum­mer. So the FDA is going to rely on the human clin­i­cal tri­al data from the BA.1 boost­er with mouse data from the BA.4 and BA.5 boost­ers to issue an emer­gency autho­riza­tion for the vac­cines this fall. The oth­er part of the ratio­nale for the deci­sion is the infer­ence that, since the BA.4 and BA.5 vac­cines are so sim­i­lar to the BA.1 vac­cine, the safe­ty pro­file will be sim­i­lar too.

    The pri­ma­ry con­cerns we’re hear­ing from experts is con­cern over the pos­si­ble loss in pub­lic faith in the vac­cine approval process if it turns out the new boost­ers don’t con­fer as much pro­tec­tion as the orig­i­nal vac­cines against the new vari­ants. As they remind us, mice aren’t peo­ple. Even if the mouse data demon­strates the new boost­ers illic­it supe­ri­or anti­body respons­es against the new vari­ants, that does­n’t mean that will be the case in human. It will prob­a­bly be the case, but there’s a risk this vac­cine gam­ble is a bust.

    But as we’ve seen, while these con­cerns over inad­e­quate anti­body respons­es are valid, that’s far from the only health risk we need to watch­ing for with this brand new tech­nol­o­gy. Don’t for­get that side-effects relat­ed to the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA may have played a role in Mod­er­na’s deci­sion to tran­si­tion from mRNA ther­a­peu­tics — which requires repeat­ed dos­es over time — to mRNA vac­cines, which only the­o­ret­i­cal­ly requires a sin­gle does over time and for which any immuno­log­i­cal side effects could be seen as a pos­i­tive adju­vant-like side-effect. The entire mRNA ther­a­peu­tics indus­try was thwart­ed for years on this issue and we’ve nev­er hear about a solu­tion. Instead, the ‘solu­tion’ was to shift to a vac­cines where those side-effects are seen as a bonus. At least a bonus in the short-term. And here we are, slat­ed to advise peo­ple to get an mRNA boost­er shot every few months.

    What are the long-term effects of these repeat­ed short-term immuno­log­i­cal ‘bonus­es’? We still don’t know. But keep in mind the we could be look­ing at a sit­u­a­tion where mRNA vac­cines are indeed net-help­ful in the short-term and medi­um term but end up slow­ly becom­ing net-harm­ful over time as the inflam­ma­tion induced by the side-effects from the LNP steadi­ly accu­mu­lates. Again, we still don’t know. It’s been one of the biggest ques­tions fac­ing this entire gam­bit from the begin­ning of the pan­dem­ic. And now, pre­dictably, we’re see­ing our abil­i­ty to even ask and answer these cru­cial long-term ques­tions thwart­ed from the out­set:

    NBC News

    FDA expect­ed to autho­rize new Covid boost­ers with­out data from tests in peo­ple

    The lack of human data means offi­cials like­ly won’t know how much bet­ter the new shots are — if at all — until the fall boost­er cam­paign is well under­way.

    By Berke­ley Lovelace Jr.
    Aug. 30, 2022, 8:09 PM UTC / Updat­ed Aug. 31, 2022, 12:22 PM UTC

    The updat­ed Covid vac­cine boost­ers, a refor­mu­lat­ed ver­sion tar­get­ing the BA.5 omi­cron sub­vari­ant, could be avail­able around Labor Day. They’ll be the first Covid shots dis­trib­uted with­out results from human tri­als. Does that mat­ter?

    Because the Biden admin­is­tra­tion has pushed for a fall boost­er cam­paign to begin in Sep­tem­ber, the mRNA vac­cine-mak­ers Pfiz­er-BioN­Tech and Mod­er­na have only had time to test the refor­mu­lat­ed shots in mice, not peo­ple. That means the Food and Drug Admin­is­tra­tion is rely­ing on the mice tri­al data — plus human tri­al results from a sim­i­lar vac­cine that tar­gets the orig­i­nal omi­cron strain, called BA.1 — to eval­u­ate the new shots, accord­ing to a recent tweet from the FDA com­mis­sion­er, Dr. Robert Califf.

    That could be a poten­tial­ly risky bet, experts say, if the shots don’t work as well as hoped.

    FDA’s gam­ble on the new Covid boost­ers

    Fed­er­al health offi­cials hope that the new vac­cines will pro­vide stronger pro­tec­tion over the exist­ing boost­er shots, which still tar­get the orig­i­nal coro­n­avirus strain. But the lack of data in humans means offi­cials like­ly won’t know how much bet­ter the new shots are — if at all — until the fall boost­er cam­paign is well under­way.

    The FDA’s deci­sion to move for­ward with­out data from human tri­als is a gam­ble, experts say, threat­en­ing to fur­ther low­er pub­lic trust in the vac­cines should the new boost­ers not work as intend­ed.

    “There’s no rea­son to think they’ll be unsafe,” said Dr. Celine Gounder, an infec­tious dis­ease spe­cial­ist at NYU Lan­gone Health in New York City. “But whether they’ll pro­vide sig­nif­i­cant­ly more pro­tec­tion than the orig­i­nal vac­cines? Of that I’m skep­ti­cal.”

    When the FDA autho­rized the first ver­sions of Pfizer’s and Moderna’s Covid vac­cines in late Decem­ber 2020, it based its deci­sions on safe­ty and effi­ca­cy data from tens of thou­sands of tri­al vol­un­teers.

    The new shots from Pfiz­er and Mod­er­na are so-called biva­lent vac­cines, designed to tar­get the BA.4 and BA.5 omi­cron sub­vari­ants, as well as the orig­i­nal coro­n­avirus strain, in a sin­gle dose.

    Because of high lev­els of immu­ni­ty from pri­or vac­ci­na­tion and infec­tion, it would be impos­si­ble for the com­pa­nies to test the new boost­ers in near­ly as many peo­ple as the orig­i­nal shots.

    The FDA asked the drug­mak­ers to update the shots in late June, with the goal of hav­ing the shots test­ed and dis­trib­uted by the fall. Mod­er­na has fin­ished enroll­ment for its new boost­er with 512 par­tic­i­pants. Pfiz­er said it began human test­ing late this month.

    Both com­pa­nies are expect­ed to release results lat­er this year.

    The FDA’s deci­sion to con­sid­er Covid boost­ers with­out human data is in line with how it eval­u­ates mod­i­fied vac­cines for influen­za each year. Clin­i­cal stud­ies in humans aren’t required for the approval of sea­son­al influen­za vac­cines, even when they’re refor­mu­lat­ed for strain changes, said Dr. Jesse Good­man of George­town Uni­ver­si­ty, a for­mer FDA vac­cine chief.

    Still, the flu vac­cine isn’t a fair com­par­i­son, said Dr. Paul Offit, a vac­cine expert at Children’s Hos­pi­tal of Philadel­phia.

    The FDA’s pol­i­cy on influen­za shots is based on decades of expe­ri­ences with strain changes where the flu vac­cines behaved gen­er­al­ly in the same way. The U.S. is still on its first iter­a­tion of the Covid vac­cines, and the mRNA tech­nol­o­gy has only been in wide­spread use since late 2020.

    The agency is mak­ing “huge assump­tions” in its con­sid­er­a­tion of the new Covid boost­ers, Offit said, adding that it’s pos­si­ble the new shots may not be any more effec­tive than the exist­ing vac­cines.

    Not all experts see it the same way.

    Dr. Peter Hotez, co-direc­tor of the Cen­ter for Vac­cine Devel­op­ment at Texas Children’s Hos­pi­tal, said updat­ing the boost­ers to match the cir­cu­lat­ing strains makes sense.

    “In an ide­al world, there is an advan­tage of com­bin­ing BA.5 with the orig­i­nal lin­eage because BA.5 is still with us,” Hotez said. “And if there’s a new vari­ant of con­cern that emerges lat­er this fall or in the win­ter, it’s a pos­si­bil­i­ty it’ll look more like BA.5 than the orig­i­nal lin­eage.”

    It’s like­ly that the new Covid boost­ers will per­form bet­ter than the exist­ing ones, but uncer­tain­ty will remain until tri­als in humans are com­plet­ed, Hotez said.

    The data in ani­mals is help­ful, he said, but there are pit­falls to sole­ly rely­ing on that kind of data.

    “The pit­falls are that ani­mals are ani­mals and humans are humans, and although there’s over­lap, some­times there are sur­pris­es,” Hotez said. (Children’s Hos­pi­tal and Bay­lor Col­lege of Med­i­cine devel­oped a low-cost vac­cine, dubbed Cor­be­vax, that was cleared for use in India.)

    Gounder, of NYU Lan­gone Health, agreed, point­ing to a study pub­lished this year in the jour­nal Cell Reports that found vac­cine-elicit­ed anti­body respons­es in mice can dif­fer from anti­body respons­es seen in non­hu­man pri­mates and humans. That study looked at neu­tral­iz­ing anti­body respons­es to the beta and gam­ma vari­ants, two ear­li­er ver­sions of the virus that spread in the U.S. but nev­er became dom­i­nant.

    The authors sug­gest­ed that cau­tion should be exer­cised when inter­pret­ing data obtained from ani­mals.

    But what about data in humans from the BA.1 boost­ers?

    Dr. Dan Barouch, direc­tor of the Cen­ter for Virol­o­gy and Vac­cine Research at Beth Israel Dea­coness Med­ical Cen­ter in Boston, added that using data from the BA.1 boost­er may also only pro­vide lim­it­ed val­ue in deter­min­ing how effec­tive the BA.5 boost­ers are.

    Barouch, who helped devel­op John­son & John­son’s Covid vac­cine, not­ed that that ver­sion of the boost­ers in pub­lished data only showed a mar­gin­al improve­ment in immune respons­es against the orig­i­nal omi­cron vari­ant com­pared with the exist­ing boost­ers.

    The clin­i­cal ben­e­fit of the BA.5 boost­er com­pared with the exist­ing vac­cines “is not clear,” he said.

    ...

    “Big pic­ture: If you’re 50-plus or you’re 12-plus and immuno­com­pro­mised and you’re more than three months out from a pri­or Covid vac­ci­na­tion or infec­tion, you should get a Covid vac­cine boost­er this fall,” Gounder said.

    ———–

    “FDA expect­ed to autho­rize new Covid boost­ers with­out data from tests in peo­ple” By Berke­ley Lovelace Jr.; NBC News; 08/30/2022

    “Because the Biden admin­is­tra­tion has pushed for a fall boost­er cam­paign to begin in Sep­tem­ber, the mRNA vac­cine-mak­ers Pfiz­er-BioN­Tech and Mod­er­na have only had time to test the refor­mu­lat­ed shots in mice, not peo­ple. That means the Food and Drug Admin­is­tra­tion is rely­ing on the mice tri­al data — plus human tri­al results from a sim­i­lar vac­cine that tar­gets the orig­i­nal omi­cron strain, called BA.1 — to eval­u­ate the new shots, accord­ing to a recent tweet from the FDA com­mis­sion­er, Dr. Robert Califf.”

    Mouse tri­als and human tri­als on a dif­fer­ent vac­cine. That’s the data that the FDA is going to be rely­ing on when it autho­rizes the the next round of mRNA COVID boost­ers tai­lored for the BA.4 and BA.5 sub­vari­ants. A deci­sion that has experts divid­ed, with many cau­tion­ing that it’s a gam­ble that risks the pub­lic’s con­fi­dence in the vac­cines, espe­cial­ly if it does­n’t turn out to pro­vide bet­ter pro­tec­tion than the old­er boost­ers that actu­al­ly have some well-pow­ered human tri­als behind them:

    ...
    The FDA’s deci­sion to move for­ward with­out data from human tri­als is a gam­ble, experts say, threat­en­ing to fur­ther low­er pub­lic trust in the vac­cines should the new boost­ers not work as intend­ed.

    “There’s no rea­son to think they’ll be unsafe,” said Dr. Celine Gounder, an infec­tious dis­ease spe­cial­ist at NYU Lan­gone Health in New York City. “But whether they’ll pro­vide sig­nif­i­cant­ly more pro­tec­tion than the orig­i­nal vac­cines? Of that I’m skep­ti­cal.”

    When the FDA autho­rized the first ver­sions of Pfizer’s and Moderna’s Covid vac­cines in late Decem­ber 2020, it based its deci­sions on safe­ty and effi­ca­cy data from tens of thou­sands of tri­al vol­un­teers.
    ...

    And note the some­what iron­ic jus­ti­fi­ca­tion for the rushed autho­riza­tion: it isn’t pos­si­ble for Mod­er­na and Pfiz­er to test these boost­ers on near­ly as many peo­ple as the tens of thou­sands who were used in the ini­tial human tri­als because of the high lev­els of immu­ni­ty and vac­ci­na­tion that already exist. Yes, we have to rush the next ver­sion of the vac­cines due to the exist­ing high lev­els of vac­ci­na­tion and immu­ni­ty:

    ...
    The new shots from Pfiz­er and Mod­er­na are so-called biva­lent vac­cines, designed to tar­get the BA.4 and BA.5 omi­cron sub­vari­ants, as well as the orig­i­nal coro­n­avirus strain, in a sin­gle dose.

    Because of high lev­els of immu­ni­ty from pri­or vac­ci­na­tion and infec­tion, it would be impos­si­ble for the com­pa­nies to test the new boost­ers in near­ly as many peo­ple as the orig­i­nal shots.
    ...

    But also note what is implied in that kind of rea­son­ing: the assump­tion that we need peo­ple who haven’t already been vac­ci­nat­ed or already had COVID in order to test what are intend­ed to be boost­ers. Isn’t the tar­get pop­u­la­tion for the boost­ers peo­ple who already had a vac­cine or an infec­tion? It’s con­fus­ing rea­son­ing.

    And it’s the kind of rea­son­ing that com­plete­ly side-steps what should be one of the major safe­ty ques­tions being asked by these com­pa­nies and the FDA. A ques­tion that only grows with each new round of boost­ers: what are the health risks of repeat­ed expo­sures to mRNA vac­cines over time? Because at this point repeat­ed expo­sure is what the doc­tor has ordered. Every­one is sup­posed to be boost­ed mul­ti­ple times a year for the fore­see­able future. Lon­gi­tu­di­nal data on the effects of repeat­ed mRNA dos­es is an absolute neces­si­ty. And yet we hear noth­ing about this risk, even in the cri­tiques of this deci­sion to rely on mouse data. The only per­ceived risks are the risks of a loss of pub­lic faith should the boost­ers not be as effec­tive as the orig­i­nal vac­cines. There’s basi­cal­ly no con­cern about detect­ing what could be emerg­ing long-term health issues that only arise from repeat­ed dos­es of this tech­nol­o­gy. Health issues that, as we saw, may have played a role in Mod­er­na’s deci­sion to tran­si­tion from mRNA ther­a­peu­tics — which requires repeat­ed dos­es over time — to mRNA vac­cines, which only the­o­ret­i­cal­ly requires a sin­gle does over time and for which any immuno­log­i­cal side effects could be seen as a pos­i­tive adju­vant-like side-effect. That’s all part of why it’s some­what absurd to point to the lack of human tri­als with each new round of influen­za vac­cines. Influen­za vac­cines have been used for decades while the entire world is basi­cal­ly on its 4th col­lec­tive dose of this mRNA tech­nol­o­gy:

    ...
    The FDA’s deci­sion to con­sid­er Covid boost­ers with­out human data is in line with how it eval­u­ates mod­i­fied vac­cines for influen­za each year. Clin­i­cal stud­ies in humans aren’t required for the approval of sea­son­al influen­za vac­cines, even when they’re refor­mu­lat­ed for strain changes, said Dr. Jesse Good­man of George­town Uni­ver­si­ty, a for­mer FDA vac­cine chief.

    Still, the flu vac­cine isn’t a fair com­par­i­son, said Dr. Paul Offit, a vac­cine expert at Children’s Hos­pi­tal of Philadel­phia.

    The FDA’s pol­i­cy on influen­za shots is based on decades of expe­ri­ences with strain changes where the flu vac­cines behaved gen­er­al­ly in the same way. The U.S. is still on its first iter­a­tion of the Covid vac­cines, and the mRNA tech­nol­o­gy has only been in wide­spread use since late 2020.

    The agency is mak­ing “huge assump­tions” in its con­sid­er­a­tion of the new Covid boost­ers, Offit said, adding that it’s pos­si­ble the new shots may not be any more effec­tive than the exist­ing vac­cines.
    ...

    And again, look at the “Big Pic­ture” mes­sage in the arti­cle: if you’re old­er than 50 or immuno­com­pro­mised and you haven’t been boost­ed in three months, go get a boost­er. We’re telling the most immuno­log­i­cal­ly chal­lenged demo­graph­ics to get mul­ti­ple shots of this new tech­nol­o­gy every year indef­i­nite­ly with­out look­ing into the long-term immuno­log­i­cal side-effects:

    ...
    “Big pic­ture: If you’re 50-plus or you’re 12-plus and immuno­com­pro­mised and you’re more than three months out from a pri­or Covid vac­ci­na­tion or infec­tion, you should get a Covid vac­cine boost­er this fall,” Gounder said.
    ...

    And now here’s a piece on Sci­ence about the FDA’s con­tro­ver­sial deci­sion that gives us more info on the kind of data Mod­er­na and Pfiz­er did actu­al­ly deliv­er to the FDA. Both com­pa­nies pro­vid­ed the FDA ini­tial data dur­ing a meet­ing back on June, where they also pre­sent­ed on the human clin­i­cal tri­al data gen­er­at­ed from their BA.1 boost­er tri­als. Pfiz­er’s data con­sist­ed of a few vague state­ments about how the “reac­to­genic­i­ty pro­file” has sim­i­lar pro­files to the orig­i­nal vac­cine. That was it. The Mod­er­na doc­u­ment had more data on the actu­al side-effects mea­sured.

    But as we’re going to see, it’s still exclu­sive­ly lon­gi­tu­di­nal data on the kinds of acute side-effects that we’re already famil­iar with like fever or chills. The far more diverse and com­pli­cat­ed health com­pli­ca­tions that could arise from immuno­log­i­cal dis­tur­bances asso­ci­at­ed with repeat­ed dos­es sim­ply are not being exam­ined.

    And as we’re also going to see, while the medi­an dura­tion between the 2nd and 3rd vac­cine dos­es in Mod­er­na’s tri­al was 8 months, it was only 4.5 months between the 3rd and 4th dos­es. It’s a reflec­tion of how we’ve just casu­al­ly adopt­ed a pol­i­cy of issu­ing boost­er shots at short­er and short­er dura­tion. It’s going to be 3–4 boost­ers a year at this rate:

    Sci­ence

    Omi­cron boost­er shots are coming—with lots of ques­tions

    COVID-19 vac­cines get their first update since the pan­dem­ic began. Here’s what you need to know about them

    By Gretchen Vogel
    30 Aug 2022 3:20 PM

    Update, 31 August, 1:30 p.m.: The U.S. Food and Drug Admin­is­tra­tion announced today it has grant­ed an emer­gency use autho­riza­tion for Moderna’s and Pfizer-BioNTech’s updat­ed boost­er vac­cines, which tar­get the BA.4/BA.5 coro­n­avirus sub­vari­ants. The U.S. Cen­ters for Dis­ease Con­trol and Prevention’s Advi­so­ry Com­mit­tee on Vac­cine Prac­tices is sched­uled to dis­cuss rec­om­men­da­tions for who should receive the vac­cines and when at their meet­ing on 1–2 Sep­tem­ber.

    For the first time since the start of the pan­dem­ic, COVID-19 vac­cines look set to receive an update. Boost­ers refor­mu­lat­ed to pro­tect against the Omi­cron vari­ant, which has dom­i­nat­ed glob­al­ly since ear­ly this year, may get deployed on both sides of the Atlantic Ocean as ear­ly as this month.

    ...

    But BA.1 is no longer cir­cu­lat­ing; the BA.4 and BA.5 sub­vari­ants eclipsed it in the spring. In June, the U.S. Food and Drug Admin­is­tra­tion (FDA) asked man­u­fac­tur­ers to devel­op a boost­er specif­i­cal­ly tar­get­ing those two sub­vari­ants, and last week, both Mod­er­na and the Pfiz­er-BioN­Tech col­lab­o­ra­tion said they have sub­mit­ted data about their BA.4/BA.5 vac­cines to FDA. Pres­i­dent Joe Biden’s admin­is­tra­tion has already placed an order for 170 mil­lion dos­es of such vac­cines. (Pfiz­er and BioN­Tech have also sub­mit­ted the data to EMA; the Euro­pean Union could first approve a BA.1‑based boost­er and switch to BA.4/BA.5 vac­cines lat­er.)

    ...

    What do the new boost­ers con­tain?

    A bit of the old and a bit of the new. Both the Pfiz­er-BioN­Tech col­lab­o­ra­tion and Mod­er­na make their vac­cines from mes­sen­ger RNA (mRNA) cod­ing for the spike pro­tein of SARS-CoV­‑2. The new vac­cines are biva­lent. Half of the mRNA codes for the spike pro­tein of the ances­tral virus strain that emerged in Wuhan, Chi­na, in late 2019, which is also in the orig­i­nal shots; the oth­er half codes for the spike pro­tein in BA.1 or the one in BA.4 and BA.5, which have iden­ti­cal spikes. Because they con­tain a low­er dose of mRNA, the shots are meant to be used as boost­ers only, and not in peo­ple who were nev­er vac­ci­nat­ed.

    What sort of data have the com­pa­nies col­lect­ed?

    Human data are only avail­able for the com­pa­nies’ boost­ers tar­get­ed to BA.1. At a June meet­ing of FDA’s vac­cine advi­so­ry com­mit­tee, both the Pfiz­er-BioN­Tech col­lab­o­ra­tion and Mod­er­na pre­sent­ed data show­ing that the shots had side effects sim­i­lar to those of the orig­i­nal vaccines—including sore­ness at the injec­tion site and fatigue—and induced strong anti­body respons­es to both the orig­i­nal strain and Omi­cron BA.1. The com­pa­nies also showed that the BA.1 vac­cines prompt­ed sig­nif­i­cant anti­body respons­es to BA.4 and BA.5, although low­er than that to BA.1.

    For the BA.4/BA.5 boost­ers, the com­pa­nies have sub­mit­ted ani­mal data. They have not released those data pub­licly, although at the June FDA meet­ing, Pfiz­er pre­sent­ed pre­lim­i­nary find­ings in eight mice giv­en BA.4/BA.5 vac­cines as their third dose.. Com­pared with the mice that received the orig­i­nal vac­cine as a boost­er, the ani­mals showed an increased response to all Omi­cron vari­ants test­ed: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.

    The com­pa­nies say clin­i­cal tri­als for the BA.4/BA.5 vac­cines will begin next month; they need clin­i­cal data both for full approval of the vaccines—their recent sub­mis­sions are only for emer­gency use authorization—and to help devel­op future updates. Pre­sum­ably they will mea­sure recip­i­ents’ anti­body lev­els, but not the vaccine’s effi­ca­cy against infec­tion or severe dis­ease. Such tri­als are very expen­sive and were not done for the BA.1 shot either.

    How can author­i­ties con­sid­er autho­riz­ing vac­cines with­out data from human tri­als?

    Influen­za vac­cines are updat­ed each spring to try to match the strain most like­ly to cir­cu­late in the fall and win­ter. The refor­mu­lat­ed shots don’t have to under­go new clin­i­cal tri­als unless the man­u­fac­tur­ers sig­nif­i­cant­ly change the way they make the vac­cine. A sim­i­lar approach for new COVID-19 vari­ants makes sense, says Leif Erik Sander, an infec­tious dis­ease expert at the Char­ité Uni­ver­si­ty Hos­pi­tal in Berlin. The changes to the mRNA are minor and pro­vid­ing updat­ed vac­cines as quick­ly as pos­si­ble is “an eth­i­cal issue,” Sander says. “We need to allow peo­ple to pro­tect them­selves from a virus that we can’t ful­ly con­trol.”

    But there is a poten­tial down­side: Autho­riz­ing updat­ed vac­cines with­out clin­i­cal data could low­er pub­lic accep­tance. “If a vari­ant boost­er is going to reduce over­all uptake, that’s a poten­tial prob­lem” that could off­set the gains in pro­tec­tion from the new vac­cine, says Deb­o­rah Cromer, a math­e­mat­i­cal mod­el­er at the Kir­by Insti­tute of the Uni­ver­si­ty of New South Wales.

    Why do the new vac­cines still con­tain mRNA tar­get­ing the ances­tral strain, which is long gone?

    It isn’t entire­ly clear. Hana El Sahly, a vac­cine devel­op­ment expert at Bay­lor Col­lege of Med­i­cine, says she can’t see a bio­log­i­cal rea­son to include both ver­sions of spike. In exper­i­ments in humans and mice, Pfiz­er found that a mono­va­lent strain-spe­cif­ic boost­er elicit­ed a some­what stronger response than the com­bi­na­tion. But in a preprint post­ed on medRx­iv on 26 August that ana­lyzed data from mul­ti­ple clin­i­cal tri­als, Cromer and her col­leagues did not find a sig­nif­i­cant dif­fer­ence between mono­va­lent and biva­lent for­mu­la­tions. Angela Branche of the Uni­ver­si­ty of Rochester Med­ical Cen­ter, who leads a study com­par­ing mul­ti­ple strain-spe­cif­ic vac­cines, notes that the next vari­ant to emerge might be more close­ly relat­ed to the ances­tral strain than to Omi­cron, so the biva­lent for­mu­la could be a use­ful hedge.

    Will the strain-spe­cif­ic mRNA lead to bet­ter pro­tec­tion?

    That’s hard to pre­dict. It depends in part on how much BA.4 and BA.5 are still cir­cu­lat­ing by the time the shots are deliv­ered and how close­ly the next dom­i­nant strain match­es them. It also depends on how many peo­ple have immu­ni­ty from a recent infec­tion.

    In their preprint, Cromer and col­leagues attempt to cal­cu­late the pos­si­ble impact of strain-spe­cif­ic vac­cines. They com­bined data from eight clin­i­cal tri­al reports that com­pared vac­cines based on the orig­i­nal spike pro­tein with for­mu­la­tions tar­get­ed to the Beta, Delta, and Omi­cron BA.1 strains. The stud­ies all mea­sured the abil­i­ty of recip­i­ents’ serum to neu­tral­ize virus vari­ants in the lab.

    They found that the biggest effect came from admin­is­ter­ing any boost­er: On aver­age, an addi­tion­al dose of a vac­cine cod­ing for the ances­tral virus’ spike pro­tein result­ed in an 11-fold increase in neu­tral­iz­ing anti­bod­ies against all vari­ants. But strain-spe­cif­ic vac­cines improved things slight­ly. Recip­i­ents of updat­ed vac­cines had, on aver­age, anti­body lev­els 1.5 times high­er than those who received an ances­tral strain vac­cine. Even if the vac­cine didn’t exact­ly match the viral strain, there was still some ben­e­fit.

    ...

    Strain-adapt­ed boost­ers had some ben­e­fit at the pop­u­la­tion lev­el as well, accord­ing to Cromer’s mod­els, although much depends on the exist­ing lev­els of immu­ni­ty in a pop­u­la­tion. If, for exam­ple, a pop­u­la­tion already has 86% pro­tec­tion against severe dis­ease, ances­tral-strain boost­ers could increase that to 98%, and updat­ed boost­ers to 98.8%. That might not sound like much, Cromer admits, “but if you have a large pop­u­la­tion and lim­it­ed hos­pi­tal beds it can make a dif­fer­ence.”

    If the ben­e­fits are lim­it­ed, do we real­ly need the new boost­ers?

    Some sci­en­tists don’t think we do. Paul Offit, a vac­cine researcher at the Children’s Hos­pi­tal of Philadel­phia, was one of two mem­bers of FDA’s com­mit­tee who vot­ed against ask­ing com­pa­nies to make Omi­cron-spe­cif­ic boost­ers. Offit doesn’t dis­pute that the new vac­cines will have some ben­e­fit but doubts it’s worth the addi­tion­al resources. Cur­rent COVID-19 vac­cines still pre­vent the most severe out­comes, Offit says, and if the goal is to stop infec­tions, even updat­ed vac­cines will have lit­tle impact.

    That’s because the incu­ba­tion peri­od for COVID-19—the time between get­ting infect­ed and becom­ing infec­tious to others—is too short, he says. Unless lev­els of neu­tral­iz­ing anti­bod­ies are already high, the immune sys­tem doesn’t have time to rec­og­nize and fight off the virus in the few days between expo­sure and when some­one sheds enough virus to infect oth­ers. Dis­eases such as measles or rubel­la have a 2‑week incu­ba­tion peri­od, which means a vac­ci­nat­ed person’s immune mem­o­ry cells can ramp up pro­duc­tion of enough anti­bod­ies in time to pre­vent them from pass­ing it on. That’s why measles and rubel­la vac­cines can halt the spread of those dis­eases, Offit says, where­as in the case of COVID-19, “even if 100% of the pop­u­la­tion were vac­ci­nat­ed and the virus hadn’t evolved at all, vac­cines would do very lit­tle to stop trans­mis­sion.”

    Even so, Branche says, the broad­ened immu­ni­ty that updat­ed vac­cines may con­fer would pay off if new vari­ants emerge. “We need to cov­er as much of the map as pos­si­ble,” she says.

    ———-

    “Omi­cron boost­er shots are coming—with lots of ques­tions” by Gretchen Vogel; Sci­ence; 08/20/2022

    “For the BA.4/BA.5 boost­ers, the com­pa­nies have sub­mit­ted ani­mal data. They have not released those data pub­licly, although at the June FDA meet­ing, Pfiz­er pre­sent­ed pre­lim­i­nary find­ings in eight mice giv­en BA.4/BA.5 vac­cines as their third dose.. Com­pared with the mice that received the orig­i­nal vac­cine as a boost­er, the ani­mals showed an increased response to all Omi­cron vari­ants test­ed: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.”

    Eight Mice. That was the ani­mal data that the Pfiz­er pre­sent­ed to the FDA dur­ing a June meet­ing on the new sub­vari­ant vac­cines. It’s not exact­ly impres­sive, sta­tis­ti­cal­ly speak­ing.

    But Mod­er­na and Pfiz­er did have some data from human clin­i­cal tri­als avail­able at that meet­ing from its BA.1 boost­er. So based on the data from those BA.1 tri­als and the mouse data, both Mod­er­na and Pfiz­er are set to grant­ed emer­gency autho­riza­tions for the new sub­vari­ant boost­ers this fall, before the human clin­i­cal tri­als can be com­plet­ed. Full autho­riza­tion will only come after the human tri­als. Of course, by that point we’ll be on the next sub­vari­ant and the next urgent­ly felt need to roll out even new­er vac­cines as soon as pos­si­ble. It points towards one of the per­verse dynam­ics emerg­ing in this sit­u­a­tion: part of the appeal of mRNA vac­cines is that you can eas­i­ly design and man­u­fac­ture new vari­eties to keep up with new viral vari­ants. So these vac­cines are always tech­no­log­i­cal­ly avail­able long before there’s been time to study their effects. In oth­er words, there’s always going to be an incen­tive to issue an emer­gency autho­riza­tion. The vac­cines are ready to go almost imme­di­ate­ly. The safe­ty data is the main hold up. So as long as reg­u­la­tors treat the sit­u­a­tion like an ongo­ing emer­gency, there’s an incen­tive to keep issu­ing the next gen­er­a­tion of mRNA COVID boost­ers with the human tri­als only com­ing lat­er:

    ...
    Human data are only avail­able for the com­pa­nies’ boost­ers tar­get­ed to BA.1. At a June meet­ing of FDA’s vac­cine advi­so­ry com­mit­tee, both the Pfiz­er-BioN­Tech col­lab­o­ra­tion and Mod­er­na pre­sent­ed data show­ing that the shots had side effects sim­i­lar to those of the orig­i­nal vaccines—including sore­ness at the injec­tion site and fatigue—and induced strong anti­body respons­es to both the orig­i­nal strain and Omi­cron BA.1. The com­pa­nies also showed that the BA.1 vac­cines prompt­ed sig­nif­i­cant anti­body respons­es to BA.4 and BA.5, although low­er than that to BA.1.

    ...

    The com­pa­nies say clin­i­cal tri­als for the BA.4/BA.5 vac­cines will begin next month; they need clin­i­cal data both for full approval of the vaccines—their recent sub­mis­sions are only for emer­gency use authorization—and to help devel­op future updates. Pre­sum­ably they will mea­sure recip­i­ents’ anti­body lev­els, but not the vaccine’s effi­ca­cy against infec­tion or severe dis­ease. Such tri­als are very expen­sive and were not done for the BA.1 shot either.

    ...

    Influen­za vac­cines are updat­ed each spring to try to match the strain most like­ly to cir­cu­late in the fall and win­ter. The refor­mu­lat­ed shots don’t have to under­go new clin­i­cal tri­als unless the man­u­fac­tur­ers sig­nif­i­cant­ly change the way they make the vac­cine. A sim­i­lar approach for new COVID-19 vari­ants makes sense, says Leif Erik Sander, an infec­tious dis­ease expert at the Char­ité Uni­ver­si­ty Hos­pi­tal in Berlin. The changes to the mRNA are minor and pro­vid­ing updat­ed vac­cines as quick­ly as pos­si­ble is “an eth­i­cal issue,” Sander says. “We need to allow peo­ple to pro­tect them­selves from a virus that we can’t ful­ly con­trol.”
    ...

    So what did the human clin­i­cal tri­al data from the BA.1 tri­als that Mod­er­na and Pfiz­er showed to the FDA actu­al­ly say about how these tri­als were being con­duct­ed? Well, for exam­ple, if you look at the PDFs of the data pre­sent­ed to the FDA by Mod­er­na back in June, we can find slides describ­ing the side-effects test­ing already done by the com­pa­nies on the new vac­cines. Pfiz­er’s data con­sist­ed of a few vague state­ments about how the “reac­to­genic­i­ty pro­file” has sim­i­lar pro­files to the orig­i­nal vac­cine. That was it.

    The Mod­er­na doc­u­ment had more data on the actu­al side-effects mea­sured. There are two fig­ures com­par­ing the side-effects observed in Mod­er­na’s clin­i­cal stud­ies on human tri­als fol­low­ing the 2nd, 3rd, and 4th dos­es of the com­pa­ny’s mRNA vac­cine. This data was much more in line with what we would want to see in terms of gath­er­ing lon­gi­tu­di­nal data on the pos­si­bly effects of repeat­ed dos­ing with the vac­cine over time. One fig­ure, entit­ed “Local Reac­to­genic­i­ty After 4thDose of mRNA-1273.214 Sim­i­lar to 2ndDose of Pri­ma­ry Series and 3rdDose of mRNA-1273”, shows the rates of pain, ery­the­ma, swelling, and axil­lary swelling or ten­der­ness fol­low­ing the 2nd, 3rd, and 4th dos­es with the vac­cine.

    The next fig­ure, “Sys­temic Reac­to­genic­i­ty After 4thDose of mRNA-1273.214 Sim­i­lar to 2ndDose of Pri­ma­ry Series and 3rdDose of mRNA-1273”, shows the rates of addi­tion­al side effects fol­low­ing the 2nd, 3rd, and 4th dos­es: Fever, Headache, Fatigue, Myal­gia, Arthral­gia, Nausea/Vomiting, and Chills.

    Keep in mind that the 2nd dose would have typ­i­cal­ly been deliv­ered 30 days after the 1st days as part of the ini­tial two-dose inoc­u­la­tion. So this data is fol­low­ing peo­ple who have been boost­ed up to two times and being used for the emer­gency autho­riza­tion for what will be the 5th dose for many peo­ple.

    Now, as we can see in the fig­ures, there were 14,677 peo­ple with data fol­low­ing a sec­ond dose, but only 167 peo­ple with data fol­low­ing a 3rd dose and 437 peo­ple with data fol­low­ing a 4th dose. So the sta­tis­ti­cal pow­er of of these tri­als dropped dra­mat­i­cal­ly from that ini­tial­ly clin­i­cal tri­al on the safe­ty of giv­ing boost­ers.

    And when we look at the fig­ure enti­tled “Demo­graph­ics and Base­line Char­ac­ter­is­tics”, we see that the medi­um inter­val between the 2nd and 3rd dos­es for the peo­ple in these tri­als was 8 months, while the medi­um inter­val between the 3nd and 4rd dos­es was 4.5 months. So the rate of dos­ing has been going up as the pow­er to find side effects asso­ci­at­ed with that repeat­ed dos­es has col­lapsed. And at this point it looks like peo­ple in the US are going to be advised to get COVID boost­ers every few months for the fore­see­able future.

    Now, in terms of assess­ing the preva­lence of the spe­cif­ic acute side effects they’re already look­ing for like fever and fatigue, hav­ing small­er and small­er sam­ples over time is prob­a­bly ade­quate. But in terms of look­ing for side-effects that specif­i­cal­ly pop up in response to repeat­ed dos­es over time — side-effects asso­ci­at­ed with com­pli­ca­tions from chron­ic inflam­ma­tion that can man­i­fest in a myr­i­ad of dif­fer­ent ways — that’s going to be a woe­ful­ly inad­e­quate sam­ple size. Espe­cial­ly when they’re not even look­ing for these kinds of side-effect. This is basi­cal­ly a safe­ty-screen­ing sys­tem set up exclu­sive­ly to detect short-term acute side-effects. Not side-effects asso­ci­at­ed with long-term immuno­log­i­cal dis­tur­bances that might be induced by repeat­ed expos­ing peo­ple to the LNP deliv­ery vehi­cle for this mRNA. And now even this woe­ful­ly inad­e­quate­ly safe­ty-screen­ing reg­i­ment is being short-cir­cuit­ed fur­ther.

    On the plus side, there’s a giant clin­i­cal tri­al cur­rent­ly under­way that will help future gen­er­a­tions under­stand the risks of repeat­ed dos­es of mRNA tech­nol­o­gy. Hun­dreds of mil­lions, even bil­lions, of peo­ple are going to be enrolled by the time it’s done. Well, not for­mal­ly enrolled. It’s an infor­mal clin­i­cal tri­al. And while it’s very well-pow­ered, sta­tis­ti­cal­ly speak­ing, it’s not actu­al­ly very well designed. Or eth­i­cal. But it’s hap­pen­ing. Let’s hope future gen­er­a­tions are actu­al­ly allowed to learn some­thing from this giant infor­mal clin­i­cal tri­al. Bet­ter late than nev­er.

    Posted by Pterrafractyl | September 6, 2022, 4:23 pm

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