Spitfire List Web site and blog of anti-fascist researcher and radio personality Dave Emory.

For The Record  

FTR #1130 Bio-Psy-Op Apocalypse Now, Part 6: The Magic Virus Theory, Part 3

WFMU-FM is pod­cast­ing For The Record–You can sub­scribe to the pod­cast HERE.

You can sub­scribe to e‑mail alerts from Spitfirelist.com HERE.

You can sub­scribe to RSS feed from Spitfirelist.com HERE.

You can sub­scribe to the com­ments made on pro­grams and posts–an excel­lent source of infor­ma­tion in, and of, itself, HERE.

Mr. Emory’s entire life’s work is avail­able on a 32GB flash dri­ve, avail­able for a con­tri­bu­tion of $65.00 or more (to KFJC). Click Here to obtain Dav­e’s 40+ years’ work.

Please con­sid­er sup­port­ing THE WORK DAVE EMORY DOES.

FTR #1130 This pro­gram was record­ed in one, 60-minute seg­ment.

Intro­duc­tion: In addi­tion to review­ing and high­light­ing cogent argu­ments that the SARS-Cov2 (Covid-19) virus may indeed have been made in a lab­o­ra­to­ry, the pro­gram exam­ines sig­nif­i­cant aspects of the hereto­fore puz­zling epi­demi­ol­o­gy of the virus. (We do NOT believe that the virus was syn­the­sized by Chi­na, as “Team Trump” is charg­ing.)

First, how­ev­er, the broad­cast sets forth infor­ma­tion about the quest for a Covid-19 vac­cine.

The make­up of Don­ald Trump’s “Oper­a­tion Warp Speed” pro­gram to devel­op a Covid-19 vac­cine in record time is alarm­ing. (No vac­cine has ever been devel­oped for human use in less than four years.)

“Oper­a­tion Warp Speed”:

  • Is head­ed by Mon­cef Slaoui, for­mer­ly the chair­man of Mod­er­na’s prod­uct devel­op­ment com­mit­tee: ” . . . . Dr. Slaoui served on the board of Mod­er­na, a biotech­nol­o­gy com­pa­ny that has an exper­i­men­tal coro­n­avirus vac­cine that just entered Phase 2 of clin­i­cal tri­als to deter­mine if it is effec­tive. As the chair­man of the Mod­er­na board’s prod­uct devel­op­ment com­mit­tee, Dr. Slaoui might have been privy to the ear­ly indi­ca­tions of tests of whether the company’s approach appeared promis­ing, now that it is being inject­ed into human sub­jects. . . .”
  • Is seen by Slaoui as promis­ing by Slaoui, who may well be ref­er­enc­ing tests on Mod­er­na’s mRNA vac­cine: “. . . . Dr. Slaoui, now a ven­ture cap­i­tal­ist, said that he had ‘recent­ly seen ear­ly data from a clin­i­cal tri­al with a coro­n­avirus vac­cine, and these data made me feel even more con­fi­dent that we will be able to deliv­er a few hun­dred mil­lion dos­es of vac­cine’ — enough to inoc­u­late much of the Unit­ed States — ‘by the end of 2020.’ . . . .”
  • Will be assist­ed by a four-star gen­er­al: ” . . . . . . . . Mr. Slaoui will serve as the chief advis­er on the effort, and Gen. Gus­tave F. Per­na, a four-star gen­er­al who is in charge the Army Matériel Com­mand, will be the chief oper­at­ing offi­cer. . . .”
  • Per­na was recruit­ed by the Chair­man of the Joint Chiefs: ” . . . . Gen­er­al Per­na, who runs the Army’s com­plex sup­ply chain, said that he was asked by Gen. Mark A. Mil­ley, the chair­man of the Joint Chiefs of Staff, to help run the man­u­fac­tur­ing logis­tics relat­ed to the vac­cine devel­op­ment. . . .”

Note that Mon­cef Slaoui holds 10 mil­lion dol­lars worth of Mod­er­na stock, which has tripled in val­ue since the Covid-19 out­break began:” . . . . The for­mer phar­ma exec­u­tive tapped by Pres­i­dent Don­ald Trump to lead the fed­er­al gov­ern­men­t’s hunt for a COVID-19 vac­cine has more than $10 mil­lion in stock options in one of the com­pa­nies receiv­ing fed­er­al fund­ing. . . . Described across four sep­a­rate fil­ings, Slaoui has 155,438 options in Mod­er­na. The stake is worth $10,366,000 at Mod­er­na’s cur­rent share price, $66.69 at the time of pub­li­ca­tion. Mod­er­na shares have almost tripled in val­ue dur­ing 2020. The $66.69 fig­ure rep­re­sents an increase of  184% from the $23.46 it was trad­ing for on Jan­u­ary 1. . . .” (The day the pro­gram was record­ed, Mod­er­na’s stock increased by 25% in val­ue, and Slaoui announced he would sell his stock.)

In past posts and pro­grams, we have not­ed the Moderna–one of the com­pa­nies select­ed to devel­op a Covid-19 vac­cine, has been sub­stan­tial­ly under­writ­ten by the Pen­ta­gon (DARPA). 

Key points of dis­cus­sion in that regard:

  1. Mod­er­na is using nov­el vac­cine tech­nol­o­gy using the injec­tion of genet­ic mate­r­i­al to cre­ate anti­bod­ies. This tech­nol­o­gy has nev­er been used on human beings. “. . . . The sec­ond phar­ma­ceu­ti­cal com­pa­ny that was select­ed by CEPI to devel­op a vac­cine for the new coro­n­avirus is Mod­er­na Inc., which will devel­op a vac­cine for the nov­el coro­n­avirus of con­cern in col­lab­o­ra­tion with the U.S. NIH and which will be fund­ed entire­ly by CEPI. The vac­cine in ques­tion, as opposed to Inovio’s DNA vac­cine, will be a mes­sen­ger RNA (mRNA) vac­cine. Though dif­fer­ent than a DNA vac­cine, mRNA vac­cines still use genet­ic mate­r­i­al ‘to direct the body’s cells to pro­duce intra­cel­lu­lar, mem­brane or secret­ed pro­teins.’ Moderna’s mRNA treat­ments, includ­ing its mRNA vac­cines, were large­ly devel­oped using a $25 mil­lion grant from DARPA and it often touts is strate­gic alliance with DARPA in press releas­es. . . .”
  2. The tech­nol­o­gy has alarm­ing pos­si­ble neg­a­tive side-effects. “. . . . Both DNA and mRNA vac­cines involve the intro­duc­tion of for­eign and engi­neered genet­ic mate­r­i­al into a person’s cells and past stud­ies have found that such vac­cines ‘pos­sess sig­nif­i­cant unpre­dictabil­i­ty and a num­ber of inher­ent harm­ful poten­tial haz­ards’ and that ‘there is inad­e­quate knowl­edge to define either the prob­a­bil­i­ty of unin­tend­ed events or the con­se­quences of genet­ic mod­i­fi­ca­tions.’ Nonethe­less, the cli­mate of fear sur­round­ing the coro­n­avirus out­break could be enough for the pub­lic and pri­vate sec­tor to devel­op and dis­trib­ute such con­tro­ver­sial treat­ments due to fear about the epi­dem­ic poten­tial of the cur­rent out­break. . . .”
  3. Loom­ing large in the back­ground of the Mod­er­na vac­cine tech­nol­o­gy is DARPA fund­ing of “gene dri­ve” tech­nol­o­gy. . . . . Con­cerns about Pen­ta­gon exper­i­ments with bio­log­i­cal weapons have gar­nered renewed media atten­tion, par­tic­u­lar­ly after it was revealed in 2017 that DARPA was the top fun­der of the con­tro­ver­sial ‘gene dri­ve’ tech­nol­o­gy, which has the pow­er to per­ma­nent­ly alter the genet­ics of entire pop­u­la­tions while tar­get­ing oth­ers for extinc­tion. At least two of DARPA’s stud­ies using this con­tro­ver­sial tech­nol­o­gy were clas­si­fied and ‘focused on the poten­tial mil­i­tary appli­ca­tion of gene dri­ve tech­nol­o­gy and use of gene dri­ves in agri­cul­ture,’ accord­ing to media reports. . . . Co-direc­tor of the ETC Group Jim Thomas said that this tech­nol­o­gy may be used as a bio­log­i­cal weapon: ‘Gene dri­ves are a pow­er­ful and dan­ger­ous new tech­nol­o­gy and poten­tial bio­log­i­cal weapons could have dis­as­trous impacts on peace, food secu­ri­ty and the envi­ron­ment, espe­cial­ly if mis­used, The fact that gene dri­ve devel­op­ment is now being pri­mar­i­ly fund­ed and struc­tured by the US mil­i­tary rais­es alarm­ing ques­tions about this entire field.’ . . . . How­ev­er, the ther­a­pies being devel­oped by Inovio, Mod­er­na and the Uni­ver­si­ty of Queens­land are in align­ment with DARPA’s objec­tives regard­ing gene edit­ing and vac­cine tech­nol­o­gy. For instance, in 2015, DARPA geneti­cist Col. Daniel Wat­ten­dorf described how the agency was inves­ti­gat­ing a ‘new method of vac­cine pro­duc­tion [that] would involve giv­ing the body instruc­tions for mak­ing cer­tain anti­bod­ies. Because the body would be its own biore­ac­tor, the vac­cine could be pro­duced much faster than tra­di­tion­al meth­ods and the result would be a high­er lev­el of pro­tec­tion.’ . . . .”

 

As dis­cussed in FTR #1124–among oth­er programs–it is now pos­si­ble to cre­ate ANY virus from scratch, using “mail-order” or “design­er” genes. In FTR #282–record­ed in May of 2001–we not­ed the ter­ri­ble sig­nif­i­cance of the devel­op­ment of such “Design­er Gene” tech­nol­o­gy.

A BBC sto­ry from 1999 high­lights the fears of experts that the advent of such tech­nol­o­gy could enable the devel­op­ment of eth­no-spe­cif­ic bio­log­i­cal weapons: ” . . . . Advances in genet­ic knowl­edge could be mis­used to devel­op pow­er­ful bio­log­i­cal weapons that could be tai­lored to strike at spe­cif­ic eth­nic groups, the British Med­ical Asso­ci­a­tion has warned. A BMA report Biotech­nol­o­gy, Weapons and Human­i­ty says that con­cert­ed inter­na­tion­al action is nec­es­sary to block the devel­op­ment of new, bio­log­i­cal weapons.  . . . The BMA report warns that legit­i­mate research into micro­bi­o­log­i­cal agents and genet­i­cal­ly tar­get­ed ther­a­peu­tic agents could be dif­fi­cult to dis­tin­guish from research geared towards devel­op­ing more effec­tive weapons. . . . Dr Vivi­enne Nathanson, BMA Head of Health Pol­i­cy Research said:  ‘The his­to­ry of human­i­ty is a his­to­ry of war. Sci­en­tif­ic advances quick­ly lead to devel­op­ments in weapons tech­nol­o­gy. . . .‘Biotech­nol­o­gy and genet­ic knowl­edge are equal­ly open to this type of malign use. . . .”

We high­light infor­ma­tion pre­sent­ed in FTR #1129, for pur­pos­es of empha­siz­ing the flim­sy nature of the argu­ment pre­sent­ed in a paper from Nature Med­i­cine.

Many sci­en­tif­ic and med­ical peo­ple dis­miss­ing the argu­ment that the Covid-19 coro­n­avirus may have been cre­at­ed in a lab­o­ra­to­ry may be act­ing out of the sin­cere desire to pre­clude a full-dress Cold War between the U.S. and Chi­na. The Trump admin­is­tra­tion has tire­less­ly flogged the “Chi­na did it and it came from a lab­o­ra­to­ry” meme. Many lib­er­als who dis­missed the obvi­ous fact that Pres­i­dent Kennedy was mur­dered by a cabal of pow­er­ful U.S. nation­al secu­ri­ty inter­ests did so because of what Peter Dale Scott calls a “lev­el one cover-up”–alleged Sovi­et and/or Cas­tro Cuban manip­u­la­tion of Lee Har­vey Oswald, fab­ri­cat­ed by the exe­cu­tion­ers them­selves.

Two telling, thought­ful, sub­stan­tive cri­tiques of the Nature Med­i­cine arti­cle shed light on the flim­sy nature of its argu­ments.

It would not be unfair to char­ac­ter­ize the arti­cle as “The War­ren Report” of the Covid-19 pan­dem­ic.

Genet­ic Engi­neer­ing

Like the Bible, it is open to seri­ous sci­en­tif­ic refu­ta­tion” . . . . To put it sim­ply, the authors are say­ing that SARS-CoV­‑2 was not delib­er­ate­ly engi­neered because if it were, it would have been designed dif­fer­ent­ly. How­ev­er, the Lon­don-based mol­e­c­u­lar geneti­cist Dr Michael Anto­niou com­ment­ed that this line of rea­son­ing fails to take into account that there are a num­ber of lab­o­ra­to­ry-based sys­tems that can select for high affin­i­ty RBD vari­ants that are able to take into account the com­plex envi­ron­ment of a liv­ing organ­ism. This com­plex envi­ron­ment may impact the effi­cien­cy with which the SARS-CoV spike pro­tein can find the ACE2 recep­tor and bind to it. An RBD select­ed via these more real­is­tic real-world exper­i­men­tal sys­tems would be just as ‘ide­al’, or even more so, for human ACE2 bind­ing than any RBD that a com­put­er mod­el could pre­dict. And cru­cial­ly, it would like­ly be dif­fer­ent in amino acid sequence. So the fact that SARS-CoV­‑2 doesn’t have the same RBD amino acid sequence as the one that the com­put­er pro­gram pre­dict­ed in no way rules out the pos­si­bil­i­ty that it was genet­i­cal­ly engi­neered. . . .”

Dr. Michael Anto­niou notes that dif­fer­ent genet­ic engi­neer­ing process­es than the one high­light­ed in the Nature Med­i­cine paper can be used: ”  . . . . There is anoth­er method by which an enhanced-infec­tiv­i­ty virus can be engi­neered in the lab. A well-known alter­na­tive process that could have been used has the cum­ber­some name of “direct­ed iter­a­tive evo­lu­tion­ary selec­tion process”. In this case, it would involve using genet­ic engi­neer­ing to gen­er­ate a large num­ber of ran­dom­ly mutat­ed ver­sions of the SARS-CoV spike pro­tein recep­tor bind­ing domain (RBD), which would then be select­ed for strong bind­ing to the ACE2 recep­tor and con­se­quent­ly high infec­tiv­i­ty of human cells. . . .”

The notion that the Nature Med­i­cine authors had not heard of the above process is not cred­i­ble: ” . . . . Such a direct­ed iter­a­tive evo­lu­tion­ary selec­tion process is a fre­quent­ly used method in lab­o­ra­to­ry research. So there is lit­tle or no pos­si­bil­i­ty that the Nature Med­i­cine arti­cle authors haven’t heard of it – not least, as it is con­sid­ered so sci­en­tif­i­cal­ly impor­tant that its inven­tors were award­ed the Nobel Prize in Chem­istry in 2018. . . .”

Of more than pass­ing sig­nif­i­cance is anoth­er arti­cle that finds seri­ous fault with the Nature Med­i­cine paper. ” . . . . Pro­fes­sor Stu­art New­man, pro­fes­sor of cell biol­o­gy and anato­my at New York Med­ical Col­lege, says that a key argu­ment used to deny that it could be a genet­i­cal­ly engi­neered strain that escaped from a lab­o­ra­to­ry actu­al­ly points to the exact oppo­site. In oth­er words, it indi­cates that SARS-CoV­‑2 could well be genet­i­cal­ly engi­neered and that it could have escaped from a lab. . . . As Adam Lau­r­ing, an asso­ciate pro­fes­sor of micro­bi­ol­o­gy, immunol­o­gy and infec­tious dis­eases at the Uni­ver­si­ty of Michi­gan Med­ical School, has not­ed, Andersen’s paper argues that, ‘the SARS-CoV­‑2 virus has some key dif­fer­ences in spe­cif­ic genes rel­a­tive to pre­vi­ous­ly iden­ti­fied coro­n­avirus­es – the ones a lab­o­ra­to­ry would be work­ing with. This con­stel­la­tion of changes makes it unlike­ly that it is the result of a lab­o­ra­to­ry ‘escape’.‘But Pro­fes­sor New­man says that this is total­ly uncon­vinc­ing because ‘The ‘key dif­fer­ences’ were in regions of the coro­n­avirus spike pro­tein that were the sub­ject of genet­ic engi­neer­ing exper­i­ments in labs around the world (main­ly in the US and Chi­na) for two decades.’ . . .”

Pro­fes­sor New­man goes on to high­light oth­er, seri­ous flaws in the argu­ment: ” . . . In an email inter­view with GMWatch, New­man, who is edi­tor-in-chief of the jour­nal Bio­log­i­cal The­o­ry and co-author (with Tina Stevens) of the book Biotech Jug­ger­naut, ampli­fied this spec­u­la­tion by not­ing, ‘The Nature Med­i­cine paper points to vari­a­tions in two sites of the spike pro­tein of the new coro­n­avirus that the authors claim must have arisen by nat­ur­al selec­tion in the wild. How­ev­er, genet­ic engi­neer­ing of one of these sites, the ACE2 recep­tor bind­ing domain, has been pro­posed since 2005 in order to help gen­er­ate vac­cines against these virus­es (see this paper). It is puz­zling that the authors of the Nature Med­i­cine com­men­tary did not cite this paper, which appeared in the promi­nent jour­nal Sci­ence.More­over, New­man added, “The sec­ond site that Ander­sen et al. assert arose by nat­ur­al means, a tar­get of enzyme cleav­age not usu­al­ly found in this class of virus­es, was in fact intro­duced by genet­ic engi­neer­ing in a sim­i­lar coro­n­avirus in a paper they do cite. This was done to explore mech­a­nisms of path­o­genic­i­ty. . . . .”

Worth not­ing, again, is the British Med­ical Asso­ci­a­tion’s warn­ing dis­cussed in FTR #1129, as well as above: ” . . . .The BMA report warns that legit­i­mate research into micro­bi­o­log­i­cal agents and genet­i­cal­ly tar­get­ed ther­a­peu­tic agents could be dif­fi­cult to dis­tin­guish from research geared towards devel­op­ing more effec­tive weapons. . . .”

As the GMWatch authors con­clude: ” . . . . Such ‘enhanced infec­tiv­i­ty’ research is car­ried out on virus­es all over the world (and not just in Chi­na) to inves­ti­gate their behav­iour and to devel­op vac­cines and oth­er ther­a­pies, as well as for ‘biode­fence’ pur­pos­es. . . .”

Reports are now emerg­ing of pos­si­ble Covid-19 infec­tion among ath­letes who par­tic­i­pat­ed at the Mil­i­tary World Games in Wuhan in Octo­ber 19. 

We have spec­u­lat­ed at some length about the pos­si­bil­i­ty that infect­ing those very healthy, superbly-con­di­tioned indi­vid­u­als might have been an excel­lent vehi­cle for spread­ing the virus around the world. 

Fur­ther dis­cus­sion of this can be found in FTR #‘s 1118 and 1122. We note that Chi­na has spec­u­lat­ed about the Wuhan Mil­i­tary World Games being a vehi­cle for the U.S. to spread the infec­tion.

We have not­ed that lan­guage is, past a point, inad­e­quate to ana­lyze and dis­cuss some of the major con­sid­er­a­tions in the Covid-19 “op.” A bio-weapons would require a very small num­ber of agents in order to be effec­tive­ly dis­sem­i­nat­ed. In addi­tion, we note that–in the age of mind con­trol–an oper­a­tive can be dis­pensed to per­form a func­tion with­out their knowl­edge.

In addi­tion to French ath­letes, con­tin­gents from Swe­den, Spain and Italy appear to have become infect­ed. The appar­ent infec­tion of the French ath­letes pre-dates the first con­firmed case in Chi­na by 20 days.

A fish mer­chant who worked near Charles De Gaulle Air­port test­ed pos­i­tive for the virus on Decem­ber 27.

The appar­ent­ly infect­ed ath­letes par­tic­i­pat­ing in the Mil­i­tary World Games fur­ther com­pli­cates the puz­zling epi­demi­ol­o­gy of the virus.

Doc­tors quot­ed in a New York Times piece under­score the anom­alous epi­demi­ol­o­gy of the virus: ” . . . . In San Jose, tis­sue sam­pling from a woman who died on Feb. 6 revealed that she was prob­a­bly the first known per­son in the U.S. whose death was linked to the coro­n­avirus — a strong sign that the virus may have been cir­cu­lat­ing in that part of North­ern Cal­i­for­nia in Jan­u­ary. But was it part of a large, pre­vi­ous­ly unrec­og­nized out­break?

“Dr. George Ruther­ford, a pro­fes­sor of epi­demi­ol­o­gy and bio­sta­tis­tics at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, the­o­rized that per­haps the woman, who worked for a com­pa­ny that had an office in Wuhan, was one of only a small num­ber of peo­ple who con­tract­ed the virus at that time and that trans­mis­sions prob­a­bly petered out for some rea­son. Oth­er­wise, he said, the region would have seen a much big­ger out­break. . . .

“. . . . Dr. [Trevor] Bed­ford said he also believed this was the more like­ly sce­nario, not­ing that up to half of peo­ple with coro­n­avirus infec­tions have no symp­toms. . . .

“. . . . There could have been a tiny num­ber of iso­lat­ed coro­n­avirus cas­es among trav­el­ers to the Unit­ed States in Decem­ber, Dr. Bed­ford said. But it is pret­ty clear that none of them spread.

In part, sci­en­tists can tell that by look­ing at the genom­ic fin­ger­prints of each case. But anoth­er clue is the rapid rate at which the virus spreads, Dr. Ruther­ford said. . . . Researchers are not see­ing any chains that appear to go that far back. . . .”

Lead­ing the Trump admin­is­tra­tion’s rhetor­i­cal and polit­i­cal charge against Chi­na is Mike Pom­peo. Charg­ing that the virus “escaped” from a lab in Wuhan and equiv­o­cat­ing about whether that release was inten­tion­al, Koch broth­ers-pro­tege Pom­peo cit­ed alleged duplic­i­ty on behalf of Chi­na’s com­mu­nist par­ty in con­nec­tion with the virus. ” . . . . ‘I can tell you that there is a sig­nif­i­cant amount of evi­dence that this came from that lab­o­ra­to­ry in Wuhan,’ Pom­peo said on ABC’s ‘This Week’ Sun­day. ‘Do you think they inten­tion­al­ly released that virus, or it was an acci­dent in the lab?’ Co-Anchor Martha Rad­datz pressed. ‘I can’t answer your ques­tion about that,’ he said, ‘because the Chi­nese Com­mu­nist Par­ty has refused to coop­er­ate with world health experts.’ . . .”

The Chi­nese med­ical and sci­en­tif­ic estab­lish­ment has worked close­ly with coun­ter­parts glob­al­ly in an attempt to ana­lyze and treat the virus.

The high­ly anom­alous epi­demi­ol­o­gy, the lack of symp­toms in half of infect­ed patients, the wide vari­ety of symp­toms the virus caus­es and, last­ly, the fact that this was a nov­el virus and result­ing infec­tion are all fac­tors to be con­sid­ered in eval­u­at­ing the time­li­ness of the Chi­nese response.

Pom­peo also asserts that the virus was not made in a lab­o­ra­to­ry.

Next, we high­light a mis­lead­ing sto­ry in Rupert Mur­doch’s The Dai­ly Tele­graph out of Syd­ney, Aus­tralia. The sto­ry alleges that the Five Eyes elec­tron­ic intel­li­gence net­work has cor­rob­o­rat­ed the “it came from a Chi­nese lab” meme.

Of more than pass­ing inter­est is the dis­clo­sure that the project on bat-borne coro­n­avirus­es con­duct­ed in the Wuhan lab­o­ra­to­ry was a joint U.S./Chinese project, and that Ralph Bar­ic was a key Amer­i­can part­ner in the project.

This is the under­tak­ing about which we have report­ed and dis­cussed exten­sive­ly in the past!  . . . . One of Dr Shi’s co-authors on that paper, Pro­fes­sor Ralph Bar­ic from North Car­oli­na Uni­ver­si­ty, said in an inter­view with ‘Sci­ence Dai­ly’ at the time: ‘This virus is high­ly path­o­gen­ic and treat­ments devel­oped against the orig­i­nal SARS virus in 2002 and the ZMapp drugs used to fight ebo­la fail to neu­tralise and con­trol this par­tic­u­lar virus.’ . . . .”

Bar­ic was the selectee to recon­struct the SARS Cov2 virus from scratch. Note that the arti­cle below dis­cuss­es the U.S. sus­pen­sion of the “gain of func­tion” exper­i­ments and 2017 resump­tion of same, some­how spin­ning this into the “Chi­na did it” dis­in­for­ma­tion.

The mil­i­tary has links to the Wuhan lab: ” . . . . Fur­ther­more, DARPA and the Pentagon’s past his­to­ry with bioweapons and their more recent exper­i­ments on genet­ic alter­ation and extinc­tion tech­nolo­gies as well as bats and coro­n­avirus­es in prox­im­i­ty to Chi­na have been large­ly left out of the nar­ra­tive, despite the infor­ma­tion being pub­licly avail­able. Also left out of the media nar­ra­tive have been the direct ties of both the USAMRIID and DARPA-part­nered Duke Uni­ver­si­ty to the city of Wuhan, includ­ing its Insti­tute of Med­ical Virol­o­gy. . . .”

A Guardian arti­cle sources UK intel­li­gence assets claim­ing that the 15-page dossier didn’t come from a Five Eyes intel­li­gence assess­ment. They assert that it was based on open-source mate­ri­als and put for­ward by the US as “a tool for build­ing a counter-nar­ra­tive and apply­ing pres­sure to Chi­na.”

We con­clude with analy­sis of Trump’s deputy nation­al secu­ri­ty advis­er.

Against the back­ground of the Trump admin­is­tra­tion’s anti-Chi­na cam­paign rhetoric and attempts to pin the blame for Covid-19 on a “lab­o­ra­to­ry” leak and/or delib­er­ate release, we note that the offen­sive is being pushed by The Don­ald’s deputy nation­al secu­ri­ty advis­er Matthew Pot­tinger.

“. . . . Matthew Pot­tinger, the deputy nation­al secu­ri­ty advis­er who report­ed on SARS out­breaks as a jour­nal­ist in Chi­na, pressed intel­li­gence agen­cies in Jan­u­ary to gath­er infor­ma­tion that might sup­port any ori­gin the­o­ry linked to a lab. . . .”

Pot­tinger is the son of for­mer Assis­tant Attor­ney Gen­er­al J. Stan­ley Pot­tinger.

Pot­tinger, Senior was: Assis­tant Attor­ney Gen­er­al for Civ­il Rights under Nixon and Ford; report­ed by Don­ald Freed and Fred Lan­dis (in “Death in Wash­ing­ton”) to have foiled inves­ti­ga­tions into the assas­si­na­tions of Mar­tin Luther King and Orlan­do Lete­lier; the attor­ney for the Hashe­mi broth­ers in the Octo­ber Sur­prise inves­ti­ga­tion; a close per­son­al friend of George H.W. Bush (for whom CIA head­quar­ters was named) and, last but cer­tain­ly not least, Glo­ria Steinem’s lover for nine years.

Despite the fact that Steinem tout­ed her CIA back­ground as good jour­nal­is­tic cre­den­tials in both “The New York Times” and “The Wash­ing­ton Post” (both with long-stand­ing CIA links them­selves), Pot­tinger has defend­ed her against charges that she worked for the CIA!!

Worth not­ing, as well, is the fact that the Lete­lier assas­si­na­tion was one of the mur­ders con­duct­ed under Oper­a­tion Con­dor, assist­ed by the CIA. Lete­lier was killed by a car bomb in Wash­ing­ton D.C., while J.Stanley Pot­tinger’s good friend George H.W. Bush was in charge of the CIA when Lete­lier was hit.

(We have cov­ered Oper­a­tion Con­dor in numer­ous pro­grams, includ­ing AFA #19One of the oper­a­tional cen­ters of Con­dor was the Chilean Nazi enclave Colo­nia Dig­nidad. In FTR #839, we set forth author Peter Lev­en­da’s brave, fright­en­ing vis­it to “The Colony.” This should be digest­ed by any­one inter­est­ed in the his­to­ry of which Pot­tinger, Sr., is a part.)

One won­ders if Matthew may have fol­lowed J. Stan­ley into the CIA, if in fact Dad­dio is Agency, as Mr. Emory sus­pects.

In FTR #s 998, 999, 1000, we set forth what Mr. Emory calls “weaponized fem­i­nism.” Refash­ion­ing the doc­trine of advanc­ing the cause of women into a legal and polit­i­cal weapon for destroy­ing tar­get­ed men, dom­i­nant man­i­fes­ta­tions of the #MeToo move­ment have served the cause of the far right.

Resembling–in its essence–the “libid­i­nal McCarthy­ism” of Arthur Miller’s play “The Cru­cible,”  many high-pro­file man­i­fes­ta­tions of #MeToo have been pro­pelled by evi­den­tiary mate­r­i­al that ranges from dubi­ous to ludi­crous to non-exis­tent.

We find it more than coin­ci­den­tal that Bernie Sanders sup­port­er Tara Read­e’s shape-shift­ing accu­sa­tions against Joe Biden have sur­faced decades after the alleged incident–coinciding with Biden’s chal­leng­ing of Trump and with Pot­tinger, Jr. help­ing to direct the admin­is­tra­tion’s traf­fic.

1. The make­up of Don­ald Trump’s “Oper­a­tion Warp Speed” pro­gram to devel­op a Covid-19 vac­cine in record time is alarm­ing. (No vac­cine has ever been devel­oped for human use in less than four years.)

“Oper­a­tion Warp Speed”:

  • Is head­ed by Mon­cef Slaoui, for­mer­ly the chair­man of Mod­er­na’s prod­uct devel­op­ment com­mit­tee: ” . . . . Dr. Slaoui served on the board of Mod­er­na, a biotech­nol­o­gy com­pa­ny that has an exper­i­men­tal coro­n­avirus vac­cine that just entered Phase 2 of clin­i­cal tri­als to deter­mine if it is effec­tive. As the chair­man of the Mod­er­na board’s prod­uct devel­op­ment com­mit­tee, Dr. Slaoui might have been privy to the ear­ly indi­ca­tions of tests of whether the company’s approach appeared promis­ing, now that it is being inject­ed into human sub­jects. . . .”
  • Is seen by Slaoui as promis­ing by Slaoui, who may well be ref­er­enc­ing tests on Mod­er­na’s mRNA vac­cine: “. . . . Dr. Slaoui, now a ven­ture cap­i­tal­ist, said that he had ‘recent­ly seen ear­ly data from a clin­i­cal tri­al with a coro­n­avirus vac­cine, and these data made me feel even more con­fi­dent that we will be able to deliv­er a few hun­dred mil­lion dos­es of vac­cine’ — enough to inoc­u­late much of the Unit­ed States — ‘by the end of 2020.’ . . . .”
  • Will be assist­ed by a four-star gen­er­al: ” . . . . . . . . Mr. Slaoui will serve as the chief advis­er on the effort, and Gen. Gus­tave F. Per­na, a four-star gen­er­al who is in charge the Army Matériel Com­mand, will be the chief oper­at­ing offi­cer. . . .”
  • Per­na was recruit­ed by the Chair­man of the Joint Chiefs: ” . . . . Gen­er­al Per­na, who runs the Army’s com­plex sup­ply chain, said that he was asked by Gen. Mark A. Mil­ley, the chair­man of the Joint Chiefs of Staff, to help run the man­u­fac­tur­ing logis­tics relat­ed to the vac­cine devel­op­ment. . . .”

“Trump Vows Vac­cine by End of Year, and Mobi­lizes Mil­i­tary to Help” by David E. Sanger, Mag­gie Haber­man and Noah Wei­land; The New York Times; 5/15/2020.

. . . .The new chief of what Mr. Trump calls Oper­a­tion Warp Speed, Mon­cef Slaoui, a for­mer chair­man of vac­cines at Glax­o­SmithK­line, called Mr. Trump’s goal “very cred­i­ble,” even though the fastest a new vac­cine has been devel­oped and dis­trib­uted is four years and most have tak­en con­sid­er­ably longer.

Dr. Slaoui, now a ven­ture cap­i­tal­ist, said that he had “recent­ly seen ear­ly data from a clin­i­cal tri­al with a coro­n­avirus vac­cine, and these data made me feel even more con­fi­dent that we will be able to deliv­er a few hun­dred mil­lion dos­es of vac­cine” — enough to inoc­u­late much of the Unit­ed States — “by the end of 2020.”

He did not iden­ti­fy which vac­cine he was refer­ring to, but until Fri­day, when he resigned to take on the new job with the White House, Dr. Slaoui served on the board of Mod­er­na, a biotech­nol­o­gy com­pa­ny that has an exper­i­men­tal coro­n­avirus vac­cine that just entered Phase 2 of clin­i­cal tri­als to deter­mine if it is effec­tive.

As the chair­man of the Mod­er­na board’s prod­uct devel­op­ment com­mit­tee, Dr. Slaoui might have been privy to the ear­ly indi­ca­tions of tests of whether the company’s approach appeared promis­ing, now that it is being inject­ed into human sub­jects. . . .

. . . . Mr. Slaoui will serve as the chief advis­er on the effort, and Gen. Gus­tave F. Per­na, a four-star gen­er­al who is in charge the Army Matériel Com­mand, will be the chief oper­at­ing offi­cer.

Mr. Slaoui said he dis­cussed the job with Jared Kush­n­er, the president’s son-in-law and senior advis­er, who had been search­ing for a so-called czar for ther­a­peu­tics and vac­cine devel­op­ment, and Dr. Deb­o­rah L. Birx, the White House’s coro­n­avirus response coor­di­na­tor.

Gen­er­al Per­na, who runs the Army’s com­plex sup­ply chain, said that he was asked by Gen. Mark A. Mil­ley, the chair­man of the Joint Chiefs of Staff, to help run the man­u­fac­tur­ing logis­tics relat­ed to the vac­cine devel­op­ment. Beyond the vac­cine itself, there are also sub­stan­tial chal­lenges in ensur­ing ade­quate capac­i­ty of the sup­plies need­ed to dis­trib­ute and admin­is­ter it, start­ing with the spe­cial glass in which vac­cine dos­es are trans­port­ed.

Mr. Slaoui and Gen­er­al Per­na met for the first time on Wednes­day, and they have been in fre­quent con­tact since then, the gen­er­al said in a sep­a­rate inter­view. They will have offices in the Depart­ment of Health and Human Ser­vices, where the sec­re­tary, Alex M. Azar II, helped devel­op Oper­a­tion Warp Speed at the president’s request. . . .

2. Mon­cef Slaoui holds 10 mil­lion dol­lars worth of Mod­er­na stock, which has tripled in val­ue since the Covid-19 out­break began:” . . . . The for­mer phar­ma exec­u­tive tapped by Pres­i­dent Don­ald Trump to lead the fed­er­al gov­ern­men­t’s hunt for a COVID-19 vac­cine has more than $10 mil­lion in stock options in one of the com­pa­nies receiv­ing fed­er­al fund­ing. . . . Described across four sep­a­rate fil­ings, Slaoui has 155,438 options in Mod­er­na. The stake is worth $10,366,000 at Mod­er­na’s cur­rent share price, $66.69 at the time of pub­li­ca­tion. Mod­er­na shares have almost tripled in val­ue dur­ing 2020. The $66.69 fig­ure rep­re­sents an increase of  184% from the $23.46 it was trad­ing for on Jan­u­ary 1. . . .”

 “The Ex-Phar­ma Exec Lead­ing Trump’s Covid-19 Vac­cine Pro­gram Has $10 Mil­lion in Stock Options for a Com­pa­ny Get­ting Fed­er­al Fund­ing’ by Kier­an Cor­co­ran; Busi­ness Insid­er; 3/16/2020.

The for­mer phar­ma exec­u­tive tapped by Pres­i­dent Don­ald Trump to lead the fed­er­al gov­ern­men­t’s hunt for a COVID-19 vac­cine has more than $10 mil­lion in stock options in one of the com­pa­nies receiv­ing fed­er­al fund­ing.

Dr Mon­cef Slaoui, a Bel­gian-Amer­i­can, was this week named Chief Sci­en­tist for Trump’s “Oper­a­tion Warp Speed,” which aims to devel­op a work­ing vac­cine as fast as pos­si­ble. . . .

. . . . In order to take up the posi­tion, Slaoui resigned his role on the board of direc­tors for Mod­er­na Inc., a biotech com­pa­ny based in Cam­bridge, Mass­a­chu­setts. Accord­ing to the Asso­ci­at­ed Press, Slaoui’s White House role is unpaid. . . .

. . . . How­ev­er, fil­ings with the US Secu­ri­ties and Exchange Com­mis­sion show that Slaoui con­tin­ues to hold valu­able stock options in Mod­er­na.

Described across four sep­a­rate fil­ings, Slaoui has 155,438 options in Mod­er­na. The stake is worth $10,366,000 at Mod­er­na’s cur­rent share price, $66.69 at the time of pub­li­ca­tion.

Mod­er­na shares have almost tripled in val­ue dur­ing 2020. The $66.69 fig­ure rep­re­sents an increase of  184% from the $23.46 it was trad­ing for on Jan­u­ary 1.

Part of this sharp increase was fueled by an injec­tion of more than $400 mil­lion from the fed­er­al gov­ern­ment to assist tri­als of a coro­n­avirus vac­cine. . . .

3. In past posts and pro­grams, we have not­ed the Moderna–one of the com­pa­nies select­ed to devel­op a Covid-19 vac­cine, has been sub­stan­tial­ly under­writ­ten by the Pen­ta­gon (DARPA). 

Key points of dis­cus­sion in that regard:

  • Mod­er­na is using nov­el vac­cine tech­nol­o­gy using the injec­tion of genet­ic mate­r­i­al to cre­ate anti­bod­ies. This tech­nol­o­gy has nev­er been used on human beings. “. . . . The sec­ond phar­ma­ceu­ti­cal com­pa­ny that was select­ed by CEPI to devel­op a vac­cine for the new coro­n­avirus is Mod­er­na Inc., which will devel­op a vac­cine for the nov­el coro­n­avirus of con­cern in col­lab­o­ra­tion with the U.S. NIH and which will be fund­ed entire­ly by CEPI. The vac­cine in ques­tion, as opposed to Inovio’s DNA vac­cine, will be a mes­sen­ger RNA (mRNA) vac­cine. Though dif­fer­ent than a DNA vac­cine, mRNA vac­cines still use genet­ic mate­r­i­al ‘to direct the body’s cells to pro­duce intra­cel­lu­lar, mem­brane or secret­ed pro­teins.’ Moderna’s mRNA treat­ments, includ­ing its mRNA vac­cines, were large­ly devel­oped using a $25 mil­lion grant from DARPA and it often touts is strate­gic alliance with DARPA in press releas­es. . . .”
  • The tech­nol­o­gy has alarm­ing pos­si­ble neg­a­tive side-effects. “. . . . Both DNA and mRNA vac­cines involve the intro­duc­tion of for­eign and engi­neered genet­ic mate­r­i­al into a person’s cells and past stud­ies have found that such vac­cines ‘pos­sess sig­nif­i­cant unpre­dictabil­i­ty and a num­ber of inher­ent harm­ful poten­tial haz­ards’ and that ‘there is inad­e­quate knowl­edge to define either the prob­a­bil­i­ty of unin­tend­ed events or the con­se­quences of genet­ic mod­i­fi­ca­tions.’ Nonethe­less, the cli­mate of fear sur­round­ing the coro­n­avirus out­break could be enough for the pub­lic and pri­vate sec­tor to devel­op and dis­trib­ute such con­tro­ver­sial treat­ments due to fear about the epi­dem­ic poten­tial of the cur­rent out­break. . . .”
  • Loom­ing large in the back­ground of the Mod­er­na vac­cine tech­nol­o­gy is DARPA fund­ing of “gene dri­ve” tech­nol­o­gy. . . . . Con­cerns about Pen­ta­gon exper­i­ments with bio­log­i­cal weapons have gar­nered renewed media atten­tion, par­tic­u­lar­ly after it was revealed in 2017 that DARPA was the top fun­der of the con­tro­ver­sial ‘gene dri­ve’ tech­nol­o­gy, which has the pow­er to per­ma­nent­ly alter the genet­ics of entire pop­u­la­tions while tar­get­ing oth­ers for extinc­tion. At least two of DARPA’s stud­ies using this con­tro­ver­sial tech­nol­o­gy were clas­si­fied and ‘focused on the poten­tial mil­i­tary appli­ca­tion of gene dri­ve tech­nol­o­gy and use of gene dri­ves in agri­cul­ture,’ accord­ing to media reports. . . . Co-direc­tor of the ETC Group Jim Thomas said that this tech­nol­o­gy may be used as a bio­log­i­cal weapon: ‘Gene dri­ves are a pow­er­ful and dan­ger­ous new tech­nol­o­gy and poten­tial bio­log­i­cal weapons could have dis­as­trous impacts on peace, food secu­ri­ty and the envi­ron­ment, espe­cial­ly if mis­used, The fact that gene dri­ve devel­op­ment is now being pri­mar­i­ly fund­ed and struc­tured by the US mil­i­tary rais­es alarm­ing ques­tions about this entire field.’ . . . . How­ev­er, the ther­a­pies being devel­oped by Inovio, Mod­er­na and the Uni­ver­si­ty of Queens­land are in align­ment with DARPA’s objec­tives regard­ing gene edit­ing and vac­cine tech­nol­o­gy. For instance, in 2015, DARPA geneti­cist Col. Daniel Wat­ten­dorf described how the agency was inves­ti­gat­ing a ‘new method of vac­cine pro­duc­tion [that] would involve giv­ing the body instruc­tions for mak­ing cer­tain anti­bod­ies. Because the body would be its own biore­ac­tor, the vac­cine could be pro­duced much faster than tra­di­tion­al meth­ods and the result would be a high­er lev­el of pro­tec­tion.’ . . . .”

Bats, Gene Edit­ing and Bioweapons: Rec­cent DARPA Exper­i­ments Raise Con­cerns Amid Coro­n­avirus Out­break” by Whit­ney Webb; The Last Amer­i­can Vagabond; 1/30/2020.

. . . . Con­cerns about Pen­ta­gon exper­i­ments with bio­log­i­cal weapons have gar­nered renewed media atten­tion, par­tic­u­lar­ly after it was revealed in 2017 that DARPA was the top fun­der of the con­tro­ver­sial ‘gene dri­ve’ tech­nol­o­gy, which has the pow­er to per­ma­nent­ly alter the genet­ics of entire pop­u­la­tions while tar­get­ing oth­ers for extinc­tion. At least two of DARPA’s stud­ies using this con­tro­ver­sial tech­nol­o­gy were clas­si­fied and ‘focused on the poten­tial mil­i­tary appli­ca­tion of gene dri­ve tech­nol­o­gy and use of gene dri­ves in agri­cul­ture,’ accord­ing to media reports. The rev­e­la­tion came after an orga­ni­za­tion called the ETC Group obtained over 1,000 emails on the military’s inter­est in the tech­nol­o­gy as part of a Free­dom of Infor­ma­tion Act (FOIA) request. Co-direc­tor of the ETC Group Jim Thomas said that this tech­nol­o­gy may be used as a bio­log­i­cal weapon: ‘Gene dri­ves are a pow­er­ful and dan­ger­ous new tech­nol­o­gy and poten­tial bio­log­i­cal weapons could have dis­as­trous impacts on peace, food secu­ri­ty and the envi­ron­ment, espe­cial­ly if mis­used, The fact that gene dri­ve devel­op­ment is now being pri­mar­i­ly fund­ed and struc­tured by the US mil­i­tary rais­es alarm­ing ques­tions about this entire field.’ . . . .

. . . . The sec­ond phar­ma­ceu­ti­cal com­pa­ny that was select­ed by CEPI to devel­op a vac­cine for the new coro­n­avirus is Mod­er­na Inc., which will devel­op a vac­cine for the nov­el coro­n­avirus of con­cern in col­lab­o­ra­tion with the U.S. NIH and which will be fund­ed entire­ly by CEPI. The vac­cine in ques­tion, as opposed to Inovio’s DNA vac­cine, will be a mes­sen­ger RNA (mRNA) vac­cine. Though dif­fer­ent than a DNA vac­cine, mRNA vac­cines still use genet­ic mate­r­i­al ‘to direct the body’s cells to pro­duce intra­cel­lu­lar, mem­brane or secret­ed pro­teins.’ Moderna’s mRNA treat­ments, includ­ing its mRNA vac­cines, were large­ly devel­oped using a $25 mil­lion grant from DARPA and it often touts is strate­gic alliance with DARPA in press releas­es. . . .

. . . . Both DNA and mRNA vac­cines involve the intro­duc­tion of for­eign and engi­neered genet­ic mate­r­i­al into a person’s cells and past stud­ies have found that such vac­cines ‘pos­sess sig­nif­i­cant unpre­dictabil­i­ty and a num­ber of inher­ent harm­ful poten­tial haz­ards’ and that ‘there is inad­e­quate knowl­edge to define either the prob­a­bil­i­ty of unin­tend­ed events or the con­se­quences of genet­ic mod­i­fi­ca­tions.’ Nonethe­less, the cli­mate of fear sur­round­ing the coro­n­avirus out­break could be enough for the pub­lic and pri­vate sec­tor to devel­op and dis­trib­ute such con­tro­ver­sial treat­ments due to fear about the epi­dem­ic poten­tial of the cur­rent out­break.

How­ev­er, the ther­a­pies being devel­oped by Inovio, Mod­er­na and the Uni­ver­si­ty of Queens­land are in align­ment with DARPA’s objec­tives regard­ing gene edit­ing and vac­cine tech­nol­o­gy. For instance, in 2015, DARPA geneti­cist Col. Daniel Wat­ten­dorf described how the agency was inves­ti­gat­ing a ‘new method of vac­cine pro­duc­tion [that] would involve giv­ing the body instruc­tions for mak­ing cer­tain anti­bod­ies. Because the body would be its own biore­ac­tor, the vac­cine could be pro­duced much faster than tra­di­tion­al meth­ods and the result would be a high­er lev­el of pro­tec­tion.’

Accord­ing to media reports on Wattendorf’s state­ments at the time, the vac­cine would be devel­oped as fol­lows:

‘Sci­en­tists would har­vest viral anti­bod­ies from some­one who has recov­ered from a dis­ease such as flu or Ebo­la. After test­ing the anti­bod­ies’ abil­i­ty to neu­tral­ize virus­es in a petri dish, they would iso­late the most effec­tive one, deter­mine the genes need­ed to make that anti­body, and then encode many copies of those genes into a cir­cu­lar snip­pet of genet­ic mate­r­i­al — either DNA or RNA, that the person’s body would then use as a cook­book to assem­ble the anti­body.’

Though Wat­ten­dorf assert­ed that the effects of those vac­cines wouldn’t be per­ma­nent, DARPA has since been pro­mot­ing per­ma­nent gene mod­i­fi­ca­tions as a means of pro­tect­ing U.S. troops from bio­log­i­cal weapons and infec­tious dis­ease. ‘Why is DARPA doing this? [To] pro­tect a sol­dier on the bat­tle­field from chem­i­cal weapons and bio­log­i­cal weapons by con­trol­ling their genome — hav­ing the genome pro­duce pro­teins that would auto­mat­i­cal­ly pro­tect the sol­dier from the inside out,’ then-DARPA direc­tor Steve Walk­er (now with Lock­heed Mar­tin) said this past Sep­tem­ber of the project, known as ‘Safe Genes.’ . . .

. . . . Now, as fear regard­ing the cur­rent coro­n­avirus out­break begins to peak, com­pa­nies with direct ties to DARPA have been tasked with devel­op­ing its vac­cine, the long-term human and envi­ron­men­tal impacts of which are unknown and will remain unknown by the time the vac­cine is expect­ed to go to mar­ket . . . .

Fur­ther­more, DARPA and the Pentagon’s past his­to­ry with bioweapons and their more recent exper­i­ments on genet­ic alter­ation and extinc­tion tech­nolo­gies as well as bats and coro­n­avirus­es in prox­im­i­ty to Chi­na have been large­ly left out of the nar­ra­tive, despite the infor­ma­tion being pub­licly avail­able. Also left out of the media nar­ra­tive have been the direct ties of both the USAMRIID and DARPA-part­nered Duke Uni­ver­si­ty to the city of Wuhan, includ­ing its Insti­tute of Med­ical Virol­o­gy. . . .

4. As dis­cussed in FTR #1124–among oth­er programs–it is now pos­si­ble to cre­ate ANY virus from scratch, using “mail-order” or “design­er” genes. Sad­ly pre­dictable jour­nal­is­tic bro­mides that the Covid-19 coro­n­avirus could not have been/was not made in a lab­o­ra­to­ry fly in the face of bio-tech­nol­o­gy that has exist­ed for 20 years.

In FTR #282–record­ed in May of 2001–we not­ed the ter­ri­ble sig­nif­i­cance of the devel­op­ment of such “Design­er Gene” tech­nol­o­gy.

A BBC sto­ry from 1999 high­lights the fears of experts that the advent of such tech­nol­o­gy could enable the devel­op­ment of eth­no-spe­cif­ic bio­log­i­cal weapons.

 . . . . Advances in genet­ic knowl­edge could be mis­used to devel­op pow­er­ful bio­log­i­cal weapons that could be tai­lored to strike at spe­cif­ic eth­nic groups, the British Med­ical Asso­ci­a­tion has warned. A BMA report Biotech­nol­o­gy, Weapons and Human­i­ty says that con­cert­ed inter­na­tion­al action is nec­es­sary to block the devel­op­ment of new, bio­log­i­cal weapons. It warns the win­dow of oppor­tu­ni­ty to do so is very nar­row as tech­nol­o­gy is devel­op­ing rapid­ly and becom­ing ever more acces­si­ble. ‘Recipes’ for devel­op­ing bio­log­i­cal agents are freely avail­able on the Inter­net, the report warns. . . . The BMA report warns that legit­i­mate research into micro­bi­o­log­i­cal agents and genet­i­cal­ly tar­get­ed ther­a­peu­tic agents could be dif­fi­cult to dis­tin­guish from research geared towards devel­op­ing more effec­tive weapons. . . . Dr Vivi­enne Nathanson, BMA Head of Health Pol­i­cy Research said:  ‘The his­to­ry of human­i­ty is a his­to­ry of war. Sci­en­tif­ic advances quick­ly lead to devel­op­ments in weapons tech­nol­o­gy. . . .‘Biotech­nol­o­gy and genet­ic knowl­edge are equal­ly open to this type of malign use. Doc­tors and oth­er sci­en­tists have an impor­tant role in pre­ven­tion. They have a duty to per­suade politi­cians and inter­na­tion­al agen­cies such as the UN to take this threat seri­ous­ly and to take action to pre­vent the pro­duc­tion of such weapons.’ . . . 

5a. We high­light infor­ma­tion pre­sent­ed in FTR #1129, for pur­pos­es of empha­siz­ing the flim­sy nature of the argu­ment pre­sent­ed in a paper from Nature Med­i­cine.

Many sci­en­tif­ic and med­ical peo­ple dis­miss­ing the argu­ment that the Covid-19 coro­n­avirus may have been cre­at­ed in a lab­o­ra­to­ry may be act­ing out of the sin­cere desire to pre­clude a full-dress Cold War between the U.S. and Chi­na. The Trump admin­is­tra­tion has tire­less­ly flogged the “Chi­na did it and it came from a lab­o­ra­to­ry” meme. Many lib­er­als who dis­missed the obvi­ous fact that Pres­i­dent Kennedy was mur­dered by a cabal of pow­er­ful U.S. nation­al secu­ri­ty inter­ests did so because of what Peter Dale Scott calls a “lev­el one cover-up”–alleged Sovi­et and/or Cas­tro Cuban manip­u­la­tion of Lee Har­vey Oswald, fab­ri­cat­ed by the exe­cu­tion­ers them­selves.

That notwith­stand­ing, there is abun­dant evi­dence of a man-made ori­gin of the virus. (We do NOT believe that the event was authored–deliberately or accidentally–by Chi­na. The Covid-19 out­break occurred in the mid­dle of a “Full-Court-Press” covert and overt regime-change oper­a­tion against Chi­na by the U.S. and its allies, and we feel that those inter­ests are the exec­u­tive ele­ments behind the pan­dem­ic.)

Two telling, thought­ful, sub­stan­tive cri­tiques of the Nature Med­i­cine arti­cle shed light on the flim­sy nature of its argu­ments.

It would not be unfair to char­ac­ter­ize the arti­cle as “The War­ren Report” of the Covid-19 pan­dem­ic.

Genet­ic Engi­neer­ing

Like the Bible, it is open to seri­ous sci­en­tif­ic refu­ta­tion” . . . . To put it sim­ply, the authors are say­ing that SARS-CoV­‑2 was not delib­er­ate­ly engi­neered because if it were, it would have been designed dif­fer­ent­ly. How­ev­er, the Lon­don-based mol­e­c­u­lar geneti­cist Dr Michael Anto­niou com­ment­ed that this line of rea­son­ing fails to take into account that there are a num­ber of lab­o­ra­to­ry-based sys­tems that can select for high affin­i­ty RBD vari­ants that are able to take into account the com­plex envi­ron­ment of a liv­ing organ­ism. This com­plex envi­ron­ment may impact the effi­cien­cy with which the SARS-CoV spike pro­tein can find the ACE2 recep­tor and bind to it. An RBD select­ed via these more real­is­tic real-world exper­i­men­tal sys­tems would be just as ‘ide­al’, or even more so, for human ACE2 bind­ing than any RBD that a com­put­er mod­el could pre­dict. And cru­cial­ly, it would like­ly be dif­fer­ent in amino acid sequence. So the fact that SARS-CoV­‑2 doesn’t have the same RBD amino acid sequence as the one that the com­put­er pro­gram pre­dict­ed in no way rules out the pos­si­bil­i­ty that it was genet­i­cal­ly engi­neered. . . .”

Dr. Michael Anto­niou notes that dif­fer­ent genet­ic engi­neer­ing process­es than the one high­light­ed in the Nature Med­i­cine paper can be used: ”  . . . . There is anoth­er method by which an enhanced-infec­tiv­i­ty virus can be engi­neered in the lab. A well-known alter­na­tive process that could have been used has the cum­ber­some name of “direct­ed iter­a­tive evo­lu­tion­ary selec­tion process”. In this case, it would involve using genet­ic engi­neer­ing to gen­er­ate a large num­ber of ran­dom­ly mutat­ed ver­sions of the SARS-CoV spike pro­tein recep­tor bind­ing domain (RBD), which would then be select­ed for strong bind­ing to the ACE2 recep­tor and con­se­quent­ly high infec­tiv­i­ty of human cells. . . .”

The notion that the Nature Med­i­cine authors had not heard of the above process is not cred­i­ble: ” . . . . Such a direct­ed iter­a­tive evo­lu­tion­ary selec­tion process is a fre­quent­ly used method in lab­o­ra­to­ry research. So there is lit­tle or no pos­si­bil­i­ty that the Nature Med­i­cine arti­cle authors haven’t heard of it – not least, as it is con­sid­ered so sci­en­tif­i­cal­ly impor­tant that its inven­tors were award­ed the Nobel Prize in Chem­istry in 2018. . . .”

“Was the COVID-19 virus genet­i­cal­ly engi­neered?” by Claire Robin­son; GMWatch; 04/22/2020.

Since the COVID-19 pan­dem­ic took off, spec­u­la­tion has been rife about its ori­gins. The truth is that nobody knows for cer­tain how the virus first took hold. But despite that uncer­tain­ty, sug­ges­tions that the virus may have been genet­i­cal­ly engi­neered, or oth­er­wise lab-gen­er­at­ed, have been reject­ed as “con­spir­a­cy the­o­ries” incom­pat­i­ble with the evi­dence.

Yet the main evi­dence that is cit­ed as end­ing all spec­u­la­tion about the role of genet­ic engi­neer­ing and as prov­ing the virus could only have been the prod­uct of nat­ur­al evo­lu­tion turns out to be sur­pris­ing­ly weak. Let’s take a look at it.

The authors of a recent­ly pub­lished paper in the jour­nal Nature Med­i­cine argue that the SARS-CoV­‑2 virus dri­ving the pan­dem­ic arose through nat­ur­al muta­tion and selec­tion in ani­mal (notably bats and pan­golins) or human hosts, and not through lab­o­ra­to­ry manip­u­la­tion and acci­den­tal release. And they say they have iden­ti­fied two key char­ac­ter­is­tics of the virus that prove this: the absence of a pre­vi­ous­ly used virus back­bone and the way in which the virus binds to human cells.

Not the “ide­al” design for infec­tiv­i­ty?

As you would expect of a virus that can cause a glob­al pan­dem­ic, SARS-CoV­‑2 is good at infect­ing human cells. It does this by bind­ing with high affin­i­ty (that is, it binds strong­ly) to the cell sur­face mem­brane pro­tein known as angiotensin-con­vert­ing enzyme 2 (ACE2), which enables it to enter human cells. But, bas­ing their argu­ment on a com­put­er mod­el­ling sys­tem, the authors of the Nature Med­i­cine paper argue that the inter­ac­tion between the virus and the ACE2 recep­tor is “not ide­al”.

They say that the recep­tor-bind­ing domain (RBD) amino acid sequence of the SARS-CoV­‑2 spike pro­tein – the part of the spike pro­tein that allows the virus to bind to the ACE2 pro­tein on human cell sur­faces – is dif­fer­ent from those shown in the SARS-CoV fam­i­ly of virus­es to be opti­mal for recep­tor bind­ing.

They appear to argue, based on their and oth­ers‘ com­put­er mod­el­ling data, that they have iden­ti­fied the “ide­al” CoV spike pro­tein RBD amino acid sequence for ACE2 recep­tor bind­ing. They then seem to imply that if you were to genet­i­cal­ly engi­neer SARS-CoV for opti­mal human ACE2 bind­ing and infec­tiv­i­ty, you would use the RBD amino acid sequence pre­dict­ed by their com­put­er mod­el­ling. But they point out that SARS-CoV­‑2 does not have exact­ly the same com­put­er pro­gram-pre­dict­ed RBD amino acid sequence. Thus they con­clude that it could not have been genet­i­cal­ly engi­neered, stat­ing: “This is strong evi­dence that SARS-CoV­‑2 is not the prod­uct of pur­pose­ful manip­u­la­tion.”

To put it sim­ply, the authors are say­ing that SARS-CoV­‑2 was not delib­er­ate­ly engi­neered because if it were, it would have been designed dif­fer­ent­ly.

How­ev­er, the Lon­don-based mol­e­c­u­lar geneti­cist Dr Michael Anto­niou com­ment­ed that this line of rea­son­ing fails to take into account that there are a num­ber of lab­o­ra­to­ry-based sys­tems that can select for high affin­i­ty RBD vari­ants that are able to take into account the com­plex envi­ron­ment of a liv­ing organ­ism. This com­plex envi­ron­ment may impact the effi­cien­cy with which the SARS-CoV spike pro­tein can find the ACE2 recep­tor and bind to it. An RBD select­ed via these more real­is­tic real-world exper­i­men­tal sys­tems would be just as “ide­al”, or even more so, for human ACE2 bind­ing than any RBD that a com­put­er mod­el could pre­dict. And cru­cial­ly, it would like­ly be dif­fer­ent in amino acid sequence. So the fact that SARS-CoV­‑2 doesn’t have the same RBD amino acid sequence as the one that the com­put­er pro­gram pre­dict­ed in no way rules out the pos­si­bil­i­ty that it was genet­i­cal­ly engi­neered.

Lim­its to com­put­er mod­el­ling

Dr Anto­niou said that the authors’ rea­son­ing is not con­clu­sive because it is based large­ly on com­put­er mod­el­ling, which, he says, is “not defin­i­tive but only pre­dic­tive. It can­not tell us whether any giv­en virus would be opti­mized for infec­tiv­i­ty in a real world sce­nario, such as in the human body. That’s because the envi­ron­ment of the human body will influ­ence how the virus inter­acts with the recep­tor. You can’t mod­el that accu­rate­ly with com­put­er mod­el­ling as there are sim­ply too many vari­ables to fac­tor into the equa­tion.”

Dr Anto­niou added, “Peo­ple can put too much faith in com­put­er pro­grams, but they are only a begin­ning. You then have to prove whether the com­put­er program’s pre­dic­tion is cor­rect or not by direct exper­i­men­ta­tion in a liv­ing organ­ism. This has not been done in the case of this hypoth­e­sis, so it remains unproven.”

It is even pos­si­ble that SARS-CoV­‑2 was opti­mized using a liv­ing organ­ism mod­el, result­ing in a virus that is bet­ter at infect­ing humans than any com­put­er mod­el could pre­dict.

More than one way to engi­neer a virus

The authors of the Nature Med­i­cine arti­cle seem to assume that the only way to genet­i­cal­ly engi­neer a virus is to take an already known virus and then engi­neer it to have the new prop­er­ties you want. On this premise, they looked for evi­dence of an already known virus that could have been used in the engi­neer­ing of SARS-CoV­‑2.

And they failed to find that evi­dence. They stat­ed, “Genet­ic data irrefutably show that SARS-CoV­‑2 is not derived from any pre­vi­ous­ly used virus back­bone.”

But Dr Anto­niou told us that while the authors did indeed show that SARS-CoV­‑2 was unlike­ly to have been built by delib­er­ate genet­ic engi­neer­ing from a pre­vi­ous­ly used virus back­bone, that’s not the only way of con­struct­ing a virus. There is anoth­er method by which an enhanced-infec­tiv­i­ty virus can be engi­neered in the lab.

A well-known alter­na­tive

A well-known alter­na­tive process that could have been used has the cum­ber­some name of “direct­ed iter­a­tive evo­lu­tion­ary selec­tion process”. In this case, it would involve using genet­ic engi­neer­ing to gen­er­ate a large num­ber of ran­dom­ly mutat­ed ver­sions of the SARS-CoV spike pro­tein recep­tor bind­ing domain (RBD), which would then be select­ed for strong bind­ing to the ACE2 recep­tor and con­se­quent­ly high infec­tiv­i­ty of human cells.

This selec­tion can be done either with puri­fied pro­teins or, bet­ter still, with a mix­ture of whole coro­n­avirus (CoV) prepa­ra­tions and human cells in tis­sue cul­ture. Alter­na­tive­ly, the SARS-CoV spike pro­tein vari­ants can be genet­i­cal­ly engi­neered with­in what is known as a “phage dis­play library”. A phage is a virus that infects bac­te­ria and can be genet­i­cal­ly engi­neered to express on its exte­ri­or coat the CoV spike pro­tein with a large num­ber of vari­ants of the RBD. This prepa­ra­tion of phage, dis­play­ing on its sur­face a “library” of CoV spike pro­tein vari­ants, is then added to human cells under lab­o­ra­to­ry cul­ture con­di­tions in order to select for those that bind to the ACE2 recep­tor.

This process is repeat­ed under more and more strin­gent bind­ing con­di­tions until CoV spike pro­tein vari­ants with a high bind­ing affin­i­ty are iso­lat­ed.

Once any of the above selec­tion pro­ce­dures for high affin­i­ty inter­ac­tion of SARS-CoV spike pro­tein with ACE2 has been com­plet­ed, then whole infec­tious CoV with these prop­er­ties can be man­u­fac­tured.

Such a direct­ed iter­a­tive evo­lu­tion­ary selec­tion process is a fre­quent­ly used method in lab­o­ra­to­ry research. So there is lit­tle or no pos­si­bil­i­ty that the Nature Med­i­cine arti­cle authors haven’t heard of it – not least, as it is con­sid­ered so sci­en­tif­i­cal­ly impor­tant that its inven­tors were award­ed the Nobel Prize in Chem­istry in 2018.

Yet the pos­si­bil­i­ty that this is the way that SARS-CoV­‑2 arose is not addressed by the Nature Med­i­cine arti­cle authors and so its use has not been dis­proven.

No proof SARS-CoV­‑2 was not genet­i­cal­ly engi­neered

In sum, the Nature Med­i­cine arti­cle authors offer no evi­dence that the SARS-CoV­‑2 virus could not have been genet­i­cal­ly engi­neered. That’s not to say that it was, of course. We can’t know one way or the oth­er on the basis of cur­rent­ly avail­able infor­ma­tion.

Dr Anto­niou wrote a short let­ter to Nature Med­i­cine to point out these omis­sions in the authors’ case. Nature Med­i­cine has no method of sub­mit­ting a sim­ple let­ter to the edi­tor, so Dr Anto­niou had to sub­mit it as a Mat­ters Aris­ing com­men­tary, which the jour­nal defines as pre­sent­ing “chal­lenges or clar­i­fi­ca­tions” to an orig­i­nal pub­lished work.

Dr Antoniou’s com­ments were titled, “SARS-CoV­‑2 could have been cre­at­ed through lab­o­ra­to­ry manip­u­la­tion”. How­ev­er, Nature Med­i­cine refused to pub­lish them on the grounds that “we do not feel that they advance or clar­i­fy under­stand­ing” of the orig­i­nal arti­cle. The jour­nal offered no sci­en­tif­ic argu­ment to rebut his points.

In our view, those points do offer clar­i­fi­ca­tion to the orig­i­nal arti­cle, and what’s more, there is a strong pub­lic inter­est case for mak­ing them pub­lic. That’s why we repro­duce Dr Antoniou’s let­ter below this arti­cle, with his per­mis­sion.

Not genet­ic engi­neer­ing – but human inter­ven­tion

There is, inci­den­tal­ly, anoth­er pos­si­ble way that SARS-CoV­‑2 could have been devel­oped in a lab­o­ra­to­ry, but in this case with­out using genet­ic engi­neer­ing. This was point­ed out by Niko­lai Petro­vsky, a researcher at the Col­lege of Med­i­cine and Pub­lic Health at Flinders Uni­ver­si­ty in South Aus­tralia. Petro­vsky says that coro­n­avirus­es can be cul­tured in lab dish­es with cells that have the human ACE2 recep­tor. Over time, the virus will gain adap­ta­tions that let it effi­cient­ly bind to those recep­tors. Along the way, that virus would pick up ran­dom genet­ic muta­tions that pop up but don’t do any­thing notice­able.

“The result of these exper­i­ments is a virus that is high­ly vir­u­lent in humans but is suf­fi­cient­ly dif­fer­ent that it no longer resem­bles the orig­i­nal bat virus,” Petro­vsky said. “Because the muta­tions are acquired ran­dom­ly by selec­tion, there is no sig­na­ture of a human gene jock­ey, but this is clear­ly a virus still cre­at­ed by human inter­ven­tion.”

Dr Anto­niou agrees that this method is pos­si­ble – but he points out that wait­ing for nature to pro­duce the desired muta­tions is a lot slow­er than using genet­ic engi­neer­ing to gen­er­ate a large num­ber of ran­dom muta­tions that you can then select for the desired out­come by a direct­ed iter­a­tive evo­lu­tion­ary pro­ce­dure.

Because genet­ic engi­neer­ing great­ly speeds up the process, it is by far the most effi­cient way to gen­er­ate nov­el path­o­gen­ic virus­es in the lab. . . .

Con­clu­sion

It is clear that there is no con­clu­sive evi­dence either way at this point as to whether SARS-CoV­‑2 arose by nat­ur­al muta­tion and selec­tion in ani­mal and/or human hosts or was genet­i­cal­ly engi­neered in a lab­o­ra­to­ry. And in this light, the ques­tion of where this virus came from should con­tin­ue to be explored with an open mind.

*****

SARS-CoV­‑2 could have been cre­at­ed through lab­o­ra­to­ry manip­u­la­tion

Dr Michael Anto­niou

Kris­t­ian Ander­sen and col­leagues (“The prox­i­mal ori­gin of SARS-CoV­‑2”, Nature Med­i­cine, 26: 450–452, 2020) argue that their amino acid sequence com­par­isons and com­pu­ta­tion­al mod­el­ling defin­i­tive­ly proves that SARS-CoV­‑2 has arisen through nat­ur­al muta­tion and selec­tion in ani­mal or human hosts, and not through lab­o­ra­to­ry manip­u­la­tion and acci­den­tal release. How­ev­er, although the authors may indeed be cor­rect in how they per­ceive SARS-CoV­‑2 to have arisen, the data they present does not exclude the pos­si­bil­i­ty that this new coro­n­avirus vari­ant could have been cre­at­ed through an in vit­ro, direct­ed iter­a­tive evo­lu­tion­ary selec­tion process (see https://en.wikipedia.org/wiki/Directed_evolution). Using this method, a very large library of ran­dom­ly muta­g­e­nized coro­n­avirus spike pro­teins could be select­ed for strong bind­ing to the ACE2 recep­tor and con­se­quent­ly high infec­tiv­i­ty of human cells. The pow­er of such direct­ed evo­lu­tion to select for opti­mal enzy­mat­ic and pro­tein-pro­tein inter­ac­tions was acknowl­edged by the award of the Nobel Prize in Chem­istry in 2018 (see https://www.nobelprize.org/prizes/chemistry/2018/summary/).

5b. Of more than pass­ing sig­nif­i­cance is anoth­er arti­cle that finds seri­ous fault with the Nature Med­i­cine paper. ” . . . . Pro­fes­sor Stu­art New­man, pro­fes­sor of cell biol­o­gy and anato­my at New York Med­ical Col­lege, says that a key argu­ment used to deny that it could be a genet­i­cal­ly engi­neered strain that escaped from a lab­o­ra­to­ry actu­al­ly points to the exact oppo­site. In oth­er words, it indi­cates that SARS-CoV­‑2 could well be genet­i­cal­ly engi­neered and that it could have escaped from a lab. . . . As Adam Lau­r­ing, an asso­ciate pro­fes­sor of micro­bi­ol­o­gy, immunol­o­gy and infec­tious dis­eases at the Uni­ver­si­ty of Michi­gan Med­ical School, has not­ed, Andersen’s paper argues that, ‘the SARS-CoV­‑2 virus has some key dif­fer­ences in spe­cif­ic genes rel­a­tive to pre­vi­ous­ly iden­ti­fied coro­n­avirus­es – the ones a lab­o­ra­to­ry would be work­ing with. This con­stel­la­tion of changes makes it unlike­ly that it is the result of a lab­o­ra­to­ry ‘escape’.‘But Pro­fes­sor New­man says that this is total­ly uncon­vinc­ing because ‘The ‘key dif­fer­ences’ were in regions of the coro­n­avirus spike pro­tein that were the sub­ject of genet­ic engi­neer­ing exper­i­ments in labs around the world (main­ly in the US and Chi­na) for two decades.’ . . .”

Pro­fes­sor New­man goes on to high­light oth­er, seri­ous flaws in the argu­ment: ” . . . In an email inter­view with GMWatch, New­man, who is edi­tor-in-chief of the jour­nal Bio­log­i­cal The­o­ry and co-author (with Tina Stevens) of the book Biotech Jug­ger­naut, ampli­fied this spec­u­la­tion by not­ing, ‘The Nature Med­i­cine paper points to vari­a­tions in two sites of the spike pro­tein of the new coro­n­avirus that the authors claim must have arisen by nat­ur­al selec­tion in the wild. How­ev­er, genet­ic engi­neer­ing of one of these sites, the ACE2 recep­tor bind­ing domain, has been pro­posed since 2005 in order to help gen­er­ate vac­cines against these virus­es (see this paper). It is puz­zling that the authors of the Nature Med­i­cine com­men­tary did not cite this paper, which appeared in the promi­nent jour­nal Sci­ence.More­over, New­man added, “The sec­ond site that Ander­sen et al. assert arose by nat­ur­al means, a tar­get of enzyme cleav­age not usu­al­ly found in this class of virus­es, was in fact intro­duced by genet­ic engi­neer­ing in a sim­i­lar coro­n­avirus in a paper they do cite. This was done to explore mech­a­nisms of path­o­genic­i­ty. . . . .”

Worth not­ing, again, is the British Med­ical Asso­ci­a­tion’s warn­ing dis­cussed in FTR #1129,as well as above: ” . . . .The BMA report warns that legit­i­mate research into micro­bi­o­log­i­cal agents and genet­i­cal­ly tar­get­ed ther­a­peu­tic agents could be dif­fi­cult to dis­tin­guish from research geared towards devel­op­ing more effec­tive weapons. . . .”

As the GMWatch authors con­clude: ” . . . . Such ‘enhanced infec­tiv­i­ty’ research is car­ried out on virus­es all over the world (and not just in Chi­na) to inves­ti­gate their behav­iour and to devel­op vac­cines and oth­er ther­a­pies, as well as for ‘biode­fence’ pur­pos­es. . . .”

“Anoth­er expert chal­lenges asser­tions that SARS-CoV­‑2 was not genet­i­cal­ly engi­neered”; GMWatch; 04/27/2020.

Anoth­er expert on biotech­nol­o­gy has attacked the evi­dence being used to quash sug­ges­tions that SARS-CoV­‑2, the virus strain that caus­es COVID-19, might have been genet­i­cal­ly engi­neered. Pro­fes­sor Stu­art New­man, pro­fes­sor of cell biol­o­gy and anato­my at New York Med­ical Col­lege, says that a key argu­ment used to deny that it could be a genet­i­cal­ly engi­neered strain that escaped from a lab­o­ra­to­ry actu­al­ly points to the exact oppo­site. In oth­er words, it indi­cates that SARS-CoV­‑2 could well be genet­i­cal­ly engi­neered and that it could have escaped from a lab.

The evi­dence that is being cit­ed as prov­ing that SARS-CoV­‑2 is “not a lab­o­ra­to­ry con­struct or a pur­pose­ful­ly manip­u­lat­ed virus” is a paper pub­lished by the immu­nol­o­gist Kris­t­ian Ander­sen and col­leagues in Nature Med­i­cine. As Adam Lau­r­ing, an asso­ciate pro­fes­sor of micro­bi­ol­o­gy, immunol­o­gy and infec­tious dis­eases at the Uni­ver­si­ty of Michi­gan Med­ical School, has not­ed, Andersen’s paper argues that, “the SARS-CoV­‑2 virus has some key dif­fer­ences in spe­cif­ic genes rel­a­tive to pre­vi­ous­ly iden­ti­fied coro­n­avirus­es – the ones a lab­o­ra­to­ry would be work­ing with. This con­stel­la­tion of changes makes it unlike­ly that it is the result of a lab­o­ra­to­ry ‘escape’.”

But Pro­fes­sor New­man says that this is total­ly uncon­vinc­ing because “The ‘key dif­fer­ences’ were in regions of the coro­n­avirus spike pro­tein that were the sub­ject of genet­ic engi­neer­ing exper­i­ments in labs around the world (main­ly in the US and Chi­na) for two decades.”

So not only does New­man think that the virus could have escaped from a lab, he also thinks that it could have orig­i­nat­ed in a virus stock that had under­gone genet­ic engi­neer­ing at some point.

In an email inter­view with GMWatch, New­man, who is edi­tor-in-chief of the jour­nal Bio­log­i­cal The­o­ry and co-author (with Tina Stevens) of the book Biotech Jug­ger­naut, ampli­fied this spec­u­la­tion by not­ing, “The Nature Med­i­cine paper points to vari­a­tions in two sites of the spike pro­tein of the new coro­n­avirus that the authors claim must have arisen by nat­ur­al selec­tion in the wild. How­ev­er, genet­ic engi­neer­ing of one of these sites, the ACE2 recep­tor bind­ing domain, has been pro­posed since 2005 in order to help gen­er­ate vac­cines against these virus­es (see this paper). It is puz­zling that the authors of the Nature Med­i­cine com­men­tary did not cite this paper, which appeared in the promi­nent jour­nal Sci­ence.

More­over, New­man added, “The sec­ond site that Ander­sen et al. assert arose by nat­ur­al means, a tar­get of enzyme cleav­age not usu­al­ly found in this class of virus­es, was in fact intro­duced by genet­ic engi­neer­ing in a sim­i­lar coro­n­avirus in a paper they do cite. This was done to explore mech­a­nisms of path­o­genic­i­ty.

New­man said that he does not believe that these changes were delib­er­ate­ly intro­duced to increase the path­o­genic­i­ty of any sin­gle strain, but that SARS-CoV­‑2 may have had genet­i­cal­ly engi­neered com­po­nents in its his­to­ry before being inad­ver­tent­ly intro­duced into the human pop­u­la­tion.

New­man is not the only sci­en­tist that has spo­ken out about the pos­si­bil­i­ty of a genet­i­cal­ly engi­neered ele­ment to the virus. We recent­ly pub­lished an arti­cle in which the mol­e­c­u­lar geneti­cist Dr Michael Anto­niou also cast doubt on asser­tions that the virus was not genet­i­cal­ly engi­neered. Dr Anto­niou set out a method by which the virus could have been genet­i­cal­ly manip­u­lat­ed and select­ed for increased infec­tiv­i­ty in the lab­o­ra­to­ry.

Nei­ther Dr Anto­niou, nor Prof New­man, nor we our­selves make any sug­ges­tion that, in the event that genet­ic engi­neer­ing was involved, the inten­tion was to cre­ate a bioweapon. Such “enhanced infec­tiv­i­ty” research is car­ried out on virus­es all over the world (and not just in Chi­na) to inves­ti­gate their behav­iour and to devel­op vac­cines and oth­er ther­a­pies, as well as for “biode­fence” pur­pos­es. . . .

7a. Reports are now emerg­ing of pos­si­ble Covid-19 infec­tion among ath­letes who par­tic­i­pat­ed at the Mil­i­tary World Games in Wuhan in Octo­ber 19. 

We have spec­u­lat­ed at some length about the pos­si­bil­i­ty that infect­ing those very healthy, superbly-con­di­tioned indi­vid­u­als might have been an excel­lent vehi­cle for spread­ing the virus around the world. 

Fur­ther dis­cus­sion of this can be found in FTR #‘s 1118 and 1122. We note that Chi­na has spec­u­lat­ed about the Wuhan Mil­i­tary World Games being a vehi­cle for the U.S. to spread the infec­tion.

We have not­ed that lan­guage is, past a point, inad­e­quate to ana­lyze and dis­cuss some of the major con­sid­er­a­tions in the Covid-19 “op.” A bio-weapons would require a very small num­ber of agents in order to be effec­tive­ly dis­sem­i­nat­ed. In addi­tion, we note that–in the age of mind con­trol–an oper­a­tive can be dis­pensed to per­form a func­tion with­out their knowl­edge.

“Did Euro­pean Ath­letes Catch Coro­n­avirus While Com­pet­ing at The Mil­i­tary World Games in Octo­ber? French Del­e­ga­tion Returned with Fevers, After Fish­mon­ger is Found to Have Been Con­t­a­m­i­nat­ed in Decem­ber” by Ross Ibbet­son; Dai­ly Mail [online]; 5/6/2020.

French ath­letes believe they caught coro­n­avirus at the World Mil­i­tary Games in Wuhan in Octo­ber, 20 days before the first record­ed case in Chi­na.

It comes after it was revealed that French­man Amirouche Ham­mar, 43, had been infect­ed with COVID-19 out­side Paris as ear­ly as Decem­ber.

The hos­pi­tal where Ham­mar was treat­ed for chest pains has since re-test­ed sam­ples and found the fish­mon­ger was pos­i­tive for the virus on Decem­ber 27. It is not known where he caught the virus, although his wife works close to Charles de Gaulle air­port.

A num­ber of French ath­letes who were at the World Mil­i­tary Games from Octo­ber 18 to 27 have since described com­ing down with severe flu-like symp­toms while at the event.

Elodie Clou­v­el, a world cham­pi­on mod­ern pen­tath­lete, was asked on March 25 whether she was anx­ious about spend­ing the sum­mer in Japan for the Olympics. She told Loire 7: ‘No because I think that with Velentin (Belaud, her part­ner, also a pen­tath­lete) we have already had the coro­n­avirus, well the COVID-19.’

The 31-year-old went on: ‘We were in Wuhan for the World Mil­i­tary Games at the end of Octo­ber. And after­wards, we all fell ill. Valentin missed three days of train­ing. Me, I was sick too. [...] I had things I had nev­er had before. We weren’t par­tic­u­lar­ly wor­ried because no one was talk­ing about it yet.’

She added: ‘A lot of ath­letes at the World Mil­i­tary Games were very ill. We were recent­ly in touch with a mil­i­tary doc­tor who told us: “I think you had it because a lot of peo­ple from this del­e­ga­tion were ill.“ ‘ . . . .

. . . . French media report that sick ath­letes were also not­ed in some oth­er del­e­ga­tions, includ­ing the Swedish del­e­ga­tion, with peo­ple return­ing to Swe­den with strong fevers.

Around 100 peo­ple from the Swedish Armed Forces attend­ed the World Mil­i­tary Games in Wuhan and stayed in the city for two weeks. 

Sev­er­al com­peti­tors fell ill and were screened for the virus, although none were report­ed to have test­ed pos­i­tive. . . .

7b. The incu­ba­tion peri­od when infect­ed peo­ple are asymp­to­matic is any­where from 2 days to 2 weeks. So it would be very inter­est­ing to know when exact­ly those ath­letes dis­played symp­toms dur­ing the games. Was it at the very begin­ning near Octo­ber 17 or near the end at Octo­ber 28? And when did those ath­letes arrive in Wuhan? 

Also keep in mind that there have been mul­ti­ple stud­ies now sug­gest­ing that more infec­tious strains may have emerged in Wuhan. In addi­tion to the Cam­bridge team’s find­ing of a “B Type” strain that emerged in Wuhan in Decem­ber that appeared to be bet­ter adapt­ed at spread­ing among Asian pop­u­la­tions, there was the ear­li­er study by a Chi­nese team that found the ear­li­er ‘S‑type’ strain get­ting rapid­ly over­tak­en by a new ‘L‑type’ strain that popped up in Wuhan in Decem­ber.

If more infec­tious strains emerged in Wuhan in Decem­ber and dom­i­nat­ed the spread of the virus around the world, while less infec­tious strains start­ed the pan­dem­ic it becomes more plau­si­ble that the ini­tial out­break didn’t start in Wuhan. Oth­er ear­ly cas­es in oth­er coun­tries (see below) as well as infect­ed ath­letes at the Mil­i­tary World Games sug­gest that it could have start­ed damn near any­where. 

“coro­n­avirus symp­toms fol­low­ing the World Mil­i­tary Games in Wuhan in Octo­ber 2019” by Dim­itris Kouimt­sidis; The Olive Press; 05/08/2020

SPANISH ath­letes returned from the World Mil­i­tary Games in Wuhan in Octo­ber hav­ing dis­played coro­n­avirus symp­toms.

Accord­ing to the Min­istry of Defence none of the sus­pect­ed vic­tims had been test­ed.

The Span­ish team was made up of about 170 peo­ple.

Accord­ing to Min­istry sources who spoke to El Mun­do, two ath­letes dis­played flu-like symp­toms dur­ing the Games between Octo­ber 17–28 and two oth­ers dis­played them upon their return to Spain.

One of these ath­letes told El Mun­do: “The author­i­ties just took it as a sore throat or flu infec­tion and they treat­ed us as if we were already cured, it was very bad.” . . .

7c. Ital­ian ath­letes also appear to have been sick­ened, and in con­sid­er­able num­bers. The lit­er­al trans­la­tions pro­vid­ed make it appear that the ath­letes were already infect­ed when they got to Wuhan. That may well be a prob­lem in trans­la­tion.

Note that fend­er Mat­teo Tal­iar­i­ol opined that “many oth­er del­e­ga­tions” got ill as well.

“Ath­letes: ‘Sick in Wuhan Back in Octo­ber’” by Foot­ball Italia Staff; Foot­ball Italia; 5/7/2020.

Some ath­letes who were at the Mil­i­tary World Games in Wuhan back in Octo­ber 2019 claim ‘every­one was sick’ with symp­toms rem­i­nis­cent of COVID-19, two months before the first con­firmed case.

The nov­el coro­n­avirus was first report­ed in Decem­ber 2019 in the Chi­nese city of Wuhan, with an inves­ti­ga­tion from ear­ly Jan­u­ary.

It then spread to Europe with the first con­firmed cas­es in Italy on Feb­ru­ary 20.

How­ev­er, there are some sug­ges­tions from ath­letes who took part in the Mil­i­tary World Games that the virus was present as ear­ly as Octo­ber 2019.

That tour­na­ment took place in Wuhan from Octo­ber 17–27, 2019.

“We all got sick, six out of six in our apart­ment, and we also heard from many oth­er del­e­ga­tions who got ill too,” Olympic gold medal­list fencer Mat­teo Tagliar­i­ol told La Repub­bli­ca.

“The medics there had almost run out of sup­plies, Vale­rio Aspromonte stayed in bed almost the whole time. I had a fever and cough for three weeks and antibi­otics did noth­ing. Then it spread to my son and my girl­friend.

“I am not a doc­tor, but the symp­toms looked like those of COVID-19. I was strug­gling to breathe and for­tu­nate­ly it went after three weeks.” . . . .

7d. More about the Ital­ian del­e­ga­tion:

Mil­i­tary World Games in Wuhan in Focus: ‘We Are All Sick;’” by Dim­i­tar Dilkoff [Copy­right Dim­i­tar Dilkoff]; Web24News; 5/7/2020.

Some ath­letes who were at the Mil­i­tary World Games in Wuhan back in Octo­ber 2019 claim ‘every­one was sick’ with symp­toms rem­i­nis­cent of COVID-19, two months before the first con­firmed case.

The nov­el coro­n­avirus was first report­ed in Decem­ber 2019 in the Chi­nese city of Wuhan, with an inves­ti­ga­tion from ear­ly Jan­u­ary.

It then spread to Europe with the first con­firmed cas­es in Italy on Feb­ru­ary 20.

How­ev­er, there are some sug­ges­tions from ath­letes who took part in the Mil­i­tary World Games that the virus was present as ear­ly as Octo­ber 2019.

That tour­na­ment took place in Wuhan from Octo­ber 17–27, 2019.

“We all got sick, six out of six in our apart­ment, and we also heard from many oth­er del­e­ga­tions who got ill too,” Olympic gold medal­list fencer Mat­teo Tagliar­i­ol told La Repub­bli­ca.

“The medics there had almost run out of sup­plies, Vale­rio Aspromonte stayed in bed almost the whole time. I had a fever and cough for three weeks and antibi­otics did noth­ing. Then it spread to my son and my girl­friend.

“I am not a doc­tor, but the symp­toms looked like those of COVID-19. I was strug­gling to breathe and for­tu­nate­ly it went after three weeks.” . . . .

Fenc­ing Olympic cham­pi­on Mat­teo Tagliar­i­ol already sus­pects the mil­i­tary world games held in Wuhan, Chi­na last Octo­ber, as a hotspot of the coro­na pan­dem­ic. “When we arrived in Wuhan, we were all sick. All six peo­ple in my apart­ment were sick, includ­ing many ath­letes from oth­er del­e­ga­tions,” the 37-year-old Ital­ian told the Cor­riere del­la Sera news­pa­per.

The Mil­i­tary World Games were held in Wuhan from Octo­ber 18–27, 2019. The first case of infec­tion was offi­cial­ly report­ed in Chi­na in Decem­ber. How­ev­er, there is spec­u­la­tion that the coro­n­avirus has already spread.

“I had a severe cough, many oth­er ath­letes had a fever,” said Tagliar­i­ol, who won gold in epee fenc­ing in Bei­jing in 2008. The worst await­ed him when he returned to Italy.

“I had a very high fever and could not breathe. Antibi­otics did not help either. I was sick and very weak for three weeks. Then my two-year-old son Leo fell ill. He coughed for three weeks. My part­ner also got sick, but in When I start­ed talk­ing about the virus, I thought: I was infect­ed. I rec­og­nized the symp­toms of COVID 19. I am an ath­lete, I was very bad for my stan­dards, “said Tagliar­i­ol.

Almost 10,000 ath­letes from more than 140 coun­tries had par­tic­i­pat­ed in the Mil­i­tary World Games in Wuhan, from Ger­many there were 243 ath­letes. More than 230,000 vol­un­teers were involved in the com­pe­ti­tions. . . .

8a. Doc­tors quot­ed in a New York Times piece under­score the anom­alous epi­demi­ol­o­gy of the virus: 

“When Did the Coro­n­avirus Arrive in the U.S.? Here’s a Review of the Evi­dence” by Mike Bak­er; The New York Times; 5/16/2020.

. . . . In San Jose, tis­sue sam­pling from a woman who died on Feb. 6 revealed that she was prob­a­bly the first known per­son in the U.S. whose death was linked to the coro­n­avirus — a strong sign that the virus may have been cir­cu­lat­ing in that part of North­ern Cal­i­for­nia in Jan­u­ary.

But was it part of a large, pre­vi­ous­ly unrec­og­nized out­break?

Dr. George Ruther­ford, a pro­fes­sor of epi­demi­ol­o­gy and bio­sta­tis­tics at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, the­o­rized that per­haps the woman, who worked for a com­pa­ny that had an office in Wuhan, was one of only a small num­ber of peo­ple who con­tract­ed the virus at that time and that trans­mis­sions prob­a­bly petered out for some rea­son. Oth­er­wise, he said, the region would have seen a much big­ger out­break. . . .

. . . . Dr. [Trevor] Bed­ford said he also believed this was the more like­ly sce­nario, not­ing that up to half of peo­ple with coro­n­avirus infec­tions have no symp­toms.

There could have been a tiny num­ber of iso­lat­ed coro­n­avirus cas­es among trav­el­ers to the Unit­ed States in Decem­ber, Dr. Bed­ford said. But it is pret­ty clear that none of them spread.

In part, sci­en­tists can tell that by look­ing at the genom­ic fin­ger­prints of each case. But anoth­er clue is the rapid rate at which the virus spreads, Dr. Ruther­ford said.

It appears that ear­ly in the out­break, one infec­tion was spread­ing to about four oth­er peo­ple, on aver­age, with an incu­ba­tion peri­od for new infec­tions of about four days. So a case seed­ed in Decem­ber would rapid­ly quadru­ple through new gen­er­a­tions, most like­ly grow­ing expo­nen­tial­ly to mil­lions of cas­es from a sin­gle unbro­ken chain of trans­mis­sion by the end of Feb­ru­ary. Researchers are not see­ing any chains that appear to go that far back.

Mod­el­ers look­ing back at the growth of out­breaks else­where have reached sim­i­lar con­clu­sions. One esti­mat­ed that New York’s out­break could have begun with per­haps 10 infect­ed peo­ple who con­tract­ed the virus some­time between the end of Jan­u­ary to the mid­dle of Feb­ru­ary, when the first cas­es of com­mu­ni­ty trans­mis­sion were iden­ti­fied and hos­pi­tals began see­ing more cas­es. . . .

8b. The anom­alous epi­demi­ol­o­gy of the virus becomes all the more sig­nif­i­cant in that we are told that New York was the epi­cen­ter of infec­tion in the Unit­ed States.

“Amer­i­can Out­break Caught Fire in New York” by Bene­dict Carey and James Glanz; The New York Times; 5/08/2020; pp. A1-A9 [West­ern Edi­tion].

8c. Lead­ing the Trump admin­is­tra­tion’s rhetor­i­cal and polit­i­cal charge against Chi­na is Mike Pom­peo. Charg­ing that the virus “escaped” from a lab in Wuhan and equiv­o­cat­ing about whether that release was inten­tion­al, Koch broth­ers-pro­tege Pom­peo cit­ed alleged duplic­i­ty on behalf of Chi­na’s com­mu­nist par­ty in con­nec­tion with the virus. ” . . . . ‘I can tell you that there is a sig­nif­i­cant amount of evi­dence that this came from that lab­o­ra­to­ry in Wuhan,’ Pom­peo said on ABC’s ‘This Week’ Sun­day. ‘Do you think they inten­tion­al­ly released that virus, or it was an acci­dent in the lab?’ Co-Anchor Martha Rad­datz pressed. ‘I can’t answer your ques­tion about that,’ he said, ‘because the Chi­nese Com­mu­nist Par­ty has refused to coop­er­ate with world health experts.’ . . .”

The Chi­nese med­ical and sci­en­tif­ic estab­lish­ment has worked close­ly with coun­ter­parts glob­al­ly in an attempt to ana­lyze and treat the virus.

The high­ly anom­alous epi­demi­ol­o­gy, the lack of symp­toms in half of infect­ed patients, the wide vari­ety of symp­toms the virus caus­es and, last­ly, the fact that this was a nov­el virus and result­ing infec­tion are all fac­tors to be con­sid­ered in eval­u­at­ing the time­li­ness of the Chi­nese response.

Pom­peo also assert that the virus was not made in a lab­o­ra­to­ry.

“Pom­peo says ‘enor­mous evi­dence’ for unproven the­o­ry that coro­n­avirus came from lab” by Ash­ley Brown, Conor Finnegan and Jack Arn­holz; ABC News; 05/03/2020

Sec­re­tary of State Mike Pom­peo said there are “enor­mous” signs that the nov­el coro­n­avirus out­break orig­i­nat­ed a bio­med­ical lab­o­ra­to­ry in Wuhan, Chi­na — the city where cas­es first explod­ed.

“I can tell you that there is a sig­nif­i­cant amount of evi­dence that this came from that lab­o­ra­to­ry in Wuhan,” Pom­peo said on ABC’s “This Week” Sun­day.

“Do you think they inten­tion­al­ly released that virus, or it was an acci­dent in the lab?” Co-Anchor Martha Rad­datz pressed.

“I can’t answer your ques­tion about that,” he said, “because the Chi­nese Com­mu­nist Par­ty has refused to coop­er­ate with world health experts.”

NEW: Sec­re­tary of State Mike Pom­peo tells @MarthaRaddatz Chi­na “did all that it could to make sure the world didn’t learn in a time­ly fash­ion” about COVID-19.“It was a clas­sic com­mu­nist dis­in­for­ma­tion effort,” he adds and they will be held “account­able.” https://t.co/EKV20Fhx2H pic.twitter.com/YrQRGkeYNk— This Week (@ThisWeekABC) May 3, 2020

The White House last week ordered U.S. intel­li­gence agen­cies to look into whether Chi­na con­cealed infor­ma­tion ear­ly on about the nov­el coro­n­avirus, two admin­is­tra­tion offi­cials told ABC News last week.

Pom­peo on Sun­day agreed the virus was not man­made.

A recent press release from the Office of the Direc­tor of Nation­al Intel­li­gence (ODNI) that said, “The Intel­li­gence Com­mu­ni­ty also con­curs with the wide sci­en­tif­ic con­sen­sus that the COVID-19 virus was not man­made or genet­i­cal­ly mod­i­fied.” . . . .

. . . . Sev­er­al pub­lic health and epi­demi­o­log­i­cal experts have told ABC News it is “vast­ly more like­ly” that the first infec­tion — what’s called “zoonot­ic spillover” — occurred in the wild, giv­en the “huge bar­ri­ers between peo­ple and virus­es in the lab­o­ra­to­ry set­ting,” accord­ing to Dr. Chris­tine John­son, direc­tor of the U.S. Agency for Inter­na­tion­al Development’s Pre­dict project and a pro­fes­sor at UC Davis School of Vet­eri­nary Med­i­cine. . . .

8d. A mis­lead­ing sto­ry in Rupert Mur­doch’s The Dai­ly Tele­graph out of Syd­ney, Aus­tralia, alleged that the Five Eyes elec­tron­ic intel­li­gence net­work has cor­rob­o­rat­ed the “it came from a Chi­nese lab” meme.

Of more than pass­ing inter­est is the dis­clo­sure that the project on bat-borne coro­n­avirus­es con­duct­ed in the Wuhan lab­o­ra­to­ry was a joint U.S./Chinese project, and that Ralph Bar­ic was a key Amer­i­can part­ner in the project.

This is the under­tak­ing about which we have report­ed and dis­cussed exten­sive­ly in the past!  . . . . One of Dr Shi’s co-authors on that paper, Pro­fes­sor Ralph Bar­ic from North Car­oli­na Uni­ver­si­ty, said in an inter­view with ‘Sci­ence Dai­ly’ at the time: ‘This virus is high­ly path­o­gen­ic and treat­ments devel­oped against the orig­i­nal SARS virus in 2002 and the ZMapp drugs used to fight ebo­la fail to neu­tralise and con­trol this par­tic­u­lar virus.’ . . . .”

Bar­ic was the selectee to recon­struct the SARS Cov2 virus from scratch. Note that the arti­cle below dis­cuss­es the U.S. sus­pen­sion of the “gain of func­tion” exper­i­ments and 2017 resump­tion of same, some­how spin­ning this into the “Chi­na did it” dis­in­for­ma­tion.

“Coro­n­avirus NSW: Dossier lays out case against Chi­na bat virus pro­gram” by Shar­ri Mark­son; The Dai­ly Tele­graph; 05/04/2020

Chi­na delib­er­ate­ly sup­pressed or destroyed evi­dence of the coro­n­avirus out­break in an “assault on inter­na­tion­al trans­paren­cy’’ that cost tens of thou­sands of lives, accord­ing to a dossier pre­pared by con­cerned West­ern gov­ern­ments on the COVID-19 con­ta­gion.

The 15-page research doc­u­ment, obtained by The Sat­ur­day Tele­graph, lays the foun­da­tion for the case of neg­li­gence being mount­ed against Chi­na.

It states that to the “endan­ger­ment of oth­er coun­tries” the Chi­nese gov­ern­ment cov­ered-up news of the virus by silenc­ing or “dis­ap­pear­ing” doc­tors who spoke out, destroy­ing evi­dence of it in lab­o­ra­to­ries and refus­ing to pro­vide live sam­ples to inter­na­tion­al sci­en­tists who were work­ing on a vac­cine.

It can also be revealed the Aus­tralian gov­ern­ment trained and fund­ed a team of Chi­nese sci­en­tists who belong to a lab­o­ra­to­ry which went on to genet­i­cal­ly mod­i­fy dead­ly coro­n­avirus­es that could be trans­mit­ted from bats to humans and had no cure, and is now the sub­ject of a probe into the ori­gins of COVID-19.

As intel­li­gence agen­cies inves­ti­gate whether the virus inad­ver­tent­ly leaked from a Wuhan lab­o­ra­to­ry, the team and its research led by sci­en­tist Shi Zhengli fea­ture in the dossier pre­pared by West­ern gov­ern­ments that points to sev­er­al stud­ies they con­duct­ed as areas of con­cern.

It cites their work dis­cov­er­ing sam­ples of coro­n­avirus from a cave in the Yun­nan province with strik­ing genet­ic sim­i­lar­i­ty to COVID-19, along with their research syn­the­sis­ing a bat-derived coro­n­avirus that could not be treat­ed. . . .

. . . . It notes a 2013 study con­duct­ed by a team of researchers, includ­ing Dr Shi, who col­lect­ed a sam­ple of horse­shoe bat fae­ces from a cave in Yun­nan province, Chi­na, which was lat­er found to con­tain a virus 96.2 per cent iden­ti­cal to SARS-CoV­‑2, the virus that caused COVID-19.

The research dossier also ref­er­ences work done by the team to syn­the­sise SARS-like coro­n­avirus­es, to analyse whether they could be trans­mis­si­ble from bats to mam­mals. This means they were alter­ing parts of the virus to test whether it was trans­mis­si­ble to dif­fer­ent species.

Their Novem­ber 2015 study, done in con­junc­tion with the Uni­ver­si­ty of North Car­oli­na, con­clud­ed that the SARS-like virus could jump direct­ly from bats to humans and there was no treat­ment that could help.

The study acknowl­edges the incred­i­ble dan­ger of the work they were con­duct­ing.

“The poten­tial to pre­pare for and mit­i­gate future out­breaks must be weighed against the risk of cre­at­ing more dan­ger­ous pathogens,” they wrote. . . .

. . . . One of Dr Shi’s co-authors on that paper, Pro­fes­sor Ralph Bar­ic from North Car­oli­na Uni­ver­si­ty, said in an inter­view with Sci­ence Dai­ly at the time: “This virus is high­ly path­o­gen­ic and treat­ments devel­oped against the orig­i­nal SARS virus in 2002 and the ZMapp drugs used to fight ebo­la fail to neu­tralise and con­trol this par­tic­u­lar virus.” . . . .

. . . . Dr Shi’s pro­tégé, Peng Zhou — now the head of the Bat Virus Infec­tion and Immu­ni­ty Project at the Wuhan Insti­tute of Virol­o­gy — spent three years at the bio-con­tain­ment facil­i­ty Aus­tralian Ani­mal Health Lab­o­ra­to­ry between 2011 and 2014. He was sent by Chi­na to com­plete his doc­tor­ate at the CSIRO from 2009–2010. . . .

. . . . The US with­drew fund­ing from con­tro­ver­sial exper­i­ments that make pathogens more potent or like­ly to spread dan­ger­ous virus­es in Octo­ber 2014, con­cerned it could lead to a glob­al pan­dem­ic.

The pause on fund­ing for 21 “gain of func­tion” stud­ies was then lift­ed in Decem­ber 2017. . . .

8e. A Guardian arti­cle sources UK intel­li­gence assets claim­ing that the 15-page dossier didn’t come from a Five Eyes intel­li­gence assess­ment. They assert that it was based on open-source mate­ri­als and put for­ward by the US as “a tool for build­ing a counter-nar­ra­tive and apply­ing pres­sure to Chi­na.”

“Five Eyes net­work con­tra­dicts the­o­ry Covid-19 leaked from lab” by Dan Sab­bagh; The Guardian; 05/04/2020

There is no cur­rent evi­dence to sug­gest that coro­n­avirus leaked from a Chi­nese research lab­o­ra­to­ry, intel­li­gence sources have told the Guardian, con­tra­dict­ing recent White House claims that there is grow­ing proof this is how the pan­dem­ic began.

The sources also insist­ed that a “15-page dossier” high­light­ed by the Aus­tralian Dai­ly Tele­graph which accused Chi­na of a dead­ly cov­er up was not culled from intel­li­gence from the Five Eyes net­work, an alliance between the UK, US, Aus­tralia, New Zealand and Cana­da. . . .

. . . . Amer­i­can sci­en­tists who have worked with the Wuhan Insti­tute add its safe­ty stan­dards are com­pa­ra­ble to West­ern equiv­a­lents – and the pre­vail­ing the­o­ry is that the virus was passed onto humans via one of the country’s live ani­mal mar­kets.

Australia’s Dai­ly Tele­graph – a Syd­ney tabloid owned by Rupert Mur­doch – has been focus­ing on the Wuhan lab for sev­er­al days, cul­mi­nat­ing in a week­end report which cit­ed a 15-page dossier com­piled, it said, by “con­cerned West­ern gov­ern­ments” amid an inves­ti­ga­tion by British and oth­er mem­bers of the Five Eyes intel­li­gence agen­cies.

Intel­li­gence sources in Aus­tralia were quick to say they believed it was based on open source, pub­lic domain mate­r­i­al. One told the Guardian they believed the infor­ma­tion that appeared in the News Corp title was most like­ly to have orig­i­nal­ly come from the US: “My instinct is that it was a tool for build­ing a counter-nar­ra­tive and apply­ing pres­sure to Chi­na. So it’s the intent behind it that’s most impor­tant. So pos­si­bly open source leads with a clas­si­fi­ca­tion slapped on it.”

9. In Mis­cel­la­neous Archive Show M4, we exam­ined Glo­ria Steinem’s CIA back­ground and peo­ple and insti­tu­tions in her milieu sug­ges­tive of the pos­si­bil­i­ty that her Agency links are not sole­ly in the past. (A tran­script of the broad­cast is avail­able on this web­site as well.) 

Against the back­ground of the Trump admin­is­tra­tion’s anti-Chi­na cam­paign rhetoric and attempts to pin the blame for Covid-19 on a “lab­o­ra­to­ry” leak and/or delib­er­ate release, we note that the offen­sive is being pushed by The Don­ald’s deputy nation­al secu­ri­ty advis­er Matthew Pot­tinger.

“. . . . Matthew Pot­tinger, the deputy nation­al secu­ri­ty advis­er who report­ed on SARS out­breaks as a jour­nal­ist in Chi­na, pressed intel­li­gence agen­cies in Jan­u­ary to gath­er infor­ma­tion that might sup­port any ori­gin the­o­ry linked to a lab. . . .”

Pot­tinger is the son of for­mer Assis­tant Attor­ney Gen­er­al J. Stan­ley Pot­tinger.

Pot­tinger, Senior was: Assis­tant Attor­ney Gen­er­al for Civ­il Rights under Nixon and Ford; report­ed by Don­ald Freed and Fred Lan­dis (in “Death in Wash­ing­ton”) to have foiled inves­ti­ga­tions into the assas­si­na­tions of Mar­tin Luther King and Orlan­do Lete­lier; the attor­ney for the Hashe­mi broth­ers in the Octo­ber Sur­prise inves­ti­ga­tion; a close per­son­al friend of George H.W. Bush (for whom CIA head­quar­ters was named) and, last but cer­tain­ly not least, Glo­ria Steinem’s lover for nine years.

Despite the fact that Steinem tout­ed her CIA back­ground as good jour­nal­is­tic cre­den­tials in both “The New York Times” and “The Wash­ing­ton Post” (both with long-stand­ing CIA links them­selves), Pot­tinger has defend­ed her against charges that she worked for the CIA!!

Worth not­ing, as well, is the fact that the Lete­lier assas­si­na­tion was one of the mur­ders con­duct­ed under Oper­a­tion Con­dor, assist­ed by the CIA. Lete­lier was killed by a car bomb in Wash­ing­ton D.C., while J.Stanley Pot­tinger’s good friend George H.W. Bush was in charge of the CIA when Lete­lier was hit.

(We have cov­ered Oper­a­tion Con­dor in numer­ous pro­grams, includ­ing AFA #19One of the oper­a­tional cen­ters of Con­dor was the Chilean Nazi enclave Colo­nia Dig­nidad. In FTR #839, we set forth author Peter Lev­en­da’s brave, fright­en­ing vis­it to “The Colony.” This should be digest­ed by any­one inter­est­ed in the his­to­ry of which Pot­tinger, Sr., is a part.)

One won­ders if Matthew may have fol­lowed J. Stan­ley into the CIA, if in fact Dad­dio is Agency, as Mr. Emory sus­pects.

In FTR #s 998, 999, 1000, we set forth what Mr. Emory calls “weaponized fem­i­nism.” Refash­ion­ing the doc­trine of advanc­ing the cause of women into a legal and polit­i­cal weapon for destroy­ing tar­get­ed men, dom­i­nant man­i­fes­ta­tions of the #MeToo move­ment have served the cause of the far right.

Resembling–in its essence–the “libid­i­nal McCarthy­ism” of Arthur Miller’s play “The Cru­cible,”  many high-pro­file man­i­fes­ta­tions of #MeToo have been pro­pelled by evi­den­tiary mate­r­i­al that ranges from dubi­ous to ludi­crous to non-exis­tent.

We find it more than coin­ci­den­tal that Bernie Sanders sup­port­er Tara Read­e’s shape-shift­ing accu­sa­tions against Joe Biden have sur­faced decades after the alleged incident–coinciding with Biden’s chal­leng­ing of Trump and with Pot­tinger, Jr. help­ing to direct the admin­is­tra­tion’s traf­fic.

“Trump Offi­cials Are Said to Press Spies to Link Virus and Wuhan Labs” by Mark Mazzetti, Julian E. Barnes, Edward Wong and Adam Gold­man; The New York Times; 04/30/2020

Sec­re­tary of State Mike Pom­peo, a for­mer C.I.A. direc­tor and the administration’s most vocal hard-lin­er on Chi­na, has tak­en the lead in push­ing Amer­i­can intel­li­gence agen­cies for more infor­ma­tion, accord­ing to cur­rent and for­mer offi­cials.

Matthew Pot­tinger, the deputy nation­al secu­ri­ty advis­er who report­ed on SARS out­breaks as a jour­nal­ist in Chi­na, pressed intel­li­gence agen­cies in Jan­u­ary to gath­er infor­ma­tion that might sup­port any ori­gin the­o­ry linked to a lab. . . .

. . . . Any Amer­i­can intel­li­gence report blam­ing a Chi­nese insti­tu­tion and offi­cials for the out­break could sig­nif­i­cant­ly harm rela­tions with Chi­na for years to come. And Trump admin­is­tra­tion offi­cials could use it to try to prod oth­er nations to pub­licly hold Chi­na account­able for coro­n­avirus deaths even when the pandemic’s exact ori­gins can­not be deter­mined.

Mr. Trump made clear on Thurs­day evening of his inter­est in intel­li­gence sup­port­ing the the­o­ry the virus emerged acci­den­tal­ly from a Wuhan lab. In response to a ques­tion from a reporter, the pres­i­dent said he had seen intel­li­gence that sup­port­ed the idea but quick­ly back­tracked, adding that he “was not allowed” to share the intel­li­gence and that his admin­is­tra­tion was exam­in­ing mul­ti­ple the­o­ries about the ori­gin of the virus. . . .

Discussion

8 comments for “FTR #1130 Bio-Psy-Op Apocalypse Now, Part 6: The Magic Virus Theory, Part 3”

  1. Here’s a set of arti­cles that’s anoth­er exam­ple of how even the mildest good-ish news relat­ed to a COVID-19 treat­ment can trig­ger a ral­ly across the entire stock mar­ket:

    The stock mar­ket ral­ly trig­gered on Mon­day by a pre­lim­i­nary COVID-19 vac­cine tri­al report by Mod­er­na, a com­pa­ny work­ing on RNA-based vac­cines for COVID-19, fiz­zled in the last hour of trad­ing on Tues­day after ques­tions about that Mod­er­na report were raised by STAT news. A broad mar­ket ral­ly and broad mar­ket drop based on a pre­lim­i­nary report and sub­se­quent ques­tions about that report. It’s the lat­est exam­ple of how the com­pa­nies work­ing on some sort of ther­a­py for COVID have the pow­er to essen­tial­ly move mar­kets with even high­ly ques­tion­able pre­lim­i­nary results as long as it can be spun as a net pos­i­tive, as was the case with Gilead­’s remde­sivir tri­als that also moved mar­kets mul­ti­ple times despite its good-ish-at-best clin­i­cal tri­al results.

    So first, here’s a Mar­ket­Watch piece about that Mod­er­na stock roller coast­er ride that makes a rather inter­est­ing point about the tim­ing of this Mod­er­na announce­ment: On Tues­day, Mod­er­na dis­closed that its Chief Exec­u­tive Stéphane Ban­cel and Chief Finan­cial Offi­cer Lorence Kim both sold stock recent­ly. On the Fri­day before Mod­er­na’s tri­al result announce­ment on Mon­day, Ban­cel sold 11,046 shares at a weight­ed aver­age price of $65.56 for about $724,200, as part of a pre­de­ter­mined trad­ing plan adopt­ed Dec. 28, 2018. Kim also sold 20,000 shares at a weight­ed aver­age price of $65.53 on Fri­day for about $1.31 mil­lion which was also part of a pre­de­ter­mined plan. But here’s what’s inter­est­ing: on Mon­day, Kim exer­cised options to buy 241,000 shares at a weight­ed aver­age price of $12.45 for about $3.00 mil­lion, also as part of a pre­de­ter­mined plan. At the same time, he sold 241,000 shares at a weight­ed aver­age price of $82.12 for about $19.79 mil­lion. So Kim bought and sold 241,000 shared simul­ta­ne­ous­ly on Mon­day for a net prof­it of $16.79 mil­lion. As the arti­cle notes, by doing this simul­ta­ne­ous­ly buying/selling trade on Mon­day in instead of Fri­day Kim made an addi­tion­al $4 mil­lion thanks to Mod­er­na’s stock surg­ing from ~$65/share on Fri­day to over $82/share on Mon­day. A surge in share price that would­n’t have hap­pened had Mod­er­na not issued these high­ly pre­lim­i­nary results that were so pre­lim­i­nary and ques­tion­able that Mod­er­na’s stock close at $71/share at the end of the day on Tues­day.

    Oh, and there was anoth­er coin­ci­den­tal announce­ment on Mon­day: Mod­er­na announced it’s issu­ing $1.34 bil­lion in new stock. New stock that’s a lot more expen­sive thanks to that pre­lim­i­nary clin­i­cal tri­al result. Or at least was a lot more expen­sive for a brief time on Mon­day and Tues­day before con­cerns about the mean­ing­ful­ness of that report dragged the stock back down.

    But a call to issue more stock can hap­pen at any point and doing so after a surge in share price like that made sense. It’s the buy/sell trade Lorence Kim on Mon­day that’s more inter­est­ing in terms of the tim­ing because the exer­cis­ing of the stock options that let him buy 241,000 shares at $12.45 was pre­de­ter­mined. So that announce­ment of the pre­lim­i­nary tri­al results was extreme­ly con­ve­nient for Kim pre­cise­ly because it only bumped up Mod­er­na’s stock price in a huge way for about a 24 hour peri­od before ques­tions were raised about the mean­ing­ful­ness of the announce­ment and the stock price dropped. Was this all just a coin­ci­dence that Mod­er­na’s Mon­day announce­ment based on high­ly pre­lim­i­nary data just hap­pened to coin­cide with the CFO mak­ing an extra large prof­it on his simul­ta­ne­ous buying/selling scheme? Who knows but the tim­ing sure is inter­est­ing:

    Mar­ket­Watch

    Moderna’s stock soars, then dips, after ques­tions arise around the lim­it­ed data shared about its COVID-19 vac­cine

    By Tomi Kil­go­re and Jaimy Lee
    Pub­lished: May 20, 2020 at 2:49 p.m. ET

    Wall Street ana­lysts large­ly view the clin­i­cal-tri­al data released by Mod­er­na, how­ev­er lim­it­ed, as a pos­i­tive

    Investors in Mod­er­na Inc., the pre­clin­i­cal biotech­nol­o­gy com­pa­ny devel­op­ing one of the front-run­ning COVID-19 vac­cine can­di­dates in the U.S., may be fac­ing a volatile ride through the clin­i­cal tri­al process.

    Shares of Mod­er­na closed at a record high of $80.00 on Mon­day after the com­pa­ny released a slice of pos­i­tive inter­im clin­i­cal data from the first phase of its COVID-19 vac­cine tri­al. That night it announced it would sell $1.34 bil­lion in stock to help fund man­u­fac­tur­ing costs asso­ci­at­ed with the exper­i­men­tal COVID-19 vac­cine. The stock took a nose dive on Tues­day, clos­ing at $71.67, like­ly due in some degree to a Stat News sto­ry that ques­tioned a lack of clin­i­cal clar­i­ty in the data it pro­vid­ed to investors.

    The company’s stock was up 3.8% in trad­ing on Wednes­day. Year-to-date, it has soared 270.2%, even though the com­pa­ny has no approved prod­ucts. In 2019, it had $60 mil­lion in rev­enue that came from col­lab­o­ra­tions and grants.

    ...

    In a clin­i­cal-tri­al data dis­clo­sure on Mon­day, Mod­er­na shared that eight out of 45 par­tic­i­pants in its COVID-19 vac­cine study devel­oped neu­tral­iz­ing anti­bod­ies, a deci­sion that Stat’s Helen Bran­swell described as a “rea­son for cau­tion.” It didn’t share infor­ma­tion about the immune response to the exper­i­men­tal vac­cine in the remain­ing 37 par­tic­i­pants.

    Mod­er­na, how­ev­er, said that the full data from the tri­al will be pub­lished by the Nation­al Insti­tute for Aller­gy and Infec­tious Dis­eases (NIAID), its spon­sor for the study. The com­pa­ny had also already dis­closed that the Food and Drug Admin­is­tra­tion (FDA) has giv­en the go-ahead for the com­pa­ny to pro­ceed with the sec­ond phase of the clin­i­cal tri­al for its mRNA vac­cine can­di­date, set to begin before the end of June.

    Despite the crit­ics cit­ed in the Stat News arti­cle, Wall Street ana­lysts large­ly view the clin­i­cal-tri­al data released by Mod­er­na, how­ev­er lim­it­ed, as a pos­i­tive.

    “While sam­ples are not yet avail­able for remain­ing par­tic­i­pants, and we lack specifics on the exact lev­els of bind­ing anti­bod­ies, we view this data as demon­stra­tive of ear­ly signs of effi­ca­cy,” Gold­man Sachs ana­lysts wrote in an investor note on Mon­day.

    Med­ical experts and ana­lysts have also raised ques­tions about the lack of com­plete data from Gilead Sci­ences Inc.’s late-stage study for remde­sivir, which was also con­duct­ed with the NIAID.) So far, only the topline results from that tri­al have been shared pub­licly, though that was enough to inform the emer­gency use autho­riza­tion grant­ed by the FDA ear­li­er this month, at least accord­ing to the FDA’s let­ter announc­ing the EUA.

    “We need to see all that data, the pub­li­ca­tion,” Dr. Eric Topol, a car­di­ol­o­gist and direc­tor of the Scripps Research Trans­la­tion­al Insti­tute, said by email on May 1. “But I do believe the drug has effi­ca­cy based on what we now know, it’s just not that potent.”

    Beyond lin­ger­ing ques­tions about access to the com­plete Phase 1 clin­i­cal tri­al data set for the inves­ti­ga­tion­al vac­cine, Moderna’s splashy offer­ing on Mon­day night aim­ing to sell about $1.3 bil­lion in stock may also have con­tributed to the dive on Tues­day.

    The com­pa­ny dis­closed late Tues­day that Chief Exec­u­tive Stéphane Ban­cel and Chief Finan­cial Offi­cer Lorence Kim sold stock recent­ly, with Monday’s stock price surge fol­low­ing the announce­ment of ear­ly data on its vac­cine can­di­date poten­tial­ly adding $4 mil­lion to Kim’s cof­fers.

    On Fri­day, Ban­cel sold 11,046 shares at a weight­ed aver­age price of $65.56 for about $724,200, as part of a pre­de­ter­mined trad­ing plan adopt­ed Dec. 28, 2018, accord­ing to a Form 4 fil­ing with the Secu­ri­ties and Exchange Com­mis­sion. He also dis­posed of 1,577 shares as part of a “bona fide” gift.

    Also, on Fri­day, Kim sold 20,000 shares at a weight­ed aver­age price of $65.53 for about $1.31 mil­lion, as part of a pre­de­ter­mined trad­ing plan. On Mon­day, he exer­cised options to buy 241,000 shares at a weight­ed aver­age price of $12.45 for about $3.00 mil­lion, also as part of a pre­de­ter­mined plan. At the same time, Kim exe­cut­ed sales of 241,000 shares, at a weight­ed aver­age price of $82.12 for about $19.79 mil­lion. That means Kim net­ted about $16.79 mil­lion on the simul­ta­ne­ous buy and sale of shares.

    If Kim had exe­cut­ed Monday’s trades on Fri­day, before the coro­n­avirus vac­cine-relat­ed stock ral­ly, he might have net­ted $12.79 mil­lion, or about $4 mil­lion less.

    Mor­gan Stan­ley ana­lysts on Wednes­day set a price tar­get of $90.00 for Mod­er­na, not­ing that they expect the com­pa­ny will sell esti­mat­ed 1.5 bil­lion dos­es dur­ing the pan­dem­ic and about 150 mil­lion dos­es each year after that. “We are pos­i­tive on the ear­ly data,” they wrote.

    Moderna’s mar­ket cap­i­tal­iza­tion is rough­ly $27.4 bil­lion, up from about $6.4 bil­lion on Jan. 2.

    The S&P 500 is down 9.3% year-to-date.

    ———–

    “Moderna’s stock soars, then dips, after ques­tions arise around the lim­it­ed data shared about its COVID-19 vac­cine” by Tomi Kil­go­re and Jaimy Lee; Mar­ket­Watch; 05/20/2020

    “Shares of Mod­er­na closed at a record high of $80.00 on Mon­day after the com­pa­ny released a slice of pos­i­tive inter­im clin­i­cal data from the first phase of its COVID-19 vac­cine tri­al. That night it announced it would sell $1.34 bil­lion in stock to help fund man­u­fac­tur­ing costs asso­ci­at­ed with the exper­i­men­tal COVID-19 vac­cine. The stock took a nose dive on Tues­day, clos­ing at $71.67, like­ly due in some degree to a Stat News sto­ry that ques­tioned a lack of clin­i­cal clar­i­ty in the data it pro­vid­ed to investors.

    Well, a record high is cer­tain­ly a good time to issue more stock. The ques­tion is whether or not that record high was ground in real pos­i­tive results from the com­pa­ny or just spin and record high hopes. And while that surge was sig­nif­i­cant, it pales in com­par­i­son to the over­all surge of over 270% this year despite the com­pa­ny not actu­al­ly hav­ing any approve prod­ucts:

    ...
    The company’s stock was up 3.8% in trad­ing on Wednes­day. Year-to-date, it has soared 270.2%, even though the com­pa­ny has no approved prod­ucts. In 2019, it had $60 mil­lion in rev­enue that came from col­lab­o­ra­tions and grants.
    ...

    And then there’s the very inter­est­ing coi­ci­dence of the tim­ing of this, which Mod­er­na’s CFO mak­ing an extra $4 mil­lion thanks to the fact that his pre­de­ter­mined exer­cise of stock options to pur­chase of 241,000 shares at $12.45 and then sell 241,000 shares at mar­ket prices just hap­pened to coin­cide with Mon­day’s surge:

    ...
    The com­pa­ny dis­closed late Tues­day that Chief Exec­u­tive Stéphane Ban­cel and Chief Finan­cial Offi­cer Lorence Kim sold stock recent­ly, with Monday’s stock price surge fol­low­ing the announce­ment of ear­ly data on its vac­cine can­di­date poten­tial­ly adding $4 mil­lion to Kim’s cof­fers.

    On Fri­day, Ban­cel sold 11,046 shares at a weight­ed aver­age price of $65.56 for about $724,200, as part of a pre­de­ter­mined trad­ing plan adopt­ed Dec. 28, 2018, accord­ing to a Form 4 fil­ing with the Secu­ri­ties and Exchange Com­mis­sion. He also dis­posed of 1,577 shares as part of a “bona fide” gift.

    Also, on Fri­day, Kim sold 20,000 shares at a weight­ed aver­age price of $65.53 for about $1.31 mil­lion, as part of a pre­de­ter­mined trad­ing plan. On Mon­day, he exer­cised options to buy 241,000 shares at a weight­ed aver­age price of $12.45 for about $3.00 mil­lion, also as part of a pre­de­ter­mined plan. At the same time, Kim exe­cut­ed sales of 241,000 shares, at a weight­ed aver­age price of $82.12 for about $19.79 mil­lion. That means Kim net­ted about $16.79 mil­lion on the simul­ta­ne­ous buy and sale of shares.

    If Kim had exe­cut­ed Monday’s trades on Fri­day, before the coro­n­avirus vac­cine-relat­ed stock ral­ly, he might have net­ted $12.79 mil­lion, or about $4 mil­lion less.
    ...

    And now here’s Tues­day’s report in STAT News that raised ques­tions about those result and man­aged to result on a broad mar­ket drop in the final hour or trad­ing on Tues­day. As the arti­cle notes, there isn’t just one red flag. There’s a lot. For starters, the pre­lim­i­nary results were based on the find­ing that eight of the 45 peo­ple who got the vac­cine devel­oped neu­tral­iz­ing anti­bod­ies. So what about the oth­er 37 peo­ple? We have no idea because Mod­er­na won’t say. Also, Mod­er­na won’t tell us the ages of those eight peo­ple which is a pret­ty impor­tant piece of infor­ma­tion.

    But that’s still good news that eight peo­ple devel­oped anti­bod­ies, right? Maybe. It was very good news that Mod­er­na spec­i­fied that they were neu­tral­iz­ing anti­bod­ies, which are the type of anti­body need­ed for immu­ni­ty. Here’s the prob­lem: Mod­er­na did­n’t actu­al­ly give the lev­els of anti­bod­ies in those eight patients and instead sim­ply stat­ed that those eight peo­ple devel­oped lev­els of anti­bod­ies on par with recov­ered COVID-19 patients. But as we’ve seen, stud­ies have found that the lev­els of anti­bod­ies in recov­ered patients vary wild­ly, with some patients have no anti­bod­ies at all while oth­ers are left with very high lev­els. So how are we to inter­pret Mod­er­na’s vague state­ment? We have no idea, but he fact that Mod­er­na refus­es to release that data does­n’t exact­ly inspire con­fi­dence.

    In addi­tion, we’re told that those eight peo­ple had their anti­body lev­els mea­sured two weeks after receiv­ing the vac­cine. And as experts point out, that tells us noth­ing about the dura­bil­i­ty of these anti­bod­ies. You can have anti­bod­ies that last a fleet­ing­ly short time or anti­bod­ies that last a life­time. For a vac­cine to mean­ing­ful­ly work the anti­bod­ies it trig­gers need to last at least a year. In oth­er words, it’s entire­ly pos­si­ble this vac­cine does indeed pro­duce anti­bod­ies and yet is large­ly worth­less as a vac­cine.

    So when will we get more mean­ing­ful data? Mod­er­na says that will be forth­com­ing when it issues a more for­mal report on its clin­i­cal tri­al that’s joint­ly issued with the Nation­al Insti­tute for Aller­gies and Infec­tious Dis­eases (NIAID). Yes, this clin­i­cal tri­al is being con­duct­ed in part­ner­ship with the NIAID, which rais­es the obvi­ous ques­tion: so what does the NIAID have to say about these pre­lim­i­nary results? Noth­ing. It refus­es to com­ment.

    Those are the ques­tions raised by this STAT News piece and sim­ply rais­ing these ques­tions helped bring about a sud­den broad pull­back in the finan­cial mar­kets late Tues­day:

    Stat News

    Vac­cine experts say Mod­er­na didn’t pro­duce data crit­i­cal to assess­ing Covid-19 vac­cine

    By Helen Bran­swell
    May 19, 2020

    Heavy hearts soared Mon­day with news that Moderna’s Covid-19 vac­cine can­di­date — the fron­trun­ner in the Amer­i­can mar­ket — seemed to be gen­er­at­ing an immune response in Phase 1 tri­al sub­jects. The company’s stock val­u­a­tion also surged, hit­ting $29 bil­lion, an aston­ish­ing feat for a com­pa­ny that cur­rent­ly sells zero prod­ucts.

    But was there good rea­son for so much enthu­si­asm? Sev­er­al vac­cine experts asked by STAT con­clud­ed that, based on the infor­ma­tion made avail­able by the Cam­bridge, Mass.-based com­pa­ny, there’s real­ly no way to know how impres­sive — or not — the vac­cine may be.

    While Mod­er­na blitzed the media, it revealed very lit­tle infor­ma­tion — and most of what it did dis­close were words, not data. That’s impor­tant: If you ask sci­en­tists to read a jour­nal arti­cle, they will scour data tables, not cor­po­rate state­ments. With sci­ence, num­bers speak much loud­er than words.

    Even the fig­ures the com­pa­ny did release don’t mean much on their own, because crit­i­cal infor­ma­tion — effec­tive­ly the key to inter­pret­ing them — was with­held.

    ...

    The silence of the NIAID

    The Nation­al Insti­tute for Aller­gy and Infec­tious Dis­eases has part­nered with Mod­er­na on this vac­cine. Sci­en­tists at NIAID made the vaccine’s con­struct, or pro­to­type, and the agency is run­ning the Phase 1 tri­al. This week’s Mod­er­na read­out came from the ear­li­est of data from the NIAID-led Phase 1.

    NIAID doesn’t hide its light under a bushel. The insti­tute gen­er­al­ly trum­pets its find­ings, often offer­ing direc­tor Antho­ny Fau­ci — who, fair enough, is pret­ty busy these days — or oth­er senior per­son­nel for inter­views.

    But NIAID did not put out a press release Mon­day and declined to pro­vide com­ment on Moderna’s announce­ment.

    The n = 8 thing

    The company’s state­ment led with the fact that all 45 sub­jects (in this analy­sis) who received dos­es of 25 micro­grams (two dos­es each), 100 micro­grams (two dos­es each), or a 250 micro­grams (one dose) devel­oped bind­ing anti­bod­ies.

    Lat­er, the state­ment indi­cat­ed that eight vol­un­teers — four each from the 25-micro­gram and 100-micro­gram arms — devel­oped neu­tral­iz­ing anti­bod­ies. Of the two types, these are the ones you’d real­ly want to see.

    We don’t know results from the oth­er 37 tri­al par­tic­i­pants. This doesn’t mean that they didn’t devel­op neu­tral­iz­ing anti­bod­ies. Test­ing for neu­tral­iz­ing anti­bod­ies is more time-con­sum­ing than oth­er anti­body tests and must be done in a biose­cu­ri­ty lev­el 3 lab­o­ra­to­ry. Mod­er­na dis­closed the find­ings from eight sub­jects because that’s all it had at that point. Still, it’s a rea­son for cau­tion.

    Sep­a­rate­ly, while the Phase 1 tri­al includ­ed healthy vol­un­teers ages 18 to 55 years, the exact ages of these eight peo­ple are unknown. If, by chance, they most­ly clus­tered around the younger end of the age spec­trum, you might expect a bet­ter response to the vac­cine than if they were most­ly from the senior end of it. And giv­en who is at high­est risk from the SARS-CoV­‑2 coro­n­avirus, pro­tect­ing old­er adults is what Covid-19 vac­cines need to do.

    There’s no way to know how durable the response will be

    The report of neu­tral­iz­ing anti­bod­ies in sub­jects who were vac­ci­nat­ed comes from blood drawn two weeks after they received their sec­ond dose of vac­cine.

    Two weeks.

    “That’s very ear­ly. We don’t know if those anti­bod­ies are durable,” said Anna Durbin, a vac­cine researcher at Johns Hop­kins Uni­ver­si­ty.

    There’s no real way to con­tex­tu­al­ize the find­ings

    Mod­er­na stat­ed that the anti­body lev­els seen were on a par with — or greater than, in the case of the 100-micro­gram dose — those seen in peo­ple who have recov­ered from Covid-19 infec­tion.

    But stud­ies have shown anti­body lev­els among peo­ple who have recov­ered from the ill­ness vary enor­mous­ly; the range that may be influ­enced by the sever­i­ty of a person’s dis­ease. John “Jack” Rose, a vac­cine researcher from Yale Uni­ver­si­ty, point­ed STAT to a study from Chi­na that showed that, among 175 recov­ered Covid-19 patients stud­ied, 10 had no detectable neu­tral­iz­ing anti­bod­ies. Recov­ered patients at the oth­er end of the spec­trum had real­ly high anti­body lev­els.

    So though the com­pa­ny said the anti­body lev­els induced by vac­cine were as good as those gen­er­at­ed by infec­tion, there’s no real way to know what that com­par­i­son means.

    STAT asked Mod­er­na for infor­ma­tion on the anti­body lev­els it used as a com­para­tor. The response: That will be dis­closed in an even­tu­al jour­nal arti­cle from NIAID, which is part of the Nation­al Insti­tutes of Health.

    “The con­va­les­cent sera lev­els are not being detailed in our data read­out, but would be expect­ed in a down­stream full data expo­si­tion with NIH and its aca­d­e­m­ic col­lab­o­ra­tors,” Colleen Hussey, the company’s senior man­ag­er for cor­po­rate com­mu­ni­ca­tions, said in an email.

    Durbin was struck by the word­ing of the company’s state­ment, point­ing to this sen­tence: “The lev­els of neu­tral­iz­ing anti­bod­ies at day 43 were at or above lev­els gen­er­al­ly seen in con­va­les­cent sera.”

    “I thought: Gen­er­al­ly? What does that mean?” Durbin said. Her ques­tion, for the time being, can’t be answered.

    Rose said the com­pa­ny should dis­close the infor­ma­tion. “When a com­pa­ny like Mod­er­na with such incred­i­bly vast resources says they have gen­er­at­ed SARS‑2 neu­tral­iz­ing anti­bod­ies in a human tri­al, I would real­ly like to see num­bers from what­ev­er assay they are using,” he said.

    Moderna’s approach to dis­clo­sure

    The com­pa­ny has not yet brought a vac­cine to mar­ket, but it has a vari­ety of vac­cines for infec­tious dis­eases in its pipeline. It doesn’t pub­lish on its work in sci­en­tif­ic jour­nals. What is known has been dis­closed through press releas­es. That’s not enough to gen­er­ate con­fi­dence with­in the sci­en­tif­ic com­mu­ni­ty.

    “My guess is that their num­bers are mar­gin­al or they would say more,” Rose said about the company’s SARS‑2 vac­cine, echo­ing a sus­pi­cion that oth­ers have about some of the company’s oth­er work.

    “I do think it’s a bit of a con­cern that they haven’t pub­lished the results of any of their ongo­ing tri­als that they men­tion in their press release. They have not pub­lished any of that,” Durbin not­ed.

    Still, she char­ac­ter­ized her­self as “cau­tious­ly opti­mistic” based on what the com­pa­ny has said so far.

    “I would like to see the data to make my own inter­pre­ta­tion of the data. But I think it is at least encour­ag­ing that we’ve seen immune respons­es with this RNA vac­cine that we haven’t seen with pre­vi­ous RNA vac­cines for oth­er pathogens. Whether it’s going to be enough, we don’t know,” Durbin said.

    Mod­er­na has been more forth­com­ing with data on at least one of its oth­er vac­cine can­di­dates. In a state­ment issued in Jan­u­ary about a Phase 1 tri­al for its cytomegalovirus (CMV) vac­cine, it quan­ti­fied how far over base­line mea­sures anti­body lev­els rose in vac­cines.

    ———-

    “Vac­cine experts say Mod­er­na didn’t pro­duce data crit­i­cal to assess­ing Covid-19 vac­cine” by Helen Bran­swell; Stat News; 05/19/2020

    “But was there good rea­son for so much enthu­si­asm? Sev­er­al vac­cine experts asked by STAT con­clud­ed that, based on the infor­ma­tion made avail­able by the Cam­bridge, Mass.-based com­pa­ny, there’s real­ly no way to know how impres­sive — or not — the vac­cine may be.”

    It’s a pret­ty big prob­lem when a com­pa­ny issues pre­lim­i­nary results that are impos­si­ble to real­is­ti­cal­ly inter­pret. Then again, if the pur­pose of the press release was sim­ply to juice Mod­er­na’s stocks (and maybe trig­ger a broad­er ral­ly), you don’t need results that can be real­is­ti­cal­ly inter­pret­ed. Unre­al­is­tic over­ly pos­i­tive inter­pre­ta­tions will do just fine. But as we saw, that unre­al­is­tic mar­ket-mov­ing inter­pre­ta­tion may not last very long once peo­ple start ask­ing ques­tions about find they can’t actu­al­ly get the answers.

    Even the fig­ures released by the com­pa­ny lacked the infor­ma­tion required to inter­pret them. But it’s the fact that 45 peo­ple start­ed the tri­al and these pre­lim­i­nary results were based sole­ly on eight of them — with no men­tion of the oth­er 37 peo­ple — that makes these results extra dif­fi­cult to inter­pret. Plus, Mod­er­na won’t tell us if the ages of those eight peo­ple which is pret­ty impor­tant for a vac­cine that for a dis­ease that pri­mar­i­ly impacts the elder­ly:

    ...
    While Mod­er­na blitzed the media, it revealed very lit­tle infor­ma­tion — and most of what it did dis­close were words, not data. That’s impor­tant: If you ask sci­en­tists to read a jour­nal arti­cle, they will scour data tables, not cor­po­rate state­ments. With sci­ence, num­bers speak much loud­er than words.

    Even the fig­ures the com­pa­ny did release don’t mean much on their own, because crit­i­cal infor­ma­tion — effec­tive­ly the key to inter­pret­ing them — was with­held.

    ...

    The n = 8 thing

    The company’s state­ment led with the fact that all 45 sub­jects (in this analy­sis) who received dos­es of 25 micro­grams (two dos­es each), 100 micro­grams (two dos­es each), or a 250 micro­grams (one dose) devel­oped bind­ing anti­bod­ies.

    Lat­er, the state­ment indi­cat­ed that eight vol­un­teers — four each from the 25-micro­gram and 100-micro­gram arms — devel­oped neu­tral­iz­ing anti­bod­ies. Of the two types, these are the ones you’d real­ly want to see.

    We don’t know results from the oth­er 37 tri­al par­tic­i­pants. This doesn’t mean that they didn’t devel­op neu­tral­iz­ing anti­bod­ies. Test­ing for neu­tral­iz­ing anti­bod­ies is more time-con­sum­ing than oth­er anti­body tests and must be done in a biose­cu­ri­ty lev­el 3 lab­o­ra­to­ry. Mod­er­na dis­closed the find­ings from eight sub­jects because that’s all it had at that point. Still, it’s a rea­son for cau­tion.

    Sep­a­rate­ly, while the Phase 1 tri­al includ­ed healthy vol­un­teers ages 18 to 55 years, the exact ages of these eight peo­ple are unknown. If, by chance, they most­ly clus­tered around the younger end of the age spec­trum, you might expect a bet­ter response to the vac­cine than if they were most­ly from the senior end of it. And giv­en who is at high­est risk from the SARS-CoV­‑2 coro­n­avirus, pro­tect­ing old­er adults is what Covid-19 vac­cines need to do.
    ...

    Then there’s the fact that we have no idea how mean­ing­ful these anti­body find­ings are with­out known the lev­els detect­ed. All they said was that the anti­body lev­els were on a par with or greater than those seen in peo­ple who have recov­ered from Covid-19. It’s a use­less state­ment giv­en that the known range of anti­body lev­els in recov­ered patients ranges from high to noth­ing. Plus, this data is from two weeks after the vac­cine was deliv­ered, which tells us absolute­ly noth­ing about their dura­bil­i­ty:

    ...
    There’s no way to know how durable the response will be

    The report of neu­tral­iz­ing anti­bod­ies in sub­jects who were vac­ci­nat­ed comes from blood drawn two weeks after they received their sec­ond dose of vac­cine.

    Two weeks.

    “That’s very ear­ly. We don’t know if those anti­bod­ies are durable,” said Anna Durbin, a vac­cine researcher at Johns Hop­kins Uni­ver­si­ty.

    There’s no real way to con­tex­tu­al­ize the find­ings

    Mod­er­na stat­ed that the anti­body lev­els seen were on a par with — or greater than, in the case of the 100-micro­gram dose — those seen in peo­ple who have recov­ered from Covid-19 infec­tion.

    But stud­ies have shown anti­body lev­els among peo­ple who have recov­ered from the ill­ness vary enor­mous­ly; the range that may be influ­enced by the sever­i­ty of a person’s dis­ease. John “Jack” Rose, a vac­cine researcher from Yale Uni­ver­si­ty, point­ed STAT to a study from Chi­na that showed that, among 175 recov­ered Covid-19 patients stud­ied, 10 had no detectable neu­tral­iz­ing anti­bod­ies. Recov­ered patients at the oth­er end of the spec­trum had real­ly high anti­body lev­els.

    ...

    “The con­va­les­cent sera lev­els are not being detailed in our data read­out, but would be expect­ed in a down­stream full data expo­si­tion with NIH and its aca­d­e­m­ic col­lab­o­ra­tors,” Colleen Hussey, the company’s senior man­ag­er for cor­po­rate com­mu­ni­ca­tions, said in an email.

    Durbin was struck by the word­ing of the company’s state­ment, point­ing to this sen­tence: “The lev­els of neu­tral­iz­ing anti­bod­ies at day 43 were at or above lev­els gen­er­al­ly seen in con­va­les­cent sera.”

    “I thought: Gen­er­al­ly? What does that mean?” Durbin said. Her ques­tion, for the time being, can’t be answered.
    ...

    But per­haps the biggest red flag here is what we’ve heard from the NIAID, which is noth­ing. That’s not typ­i­cal of the NIAID, as the hyp­ing of remde­sivir has made clear:

    ...
    The silence of the NIAID

    The Nation­al Insti­tute for Aller­gy and Infec­tious Dis­eases has part­nered with Mod­er­na on this vac­cine. Sci­en­tists at NIAID made the vaccine’s con­struct, or pro­to­type, and the agency is run­ning the Phase 1 tri­al. This week’s Mod­er­na read­out came from the ear­li­est of data from the NIAID-led Phase 1.

    NIAID doesn’t hide its light under a bushel. The insti­tute gen­er­al­ly trum­pets its find­ings, often offer­ing direc­tor Antho­ny Fau­ci — who, fair enough, is pret­ty busy these days — or oth­er senior per­son­nel for inter­views.

    But NIAID did not put out a press release Mon­day and declined to pro­vide com­ment on Moderna’s announce­ment.
    ...

    So why did we hear noth­ing from the NIAID? Well, one obvi­ous pos­si­bil­i­ty is that the NIAID does­n’t agree with Mod­er­na’s pos­i­tive spin in these very pre­lim­i­nary results. But anoth­er pos­si­bil­i­ty is sim­ply that the NIAID had no idea Mod­er­na was about to do this and was caught by sur­prise with Mon­day’s announce­ment. As we saw in the pre­vi­ous arti­cle, Mon­day was a very for­tu­itous day for Mod­er­na to make that announce­ment, at least for the com­pa­ny’s CFO (and any oth­er employ­ees who may have had sim­i­lar pre-planned stock option schemes). Did Mod­er­na sur­prise the NIAID too? We don’t know and will prob­a­bly nev­er know but, again, the tim­ing of this all sure is inter­est­ing.

    Final­ly, here’s a piece in Fier­cePhar­ma about the charges of con­flict of inter­est against the fig­ure just tapped by Pres­i­dent Trump to lead “Oper­a­tion Warp Speed”, a fed­er­al pro­gram with the goal of putting out a COVID vac­cine by the end of 2020 that Trump announced on Fri­day. And, yes, that head of Oper­a­tion Warp Speed just hap­pens to be Mod­er­na board mem­ber Mon­cef Slaoui. Slaoui resigned from Mod­er­na’s board with this appoint­ment but he did­n’t entire­ly divorce him­self from the com­pa­ny: It turns out he kept 155,000 Mod­er­na shares that were were about $10 mil­lion on Fri­day. This prompt­ed Sen­a­tor Eliz­a­beth War­ren to call Slaoui out for this obvi­ous con­flict of inter­est and Slaoui announced he’s plan­ning on sell­ing.

    Now, relat­ed to that Mon­day announce­ment by Mod­er­na, it turns out Slaoui actu­al­ly hint­ed at those results on Fri­day dur­ing the “Oper­a­tion Warp Speed” announce­ment cer­e­mo­ny at the White House. Slaoui told reporters that he was “con­fi­dent” in that goal after view­ing ear­ly data from an undis­closed pro­gram. It’s hard to imag­ine that was­n’t a ref­er­ence to Mod­er­na’s ear­ly results. Video of Slaoui mak­ing that state­ment was lat­er tweet­ed out by the White House. So that’s an impor­tant con­text for Mod­er­na’s Mon­day announce­ment that moved mar­kets based on seem­ing­ly flim­sy data: the Trump White House was clear­ly very inter­est­ed in those pre­lim­i­nary results too:

    Fier­cePhar­ma

    ‘Warp Speed’ head Slaoui, chal­lenged for ‘huge con­flict of inter­est,’ sells off $12.4M in Mod­er­na stock

    by Eric Sagonowsky
    May 19, 2020 11:50am

    As the Oper­a­tion Warp Speed pro­gram races ahead with COVID-19 vac­cine can­di­dates, one of its new lead­ers kept mil­lions of dol­lars of stock in Mod­er­na, the biotech lead­ing the pack.

    But now, after an influ­en­tial sen­a­tor chal­lenged that own­er­ship inter­est, he’s plan­ning to sell.

    Fol­low­ing Mon­cef Slaoui’s Fri­day appoint­ment as a co-leader of the Warp Speed pro­gram, he’s set to sell about 155,000 shares in Mod­er­na, accord­ing to press reports. They were worth an esti­mat­ed $10 mil­lion Fri­day, but after Mon­day’s stock run-up on pos­i­tive ear­ly data, they’re now val­ued at about $12.4 mil­lion.

    Slaoui is set to donate to can­cer research the excess pro­ceeds from the sale, or about $2.4 mil­lion, accord­ing to CNBC. Slaoui also resigned as a Mod­er­na board mem­ber with the appoint­ment.

    Pres­i­dent Don­ald Trump unveiled the “Warp Speed” project at a Rose Gar­den event on Fri­day. Aside from Slaoui, a Glax­o­SmithK­line vet­er­an, the four-star gen­er­al Gus­tave Per­na will also lead the pro­gram.

    Fol­low­ing Slaoui’s selec­tion, Sen. Eliz­a­beth War­ren tweet­ed that it’s a “huge con­flict of inter­est” for him to keep the Mod­er­na stock as he assumes the new role. She said he should “divest imme­di­ate­ly.”

    In a now-delet­ed tweet, Slaoui respond­ed that there “is no con­flict of inter­est, and there nev­er has been,” Busi­ness Insid­er reports.

    Slaoui spent near­ly three decades at Glax­o­SmithK­line and retired in 2017. Then, he joined the boards of Mod­er­na and oth­er life sci­ences com­pa­nies.

    Oper­a­tion Warp Speed is aim­ing to deliv­er a COVID-19 vac­cine by the end of the year. At Fri­day’s event, Slaoui said he was “con­fi­dent” in that goal after view­ing ear­ly data from an undis­closed pro­gram. Mod­er­na announced its promis­ing data, from eight patients in a phase 1 study, ear­ly Mon­day morn­ing.

    ...

    ———-

    “ ‘Warp Speed’ head Slaoui, chal­lenged for ‘huge con­flict of inter­est,’ sells off $12.4M in Mod­er­na stock” by Eric Sagonowsky; Fier­cePhar­ma; 05/19/2020

    “Fol­low­ing Mon­cef Slaoui’s Fri­day appoint­ment as a co-leader of the Warp Speed pro­gram, he’s set to sell about 155,000 shares in Mod­er­na, accord­ing to press reports. They were worth an esti­mat­ed $10 mil­lion Fri­day, but after Mon­day’s stock run-up on pos­i­tive ear­ly data, they’re now val­ued at about $12.4 mil­lion.

    It’s glimpse into the mind­set of the peo­ple at the head of Oper­a­tion Warp Speed: Slaoui did­n’t both­er to divest until he was called out for hold­ing onto Mod­er­na stock and then when he was called out by Sen­a­tor War­ren for this obvi­ous and mas­sive con­flict of inter­est he tweets out that “is no con­flict of inter­est, and there nev­er has been”:

    ...
    Fol­low­ing Slaoui’s selec­tion, Sen. Eliz­a­beth War­ren tweet­ed that it’s a “huge con­flict of inter­est” for him to keep the Mod­er­na stock as he assumes the new role. She said he should “divest imme­di­ate­ly.”

    In a now-delet­ed tweet, Slaoui respond­ed that there “is no con­flict of inter­est, and there nev­er has been,” Busi­ness Insid­er reports.
    ...

    And then there’s that inter­est­ing com­ment for Slaoui dur­ing the Oper­a­tion Warp Speed cer­e­mo­ny where he expressed con­fi­dence that the goal of achiev­ing a vac­cine by the end of the year was achiev­able after view­ing some sort of mys­tery pre­lim­i­nary data. Then on Mon­day Mod­er­na makes its big announce­ment:

    ...
    Oper­a­tion Warp Speed is aim­ing to deliv­er a COVID-19 vac­cine by the end of the year. At Fri­day’s event, Slaoui said he was “con­fi­dent” in that goal after view­ing ear­ly data from an undis­closed pro­gram. Mod­er­na announced its promis­ing data, from eight patients in a phase 1 study, ear­ly Mon­day morn­ing.
    ...

    So was the Trump White House push­ing Mod­er­na to make that pre­lim­i­nary announce­ment as part of a hype-build­ing exer­cise for Oper­a­tion Warp Speed? It would be a very Trumpian thing to do so it’s not hard to imag­ine.

    But we also have ask about anoth­er high­ly Trumpian act: so did any Trump admin­is­tra­tion insid­ers hap­pen to make any for­tu­itous invest­ments in Mod­er­na ear­ly on Mon­day? Per­haps with fore­knowl­edge of Mod­er­na’s announce­ment? Maybe not direct insid­ers but friends of friends or some­thing? We have no idea at this point but it’s such a Trumpian move it’s almost hard to imag­ine some­thing like that did­n’t hap­pen. This is the pres­i­dent who declared the emol­u­ments clause does­n’t apply to him, after all. It’s not like we have any rea­son to assume there’s a moral obsta­cle with­in White House cir­cles to COVID response insid­er-trad­ing. It’s more a ques­tion of whether or not they have rea­son to believe they would be caught doing it.

    And that points to a gen­er­al ques­tion about the fed­er­al COVID response: if there was insid­er trad­ing going on would we learn about it? What if it’s not direct insid­er trad­ing but like friends of friends? Let’s say Jared Kush­n­er learns about an upcom­ing announce­ment by Mod­er­na or Gilead and hands that infor­ma­tion over to a friend. Is there any real­is­tic pos­si­bil­i­ty we would learn about that? If not, we should prob­a­bly assume it’s hap­pen­ing. This is a pirate admin­is­tra­tion, after all.

    Final­ly, it’s worth not­ing some­thing about the nature of the RNA-based vac­cines Mod­er­na is work­ing on and these high­ly ambi­tious vac­cine time­lines: unlike most oth­er vac­cine devel­op­ment, the RNA-based approach is actu­al­ly remark­able sim­ple and does­n’t result in per­ma­nent­ly alter­ing some­one’s genome. It’s part of what’s so excit­ing about the tech­nol­o­gy if it turns out to be safe and effec­tive. The noto­ri­ous­ly dif­fi­cult devel­op­ment of vac­cines would be made dra­mat­i­cal­ly sim­pler and cheap­er. That’s why Mod­er­na’s own time­line for the vac­cine devel­op­ment shows the com­pa­ny had a can­di­date vac­cine on Jan­u­ary 13, two days after the ini­tial release of the SARS-CoV­‑2 genet­ic sequence. It’s a straight­for­ward process. The tru­ly hard part here is prov­ing this new tech­nol­o­gy is safe for use in humans and effec­tive and con­vinc­ing the broad­er pub­lic that RNA-based vac­cines are safe and some­thing they would be will­ing to put in their bod­ies. Get­ting gov­ern­ment and pub­lic approval for Mod­er­na’s prod­ucts is the big chal­lenge, not the under­ly­ing tech­nol­o­gy. The tech­nol­o­gy is rel­a­tive­ly easy and well estab­lished. Grant­ed, mak­ing a vac­cine for COVID might be chal­leng­ing but that could have more to do with the char­ac­ter­is­tics of virus than chal­lenges in the under­ly­ing tech­nol­o­gy. And yet here we are, with human clin­i­cal tri­als for a COVID vac­cine under­way and high hopes of using this RNA vac­cine tech­nol­o­gy on the entire world, with much of the pub­lic clam­or­ing for any vac­cine even if it’s a new RNA vac­cine, at least if Mod­er­na ends up being the first com­pa­ny to bring a vac­cine to the mar­ket and there are no oth­er options. In oth­er words, the pan­dem­ic is effec­tive­ly doing Mod­er­na’s hard work for it. It’s one of the more extreme exam­ples of pri­va­tiz­ing prof­it while social­iz­ing costs.

    Posted by Pterrafractyl | May 20, 2020, 3:03 pm
  2. @Pterrafractyl–

    Looks like the mar­ket got (ahem) a shot in the arm from Mod­er­na’s announce­ment.

    “Now, this won’t hurt a bit!”

    Keep up the great work,

    Dave

    Posted by Dave Emory | May 20, 2020, 4:59 pm
  3. Now that it’s look­ing like Mod­er­na’s mRNA COVID vac­cine is on track to being the first avail­able vac­cine for COVID-19 (assum­ing it works), the ques­tion of what Mod­er­na is plan­ning on charg­ing for the vac­cine is going to be an increas­ing­ly impor­tant issue. Unlike drugs like remde­sivir — which has costs esti­mates of poten­tial­ly thou­sands of dol­lars per treat­ment in part due to the dif­fi­cul­ty of man­u­fac­tur­ing it and the result­ing lim­it­ed sup­ply — part of the appeal of mRNA vac­cines is that, from a tech­ni­cal stand­point, they are rel­a­tive­ly sim­ple and cheap to pro­duce and it can be rapid­ly done at scale. That’s ide­al from the stand­point of a vac­cine for a dis­ease like COVID because if there’s any hope of stomp­ing the dis­ease out for good you need to vac­ci­nate basi­cal­ly every­one on the plan­et as fast as pos­si­ble. But that’s just the tech­ni­cal side of things. If peo­ple can’t afford the vac­cine they aren’t going to get it whether its tech­ni­cal­ly avail­able or not and we have no idea of the rel­a­tive sim­plic­i­ty of man­u­fac­tur­ing mRNA vac­cines is going to trans­late into low­er costs.

    So what do we know yet about Mod­er­na’s pric­ing plans? Well, so far we know that Mod­er­na has­n’t decid­ed on a price. That’s what Mod­er­na’s CEO stat­ed dur­ing a con­fer­ence call on Mon­day when Mod­er­na released those vague­ly pos­i­tive very pre­lim­i­nary results of the vac­cine clin­i­cal tri­al. Omi­nous­ly, Mod­er­na said it’s think­ing about what Covid-19 ill­ness costs the health-care sys­tem. That sure sounds like the com­pa­ny is engaged in some sort of inter­nal ratio­nale for charg­ing a lot per dose (because, hey, at least it’s cheap­er than let­ting peo­ple get sick and go into inten­sive care, right?).

    But finan­cial ana­lysts and investors aren’t shy about dis­cussing what they have in mind in the fol­low­ing Bar­ron’s arti­cle. The expect­ed price range var­ied sig­nif­i­cant­ly between ana­lysts. On the low end, Mor­gan Stan­ley ana­lysts sug­gest­ed over the week­end that pric­ing could start at $5–10/dose and rise to a range of $13–30/dose in future years for pre­ven­ta­tive dos­es. On the high end, BMO Cap­i­tal Mar­kets ana­lyst George Farmer thinks Mod­er­na could start with $125/dose and raise it to $200/dose over time. At least in the US. Farmer notes that since most nation­al health care sys­tems are gov­ern­ment-run they won’t pay near­ly that much. Farmer fur­ther guessti­mates that sales in the devel­oped world will amount to half or two-thirds the dol­lar lev­els of the U.S. and poor­er nations will only be able to around 5% of the total sales. So the US con­sumers are expect­ed to spend about as much on the vac­cine as the rest of the world com­bined. It points to one of the inter­est­ing poten­tial impacts the glob­al hunt for a vac­cine could have on the health­care debate in the US: the Amer­i­can pub­lic just might get a big les­son in US health­care con­sumers pay vast­ly more than peo­ple else­where for the exact same med­i­cine.

    But pro­ject­ed over­all sales for Mod­er­na also depend heav­i­ly on anoth­er assump­tion: how long does the vac­cine con­fer immu­ni­ty. If, for exam­ple, the vac­cine only needs to be tak­en every few years, that’s around 100 mil­lion Amer­i­cans alone. At a $30 to $130 price range that would be $3 bil­lion to $13 bil­lion annu­al­ly from the US alone. But, of course, hav­ing a vac­cine that con­fers immu­ni­ty for three years is kind of a near best case sce­nario at this point (with the best case sce­nario being life­long immu­ni­ty). But we still have no idea how long the vac­cine con­fers immu­ni­ty or if the SARS-CoV­‑2 virus is the kind of virus that you can even devel­op immu­ni­ty to at all. In oth­er words, that BMO esti­mate of $3 bil­lion to $13 bil­lion annu­al in COVID vac­cine sales is high­ly opti­mistic from a med­ical stand­point and there­fore high­ly pes­simistic from sales stand­point. If these vac­cines need to be tak­en annu­al­ly that BMP esti­mate would jump to $9 bil­lion to $39 bil­lion annu­al sales esti­mate. And what if the vac­cine only con­fers like 6 months of immu­ni­ty. Peo­ple will still take it, right? Just twice a year. How about just three months of immu­ni­ty? Will peo­ple take a sea­son­able vac­cine shot? Prob­a­bly. That’s where we are. If it’s a choice between four vac­cine shots a year or keep­ing things shut­down it’s hard to imag­ine the vast major­i­ty of peo­ple won’t got with the vac­cine. We still have no idea what kind of sit­u­a­tion we’re look­ing at in terms of the basi­cal via­bil­i­ty of any vac­cine because we still under­stand so lit­tle about this virus. And a near-worst-case sce­nario where a vac­cine is viable, but only bare­ly and does­n’t last very long, just might be the best case sce­nario for Mod­er­na and oth­er vac­cine man­u­fac­tur­ers:

    Bar­ron’s

    A Covid-19 Vac­cine Could Be Worth Bil­lions for Mod­er­na and Its Rivals

    By Bill Alpert
    May 19, 2020 11:39 am ET

    Fresh on the heels of the first data from human tests of its Covid-19 vac­cine, Mod­er­na sold $1.3 bil­lion worth of stock on Mon­day at a price of $76 a share. That’s a four­fold rise from price where the biotech’s stock start­ed the year, and a mar­ket val­ue of $30 bil­lion for a com­pa­ny that has yet to sell its first prod­uct.

    What investors are bet­ting on, for Mod­er­na and oth­ers devel­op­ing vac­cines against the SARS-CoV­‑2 virus, is that a third of the devel­oped world’s pop­u­la­tion will get vac­ci­nat­ed every year. That could amount to a $10 bil­lion annu­al busi­ness, at an esti­mat­ed price of $30 per vac­ci­na­tion. At high­er prices, Covid vac­cine rev­enue would be big­ger still.

    In Tues­day morn­ing trad­ing, Mod­er­na stock was down 5% from Monday’s close, at $76.

    On a Mon­day con­fer­ence call, Mod­er­na CEO Stéphane Ban­cel said the Cam­bridge, Mass., com­pa­ny had not yet decid­ed on a price , in the event that their mRNA-1273 vac­cine proves effec­tive in the Phase 2 and 3 tri­als it will run this year. He said that Mod­er­na was think­ing about what Covid-19 ill­ness costs the health-care sys­tem.

    Covid’s cost obvi­ous­ly goes beyond the hos­pi­tal, and it’s already been gigan­tic . In the U.S. alone, near­ly 90,000 have died in a few months’ time. The scale of the coro­n­avirus’ impact explains why there’s such a range of esti­mates on Wall Street for what vac­cine mak­ers will charge. Mor­gan Stan­ley ana­lysts this past week­end sug­gest­ed that pric­ing might start at $5 to $10 a dose dur­ing this first pan­dem­ic cri­sis, then rise to a range of $13 to $30 for pre­ven­tive dos­es in future years.

    But at BMO Cap­i­tal Mar­kets, ana­lyst George Farmer spec­u­lat­ed that Mod­er­na could start charg­ing $125 per treat­ment in the U.S. mar­ket and raise that price over time to $200. Most of the world’s health-care sys­tems are gov­ern­ment-run, so Farmer’s mod­el assumes that pric­ing abroad will be a frac­tion of America’s gen­er­ous pric­ing.

    Vac­ci­na­tions will like­ly con­sist of a first shot and then a boost­er one month lat­er. After clin­i­cal tri­als answer the first cru­cial ques­tion of whether vac­cine can­di­dates like Moderna’s pre­vent Covid in humans, the next ques­tion will be how long immu­ni­ty lasts. Assum­ing some­what less muta­bil­i­ty than is the case with the flu virus, researchers are guess­ing that peo­ple might need a SARS-CoV­‑2 vac­ci­na­tion every few years. That’s how ana­lysts like BMO’s Farmer arrive at a count of rough­ly a third of the pop­u­la­tion need­ing a vac­ci­na­tion per year.

    The U.S. pop­u­la­tion could rise from about 330 mil­lion today to more than 360 mil­lion by the decade’s end, depend­ing on a bunch of social and eco­nom­ic fac­tors, such as future immi­gra­tion lev­els. Dif­fer­ent age groups will get vac­ci­nat­ed at dif­fer­ing rates—hopefully unim­ped­ed by anti­vac­ci­na­tion sen­ti­ments. BMO esti­mates that will work out to about 30% of America’s head count get­ting vac­ci­nat­ed each year, or some 100 mil­lion treat­ments a year by the sec­ond half of this decade. Put a price from $30 to $130 on those num­bers, and you get $3 bil­lion to $13 bil­lion in U.S. sales.

    Glob­al sales are hard­er to fore­cast, with prices and vac­ci­na­tion rates like­ly to vary wide­ly through­out the devel­oped and devel­op­ing coun­tries. BMO’s Farmer guessti­mates that sales in the devel­oped world will amount to half or two-thirds the dol­lar lev­els of the U.S. Poor­er nations will only be able to chip in around 5%. Still, he sees Covid vac­cines exceed­ing $30 bil­lion in sales by the end of the decade. That mar­ket size embold­ened him to raise his price tar­get on Mod­er­na stock to $112 from $83, after yesterday’s encour­ag­ing news on the first hand­ful of patients in Moderna’s Phase 1 tri­al.

    Even if Moderna’s vac­cine becomes the first one available—perhaps this fall, for front-line workers—it won’t be the only one. Pfiz­er (PFE) and its part­ner BioN­Tech (BNTX) are also in the clin­ic with a vac­cine that uses tech­nol­o­gy sim­i­lar to Moderna’s. And oth­er vac­cine approach­es are being test­ed by the likes of John­son & John­son (JNJ) and the vac­cine mar­ket incum­bents Sanofi (SNY) and Glax­o­SmithK­line (GSK).

    ...

    ———

    “A Covid-19 Vac­cine Could Be Worth Bil­lions for Mod­er­na and Its Rivals” by Bill Alpert; Bar­ron’s; 05/19/2020

    “On a Mon­day con­fer­ence call, Mod­er­na CEO Stéphane Ban­cel said the Cam­bridge, Mass., com­pa­ny had not yet decid­ed on a price , in the event that their mRNA-1273 vac­cine proves effec­tive in the Phase 2 and 3 tri­als it will run this year. He said that Mod­er­na was think­ing about what Covid-19 ill­ness costs the health-care sys­tem.”

    What is Mod­er­na plan­ning on charg­ing? It sure sounds like they’re plan­ning on charg­ing as much as they think they can get away with and they just haven’t fig­ure out what that is yet. But the ana­lysts are hap­py to spec­u­late. Will it be Mor­gan Stan­ley’s ini­tial $5–10 range that ris­es to $13–30 or will it be clos­er to BMO’s range of $125–200? We’ll find out, assum­ing the vac­cine ends up work­ing. And should that hap­pen, the US pub­lic just might find out how much more its pay­ing per vac­cine than the rest of the world because that’s how Amer­i­ca’s health­care sys­tem works. Amer­i­cans sys­tem­at­i­cal­ly pay WAY more than every­one else for med­i­cine:

    ...
    Covid’s cost obvi­ous­ly goes beyond the hos­pi­tal, and it’s already been gigan­tic . In the U.S. alone, near­ly 90,000 have died in a few months’ time. The scale of the coro­n­avirus’ impact explains why there’s such a range of esti­mates on Wall Street for what vac­cine mak­ers will charge. Mor­gan Stan­ley ana­lysts this past week­end sug­gest­ed that pric­ing might start at $5 to $10 a dose dur­ing this first pan­dem­ic cri­sis, then rise to a range of $13 to $30 for pre­ven­tive dos­es in future years.

    But at BMO Cap­i­tal Mar­kets, ana­lyst George Farmer spec­u­lat­ed that Mod­er­na could start charg­ing $125 per treat­ment in the U.S. mar­ket and raise that price over time to $200. Most of the world’s health-care sys­tems are gov­ern­ment-run, so Farmer’s mod­el assumes that pric­ing abroad will be a frac­tion of America’s gen­er­ous pric­ing.

    ...

    Glob­al sales are hard­er to fore­cast, with prices and vac­ci­na­tion rates like­ly to vary wide­ly through­out the devel­oped and devel­op­ing coun­tries. BMO’s Farmer guessti­mates that sales in the devel­oped world will amount to half or two-thirds the dol­lar lev­els of the U.S. Poor­er nations will only be able to chip in around 5%. Still, he sees Covid vac­cines exceed­ing $30 bil­lion in sales by the end of the decade. That mar­ket size embold­ened him to raise his price tar­get on Mod­er­na stock to $112 from $83, after yesterday’s encour­ag­ing news on the first hand­ful of patients in Moderna’s Phase 1 tri­al.
    ...

    Note that Georg Farmer’s price tar­get for the val­ue of Mod­er­na’s stock up to $112/share is over 70% high­er than the $65/share the stock was at on Fri­day before Mon­day’s surge. That’s how rapid­ly the per­ceived val­ue of Mod­er­na is grow­ing.

    But price range is just one part of esti­mat­ing the total poten­tial rev­enues. There’s also the ques­tion of how often the vac­cine will be required. Is this a once-in-a-life­time vac­cine? Once a decade? Every few years? Annu­al­ly? Every six months? We have no idea what kind of sce­nario we’re look­ing at. But the worse it is from a med­ical stand­point the bet­ter it is for Mod­er­na’s share­hold­ers as long as some sort of vac­cine at least kind of works for, say, a few months. There’s going to be some min­i­mum dura­tion below which a vac­cine won’t be worth tak­ing and the clos­er it ends up being to that min­i­mum dura­tion the bet­ter it is for investors:

    ...
    Vac­ci­na­tions will like­ly con­sist of a first shot and then a boost­er one month lat­er. After clin­i­cal tri­als answer the first cru­cial ques­tion of whether vac­cine can­di­dates like Moderna’s pre­vent Covid in humans, the next ques­tion will be how long immu­ni­ty lasts. Assum­ing some­what less muta­bil­i­ty than is the case with the flu virus, researchers are guess­ing that peo­ple might need a SARS-CoV­‑2 vac­ci­na­tion every few years. That’s how ana­lysts like BMO’s Farmer arrive at a count of rough­ly a third of the pop­u­la­tion need­ing a vac­ci­na­tion per year.

    The U.S. pop­u­la­tion could rise from about 330 mil­lion today to more than 360 mil­lion by the decade’s end, depend­ing on a bunch of social and eco­nom­ic fac­tors, such as future immi­gra­tion lev­els. Dif­fer­ent age groups will get vac­ci­nat­ed at dif­fer­ing rates—hopefully unim­ped­ed by anti­vac­ci­na­tion sen­ti­ments. BMO esti­mates that will work out to about 30% of America’s head count get­ting vac­ci­nat­ed each year, or some 100 mil­lion treat­ments a year by the sec­ond half of this decade. Put a price from $30 to $130 on those num­bers, and you get $3 bil­lion to $13 bil­lion in U.S. sales.
    ...

    It’s also worth keep­ing in mind one of the oth­er dynam­ics at work here: Mod­er­na and oth­er vac­cine man­u­fac­tur­ers will make the most mon­ey in the long run if this dis­ease is nev­er ful­ly stomped out and new forms come back year after year for­ev­er. And the most effec­tive way to stomp it out is to ensure the vac­cine is avail­able to vir­tu­al­ly every­one with­in a sin­gle sea­son so the virus sim­ply can’t find new hosts. So if, for what­ev­er rea­son, the vac­cine is made avail­able to almost every­one, but not every­one, and the out­break con­tin­ues to spread in some pock­ets of the world keep­ing the virus alive that’s kind of a best case sce­nario for the vac­cine man­u­fac­tur­ers. Almost stomp it out, but not quite. Year after year. That’s part of why the pric­ing and avail­abil­i­ty of the vac­cine is the kind of debate that needs to be tak­ing place now at a glob­al lev­el.

    Next, here’s just a quick reminder that this vac­cine isn’t being devel­oped by Mod­er­na alone. It’s being cre­at­ed in part­ner­ship with the Nation­al Insti­tutes of Health and just this April received $483 mil­lion in fund­ing from Bio­med­ical Advanced Research and Devel­op­ment Author­i­ty (BARDA) to begin the process of scal­ing up the man­u­fac­tur­ing of the vac­cine. Yep, almost half a bil­lion dol­lars came from the fed­er­al gov­ern­ment to help speed this up. Is that going to be fac­tored into the price of the vac­cine?

    The idea for the fund­ing was that the vac­cine was show­ing so much promise that Mod­er­na should just begin the process now of mass man­u­fac­tur­ing it so the dos­es are avail­able once it final­ly gets approval instead of wait­ing for it to go through the clin­i­cal tri­als. Keep in mind Mod­er­na just released infor­ma­tion on its first eight vac­cine human test sub­jects on Mon­day so data on human tri­als clear­ly weren’t avail­able when this deci­sion was made a month ago. Pre­sum­ably there was some pos­i­tive results in ani­mal tri­als they could point to. Either way, it’s a reminder that, like Gilead­’s remde­sivir, Mod­er­na’s vac­cine was clear­ly tapped from the very begin­ning to be fast-tracked and sup­port­ed with large fed­er­al grants despite this tech­nol­o­gy not yet being estab­lished as safe in humans. Now, pay­ing to have Mod­er­na devel­op those dos­es in par­al­lels with the safe­ty tri­als seems like a rea­son­able gam­ble to make giv­en the cir­cum­stance. If the tech­nol­o­gy pans out as hoped it real­ly could be exact­ly what we need. But on the oth­er hand, we don’t real­ly hear about this kind of robust fed­er­al sup­port for oth­er poten­tial vac­cines or drug ther­a­pies. It’s just the favored treat­ments of Gilead­’s remde­sivir and Mod­er­na’s vac­cine. In oth­er words, the prob­lem isn’t the fast-track­ing of Mod­er­na’s vac­cine or Gilead­’s remde­sivir. The prob­lem is the appar­ent­ly exclu­sive fast-track­ing of these med­i­cines to the exclu­sion of every­thing else. A prob­lem that becomes a lot hard­er to ignore when we hear about the tens of bil­lions of dol­lars Mod­er­na could end up mak­ing year after year on this sin­gle vac­cine alone:

    CNBC

    Mod­er­na soars after get­ting $483 mil­lion in fed­er­al fund­ing for coro­n­avirus vac­cine devel­op­ment

    Kevin Stankiewicz
    Pub­lished Fri, Apr 17 2020 8:26 AM EDT Updat­ed Fri, Apr 17 2020 6:32 PM EDT

    * Moderna’s stock closed the ses­sion 15% high­er.
    * The biotech announced it received as much as $483 mil­lion in fed­er­al fund­ing to accel­er­ate devel­op­ment of its poten­tial coro­n­avirus vac­cine.
    * Mod­er­na CEO Stephane Ban­cel told CNBC the fund­ing is par­tic­u­lar­ly crit­i­cal in aid­ing man­u­fac­tur­ing efforts.

    Moderna’s stock was surg­ing Fri­day after the biotech com­pa­ny announced it has received as much as $483 mil­lion in fed­er­al fund­ing to accel­er­ate devel­op­ment of a coro­n­avirus vac­cine.

    Shares of the Cam­bridge, Mass­a­chu­setts-based firm closed 15.4% high­er to $46.85. Dur­ing Friday’s ses­sion, the stock hit an intra­day all-time high of $49.

    Mod­er­na CEO Stephane Ban­cel said Fri­day on CNBC’s “Squawk Box” that the fund­ing is par­tic­u­lar­ly crit­i­cal in aid­ing man­u­fac­tur­ing efforts.

    “Instead of wait­ing for the data and then scal­ing up with man­u­fac­tur­ing process ... we can make as many dos­es as we can. We are doing both in par­al­lel,” he said. The com­pa­ny plans to hire up to 150 peo­ple to sup­port the effort.

    Ban­cel said the com­pa­ny “couldn’t have done this” with­out the fund­ing com­mit­ment from the Bio­med­ical Advanced Research and Devel­op­ment Author­i­ty, which is part of the Depart­ment of Health and Human Ser­vices.

    Mod­er­na has part­nered with the Nation­al Insti­tutes of Health on devel­op­ment of its Covid-19 vac­cine. Phase 1 human tri­als of the poten­tial vac­cine began in the Seat­tle area in mid-March.

    The tri­al was launched in “record speed,” White House health advi­sor Dr. Antho­ny Fau­ci said at the time.

    Ban­cel on Fri­day reit­er­at­ed Moderna’s time­line for vac­cine devel­op­ment. He said he hopes to have safe­ty data from the phase 1 tri­al this spring, which could allow it to advance to the next stage in the sec­ond quar­ter of this year.

    The phase 1 tri­al is being con­duct­ed with 45 peo­ple, while phase 2 would involve an expan­sion into “hun­dreds of healthy sub­jects,” Ban­cel said.

    Devel­op­ment also needs to include a large effec­tive­ness study involv­ing thou­sands of peo­ple, Ban­cel said. Mod­er­na hopes to start that phase in the fall, depend­ing on results from all the pre­ced­ing stages.

    ...

    ———–

    “Mod­er­na soars after get­ting $483 mil­lion in fed­er­al fund­ing for coro­n­avirus vac­cine devel­op­ment” by Kevin Stankiewicz; CNBC; 04/17/2020

    “Instead of wait­ing for the data and then scal­ing up with man­u­fac­tur­ing process ... we can make as many dos­es as we can. We are doing both in par­al­lel,” he said. The com­pa­ny plans to hire up to 150 peo­ple to sup­port the effort.”

    It’s quite a show of con­fi­dence: $483 mil­lion from BARDA to mass pro­duce an unproven vac­cine in par­al­lel with the clin­i­cal tri­als. Let’s hope those clin­i­cal tri­als show zero safe­ty risks because after a com­mit­ment like this from the fed­er­al gov­ern­ment it’s going to be very tempt­ing to find any excuse to use the vac­cine even if ques­tions remain about its safe­ty.

    And note the share price surge that came with that announce­ment: a 15% surge from ~$40/share to $46.85/share on thew news of the grant:

    ...
    Shares of the Cam­bridge, Mass­a­chu­setts-based firm closed 15.4% high­er to $46.85. Dur­ing Friday’s ses­sion, the stock hit an intra­day all-time high of $49.
    ...

    Com­pare that to the over $80/share it hit on Mon­day fol­low­ing the pre­lim­i­nary clin­i­cal tri­al results. And then there’s the tar­get price of $112 by BMO finan­cial ana­lyst Georg Farmer based on the gues­ti­mate that Mod­er­na could be mak­ing tens of bil­lions of dol­lars every­one year on this vac­cine. It’s a sign of just how wild­ly prof­itable this com­pa­ny might be to investors. But those wild prof­its can only be real­ized as long as the vac­cine is wide­ly, but not entire­ly, avail­able to the whole world.

    Posted by Pterrafractyl | May 21, 2020, 3:52 pm
  4. Here’s a pair of arti­cles relat­ed to Mod­er­na’s hunt for a COVID vac­cine with some pret­ty omi­nous impli­ca­tions about the poten­tial safe­ty of Mod­er­na’s mRNA vac­cine tech­nol­o­gy and poten­tial­ly any COVID vac­cine: First here’s a STAT News arti­cle about Mod­er­na from 2016 about the sto­ry of Mod­er­na’s cor­po­rate cul­ture of secre­cy and a rep­u­ta­tion for being a tough employ­er that had been dri­ving away a num­ber of its top researchers and man­agers. It also describes the var­i­ous strug­gles the com­pa­ny has had in its quest to bring an mRNA ther­a­py to mar­ket and that’s the part of the arti­cle that could have pret­ty omi­nous impli­ca­tions for the safe­ty of Mod­er­na’s mRNA vac­cines. Because it turns out pro­duc­ing vac­cines were far from the first choice for Mod­er­na. The first choice is ther­a­pies for dis­eases that required repeat­ed mRNA dos­es for years. Vac­cines are, ide­al­ly, just a sin­gle dose and there­fore much less prof­itable. It’s one of those “the mon­ey is in the treat­ment, not the cure” sit­u­a­tions.

    But Mod­er­na was refo­cus­ing on vac­cines nonethe­less at the time of that 2016 arti­cle. Why? Pre­cise­ly because vac­cines poten­tial­ly only require a sin­gle dose to work. So why would Mod­er­na want to piv­ot to a prod­uct that only one dose instead of repeat­ed dos­es? Because that would reduce the poten­tial­ly safe­ty issues with their tech­nol­o­gy because there won’t be repeat­ed dos­es. As the arti­cle describes, one of the major chal­lenges with mRNA tech­nol­o­gy is fig­ur­ing out how to deliv­er the mRNA into cells with­out caus­ing side-effects. It’s the major remain­ing tech­ni­cal chal­lenge for this tech­nol­o­gy and its a chal­lenge that led to much big­ger phar­ma­ceu­ti­cal rivals basi­cal­ly giv­ing up on their own mRNA ther­a­py tech­nol­o­gy. But with vac­cines that can osten­si­bly deliv­er their ther­a­peu­tic ben­e­fits with a sin­gle dose if there is a safe­ty issue with their tech­nol­o­gy at least it hope­ful­ly would­n’t be a huge issue. That’s why Mod­er­na was switch­ing its focus to vac­cines in 2016:

    STAT News

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

    By Dami­an Garde
    Sep­tem­ber 13, 2016

    CAMBRIDGE, Mass. — At first glance, Mod­er­na Ther­a­peu­tics looks like the most envi­able biotech start­up in the world. It has smashed fundrais­ing records and teamed up with phar­ma­ceu­ti­cal giants as it pur­sues a rad­i­cal plan to rev­o­lu­tion­ize med­i­cine by trans­form­ing human cells into drug fac­to­ries.

    But the real­i­ty is more com­pli­cat­ed.

    A STAT inves­ti­ga­tion found that the company’s caus­tic work envi­ron­ment has for years dri­ven away top tal­ent and that behind its obses­sion with secre­cy, there are signs Mod­er­na has run into road­blocks with its most ambi­tious projects.

    At the cen­ter of it all is Stéphane Ban­cel, a first-time biotech CEO with an unwa­ver­ing belief that Moderna’s sci­ence will work — and that employ­ees who don’t “live the mis­sion” have no place in the com­pa­ny. Con­fi­dent and intense, Ban­cel told STAT that Moderna’s sci­ence is on track and, when it is final­ly made pub­lic, that it will meet the brash goal he him­self has set: The new drugs will change the world.

    But inter­views with more than 20 cur­rent and for­mer employ­ees and asso­ciates sug­gest Ban­cel has ham­pered progress at Mod­er­na because of his ego, his need to assert con­trol and his impa­tience with the set­backs that are an inevitable part of sci­ence. Mod­er­na is worth more than any oth­er pri­vate biotech in the US, and for­mer employ­ees said they felt that Ban­cel prized the company’s ever-increas­ing val­u­a­tion, now approach­ing $5 bil­lion, over its sci­ence.

    As he pur­sued a com­plex and risky strat­e­gy for drug devel­op­ment, Ban­cel built a cul­ture of recrim­i­na­tion at Mod­er­na, for­mer employ­ees said. Failed exper­i­ments have been met with rep­ri­mands and even on-the-spot fir­ings. They recalled abu­sive emails, dress­ings down at com­pa­ny meet­ings, exceed­ing­ly long hours, and unex­plained ter­mi­na­tions.

    At least a dozen high­ly placed exec­u­tives have quit in the past four years, includ­ing heads of finance, tech­nol­o­gy, man­u­fac­tur­ing, and sci­ence. In just the past 12 months, respect­ed lead­ers of Moderna’s can­cer and rare dis­ease pro­grams both resigned, even though the company’s remark­able fundrais­ing had put ample resources at their dis­pos­al. Each had been at the com­pa­ny less than 18 months, and the posi­tions have yet to be filled.

    Low­er-rank­ing employ­ees, mean­while, said they’ve been dis­ap­point­ed and con­fused by Moderna’s piv­ot to less ambi­tious — and less trans­for­ma­tive — treat­ments. Mod­er­na has pushed off projects meant to upend the drug indus­try to focus first on the less daunt­ing (and most like­ly, far less lucra­tive) field of vac­cines — though it is years behind com­peti­tors in that are­na.

    The com­pa­ny has pub­lished no data sup­port­ing its vaunt­ed tech­nol­o­gy, and it’s so secre­tive that some job can­di­dates have to sign nondis­clo­sure agree­ments before they come in to inter­view. Out­side ven­ture cap­i­tal­ists said Mod­er­na has so many investors clam­or­ing to get in that it can afford to turn away any who ask too many ques­tions. Some small play­ers have been giv­en only a peek at Moderna’s data before com­mit­ting mil­lions to the com­pa­ny, accord­ing to peo­ple famil­iar with the mat­ter.

    “It’s a case of the emperor’s new clothes,” said a for­mer Mod­er­na sci­en­tist. “They’re run­ning an invest­ment firm, and then hope­ful­ly it also devel­ops a drug that’s suc­cess­ful.”

    Like many employ­ees and for­mer employ­ees, the sci­en­tist request­ed anonymi­ty because of a nondis­clo­sure agree­ment. Oth­ers would not per­mit their names to be pub­lished out of fear that speak­ing can­did­ly about big play­ers in the indus­try would hurt their job prospects down the road.

    Mod­er­na just moved its first two poten­tial treat­ments — both vac­cines — into human tri­als. In keep­ing with the cul­ture of secre­cy, though, exec­u­tives won’t say which dis­eases the vac­cines tar­get, and they have not list­ed the stud­ies on the pub­lic fed­er­al reg­istry, ClinicalTrials.gov. List­ing is option­al for Phase 1 tri­als, which are meant to deter­mine if a drug is safe, but most com­pa­nies vol­un­tar­i­ly dis­close their work.

    ...

    An ambi­tious CEO dreams big

    Ban­cel, 44, had no expe­ri­ence run­ning a drug devel­op­ment oper­a­tion when one of biotech’s most suc­cess­ful ven­ture cap­i­tal­ists tapped him to lead Mod­er­na. He’d spent most of his career in sales and oper­a­tions, not sci­ence.

    But he had made no secret of his ambi­tion.

    A native of France, Ban­cel earned a master’s in chem­i­cal engi­neer­ing from the Uni­ver­si­ty of Min­neso­ta and an MBA from Har­vard in 2000. As Har­vard Busi­ness School class­mates rushed to cash in on the dot-com boom, Ban­cel laid out a plan to play “chess, not check­ers.”

    “I was always think­ing, one day, some­body will have to make a deci­sion about me get­ting a CEO job,” he told an audi­ence at his alma mater in April. “… How do I make sure I’m not the brides­maid? How do I make sure that I’m not always the per­son who’s almost select­ed but doesn’t get the role?”

    He went into sales and rose through the oper­a­tional ranks at phar­ma­ceu­ti­cal giant Eli Lil­ly, even­tu­al­ly lead­ing the company’s Bel­gian oper­a­tion. And in 2007, at just 34, he achieved his goal, step­ping in as CEO of the French diag­nos­tics firm bio­Mérieux, which employs rough­ly 6,000 peo­ple.

    The com­pa­ny improved its mar­gins under Bancel’s tenure, and he devel­oped a rep­u­ta­tion as a stern man­ag­er who got results, accord­ing to an equi­ties ana­lyst who cov­ered bio­Mérieux at the time.

    “He doesn’t suf­fer fools light­ly,” the ana­lyst said, speak­ing on con­di­tion of anonymi­ty to com­ply with com­pa­ny pol­i­cy. “I think if you’re under­per­form­ing, you’ll prob­a­bly find your­self look­ing for anoth­er job.”

    Bancel’s rise caught the eye of the biotech invest­ment firm Flag­ship Ven­tures, based here in Cam­bridge. Flag­ship CEO Noubar Afeyan repeat­ed­ly tried to entice him to take over one of the firm’s many star­tups, Ban­cel said. But he reject­ed one prospect after anoth­er because the star­tups seemed too nar­row in scope.

    Mod­er­na was dif­fer­ent.

    The company’s core idea was seduc­tive­ly sim­ple: cut out the mid­dle­man in biotech.

    For decades, com­pa­nies have endeav­ored to craft bet­ter and bet­ter pro­tein ther­a­pies, lead­ing to new treat­ments for can­cer, autoim­mune dis­or­ders, and rare dis­eases. Such ther­a­pies are cost­ly to pro­duce and have many lim­i­ta­tions, but they’ve giv­en rise to a multi­bil­lion-dol­lar indus­try. The anti-inflam­ma­to­ry Humi­ra, the world’s top drug at $14 bil­lion in sales a year, is a shin­ing exam­ple of pro­tein ther­a­py.

    Moderna’s tech­nol­o­gy promised to sub­vert the whole field, cre­at­ing ther­a­peu­tic pro­teins inside the body instead of in man­u­fac­tur­ing plants. The key: har­ness­ing mes­sen­ger RNA, or mRNA.

    In nature, mRNA mol­e­cules func­tion like recipe books, direct­ing cel­lu­lar machin­ery to make spe­cif­ic pro­teins. Mod­er­na believes it can play that sys­tem to its advan­tage by using syn­thet­ic mRNA to com­pel cells to pro­duce whichev­er pro­teins it choos­es. In effect, the mRNA would turn cells into tiny drug fac­to­ries.

    It’s high­ly risky. Big phar­ma com­pa­nies had tried sim­i­lar work and aban­doned it because it’s exceed­ing­ly hard to get RNA into cells with­out trig­ger­ing nasty side effects. But if Mod­er­na can get it to work, the process could be used to treat scores of dis­eases, includ­ing can­cers and rare dis­eases that can be death sen­tences for chil­dren.

    ...

    Under Ban­cel, Mod­er­na has been loath to pub­lish its work in Sci­ence or Nature, but enthu­si­as­tic to her­ald its poten­tial on CNBC and CNN, tak­ing part in seg­ments on the world’s most dis­rup­tive com­pa­nies and the poten­tial “cure for can­cer.”

    ...

    Res­ig­na­tions, dis­missals, and churn

    From the begin­ning, Ban­cel made clear that Moderna’s sci­ence sim­ply had to work. And that any­one who couldn’t make it work didn’t belong.

    The ear­ly Mod­er­na was a chaot­ic, unpre­dictable work­place, accord­ing to for­mer employ­ees. One recalls find­ing him­self out of a job when a quick-turn­around exper­i­ment failed to pan out. Anoth­er helped train a group of new hires only to real­ize they were his replace­ments.

    “There was a kind of Jack Welch-ian, ‘We fire the bot­tom 10 per­cent’ from the very begin­ning,” said a for­mer Mod­er­na man­ag­er. “That’s prob­a­bly the biggest HR dif­fer­ence between Mod­er­na and vir­tu­al­ly any oth­er biotech, where they talk so much about devel­op­ing their peo­ple.”

    Mod­er­na went through two heads of chem­istry in a sin­gle year, accord­ing to for­mer employ­ees, and its chief sci­en­tif­ic offi­cer and head of man­u­fac­tur­ing left short­ly there­after. Those who fell out of favor with Ban­cel would find them­selves exclud­ed from key meet­ings, pushed aside until they resigned or ulti­mate­ly got dis­missed, employ­ees said.

    Most stun­ning to employ­ees was the abrupt depar­ture of Joseph Bolen, who came aboard in 2013 to lead Moderna’s R&D efforts.

    Bolen was a big-name hire in biotech cir­cles, an expe­ri­enced chief sci­en­tif­ic offi­cer who had guid­ed Mil­len­ni­um Phar­ma­ceu­ti­cals to FDA approval for a block­buster can­cer drug. He’d been pro­filed in The Sci­en­tist, which dubbed him “the people’s CSO” for his abil­i­ty to keep morale high and research focused. Land­ing him was a coup.

    But two years into his tenure at Mod­er­na, he abrupt­ly stepped down last Octo­ber, mak­ing no pub­lic state­ment save for chang­ing his LinkedIn sta­tus to “resigned.”

    “No sci­en­tist in his right mind would leave that job unless there was some­thing wrong with the sci­ence or the per­son­nel,” said a per­son close to the com­pa­ny at the time.

    Insid­ers said Ban­cel had effec­tive­ly pushed Bolen out, hir­ing par­al­lel exec­u­tives until Bolen was in charge of just “a postage stamp” worth of ter­ri­to­ry, as one for­mer Mod­er­na man­ag­er put it. Bolen declined to com­ment.

    For his part, Ban­cel acknowl­edged the changes that lim­it­ed Bolen’s pow­er but insist­ed the part­ing was friend­ly. Ban­cel said he tried to con­vince Bolen to stay, but the sci­en­tist “vot­ed him­self off the island.”

    Bolen wasn’t alone. Chief Infor­ma­tion Offi­cer John Reyn­ders joined in 2013 to make Mod­er­na what he called the world’s “first ful­ly dig­i­tal biotech,” only to step down a year lat­er. Michael Morin, brought in to lead Moderna’s sci­en­tif­ic efforts in can­cer in 2014, last­ed less than 18 months. As did Greg Licholai, hired in 2015 to direct the company’s projects in rare dis­eases. The lat­ter two key lead­er­ship posi­tions remain unfilled.

    “You won­der,” influ­en­tial biotech blog­ger Derek Lowe wrote last year, “if Mod­er­na real­ly is a rock­et ship get­ting ready to launch and spray a for­ma­tion of new drugs across the sky, then why are these peo­ple leav­ing?”

    The com­pa­ny has a sim­ple expla­na­tion: Mod­er­na lives in dog years com­pared with oth­er biotechs.

    “We force every­one to grow with the com­pa­ny at unprece­dent­ed speed,” Mod­er­na Chief Finan­cial Offi­cer Lorence Kim said. “Some peo­ple grow with the com­pa­ny; oth­ers don’t.”

    ...

    A gold rush for Mod­er­na

    Hoge, who joined the com­pa­ny in 2012, describes the ear­ly days of Mod­er­na as “when we were liv­ing in the caves.” The com­pa­ny often had only enough cash to keep the lights on for six months at a time, he said. “The strat­e­gy was just to sur­vive.”

    Mod­er­na 1.0, and life in the caves, came to a close in 2013, accord­ing to com­pa­ny lore.

    That’s when Mod­er­na — which had just 25 employ­ees — signed a stag­ger­ing $240 mil­lion part­ner­ship with UK phar­ma­ceu­ti­cal giant AstraZeneca. It was the most mon­ey phar­ma had ever spent on drugs that had not yet been test­ed in humans.

    The agree­ment is com­mem­o­rat­ed in one of Moderna’s offices by a framed clip­ping from the New York Times. Page B7 of the March 21, 2013 edi­tion: “AstraZeneca Makes a Bet On an Untest­ed Tech­nique.”

    For AstraZeneca, the unprece­dent­ed deal came at a time of uncer­tain­ty. A series of clin­i­cal fail­ures had led the firm to fire its head of research and lay off 1,600 sci­en­tists. Pas­cal Sori­ot, just six months into his tenure as CEO, was under pres­sure from investors to chart a new course. And Mod­er­na, with its brash ambi­tion to bring 100 drugs to clin­i­cal tri­als with­in a decade, gave Sori­ot a way for­ward.

    The rich deal start­ed a gold rush for Mod­er­na. Every­one, it seemed, want­ed in.

    Before the end of 2013, Mod­er­na would turn heads again with a $110 mil­lion invest­ment round, fol­lowed by a high-dol­lar part­ner­ship with biotech giant Alex­ion.

    In ear­ly 2015, Mod­er­na dis­closed a $450 mil­lion financ­ing round, the largest ever for a pri­vate biotech com­pa­ny. This month, the com­pa­ny broke its own record, rais­ing anoth­er $474 mil­lion.

    The run-up was “biotech fer­vor to the extreme,” accord­ing to a ven­ture cap­i­tal­ist not involved with the com­pa­ny, request­ing anonymi­ty to speak can­did­ly. While big­ger investors got to see all the company’s data from ani­mal exper­i­ments, some of Moderna’s small­er investors put in funds based on just a peek, accord­ing to peo­ple famil­iar with the process. Moderna’s fundrais­ing suc­cess had cre­at­ed a seller’s mar­ket: Why deal with the ques­tions of one poten­tial investor when it had 10 more lined up?

    Afeyan, Moderna’s chair­man and cofounder, insists the company’s investors have done their home­work. To say they bought in with­out due dili­gence “would be a bit of an insult to these peo­ple,” he said.

    Though it has yet to reveal data from a sin­gle clin­i­cal tri­al, Mod­er­na is now val­ued at $4.7 bil­lion, accord­ing to Pitch­book.

    That’s twice as much as Spark Ther­a­peu­tics, the com­pa­ny wide­ly expect­ed to mar­ket the Unit­ed States’s first gene ther­a­py, which has shown signs in clin­i­cal tri­als that it can reverse blind­ness caused by a rare genet­ic dis­or­der. Mod­er­na is also worth bil­lions more than Juno Ther­a­peu­tics and Kite Phar­ma, star­tups devel­op­ing nov­el treat­ments for can­cer that have demon­strat­ed promis­ing results in ear­ly human tri­als.

    Mod­er­na has long shak­en off rumors that it is soon to mar­ket its shares on Wall Street, with Hoge liken­ing the com­pa­ny to a child star: “You don’t want to go through your ado­les­cence pub­licly,” he told STAT.

    But that’s about to change. Moderna’s next planned step is an ini­tial pub­lic offer­ing, accord­ing to a per­son close to the com­pa­ny. Ban­cel declined to say just when Mod­er­na might go pub­lic, but the com­pa­ny has already pre­pared: In its lat­est fil­ings with the Secu­ri­ties and Exchange Com­mis­sion, Mod­er­na changed its busi­ness struc­ture from an LLC to a C cor­po­ra­tion, com­plet­ing a nec­es­sary step before mount­ing an IPO.

    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.

    And it could still go either way, for­mer employ­ees said. If Moderna’s promis­es come to fruition, it could be a pil­lar of the biotech indus­try. If they don’t, it could find a place among a short list of com­pa­nies that have cast a shad­ow over the entire indus­try and left investors dis­il­lu­sioned.

    “Either we’ll be talk­ing about it as the next Genen­tech,” a for­mer Mod­er­na man­ag­er said, “or we’ll think, ‘Well, back then, first there was Tur­ing, then there was Valeant, and then there was Mod­er­na.”

    Enough cash to absorb some set­backs

    Moderna’s man­age­ment and its investors are keep­ing the faith, point­ing to the company’s pipeline of 11 drug can­di­dates and more than 90 pre­clin­i­cal projects.

    And with Moderna’s huge cash reserves — esti­mat­ed at $1.5 bil­lion — it can afford a few set­backs, pro­po­nents said. The com­pa­ny said it’s pour­ing mon­ey into its man­u­fac­tur­ing oper­a­tion, plan­ning to spend $100 mil­lion this year on a new plant. Mod­er­na has pio­neered an auto­mat­ed sys­tem mod­eled on the soft­ware Tes­la uses to man­age orders, Ban­cel said: Sci­en­tists sim­ply enter the pro­tein they want a cell to express, and testable mRNA arrives with­in weeks.

    “If we have a bump in the road in the clin­ic, we will not have to wait years to go back to the draw­ing board,” Ban­cel said.

    That has always been part of the plan, for­mer employ­ees said, point­ing to Bancel’s fas­ci­na­tion with the tech indus­try. Uber and Ama­zon were not the first to come up with their respec­tive busi­ness ideas, but they were the ones that built enough scale to ward off com­pe­ti­tion. And Mod­er­na is posi­tion­ing itself to do the same in mRNA.

    “Now, as we’re going to human [tri­als], it’s pret­ty clear no one else is going to catch us,” said Dr. Ken­neth Chien, a pro­fes­sor at Karolin­s­ka Insti­tutet work­ing with Mod­er­na and AstraZeneca.

    Dr. Tal Zaks, Moderna’s chief med­ical offi­cer, promis­es that the com­pa­ny will soon break its silence on the pub­lish­ing front. He said next year Mod­er­na will dis­close the ani­mal data that helped get its two vac­cines into the clin­ic. The com­pa­ny has also com­mit­ted to pub­lish­ing full results from all of its human tri­als, start­ing with the vac­cine stud­ies next year.

    Moderna’s ret­i­cence to share data ear­li­er is “not because we decid­ed to be secret,” Zaks said. “This is the nat­ur­al evo­lu­tion of a plat­form. As we go into the clin­ic, we will be very trans­par­ent.”

    ...

    ———–

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

    “It’s high­ly risky. Big phar­ma com­pa­nies had tried sim­i­lar work and aban­doned it because it’s exceed­ing­ly hard to get RNA into cells with­out trig­ger­ing nasty side effects. But if Mod­er­na can get it to work, the process could be used to treat scores of dis­eases, includ­ing can­cers and rare dis­eases that can be death sen­tences for chil­dren.”

    Yep, it’s risky tech­nol­o­gy. Risky from an invest­ment stand­point because it’s so risky from a health and safe­ty stand­point. That’s why hopes are so high for Mod­er­na’s investors: if the com­pa­ny real­ly can man­age to devel­op the tech­nol­o­gy required to get the mRNA into cells with­out trig­ger­ing nasty side effects that real­ly will be a sig­nif­i­cant inno­va­tion. Most of the rest of the tech­nol­o­gy required to devel­op this tech­nol­o­gy already exists...getting the mRNA into the cells with­out side effects is the last big tech­ni­cal hur­dle.

    So how much progress has Mod­er­na made on this front? That’s unclear, thanks in part to a cul­ture of secre­cy at the com­pa­ny where the results of its itner­nal work is rarely pub­lished. What is clear is that a num­ber of high-lev­el depar­tures of the com­pa­ny’s top sci­en­tists had been tak­ing place which raised the ques­tion: are they leav­ing because of abu­sive unrea­son­able man­age­ment or because there’s a prob­lem with the sci­ence?

    ...
    Under Ban­cel, Mod­er­na has been loath to pub­lish its work in Sci­ence or Nature, but enthu­si­as­tic to her­ald its poten­tial on CNBC and CNN, tak­ing part in seg­ments on the world’s most dis­rup­tive com­pa­nies and the poten­tial “cure for can­cer.”

    ...

    Res­ig­na­tions, dis­missals, and churn

    ...

    Mod­er­na went through two heads of chem­istry in a sin­gle year, accord­ing to for­mer employ­ees, and its chief sci­en­tif­ic offi­cer and head of man­u­fac­tur­ing left short­ly there­after. Those who fell out of favor with Ban­cel would find them­selves exclud­ed from key meet­ings, pushed aside until they resigned or ulti­mate­ly got dis­missed, employ­ees said.

    Most stun­ning to employ­ees was the abrupt depar­ture of Joseph Bolen, who came aboard in 2013 to lead Moderna’s R&D efforts.

    Bolen was a big-name hire in biotech cir­cles, an expe­ri­enced chief sci­en­tif­ic offi­cer who had guid­ed Mil­len­ni­um Phar­ma­ceu­ti­cals to FDA approval for a block­buster can­cer drug. He’d been pro­filed in The Sci­en­tist, which dubbed him “the people’s CSO” for his abil­i­ty to keep morale high and research focused. Land­ing him was a coup.

    But two years into his tenure at Mod­er­na, he abrupt­ly stepped down last Octo­ber, mak­ing no pub­lic state­ment save for chang­ing his LinkedIn sta­tus to “resigned.”

    “No sci­en­tist in his right mind would leave that job unless there was some­thing wrong with the sci­ence or the per­son­nel,” said a per­son close to the com­pa­ny at the time.

    ...

    Bolen wasn’t alone. Chief Infor­ma­tion Offi­cer John Reyn­ders joined in 2013 to make Mod­er­na what he called the world’s “first ful­ly dig­i­tal biotech,” only to step down a year lat­er. Michael Morin, brought in to lead Moderna’s sci­en­tif­ic efforts in can­cer in 2014, last­ed less than 18 months. As did Greg Licholai, hired in 2015 to direct the company’s projects in rare dis­eases. The lat­ter two key lead­er­ship posi­tions remain unfilled.

    “You won­der,” influ­en­tial biotech blog­ger Derek Lowe wrote last year, “if Mod­er­na real­ly is a rock­et ship get­ting ready to launch and spray a for­ma­tion of new drugs across the sky, then why are these peo­ple leav­ing?”
    ...

    And those con­cerns about the sci­ence only grew when we learned that Mod­er­na was shift­ing its focus to vac­cines, a mar­ket that the com­pa­ny was decid­ed­ly NOT inter­est­ed in ear­ly on. The big mon­ey is in using mRNA for pro­tein ther­a­pies that peo­ple need over and over. But vac­cine have one big ben­e­fit: they don’t need to be tak­en over and over, at least not in the­o­ry, so any safe­ty issues asso­ci­at­ed with the deliv­ery of the mRNA will hope­ful­ly be min­i­mized:

    ...
    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.
    ...

    Final­ly, note who some of Mod­er­na’s investors and part­ners are: phar­ma­ceu­ti­cal giants like AstraZeneca, Alex­ion, and Mer­ck (which made a $200 mil­lion invest­ment in Mod­er­na in 2016 and anoth­er $125 mil­lion invest­ment in 2018). After read­ing about how the phar­ma­ceu­ti­cal giants had giv­en up on mRNA tech­nolo­gies after being unable to over­come the safe­ty issues you have to won­der if Mod­er­na is being treat­ed by the larg­er indus­try as a means of basi­cal­ly exper­i­ment­ing with brin­ing this tech­nol­o­gy out to the pub­lic while min­i­miz­ing the poten­tial con­se­quences if it turns out to be harm­ful:

    ...
    A gold rush for Mod­er­na

    Hoge, who joined the com­pa­ny in 2012, describes the ear­ly days of Mod­er­na as “when we were liv­ing in the caves.” The com­pa­ny often had only enough cash to keep the lights on for six months at a time, he said. “The strat­e­gy was just to sur­vive.”

    Mod­er­na 1.0, and life in the caves, came to a close in 2013, accord­ing to com­pa­ny lore.

    That’s when Mod­er­na — which had just 25 employ­ees — signed a stag­ger­ing $240 mil­lion part­ner­ship with UK phar­ma­ceu­ti­cal giant AstraZeneca. It was the most mon­ey phar­ma had ever spent on drugs that had not yet been test­ed in humans.

    ...

    Before the end of 2013, Mod­er­na would turn heads again with a $110 mil­lion invest­ment round, fol­lowed by a high-dol­lar part­ner­ship with biotech giant Alex­ion.

    In ear­ly 2015, Mod­er­na dis­closed a $450 mil­lion financ­ing round, the largest ever for a pri­vate biotech com­pa­ny. This month, the com­pa­ny broke its own record, rais­ing anoth­er $474 mil­lion.
    ...

    So was a look at Mod­er­na’s tech­nol­o­gy in 2016, when the strat­e­gy to shift to vac­cines over safe­ty con­cerns was still rel­a­tive­ly new for the com­pa­ny. Has there been any sig­nif­i­cant updates since then? Well, the com­pa­ny did pub­lish a study on human clin­i­cal tri­als of two influen­za vac­cines that appear to show no sig­nif­i­cant side effects and elic­it an immune response. It could be worse. But don’t for­get that the com­pa­ny was allowed to lit­er­al­ly run the ani­mal tri­als in par­al­lel with human tri­als back in March, so if there’s a dif­fer­ent prob­lem with the COVID vac­cine that did­n’t arise with the influen­za vac­cines that may have been revealed in ani­mal tri­als we may not know in time.

    More gen­er­al­ly, if repeat­ed dos­ing is a poten­tial safe­ty issue, what does that mean if this is a vac­cine that needs to be tak­en annu­al­ly? Or maybe more than once a year if the anti­bod­ies don’t last? Don’t for­get that the big hope for Mod­er­na investors is that the SARS-CoV­‑2 virus nev­er real­ly goes away but instead keeps mutat­ing and cre­at­ing a per­ma­nent annu­al glob­al COVID vac­cine mar­ket. It’s all a big rea­son why any procla­ma­tions that the vac­cine is “safe enough for a sin­gle dose” real­ly needs to come with an expla­na­tion of just how unsafe this mRNA deliv­ery tech­nol­o­gy real­ly is because we could eas­i­ly end up hav­ing to take a lot more than one dose. It’s also a reminder that even if Mod­er­na or one of the oth­er com­pa­nies work­ing on an mRNA Covid vac­cine suc­ceeds, that’s not a rea­son for the world to stop search­ing for non-mRNA vac­cine options. In oth­er words, the solu­tion to COVID-19 isn’t just a vac­cine. The solu­a­tion is a vac­cine that’s proven to be safe beyond just a sin­gle dose.

    But as the fol­low­ing arti­cle from Nature Reviews Immunol­o­gy from a month ago omi­nous­ly warns us, there’s anoth­er major safe­ty issue with the SARS-CoV­‑2 vac­cine: It was observed with the orig­i­nal SARS out­break that if some­one devel­ops anti­bod­ies but not at a high enough lev­el to neu­tral­ize the infec­tion that can actu­al­ly make the infec­tion more severe. This process is known as anti­body-depen­dent enhance­ment (ADE). This appears to be due to an inter­ac­tion between the virus, pre-exist­ing anti-bod­ies and immune cells. Specif­i­cal­ly, researchers have found that when an immune cell (like a macrophage) con­sumes a a virus with anti­bod­ies attached the immune cell will cause an increase in pro-inflam­ma­to­ry cytokines and a decrease in anti-inflam­ma­to­ry cytokines. It’s the ramp­ing up of the inflam­ma­tion that caus­es the dam­age asso­ci­at­ed with ADE. But this only hap­pens when the neu­tral­iz­ing anti­body lev­els are below some thresh­old.

    It’s also worth not­ing that T cells, which SARS-CoV­‑2 appears to be able to attack and kill, are the immune cells that don’t nor­mal­ly expresse Fc Recep­tors. So this phe­nom­e­na prob­a­bly does­n’t involve them.

    So if SARS-CoV­‑2 behaves sim­i­lar to the orig­i­nal SARS, we could be look­ing at a sit­u­a­tion where sub­se­quent rein­fec­tions with SARS-CoV­‑2 are actu­al­ly worse if the pre­vi­ous infec­tions result­ed in anti­bod­ies but not at a high enough con­cen­tra­tion. Sim­i­lar­ly, if a vac­cine induced an immune response that isn’t high enough it could actu­al­ly make the even­tu­al infec­tions even worse. This has been demon­strat­ed in Mice with SARS vac­cines. As the authors also note, there’s some evi­dence aged ani­mals might have a hard­er time gen­er­at­ing the required lev­els of anti­bod­ies after vac­ci­na­tion. So it’s pos­si­ble to have a vac­cine that pro­tects the young and actu­al­ly makes the elder­ly more vul­ner­a­ble:

    Nature Reviews Immunol­o­gy

    The poten­tial dan­ger of sub­op­ti­mal anti­body respons­es in COVID-19

    Akiko Iwasa­ki & Yex­in Yang
    Pub­lished: 21 April 2020

    There is a des­per­ate need for effec­tive ther­a­pies and vac­cines for SARS-CoV­‑2 to mit­i­gate the grow­ing eco­nom­ic cri­sis that has ensued from soci­etal lock­down. Vac­cines are being devel­oped at an unprece­dent­ed speed and are already in clin­i­cal tri­als, with­out pre­clin­i­cal test­ing for safe­ty and effi­ca­cy. Yet, safe­ty eval­u­a­tion of can­di­date vac­cines must not be over­looked.

    ...

    The qual­i­ty and quan­ti­ty of the anti­body response dic­tates func­tion­al out­comes. High-affin­i­ty anti­bod­ies can elic­it neu­tral­iza­tion by rec­og­niz­ing spe­cif­ic viral epi­topes (Fig.1a). Neu­tral­iz­ing anti­bod­ies are defined in vit­ro by their abil­i­ty to block viral entry, fusion or egress. In vivo, neu­tral­iz­ing anti­bod­ies can func­tion with­out addi­tion­al medi­a­tors, although the Fc region is required for neu­tral­iza­tion of influen­za virus2. In the case of SARS-CoV, viral dock­ing on ACE2 on host cells is blocked when neu­tral­iz­ing anti­bod­ies, for exam­ple, rec­og­nize the recep­tor-bind­ing domain (RBD) on the spike (S) pro­tein3. S pro­tein-medi­at­ed viral fusion can be blocked by neu­tral­iz­ing anti­bod­ies tar­get­ing the hep­tad repeat 2 (HR2) domain3. In addi­tion, neu­tral­iz­ing anti­bod­ies can inter­act with oth­er immune com­po­nents, includ­ing com­ple­ment, phago­cytes and nat­ur­al killer cells. These effec­tor respons­es can aid in pathogen clear­ance, with engage­ment of phago­cytes shown to enhance anti­body-medi­at­ed clear­ance of SARS-CoV4. How­ev­er, in rare cas­es, pathogen-spe­cif­ic anti­bod­ies can pro­mote pathol­o­gy, result­ing in a phe­nom­e­non known as anti­body-depen­dent enhance­ment (ADE).

    Fig. 1: Poten­tial out­comes of anti­body response to coro­n­avirus.

    Anti­body-depen­dent enhance­ment

    Although anti­bod­ies are gen­er­al­ly pro­tec­tive and ben­e­fi­cial, the ADE phe­nom­e­non is doc­u­ment­ed for dengue virus and oth­er virus­es. In SARS-CoV infec­tion, ADE is medi­at­ed by the engage­ment of Fc recep­tors (FcRs) expressed on dif­fer­ent immune cells, includ­ing mono­cytes, macrophages and B cells5,6. Pre-exist­ing SARS-CoV-spe­cif­ic anti­bod­ies may thus pro­mote viral entry into FcR-express­ing cells (Fig. 1b). This process is inde­pen­dent of ACE2 expres­sion and endo­so­mal pH and pro­teas­es, sug­gest­ing dis­tinct cel­lu­lar path­ways of ACE2-medi­at­ed and FcR-medi­at­ed viral entry6. There is no evi­dence that ADE facil­i­tates the spread of SARS-CoV in infect­ed hosts. In fact, infec­tion of macrophages through ADE does not result in pro­duc­tive viral repli­ca­tion and shed­ding7. Instead, inter­nal­iza­tion of virus–antibody immune com­plex­es can pro­mote inflam­ma­tion and tis­sue injury by acti­vat­ing myeloid cells via FcRs5. Virus intro­duced into the endo­some through this path­way will like­ly engage the RNA-sens­ing Toll-like recep­tors (TLRs) TLR3, TLR7 and TLR8 (Fig. 1c). Uptake of SARS-CoV through ADE in macrophages led to ele­vat­ed pro­duc­tion of TNF and IL‑6 (ref.5). In mice infect­ed with SARS-CoV, ADE was asso­ci­at­ed with decreased lev­els of the anti-inflam­ma­to­ry cytokines IL-10 and TGFß and increased lev­els of the pro-inflam­ma­to­ry chemokines CCL2 and CCL3 (ref.8). Fur­ther­more, immu­niza­tion of non-human pri­mates with a mod­i­fied vac­cinia Ankara (MVA) virus encod­ing the full-length S pro­tein of SARS-CoV pro­mot­ed acti­va­tion of alve­o­lar macrophages, lead­ing to acute lung injury9.

    Pro­tec­tive ver­sus path­o­gen­ic anti­bod­ies

    Mul­ti­ple fac­tors deter­mine whether an anti­body neu­tral­izes a virus and pro­tects the host or caus­es ADE and acute inflam­ma­tion. These include the speci­fici­ty, con­cen­tra­tion, affin­i­ty and iso­type of the anti­body. Viral vec­tor vac­cines encod­ing SARS-CoV S pro­tein and nucle­o­cap­sid (N) pro­tein pro­voke anti‑S and anti‑N IgG in immu­nized mice, respec­tive­ly, to a sim­i­lar extent. How­ev­er, upon re-chal­lenge, N pro­tein-immu­nized mice show sig­nif­i­cant upreg­u­la­tion of pro-inflam­ma­to­ry cytokine secre­tion, increased neu­trophil and eosinophil lung infil­tra­tion, and more severe lung pathol­o­gy8. Sim­i­lar­ly, anti­bod­ies tar­get­ing dif­fer­ent epi­topes on the S pro­tein may vary in their poten­tial to induce neu­tral­iza­tion or ADE. For exam­ple, anti­bod­ies reac­tive to the RBD domain or the HR2 domain of the S pro­tein induce bet­ter pro­tec­tive anti­body respons­es in non-human pri­mates, where­as anti­bod­ies spe­cif­ic for oth­er S pro­tein epi­topes can induce ADE10. In vit­ro data sug­gest that for cells express­ing FcRs, ADE occurs when anti­body is present at a low con­cen­tra­tion but damp­ens at the high-con­cen­tra­tion range. Mean­while, increas­ing anti­body con­cen­tra­tions pro­motes SARS-CoV neu­tral­iza­tion by block­ing viral entry into host cells6. For oth­er virus­es, high-affin­i­ty anti­bod­ies capa­ble of block­ing recep­tor bind­ing tend to not induce ADE.

    In the ‘mul­ti­ple hit’ mod­el of neu­tral­iza­tion, the virus-block­ing effect cor­re­lates with the num­ber of anti­bod­ies coat­ing the viri­on, which is col­lec­tive­ly affect­ed by anti­body con­cen­tra­tion and affin­i­ty11. Mon­o­clon­al anti­bod­ies with high­er affin­i­ty for the enve­lope (E) pro­tein of West Nile Virus (WNV) induced bet­ter pro­tec­tion in mice receiv­ing a lethal dose of WNV11. For a giv­en con­cen­tra­tion of anti­body and a spe­cif­ic tar­get­ing domain, the sto­i­chiom­e­try of anti­body engage­ment on a viri­on is depen­dent on the strength of inter­ac­tion between anti­body and anti­gen. ADE is induced when the sto­i­chiom­e­try is below the thresh­old for neu­tral­iza­tion. There­fore, high­er affin­i­ty anti­bod­ies can reach that thresh­old at a low­er con­cen­tra­tion and medi­ate bet­ter pro­tec­tion11.

    Anti­body iso­types con­trol their effec­tor func­tions. IgM is con­sid­ered more pro-inflam­ma­to­ry as it acti­vates com­ple­ment effi­cient­ly. IgG sub­class­es mod­u­late immune respons­es via the engage­ment of dif­fer­ent FcRs. Most FcγRs sig­nal through ITA­Ms, but FcγRI­Ib con­tains an ITIM on its cyto­plas­mic tail that medi­ates an anti-inflam­ma­to­ry response. Ectopic expres­sion of FcγRI­Ia and FcγRI­Ib, but not of FcγRI or FcγRI­I­Ia, induced ADE of SARS-CoV infec­tion6. Allel­ic poly­mor­phisms in FcγRI­Ia are asso­ci­at­ed with SARS pathol­o­gy, and indi­vid­u­als with an FcγRI­Ia iso­form that binds to both IgG1 and IgG2 were found to devel­op more severe dis­ease than indi­vid­u­als with Fcγthat only binds to IgG2 (ref.12).

    Vac­cine approach­es

    It is cru­cial to deter­mine which vac­cines and adju­vants can elic­it pro­tec­tive anti­body respons­es to SARS-CoV­‑2. Pre­vi­ous stud­ies have shown that the immu­niza­tion of mice with inac­ti­vat­ed whole SARS-CoV13, the immu­niza­tion of rhe­sus macaques9 with MVA-encod­ed S pro­tein and the immu­niza­tion of mice with DNA vac­cine encod­ing full-length S pro­tein14 could induce ADE or eosinophil-medi­at­ed immunopathol­o­gy to some extent, pos­si­bly owing to low qual­i­ty and quan­ti­ty of anti­body pro­duc­tion. Addi­tion­al­ly, we need to con­sid­er whether a vac­cine is safe and effec­tive in aged hosts. For instance, dou­ble-inac­ti­vat­ed SARS-CoV vac­cine failed to induce neu­tral­iz­ing anti­body respons­es in aged mice13. Fur­ther­more, although an alum-adju­vant­ed dou­ble-inac­ti­vat­ed SARS-CoV vac­cine elicit­ed high­er anti­body titres in aged mice, it skewed the IgG sub­class toward IgG1 instead of IgG2, which was asso­ci­at­ed with a T helper 2 (TH2)-type immune response, enhanced eosinophil­ia and lung pathol­o­gy13. By con­trast, stud­ies in mice showed that sub­unit or pep­tide vac­cines that focus the anti­body response against spe­cif­ic epi­topes with­in the RBD of the S pro­tein con­ferred pro­tec­tive anti­body respons­es3. In addi­tion, live atten­u­at­ed SARS-CoV vac­cine induced pro­tec­tive immune respons­es in aged mice15. Routes of vac­cine admin­is­tra­tion can fur­ther affect vac­cine effi­ca­cy. Com­pared with the intra­mus­cu­lar route, intranasal admin­is­tra­tion of a recom­bi­nant ade­no-asso­ci­at­ed virus vac­cine encod­ing SARS-CoV RBD induced sig­nif­i­cant­ly high­er titres of mucos­al IgA in the lung and reduced lung pathol­o­gy upon chal­lenge with SARS-CoV3.

    Con­clud­ing remarks

    There are now mul­ti­ple vac­cine can­di­dates (includ­ing nucle­ic acid vac­cines, viral vec­tor vac­cines and sub­unit vac­cines) in the pre­clin­i­cal and clin­i­cal tri­al stages as researchers and insti­tutes from all over the world come togeth­er to accel­er­ate the devel­op­ment of a SARS-CoV­‑2 vac­cine. Recent stud­ies of anti­body respons­es in patients with COVID-19 have asso­ci­at­ed high­er titres of anti‑N IgM and IgG at all time points fol­low­ing the onset of symp­toms with a worse dis­ease out­come16. More­over, high­er titres of anti‑S and anti‑N IgG and IgM cor­re­late with worse clin­i­cal read­outs and old­er age17, sug­gest­ing poten­tial­ly detri­men­tal effects of anti­bod­ies in some patients. How­ev­er, 70% of patients who recov­ered from mild COVID-19 had mea­sur­able neu­tral­iz­ing anti­bod­ies that per­sist­ed upon revis­it to the hospital18. Thus, insights gained from study­ing the anti­body fea­tures that cor­re­late with recov­ery as opposed to wors­en­ing of dis­ease will inform the type of anti­bod­ies to assess in vac­cine stud­ies. We argue that ADE should be giv­en full con­sid­er­a­tion in the safe­ty eval­u­a­tion of emerg­ing can­di­date vac­cines for SARS-CoV­‑2. In addi­tion to vac­cine approach­es, mon­o­clon­al anti­bod­ies could be used to tack­le this virus. Unlike vac­cine-induced anti­bod­ies, mon­o­clon­al anti­bod­ies can be engi­neered with mol­e­c­u­lar pre­ci­sion. Safe and effec­tive neu­tral­iz­ing anti­bod­ies could be pro­duced on a mass-scale for deliv­ery to pop­u­la­tions across the world in the com­ing months.

    ...

    ———–

    “The poten­tial dan­ger of sub­op­ti­mal anti­body respons­es in COVID-19” by Akiko Iwasa­ki & Yex­in Yang; Nature Reviews Immunol­o­gy; 04/21/2020

    The qual­i­ty and quan­ti­ty of the anti­body response dic­tates func­tion­al out­comes. High-affin­i­ty anti­bod­ies can elic­it neu­tral­iza­tion by rec­og­niz­ing spe­cif­ic viral epi­topes (Fig.1a). Neu­tral­iz­ing anti­bod­ies are defined in vit­ro by their abil­i­ty to block viral entry, fusion or egress. In vivo, neu­tral­iz­ing anti­bod­ies can func­tion with­out addi­tion­al medi­a­tors, although the Fc region is required for neu­tral­iza­tion of influen­za virus2. In the case of SARS-CoV, viral dock­ing on ACE2 on host cells is blocked when neu­tral­iz­ing anti­bod­ies, for exam­ple, rec­og­nize the recep­tor-bind­ing domain (RBD) on the spike (S) pro­tein3. S pro­tein-medi­at­ed viral fusion can be blocked by neu­tral­iz­ing anti­bod­ies tar­get­ing the hep­tad repeat 2 (HR2) domain3. In addi­tion, neu­tral­iz­ing anti­bod­ies can inter­act with oth­er immune com­po­nents, includ­ing com­ple­ment, phago­cytes and nat­ur­al killer cells. These effec­tor respons­es can aid in pathogen clear­ance, with engage­ment of phago­cytes shown to enhance anti­body-medi­at­ed clear­ance of SARS-CoV4. How­ev­er, in rare cas­es, pathogen-spe­cif­ic anti­bod­ies can pro­mote pathol­o­gy, result­ing in a phe­nom­e­non known as anti­body-depen­dent enhance­ment (ADE).”

    The qual­i­ty and quan­ti­ty of the anti­body response dic­tates func­tion­al out­comes. That needs to become like a mantra for the vac­cine hunt. Because if the vac­cine is elic­it­ing a low qual­i­ty response it might not just not be help­ful. It could actu­al­ly cause harm by pro­mot­ing an over­ly pow­er­ful inflam­ma­to­ry response in the form of ADE. That’s what they found with SARS so there’s no rea­son to assume that won’t be the case with SARS-CoV­‑2:

    ...
    Although anti­bod­ies are gen­er­al­ly pro­tec­tive and ben­e­fi­cial, the ADE phe­nom­e­non is doc­u­ment­ed for dengue virus and oth­er virus­es. In SARS-CoV infec­tion, ADE is medi­at­ed by the engage­ment of Fc recep­tors (FcRs) expressed on dif­fer­ent immune cells, includ­ing mono­cytes, macrophages and B cells5,6. Pre-exist­ing SARS-CoV-spe­cif­ic anti­bod­ies may thus pro­mote viral entry into FcR-express­ing cells (Fig. 1b). This process is inde­pen­dent of ACE2 expres­sion and endo­so­mal pH and pro­teas­es, sug­gest­ing dis­tinct cel­lu­lar path­ways of ACE2-medi­at­ed and FcR-medi­at­ed viral entry6. There is no evi­dence that ADE facil­i­tates the spread of SARS-CoV in infect­ed hosts. In fact, infec­tion of macrophages through ADE does not result in pro­duc­tive viral repli­ca­tion and shed­ding7. Instead, inter­nal­iza­tion of virus–antibody immune com­plex­es can pro­mote inflam­ma­tion and tis­sue injury by acti­vat­ing myeloid cells via FcRs5. Virus intro­duced into the endo­some through this path­way will like­ly engage the RNA-sens­ing Toll-like recep­tors (TLRs) TLR3, TLR7 and TLR8 (Fig. 1c). Uptake of SARS-CoV through ADE in macrophages led to ele­vat­ed pro­duc­tion of TNF and IL‑6 (ref.5). In mice infect­ed with SARS-CoV, ADE was asso­ci­at­ed with decreased lev­els of the anti-inflam­ma­to­ry cytokines IL-10 and TGFß and increased lev­els of the pro-inflam­ma­to­ry chemokines CCL2 and CCL3 (ref.8). Fur­ther­more, immu­niza­tion of non-human pri­mates with a mod­i­fied vac­cinia Ankara (MVA) virus encod­ing the full-length S pro­tein of SARS-CoV pro­mot­ed acti­va­tion of alve­o­lar macrophages, lead­ing to acute lung injury9.

    Pro­tec­tive ver­sus path­o­gen­ic anti­bod­ies

    Mul­ti­ple fac­tors deter­mine whether an anti­body neu­tral­izes a virus and pro­tects the host or caus­es ADE and acute inflam­ma­tion. These include the speci­fici­ty, con­cen­tra­tion, affin­i­ty and iso­type of the anti­body. Viral vec­tor vac­cines encod­ing SARS-CoV S pro­tein and nucle­o­cap­sid (N) pro­tein pro­voke anti‑S and anti‑N IgG in immu­nized mice, respec­tive­ly, to a sim­i­lar extent. How­ev­er, upon re-chal­lenge, N pro­tein-immu­nized mice show sig­nif­i­cant upreg­u­la­tion of pro-inflam­ma­to­ry cytokine secre­tion, increased neu­trophil and eosinophil lung infil­tra­tion, and more severe lung pathol­o­gy8. Sim­i­lar­ly, anti­bod­ies tar­get­ing dif­fer­ent epi­topes on the S pro­tein may vary in their poten­tial to induce neu­tral­iza­tion or ADE. For exam­ple, anti­bod­ies reac­tive to the RBD domain or the HR2 domain of the S pro­tein induce bet­ter pro­tec­tive anti­body respons­es in non-human pri­mates, where­as anti­bod­ies spe­cif­ic for oth­er S pro­tein epi­topes can induce ADE10. In vit­ro data sug­gest that for cells express­ing FcRs, ADE occurs when anti­body is present at a low con­cen­tra­tion but damp­ens at the high-con­cen­tra­tion range. Mean­while, increas­ing anti­body con­cen­tra­tions pro­motes SARS-CoV neu­tral­iza­tion by block­ing viral entry into host cells6. For oth­er virus­es, high-affin­i­ty anti­bod­ies capa­ble of block­ing recep­tor bind­ing tend to not induce ADE.

    In the ‘mul­ti­ple hit’ mod­el of neu­tral­iza­tion, the virus-block­ing effect cor­re­lates with the num­ber of anti­bod­ies coat­ing the viri­on, which is col­lec­tive­ly affect­ed by anti­body con­cen­tra­tion and affin­i­ty11. Mon­o­clon­al anti­bod­ies with high­er affin­i­ty for the enve­lope (E) pro­tein of West Nile Virus (WNV) induced bet­ter pro­tec­tion in mice receiv­ing a lethal dose of WNV11. For a giv­en con­cen­tra­tion of anti­body and a spe­cif­ic tar­get­ing domain, the sto­i­chiom­e­try of anti­body engage­ment on a viri­on is depen­dent on the strength of inter­ac­tion between anti­body and anti­gen. ADE is induced when the sto­i­chiom­e­try is below the thresh­old for neu­tral­iza­tion. There­fore, high­er affin­i­ty anti­bod­ies can reach that thresh­old at a low­er con­cen­tra­tion and medi­ate bet­ter pro­tec­tion11.
    ...

    ADE is induced when the sto­i­chiom­e­try is below the thresh­old for neu­tral­iza­tion. That’s anoth­er state­ment wor­thy of a mantra. These vac­cines real­ly do need to be ‘good enough’ to work to avoid dis­as­ter. But there’s no guar­an­tee that a vac­cine that induces a high enough neu­tral­iz­ing anti­body thresh­old for neu­tral­iza­tion in younger peo­ple will do the same in the elder­ly or those with com­pro­mised immune sys­tems. That’s also what they found with stud­ies of a SARS vac­cine in mice. The aged mice could­n’t cre­ate the neu­tral­iz­ing anti­bod­ies from a dou­ble-inac­ti­vat­ed SARS-CoV vac­cine (so a vac­cine made from inac­ti­vat­ed virus­es). But when they tried it with a alum-adju­vant­ed dou­ble-inac­ti­vat­ed SARS-CoV vac­cine in aged mice they did see an immune response but it was the type of response that increased the type of immune response asso­ci­at­ed with increased lung dam­age:

    ...
    It is cru­cial to deter­mine which vac­cines and adju­vants can elic­it pro­tec­tive anti­body respons­es to SARS-CoV­‑2. Pre­vi­ous stud­ies have shown that the immu­niza­tion of mice with inac­ti­vat­ed whole SARS-CoV13, the immu­niza­tion of rhe­sus macaques9 with MVA-encod­ed S pro­tein and the immu­niza­tion of mice with DNA vac­cine encod­ing full-length S pro­tein14 could induce ADE or eosinophil-medi­at­ed immunopathol­o­gy to some extent, pos­si­bly owing to low qual­i­ty and quan­ti­ty of anti­body pro­duc­tion. Addi­tion­al­ly, we need to con­sid­er whether a vac­cine is safe and effec­tive in aged hosts. For instance, dou­ble-inac­ti­vat­ed SARS-CoV vac­cine failed to induce neu­tral­iz­ing anti­body respons­es in aged mice13. Fur­ther­more, although an alum-adju­vant­ed dou­ble-inac­ti­vat­ed SARS-CoV vac­cine elicit­ed high­er anti­body titres in aged mice, it skewed the IgG sub­class toward IgG1 instead of IgG2, which was asso­ci­at­ed with a T helper 2 (TH2)-type immune response, enhanced eosinophil­ia and lung pathol­o­gy13. By con­trast, stud­ies in mice showed that sub­unit or pep­tide vac­cines that focus the anti­body response against spe­cif­ic epi­topes with­in the RBD of the S pro­tein con­ferred pro­tec­tive anti­body respons­es3. In addi­tion, live atten­u­at­ed SARS-CoV vac­cine induced pro­tec­tive immune respons­es in aged mice15. Routes of vac­cine admin­is­tra­tion can fur­ther affect vac­cine effi­ca­cy. Com­pared with the intra­mus­cu­lar route, intranasal admin­is­tra­tion of a recom­bi­nant ade­no-asso­ci­at­ed virus vac­cine encod­ing SARS-CoV RBD induced sig­nif­i­cant­ly high­er titres of mucos­al IgA in the lung and reduced lung pathol­o­gy upon chal­lenge with SARS-CoV3.
    ...

    It’s worth recall­ing that the pre­lim­i­nary results from the Mod­er­na COVID-19 vac­cine of 8 patients show­ing ade­quate lev­els of neu­tral­iz­ing anti­bod­ies was on patiens aged 18–55. So those results tell us noth­ing about how elder­ly immune sys­tems will respond.

    Final­ly, note the rec­om­men­da­tions of the authors: Instead of rely­ing on vac­cines, mon­o­clon­al anti­bod­ies would be a much safer approach because at least then there can be pre­cise con­trol over which types of anti­bod­ies are being used to fight the virus. Because it’s not just the lev­el of the anti­body but the tar­get of the anti­body (which part of the virus it tar­gets) that appears to deter­mine whether or not ADE is induced. So instead of elic­it­ing an immune response and hop­ing that the body pro­duces the right anti­bod­ies at the right lev­els, we just man­u­fac­ture large num­ber of mon­o­clon­al anti­bod­ies to give direct­ly to patients:

    ...
    Con­clud­ing remarks

    There are now mul­ti­ple vac­cine can­di­dates (includ­ing nucle­ic acid vac­cines, viral vec­tor vac­cines and sub­unit vac­cines) in the pre­clin­i­cal and clin­i­cal tri­al stages as researchers and insti­tutes from all over the world come togeth­er to accel­er­ate the devel­op­ment of a SARS-CoV­‑2 vac­cine. Recent stud­ies of anti­body respons­es in patients with COVID-19 have asso­ci­at­ed high­er titres of anti‑N IgM and IgG at all time points fol­low­ing the onset of symp­toms with a worse dis­ease out­come16. More­over, high­er titres of anti‑S and anti‑N IgG and IgM cor­re­late with worse clin­i­cal read­outs and old­er age17, sug­gest­ing poten­tial­ly detri­men­tal effects of anti­bod­ies in some patients. How­ev­er, 70% of patients who recov­ered from mild COVID-19 had mea­sur­able neu­tral­iz­ing anti­bod­ies that per­sist­ed upon revis­it to the hospital18. Thus, insights gained from study­ing the anti­body fea­tures that cor­re­late with recov­ery as opposed to wors­en­ing of dis­ease will inform the type of anti­bod­ies to assess in vac­cine stud­ies. We argue that ADE should be giv­en full con­sid­er­a­tion in the safe­ty eval­u­a­tion of emerg­ing can­di­date vac­cines for SARS-CoV­‑2. In addi­tion to vac­cine approach­es, mon­o­clon­al anti­bod­ies could be used to tack­le this virus. Unlike vac­cine-induced anti­bod­ies, mon­o­clon­al anti­bod­ies can be engi­neered with mol­e­c­u­lar pre­ci­sion. Safe and effec­tive neu­tral­iz­ing anti­bod­ies could be pro­duced on a mass-scale for deliv­ery to pop­u­la­tions across the world in the com­ing months.
    ...

    So that’s anoth­er thing to keep in eye on: will the race for the dis­cov­ery and mass pro­duc­tion of a vac­cine include a par­al­lel race for the dis­cov­ery and mass pro­duc­tion of mon­o­clon­al anti­bod­ies? We’ll see. We’ll also see what hap­pens if this virus becomes a reg­u­lar annu­al virus like the flu and we just keep get­ting reex­posed to the virus year after year. How will this poten­tial for ADE play into that sce­nario?

    Also note that Mod­er­na’s phase I clin­i­cal tri­al does include peo­ple over the age of 70. We haven’t seen results on that group yet though. We only got the results for eight patients in the youngest group. So at this point we can’t rule out the pos­si­bil­i­ty that the Mod­er­na vac­cine will work on the young and harm the elder­ly. Because this whole night­mare pan­dem­ic was­n’t eugenic enough appar­ent­ly.

    Posted by Pterrafractyl | May 22, 2020, 2:58 pm
  5. Good evening Dave. The down­load for FTR 1130 is not the full show. It cuts off imme­di­ate­ly after you say Tara Read­e’s name at the 57:27 mark. All your work is much appre­ci­at­ed. John

    Posted by John Martin | May 23, 2020, 4:14 pm
  6. @John Mar­tin–

    Unfor­tu­nate­ly, that is the way it is–this was a live record­ing, and the file cut off because I had tech­ni­cal prob­lems at the start of the pro­gram.

    Please ref­er­ence the writ­ten descrip­tion to get the gist of the clos­ing remarks about Tara Reade.

    I hope to do a pro­gram about this unfor­tu­nate woman and the mas­sive prob­lems with her sto­ry and her lack of cred­i­bil­i­ty on many issues going back many years.

    Two arti­cles on her in “The Nation” and “Politi­co” cov­er much of what is avail­able.

    Best,

    Dave

    Posted by Dave Emory | May 23, 2020, 4:51 pm
  7. There was a recent piece in GMWatch that points out a 2017 pub­lished coro­n­avirus research paper that’s notable for both who authored it, who sup­port­ed those authors, and the tech­niques they used in the paper: The paper was pub­lished in 2017 by a group of sci­en­tists from the Wuhan Insti­tute of Virol­o­gy (WIV), includ­ing Chi­na’s top bat coro­n­avirus researcher Shi Zhengli. In terms of the the­o­ry that the SARS-CoV­‑2 virus escaped from the WIV, it’s Shi Zhengli’s research into bat coro­n­avirus­es that con­sid­ered the like­li­est cul­prit. But the paper’s authors weren’t just based in Chi­na. The co-authors includ­ed Peter Daszak of the US-based Eco­Health Alliance and fund­ing was pro­vid­ed in part by the US Nation­al Insti­tutes of Health (NIH) and USAID.

    The spe­cif­ic top­ic of the paper is also quite notable: which muta­tions allow bat coro­n­avirus­es to bind to the human ACE2 recep­tor. So it was gain-of-func­tion research about the kind of func­tion that SARS-CoV­‑2 clear­ly gained. Recall the recent study by Pro­fes­sor Niko­lai Petro­vsky that used com­put­er mod­els to sim­u­late the bind­ing capac­i­ty of dif­fer­ent coro­n­avirus­es to human ACE2 recep­tors that pre­dict­ed SARS-CoV­‑2 is bet­ter at bind­ing to human ACE2 recep­tors than any of the oth­er ani­mal coro­n­avirus­es they test­ed includ­ed bat and pan­golin coro­n­avirus­es. Impor­tant­ly, the gain-of-fuc­tion research involved the kinds of tech­niques that would­n’t leave behind signs of human inter­ven­tion.

    As the fol­low­ing GMWatch arti­cle reminds us, this was­n’t the only gain-of-func­tion research involv­ing bat coro­n­avirus­es and US researchers and Dr. Shi Zhengli’s lab. There was also that 2015 paper on the gain-of-func­tion research using a chimeric virus bat coro­n­avirus done in col­lab­o­ra­tion with Ralph Bar­ic’s lab at the Uni­ver­si­ty of North Car­oli­na Chapel Hill. So this 2017 paper was­n’t some sort of unique col­lab­o­ra­tion. It reflect­ed the sta­tus of inter­na­tion­al col­lab­o­ra­tion on this type of gain-of-func­tion research between Chi­nese and West­ern researchers that was well estab­lished by the time of that 2017 pub­li­ca­tion and ful­ly endorsed by US gov­ern­ment agen­cies. An inter­na­tion­al col­lab­o­ra­tion under­scored by the fact that the WIV is a BSL‑4 lab built under the super­vi­sion of the inter­na­tion­al com­mu­ni­ty and staffed with sci­en­tists fre­quent­ly trained in the West.

    The arti­cle points out anoth­er more recent pub­li­ca­tion from Dr. Shi Zhengli’s lab from May of 2020 that inves­ti­gates the rel­a­tive bind­ing strengths of the orig­i­nal SARS virus and dif­fer­ent bat coro­n­avirus­es to bat and human ACE2 recep­tors. It does­n’t sounds like it involved actu­al­ly cre­at­ing new chimeric virus­es but just study­ing exist­ing virus­es. Notably, as as the fol­low­ing GMWatch piece points out, the research was car­ried out under safe­ty con­di­tions that could be con­sid­ered over­ly lax. The paper states the research was car­ried out in a BSL‑2 envi­ron­ment. And while virus­es like SARS-CoV (the orig­i­nal SARS) don’t require a BSL‑4 envi­ron­ment to safe­ly work under, they do required BSL‑3 as Ebright points out. Then again, since they are lit­er­al­ly pub­lish­ing these seem­ing­ly over­lay lax con­di­tions in their pub­li­ca­tion they pre­sum­ably felt it was secure enough so it would be inter­est­ing to hear addi­tion­al view­points on what kind of unnec­es­sary risks were being tak­en by this research. Either way, since this is Chi­na’s pre­mier viral coro­n­avirus research group pub­lish­ing in this paper that they’re using BSL‑2 set­tings for research that should have at least BSL‑3, and this is the same group that has a long track record of col­lab­o­ra­tion with inter­na­tion­al researchers, we can be pret­ty con­fi­dent that if there’s a pat­tern of research of this nature being car­ried out under debat­ly lax con­di­tions it’s not a secret. In gen­er­al, it’s hard to imag­ine that the Chi­nese researchers who are the pri­ma­ry sus­pects as the group that leaked the SARS-CoV­‑2 virus from a lab would pub­lish these paper stat­ing over­ly lax secu­ri­ty mea­sures were used unless they were under the impres­sion that they were indeed tak­ing ade­quate pre­cau­tions.

    More gen­er­al­ly, with­in the glob­al mil­i­tary bio­log­i­cal war­fare com­mu­ni­ty, how was the kind of gain-of-func­tion research described in that 2017 paper per­ceived when it was being car­ried out inside Chi­na but with the coop­er­a­tion of the US? Yes, it has clear pub­lic health and defen­sive ben­e­fits to under­stand on how virus­es can jump from ani­mal to human or become more vir­u­lent. But this has always also been obvi­ous dual use research with offen­sive poten­tial. There’s no sep­a­rat­ing the two. So what kind of impact did that 2017 paper have when it was pub­licly revealed that gain-of-func­tion research on human ACE2 recep­tor bind­ing of bat coro­n­avirus using tech­niques that would­n’t leave signs of human inter­ven­tion was being car­ried out joint­ly between the US and Chi­na? Espe­cial­ly since, as the arti­cle notes, there real­ly is a his­to­ry of the SARS virus escap­ing from Chi­nese BSL‑3 research labs. So when it was pub­licly dis­closed in this 2017 pub­li­ca­tion that you had US-spon­sored Chi­nese “gain-of-func­tion” research on what allows bat coro­n­avirus­es to infect human that would have undoubt­ed­ly made a few peo­ple real­ize that a major oppor­tu­ni­ty exists for releas­ing a man-made bat coro­n­avirus and ensur­ing Chi­na got the blame. And since it was US-financed research the temp­ta­tion to cre­ate a lab-release inci­dent could have been even greater for third par­ties. It’s one of the more remark­able con­texts of the cur­rent COVID-19 pan­dem­ic and the cam­paign being waged by the Trump admin­is­tra­tion to blame it on a leak from a Chi­nese lab: the cur­rent cam­paign to blame Chi­na for a leak from the lab is prob­a­bly some­thing some­one has been think­ing about wag­ing at least since that 2017 paper:

    GMWatch

    Wuhan and US sci­en­tists used unde­tectable meth­ods of genet­ic engi­neer­ing on bat coro­n­avirus­es

    Report by Jonathan Matthews and Claire Robin­son
    Details Pub­lished: 20 May 2020

    Evi­dence has emerged that researchers at the Wuhan Insti­tute of Virol­o­gy (WIV) in Chi­na, work­ing in col­lab­o­ra­tion with sci­en­tists in the USA, have been genet­i­cal­ly engi­neer­ing bat virus­es for the past sev­er­al years to inves­ti­gate infec­tiv­i­ty – using unde­tectable meth­ods. The WIV is just a few miles from the Chi­nese city where the COVID-19 pan­dem­ic is thought to have orig­i­nat­ed and is the chief sus­pect in the pos­si­ble sce­nario that the virus emerged from a lab.

    The evi­dence rebuts claims by jour­nal­ists and some sci­en­tists that the SARS-CoV­‑2 virus respon­si­ble for the cur­rent COVID-19 pan­dem­ic could not have been genet­i­cal­ly engi­neered because it lacks the “signs” or “sig­na­tures” that sup­pos­ed­ly would be left behind by genet­ic engi­neer­ing tech­niques.

    Those mak­ing these claims cite as evi­dence a let­ter pub­lished in Nature Med­i­cine in March by Amer­i­can micro­bi­ol­o­gist Kris­t­ian Ander­sen and col­leagues. The arti­cle stat­ed that there was no evi­dence that the virus had been genet­i­cal­ly manip­u­lat­ed and con­clud­ed that it emerged through nat­ur­al muta­tion and selec­tion in ani­mal and human hosts.[1]

    Typ­i­cal of the media response to the Nature Med­i­cine let­ter was an arti­cle pub­lished in The Sci­en­tist, which stat­ed, “there are no signs of genet­ic manip­u­la­tion in the SARS-CoV­‑2 genome”. The BBC also report­ed that “the study of the coro­n­avirus genome … found no signs it had been engi­neered”.

    Oth­er experts, how­ev­er, have point­ed out that there are well known ways of manip­u­lat­ing the genet­ic mate­r­i­al of a virus with­out leav­ing any such signs.

    Now Dr Richard Ebright, an infec­tious dis­ease expert at Rut­gers Uni­ver­si­ty (USA), has alert­ed the pub­lic to evi­dence that WIV and US-based researchers were genet­i­cal­ly engi­neer­ing bat virus­es to inves­ti­gate their abil­i­ty to infect humans, using com­mon­ly used meth­ods that leave no sign or sig­na­ture of human manip­u­la­tion.

    Ebright flagged up a sci­en­tif­ic paper pub­lished in 2017 by WIV sci­en­tists, includ­ing Shi Zhengli, the virol­o­gist lead­ing the research into bat coro­n­avirus­es, work­ing in col­lab­o­ra­tion with Peter Daszak of the US-based Eco­Health Alliance. Fund­ing was shared between Chi­nese and US insti­tu­tions, the lat­ter includ­ing the US Nation­al Insti­tutes of Health and USAID. The researchers report hav­ing con­duct­ed virus infec­tiv­i­ty exper­i­ments where genet­ic mate­r­i­al is com­bined from dif­fer­ent vari­eties of SARS-relat­ed coro­n­avirus­es to form nov­el “chimeric” ver­sions. This formed part of their research into what muta­tions were need­ed to allow cer­tain bat coro­n­avirus­es to bind to the human ACE2 recep­tor – a key step in the human infec­tiv­i­ty of SARS-CoV­‑2.

    The WIV sci­en­tists did this, Ebright points out, “using ‘seam­less lig­a­tion’ pro­ce­dures that leave no sig­na­tures of human manip­u­la­tion”. This is note­wor­thy because it is a type of genet­ic engi­neer­ing that Ander­sen and his team exclud­ed from their inves­ti­ga­tion into whether SARS-CoV­‑2 could have been engi­neered – and it was in use at the very lab that is the prime sus­pect for a lab escape.

    A group of sci­en­tists from the Uni­ver­si­ty of North Car­oli­na in the USA, with the WIV’s Shi Zhengli as a col­lab­o­ra­tor, pub­lished a study in 2015 describ­ing sim­i­lar exper­i­ments involv­ing chimeric coro­n­avirus­es, which were also cre­at­ed using stan­dard unde­tectable genet­ic engi­neer­ing tech­niques.

    Dr Michael Anto­niou, a Lon­don-based mol­e­c­u­lar geneti­cist, told us that these meth­ods of genet­ic engi­neer­ing have been com­mon­ly used for decades and do not leave any kind of “sig­na­ture”. Com­ment­ing on Ander­sen and his team’s omis­sion of these meth­ods from their arti­cle in Nature Med­i­cine, Dr Anto­niou told us, “This shows that these authors’ con­clu­sions about whether genet­ic engi­neer­ing could have been involved are not jus­ti­fied by the avail­able evi­dence.”

    Min­i­mal biosafe­ty

    Richard Ebright also flagged up anoth­er paper by WIV sci­en­tists that rais­es con­cerns. In a just-pub­lished pre-print, they describe inves­ti­gat­ing the abil­i­ty of spike pro­teins from bat SARS-relat­ed CoV (SARSr-CoV), among oth­er coro­n­avirus­es, to bind to bat and human ACE2 recep­tors – in oth­er words, how effi­cient­ly they infect humans. Ebright points out that the paper states, “All work with the infec­tious virus was per­formed under biosafe­ty lev­el 2 con­di­tions”. This lev­el is suit­able for work involv­ing agents of only “mod­er­ate poten­tial haz­ard to per­son­nel and the envi­ron­ment”.

    The high­est lev­el of biosafe­ty is lev­el 4 (BSL‑4). This is for work with agents that could eas­i­ly be aerosol-trans­mit­ted with­in the lab­o­ra­to­ry and cause severe to fatal dis­ease in humans for which there are no avail­able vac­cines or treat­ments. Because the WIV has a BSL‑4 lab, many have assumed that work like this on infec­tious bat coro­n­avirus­es linked to SARS, a close­ly relat­ed coro­n­avirus to SARS-CoV­‑2, was being con­duct­ed at the high­est BSL‑4 lev­el of biose­cu­ri­ty. Clear­ly, as the WIV researchers state, this was not the case. But they are not at fault in fail­ing to use BSL‑4 for this work, as SARS coro­n­avirus­es are not aerosol-trans­mit­ted.

    The work does, how­ev­er, fall under biosafe­ty lev­el 3, which is for work involv­ing microbes that can cause seri­ous and poten­tial­ly lethal dis­ease via inhala­tion. So it seems inex­cus­able that it was car­ried out only at the rel­a­tive­ly low biosafe­ty lev­el 2, which, as Ebright says, “pro­vides only min­i­mal pro­tec­tions against infec­tion of lab work­ers”.

    Evo­lu­tion­ary oppor­tu­ni­ty for virus­es to jump to humans

    The bio­sci­en­tist Dr Jonathan Lath­am crit­i­cised the kind of research on bat coro­n­avirus­es that has been tak­ing place in Wuhan and the USA as “pro­vid­ing an evo­lu­tion­ary oppor­tu­ni­ty” for such virus­es “to jump into humans”. Lath­am, who has a doc­tor­ate in virol­o­gy, argues that this kind of work is sim­ply “pro­vid­ing oppor­tu­ni­ties for con­t­a­m­i­na­tion events and leak­ages from labs, which hap­pen on a rou­tine basis”.

    Giv­en that lab acci­dents are com­mon, includ­ing in Chi­na where the SARS virus has escaped from high-lev­el con­tain­ment facil­i­ties mul­ti­ple times, the details emerg­ing about the research activ­i­ties of the WIV and US sci­en­tists again under­line the need for a cred­i­ble inde­pen­dent inves­ti­ga­tion of the most foren­sic kind into the ori­gins of the cur­rent pan­dem­ic. And a broad­er inves­ti­ga­tion is also need­ed into the full range of bio­log­i­cal threats aris­ing from var­i­ous areas of poten­tial­ly haz­ardous but lax­ly reg­u­lat­ed biotech­nol­o­gy research.

    Notes

    1. In the Nature Med­i­cine let­ter, Ander­sen and col­leagues didn’t actu­al­ly look for – and fail to find – a “sign” or “sig­na­ture” of genet­ic engi­neer­ing, akin to a call­ing card left by a vis­i­tor. That’s no sur­prise, as they doubt­less knew that such a search would have been futile. What they actu­al­ly said was that if genet­ic engi­neer­ing had been involved, the virus would be dif­fer­ent from how it is: it would have been designed in a more “ide­al” way for human infec­tiv­i­ty, based on the pre­dic­tions of their com­put­er mod­el­ling sys­tem.

    There are mas­sive prob­lems with this argu­ment, as experts have point­ed out. Com­put­er mod­el­ling pro­grams are only as good as the data that are put into them by humans, so it is not valid to assume that the pro­gram – or the humans that designed it – knows what an “ide­al” virus would look like in real-world con­di­tions.

    The let­ter also stat­ed that if some­one were try­ing to engi­neer the virus as a pathogen, they would “prob­a­bly” have con­struct­ed it from the back­bone of a virus already known to be infec­tive to humans (note that “prob­a­bly” leaves plen­ty of wrig­gle room for alter­na­tive meth­ods of con­struct­ing a virus). But it’s pos­si­ble that if it was engi­neered from a back­bone, it was one that is not known out­side their research group. This is pos­si­ble if secre­cy were involved – for exam­ple, for bioweapons/biodefence research or com­mer­cial vac­cine devel­op­ment.

    ...

    ———–

    “Wuhan and US sci­en­tists used unde­tectable meth­ods of genet­ic engi­neer­ing on bat coro­n­avirus­es” by Jonathan Matthews and Claire Robin­son; GMWatch; 05/20/2020

    “Ebright flagged up a sci­en­tif­ic paper pub­lished in 2017 by WIV sci­en­tists, includ­ing Shi Zhengli, the virol­o­gist lead­ing the research into bat coro­n­avirus­es, work­ing in col­lab­o­ra­tion with Peter Daszak of the US-based Eco­Health Alliance. Fund­ing was shared between Chi­nese and US insti­tu­tions, the lat­ter includ­ing the US Nation­al Insti­tutes of Health and USAID. The researchers report hav­ing con­duct­ed virus infec­tiv­i­ty exper­i­ments where genet­ic mate­r­i­al is com­bined from dif­fer­ent vari­eties of SARS-relat­ed coro­n­avirus­es to form nov­el “chimeric” ver­sions. This formed part of their research into what muta­tions were need­ed to allow cer­tain bat coro­n­avirus­es to bind to the human ACE2 recep­tor – a key step in the human infec­tiv­i­ty of SARS-CoV­‑2.”

    A 2017 paper involv­ing the build­ing of chimeric virus­es to infect humans con­duct­ed by Chi­nese researchers in con­junc­tion with the US-based Eco­Health Alliance and with fund­ing by US gov­ern­ment insti­tutes. And the exper­i­ments were using tech­niques to cre­ate the virus­es that leave no sig­na­tures of human manip­u­la­tion. That had to turn heads with­in the glob­al bio­log­i­cal war­fare com­mu­ni­ty at the time. Espe­cial­ly since it was pre­ced­ed by that 2015 col­lab­o­ra­tion between the same Chi­nese researchers and Ralph Bar­ic’s lab in the North Car­oli­na that that sim­i­lar­ly involved chimeric bat coro­n­avirus­es:

    ...
    The WIV sci­en­tists did this, Ebright points out, “using ‘seam­less lig­a­tion’ pro­ce­dures that leave no sig­na­tures of human manip­u­la­tion”. This is note­wor­thy because it is a type of genet­ic engi­neer­ing that Ander­sen and his team exclud­ed from their inves­ti­ga­tion into whether SARS-CoV­‑2 could have been engi­neered – and it was in use at the very lab that is the prime sus­pect for a lab escape.

    A group of sci­en­tists from the Uni­ver­si­ty of North Car­oli­na in the USA, with the WIV’s Shi Zhengli as a col­lab­o­ra­tor, pub­lished a study in 2015 describ­ing sim­i­lar exper­i­ments involv­ing chimeric coro­n­avirus­es, which were also cre­at­ed using stan­dard unde­tectable genet­ic engi­neer­ing tech­niques.

    Dr Michael Anto­niou, a Lon­don-based mol­e­c­u­lar geneti­cist, told us that these meth­ods of genet­ic engi­neer­ing have been com­mon­ly used for decades and do not leave any kind of “sig­na­ture”. Com­ment­ing on Ander­sen and his team’s omis­sion of these meth­ods from their arti­cle in Nature Med­i­cine, Dr Anto­niou told us, “This shows that these authors’ con­clu­sions about whether genet­ic engi­neer­ing could have been involved are not jus­ti­fied by the avail­able evi­dence.”
    ...

    And then there’s the obser­va­tion by Pro­fes­sor Richard Ebright of a May 2020 pub­li­ca­tion (pre-pub­li­ca­tion, actu­al­ly) by Dr. Shi Zhengli’s lab that was arguably car­ried out under BSL‑2 con­di­tions when it should have used at least BSL‑3. Is this accu­rate that BSL‑3 was required for the research they describe? If so, hav­ing the same Chi­nese research team cur­rent­ly blamed from releas­ing the virus issue a pub­li­ca­tion that plain­ly admits to using over­ly lax secu­ri­ty mea­sures is one of the most bizarre twists in all of this so it will be very inter­est­ing to learn if this lat­est pub­li­ca­tion real­ly was done under improp­er­ly lax con­di­tions or not:

    ...
    Richard Ebright also flagged up anoth­er paper by WIV sci­en­tists that rais­es con­cerns. In a just-pub­lished pre-print, they describe inves­ti­gat­ing the abil­i­ty of spike pro­teins from bat SARS-relat­ed CoV (SARSr-CoV), among oth­er coro­n­avirus­es, to bind to bat and human ACE2 recep­tors – in oth­er words, how effi­cient­ly they infect humans. Ebright points out that the paper states, “All work with the infec­tious virus was per­formed under biosafe­ty lev­el 2 con­di­tions”. This lev­el is suit­able for work involv­ing agents of only “mod­er­ate poten­tial haz­ard to per­son­nel and the envi­ron­ment”.

    The high­est lev­el of biosafe­ty is lev­el 4 (BSL‑4). This is for work with agents that could eas­i­ly be aerosol-trans­mit­ted with­in the lab­o­ra­to­ry and cause severe to fatal dis­ease in humans for which there are no avail­able vac­cines or treat­ments. Because the WIV has a BSL‑4 lab, many have assumed that work like this on infec­tious bat coro­n­avirus­es linked to SARS, a close­ly relat­ed coro­n­avirus to SARS-CoV­‑2, was being con­duct­ed at the high­est BSL‑4 lev­el of biose­cu­ri­ty. Clear­ly, as the WIV researchers state, this was not the case. But they are not at fault in fail­ing to use BSL‑4 for this work, as SARS coro­n­avirus­es are not aerosol-trans­mit­ted.

    The work does, how­ev­er, fall under biosafe­ty lev­el 3, which is for work involv­ing microbes that can cause seri­ous and poten­tial­ly lethal dis­ease via inhala­tion. So it seems inex­cus­able that it was car­ried out only at the rel­a­tive­ly low biosafe­ty lev­el 2, which, as Ebright says, “pro­vides only min­i­mal pro­tec­tions against infec­tion of lab work­ers”.
    ...

    So the whole world was informed back in 2017 that this kind of dan­ger­ous research involv­ing the cre­ation of bat coro­n­avirus­es to infect humans was being car­ried out in Chi­na but fund­ed in part by the US. Flash for­ward a cou­ple of years and we have some sort of night­mare virus that ini­tial­ly seemed to pop up near­by the WIV and the Trump admin­is­tra­tion aggres­sive­ly push­ing the idea that it escaped from that lab.

    It’s a sit­u­a­tion made all the more remark­able by the fact that, as the fol­low­ing 2017 Nature describes, the WIV was Chi­na’s first BSL‑4 cer­ti­fied lab and only achieved that cer­ti­fi­ca­tion in 2017 with the help of the West. The first of a planned 5 to 7 new BSL‑4 facil­i­ties that will be built inside Chi­na by 2025. The WIV was also set up as one of the World Health Orga­ni­za­tion’s “Ref­er­ence Labs” linked to sim­i­lar labs around the world. So the WIV as a BSL‑4 lab was real­ly part of this broad­er inter­na­tion­al project to cre­ate a glob­al net­work of labs study­ing infec­tious dis­eases. As such, the WIV’s BSL‑4 cer­ti­fi­ca­tion was hailed inside Chi­na as putting a Chi­nese lab into the glob­al elite net­work of labs capa­ble of car­ry­ing out the most dan­ger­ous kinds of research. So Chi­na has only recent­ly even achieved the tech­ni­cal abil­i­ty to safe­ly car­ry out the most dan­ger­ous types of research on infec­tious dis­eases and this was achieved as part of an inter­na­tion­al effort to wel­come Chi­na into the com­mu­ni­ty of elite infec­tious dis­ease research and just the first of many planned BSL‑4 facil­i­ties in Chi­na:

    Nature
    Vol 542 pg 399–401

    News In Focus

    Inside China’s pathogen lab Max­i­mum-secu­ri­ty biosafe­ty facil­i­ty nears approval, spark­ing excite­ment and con­cern.

    BY DAVID CYRANOSKI, WUHAN, CHINA
    Feb­ru­ary 23, 2017

    A lab­o­ra­to­ry in Wuhan is on the cusp of being cleared to work with the world’s most dan­ger­ous pathogens. The move is part of a plan to build between five and sev­en biosafe­ty level‑4 (BSL‑4) labs across the Chi­nese main­land by 2025, and has gen­er­at­ed much excite­ment, as well as some con­cerns.

    Some sci­en­tists out­side Chi­na wor­ry about pathogens escap­ing, and the addi­tion of a bio­log­i­cal dimen­sion to geopo­lit­i­cal ten­sions between Chi­na and oth­er nations. But Chi­nese micro­bi­ol­o­gists are cel­e­brat­ing their entrance to the elite cadre empow­ered to wres­tle with the world’s great­est bio­log­i­cal threats.

    “It will offer more oppor­tu­ni­ties for Chi­nese researchers, and our con­tri­bu­tion on the BSL-4-lev­el pathogens will ben­e­fit the world,” says George Gao, direc­tor of the Chi­nese Acad­e­my of Sci­ences Key Lab­o­ra­to­ry of Path­o­gen­ic Micro­bi­ol­o­gy and Immunol­o­gy in Bei­jing. There are already two BSL‑4 labs in Tai­wan, but the Nation­al Bio-safe­ty Lab­o­ra­to­ry, Wuhan, would be the first on the Chi­nese main­land.

    The lab was cer­ti­fied as meet­ing the stan­dards and cri­te­ria of BSL‑4 by the Chi­na Nation­al Accred­i­ta­tion Ser­vice for Con­for­mi­ty Assess­ment (CNAS) in Jan­u­ary. The CNAS exam­ined the lab’s infra­struc­ture, equip­ment and man­age­ment, says a CNAS rep­re­sen­ta­tive, paving the way for the Min­istry of Health to give its approval. A rep­re­sen­ta­tive from the min­istry says it will move slow­ly and cau­tious­ly; if the assess­ment goes smooth­ly, it could approve the lab­o­ra­to­ry by the end of June.

    BSL‑4 is the high­est lev­el of bio­con­tain­ment: its cri­te­ria include fil­ter­ing air and treat­ing water and waste before they leave the lab­o­ra­to­ry, and stip­u­lat­ing that researchers change clothes and show­er before and after using lab facil­i­ties. Such labs are often con­tro­ver­sial. The first BSL‑4 lab in Japan was built in 1981, but oper­at­ed with low­er-risk pathogens until 2015, when safe­ty con­cerns were final­ly over­come.

    The expan­sion of BSL-4-lab net­works in the Unit­ed States and Europe over the past 15 years — with more than a dozen now in oper­a­tion or under con­struc­tion in each region — also met with resis­tance, includ­ing ques­tions about the need for so many facil­i­ties.

    The Wuhan lab cost 300 mil­lion yuan (US$44 mil­lion), and to allay safe­ty con­cerns it was built far above the flood plain and with the capac­i­ty to with­stand a magnitude‑7 earth­quake, although the area has no his­to­ry of strong earth­quakes. It will focus on the con­trol of emerg­ing dis­eases, store puri­fied virus­es and act as a World Health Orga­ni­za­tion ‘ref­er­ence lab­o­ra­to­ry’ linked to sim­i­lar labs around the world. “It will be a key node in the glob­al biosafe­ty-lab net­work,” says lab direc­tor Yuan Zhim­ing.

    The Chi­nese Acad­e­my of Sci­ences approved the con­struc­tion of a BSL‑4 lab­o­ra­to­ry in 2003, and the epi­dem­ic of SARS (severe acute res­pi­ra­to­ry syn­drome) around the same time lent the project momen­tum. The lab was designed and con­struct­ed with French assis­tance as part of a 2004 coop­er­a­tive agree­ment on the pre­ven­tion and con­trol of emerg­ing infec­tious dis­eases. But the com­plex­i­ty of the project, China’s lack of expe­ri­ence, dif­fi­cul­ty in main­tain­ing fund­ing and long gov­ern­ment approval pro­ce­dures meant that con­struc­tion wasn’t fin­ished until the end of 2014.

    The lab’s first project will be to study the BSL‑3 pathogen that caus­es Crimean–Congo haem­or­rhag­ic fever: a dead­ly tick-borne virus that affects live­stock across the world, includ-ing in north­west Chi­na, and that can jump to peo­ple.

    Future plans include study­ing the pathogen that caus­es SARS, which also doesn’t require a BSL‑4 lab, before mov­ing on to Ebo­la and the West African Las­sa virus, which do. Some one mil­lion Chi­nese peo­ple work in Africa; the coun­try needs to be ready for any even­tu­al­i­ty, says Yuan. “Virus­es don’t know bor­ders.”

    Gao trav­elled to Sier­ra Leone dur­ing the recent Ebo­la out­break, allow­ing his team to report the speed with which the virus mutat­ed into new strains (Y.-G. Tong et al. Nature 524,93–96; 2015). The Wuhan lab will give his group a chance to study how such virus­es cause dis­ease, and to devel­op treat­ments based on anti­bod­ies and small mol­e­cules, he says.

    The oppor­tu­ni­ties for inter­na­tion­al col­lab­o­ra­tion, mean­while, will aid the genet­ic analy­sis and epi­demi­ol­o­gy of emer­gent dis­eases. “The world is fac­ing more new emerg­ing virus­es, and we need more con­tri­bu­tion from Chi­na,” says Gao. In par­tic­u­lar, the emer­gence of zoonot­ic virus­es — those that jump to humans from ani­mals, such as SARS or Ebo­la — is a con­cern, says Bruno Lina, direc­tor of the Vir­Path virol­o­gy lab in Lyon, France.

    Many staff from the Wuhan lab have been train­ing at a BSL‑4 lab in Lyon, which some sci­en­tists find reas­sur­ing. And the facil­i­ty has already car­ried out a test-run using a low-risk virus.

    But wor­ries sur­round the Chi­nese lab, too. The SARS virus has escaped from high-lev­el con­tain­ment facil­i­ties in Bei­jing mul­ti­ple times, notes Richard Ebright, a mol­e­c­u­lar biol­o­gist at Rut­gers Uni­ver­si­ty in Pis­cat­away, New Jer­sey. Tim Tre­van, founder of CHROME Biosafe­ty and Biose­cu­ri­ty Con­sult­ing in Dam­as­cus, Mary­land, says that an open cul-ture is impor­tant to keep­ing BSL‑4 labs safe, and he ques­tions how easy this will be in Chi­na, where soci­ety empha­sizes hier­ar­chy. “Diver­si­ty of view­point, flat struc­tures where every­one feels free to speak up and open­ness of infor­ma­tion are impor­tant,” he says.

    Yuan says that he has worked to address this issue with staff. “We tell them the most impor­tant thing is that they report what they have or haven’t done,” he says. And the lab’s inter­na­tion­al col­lab­o­ra­tions will increase open­ness. “Trans­paren­cy is the basis of the lab,” he adds.

    The plan to expand into a net­work height­ens such con­cerns. One BSL‑4 lab in Harbin is already await­ing accred­i­ta­tion; the next two are expect­ed to be in Bei­jing and Kun­ming, the lat­ter focused on using mon­key mod­els to study dis­ease.

    Lina says that China’s size jus­ti­fies this scale, and that the oppor­tu­ni­ty to com­bine BSL‑4 research with an abun­dance of research mon­keys — Chi­nese researchers face less red tape than those in the West when it comes to research on pri­mates — could be pow­er­ful. “If you want to test vac­cines or antivi­rals, you need a non-human pri­mate mod­el,” says Lina.

    But Ebright is not con­vinced of the need for more than one BSL‑4 lab in main­land Chi­na. He sus­pects that the expan­sion there is a reac­tion to the net­works in the Unit­ed States and Europe, which he says are also unwar­rant­ed. He adds that gov­ern­ments will assume that such excess capac­i­ty is for the poten­tial devel­op­ment of bioweapons.

    “These facil­i­ties are inher­ent­ly dual use,” he says. The prospect of ramp­ing up oppor­tu­ni­ties to inject mon­keys with pathogens also wor­ries, rather than excites, him: “They can run, they can scratch, they can bite.”

    ...

    ————-

    “Inside China’s pathogen lab Max­i­mum-secu­ri­ty biosafe­ty facil­i­ty nears approval, spark­ing excite­ment and con­cern.” by DAVID CYRANOSKI; Nature, Vol 542, pgs 300–401; 02/23/2017

    “A lab­o­ra­to­ry in Wuhan is on the cusp of being cleared to work with the world’s most dan­ger­ous pathogens. The move is part of a plan to build between five and sev­en biosafe­ty level‑4 (BSL‑4) labs across the Chi­nese main­land by 2025, and has gen­er­at­ed much excite­ment, as well as some con­cerns. ”

    The WIV was just the first of a planned set of new BSL‑4 labs inside Chi­na. A planned expan­sion that mir­rors the explo­sion of BSL‑4 facil­i­ties in North Amer­i­can and Europe since the ear­ly 2000s and will make the WIV one of the WHO’s “ref­er­ence labs” linked to that grow­ing inter­na­tion­al net­work. That’s part of the con­text of the research car­ried about by Dr. Shi Zhengli’s lab: it was one part of a much broad­er inter­na­tion­al col­lab­o­ra­tion.

    ...
    BSL‑4 is the high­est lev­el of bio­con­tain­ment: its cri­te­ria include fil­ter­ing air and treat­ing water and waste before they leave the lab­o­ra­to­ry, and stip­u­lat­ing that researchers change clothes and show­er before and after using lab facil­i­ties. Such labs are often con­tro­ver­sial. The first BSL‑4 lab in Japan was built in 1981, but oper­at­ed with low­er-risk pathogens until 2015, when safe­ty con­cerns were final­ly over­come.

    The expan­sion of BSL-4-lab net­works in the Unit­ed States and Europe over the past 15 years — with more than a dozen now in oper­a­tion or under con­struc­tion in each region — also met with resis­tance, includ­ing ques­tions about the need for so many facil­i­ties.

    The Wuhan lab cost 300 mil­lion yuan (US$44 mil­lion), and to allay safe­ty con­cerns it was built far above the flood plain and with the capac­i­ty to with­stand a magnitude‑7 earth­quake, although the area has no his­to­ry of strong earth­quakes. It will focus on the con­trol of emerg­ing dis­eases, store puri­fied virus­es and act as a World Health Orga­ni­za­tion ‘ref­er­ence lab­o­ra­to­ry’ linked to sim­i­lar labs around the world. “It will be a key node in the glob­al biosafe­ty-lab net­work,” says lab direc­tor Yuan Zhim­ing.

    ...

    Future plans include study­ing the pathogen that caus­es SARS, which also doesn’t require a BSL‑4 lab, before mov­ing on to Ebo­la and the West African Las­sa virus, which do. Some one mil­lion Chi­nese peo­ple work in Africa; the coun­try needs to be ready for any even­tu­al­i­ty, says Yuan. “Virus­es don’t know bor­ders.”
    ...

    And note how many of the WIV’s staff were trained at a BSL‑4 lab in Lyon in France. Recall how key mem­bers of Dr. Shi Zhengli’s team were also trained in Aus­tralia. So this BSL‑4 lab in Wuhan real­ly was an inter­na­tion­al effort, osten­si­bly with the goal of allow­ing Chi­na to join inter­na­tion­al emerg­ing virus mon­i­tor­ing and research:

    ...
    The oppor­tu­ni­ties for inter­na­tion­al col­lab­o­ra­tion, mean­while, will aid the genet­ic analy­sis and epi­demi­ol­o­gy of emer­gent dis­eases. “The world is fac­ing more new emerg­ing virus­es, and we need more con­tri­bu­tion from Chi­na,” says Gao. In par­tic­u­lar, the emer­gence of zoonot­ic virus­es — those that jump to humans from ani­mals, such as SARS or Ebo­la — is a con­cern, says Bruno Lina, direc­tor of the Vir­Path virol­o­gy lab in Lyon, France.

    Many staff from the Wuhan lab have been train­ing at a BSL‑4 lab in Lyon, which some sci­en­tists find reas­sur­ing. And the facil­i­ty has already car­ried out a test-run using a low-risk virus.

    But wor­ries sur­round the Chi­nese lab, too. The SARS virus has escaped from high-lev­el con­tain­ment facil­i­ties in Bei­jing mul­ti­ple times, notes Richard Ebright, a mol­e­c­u­lar biol­o­gist at Rut­gers Uni­ver­si­ty in Pis­cat­away, New Jer­sey. Tim Tre­van, founder of CHROME Biosafe­ty and Biose­cu­ri­ty Con­sult­ing in Dam­as­cus, Mary­land, says that an open cul-ture is impor­tant to keep­ing BSL‑4 labs safe, and he ques­tions how easy this will be in Chi­na, where soci­ety empha­sizes hier­ar­chy. “Diver­si­ty of view­point, flat struc­tures where every­one feels free to speak up and open­ness of infor­ma­tion are impor­tant,” he says.

    Yuan says that he has worked to address this issue with staff. “We tell them the most impor­tant thing is that they report what they have or haven’t done,” he says. And the lab’s inter­na­tion­al col­lab­o­ra­tions will increase open­ness. “Trans­paren­cy is the basis of the lab,” he adds.
    ...

    Final­ly, note warn­ing from Richard Ebright in 2017: while the stat­ed pur­pose of this kind of research is for defen­sive rea­sons and to the ben­e­fit of pub­lic health, these are still inher­ent­ly dual use facil­i­ties and with the excess capac­i­ty for viral research that’s going to come from all of these planned new BSL‑4 facil­i­ties the poten­tial for using that excess capac­i­ty for offen­sive bioweapon research only grows. And it’s a cri­tique he does­n’t lim­it to Chi­na. He includes the excess capac­i­ty of US and Euro­pean BSL‑4 facil­i­ties:

    ...
    The plan to expand into a net­work height­ens such con­cerns. One BSL‑4 lab in Harbin is already await­ing accred­i­ta­tion; the next two are expect­ed to be in Bei­jing and Kun­ming, the lat­ter focused on using mon­key mod­els to study dis­ease.

    Lina says that China’s size jus­ti­fies this scale, and that the oppor­tu­ni­ty to com­bine BSL‑4 research with an abun­dance of research mon­keys — Chi­nese researchers face less red tape than those in the West when it comes to research on pri­mates — could be pow­er­ful. “If you want to test vac­cines or antivi­rals, you need a non-human pri­mate mod­el,” says Lina.

    But Ebright is not con­vinced of the need for more than one BSL‑4 lab in main­land Chi­na. He sus­pects that the expan­sion there is a reac­tion to the net­works in the Unit­ed States and Europe, which he says are also unwar­rant­ed. He adds that gov­ern­ments will assume that such excess capac­i­ty is for the poten­tial devel­op­ment of bioweapons.

    “These facil­i­ties are inher­ent­ly dual use,” he says. The prospect of ramp­ing up oppor­tu­ni­ties to inject mon­keys with pathogens also wor­ries, rather than excites, him: “They can run, they can scratch, they can bite.”
    ...

    So that’s all part of what’s so fas­ci­nat­ing about the grow­ing war of words between Chi­na and the West on the ori­gins of this virus: with the Trump admin­is­tra­tion lead­ing the way the West is dou­bling and tripling down on the idea that virus came from a Chi­nese lab that was set up with West­ern help and con­duct­ing West­ern-backed “gain-of-func­tion” research. It points towards one of the like­li­er out­comes from the cur­rent blame game: the end­ing of these kinds of inter­na­tion­al col­lab­o­ra­tions. At least inter­na­tion­al col­lab­o­ra­tions with Chi­na. There will no doubt still be lots of “gain-of-func­tion” research tak­ing place but it’s prob­a­bly not going to be research were you have Chi­nese researchers fund­ed by West­ern gov­ern­ments where every­one shares the find­ings. It rais­es the grim ques­tion of whether or not the col­lapse of inter­na­tion­al col­lab­o­ra­tions on this type of research will result in even more intense biowar­fare research or less. It’s one of the many hor­ri­ble para­dox­es asso­ci­at­ed with this top­ic: does more inter­na­tion­al open­ness about research that could be used to cre­ate dooms­day virus­es incen­tivize or dis­in­cen­tivize secret research on the cre­ation of dooms­day virus­es? This kind of research is going to hap­pen one way or anoth­er so is it bet­ter to have every­one do it joint­ly or in secret? That’s one of the ques­tions that’s going to be implic­it­ly asked by this blame-it-on-Chi­na cam­paign because we real­ly could see a major drop in inter­na­tion­al emerg­ing dis­ease col­lab­o­ra­tions as a result of this.

    But as Pro­fes­sor Ebright sug­gests, we real­ly need to be cre­at­ing a world where this research does­n’t hap­pen at all because there’s no way to ensure all of this ‘defen­sive’ research does­n’t get used offen­sive­ly. And yet, based on how the world works today if a nation isn’t pre­pared for war it’s poten­tial­ly doomed. Still, if nations do con­tin­ue prepar­ing for war human­i­ty is doomed in the end any­way as our capac­i­ty to destroy our­selves keeps grow­ing. It’s just a mat­ter of time. Maybe it will be super virus­es. Per­haps super nukes. Maybe anti-mat­ter nukes some day, who knows. Or just pol­lut­ing every­thing and destroy­ing as the glob­al mil­i­tary indus­tri­al com­plex con­tin­ues to explode while the bios­phere uncon­trol­lably until eco-col­lapse snuffs us out, maybe leav­ing a few dooms­day bunkers oper­at­ing for a while. Human­i­ty is basi­cal­ly com­mit­ting sui­cide at this point in his­to­ry and a big part of that sui­ci­dal impulse is derived from an inabil­i­ty to even rec­og­nize, let alone come to terms with, these fun­da­men­tal exis­ten­tial para­dox­es about the vital need to pre­pare for war and the utter doom that cre­ates. It’s a form of ‘MAD’­ness that under­scores how any­one not on team ‘Let’s fig­ure out how we can build a post-War future ASAP’ is part of the prob­lem. And yet there is no sign at all that we are com­ing any clos­er to address­ing that fun­da­men­tal para­dox.

    And that points towards a pos­si­ble pos­i­tive out­come from all of this: the inher­ent mad­ness of Mutu­al­ly Assured Destruc­tion in the nuclear age clear­ly was­n’t enough to force human­i­ty to grap­ple with the basic para­dox that indi­vid­ual nation­als might be doomed if they don’t pre­pare for war and yet we’re all doomed if we do keep prepar­ing for war. Doomed if we do and doomed if we don’t. Nuclear MAD­ness should have made that clear but human­i­ty just decid­ed to deal with it by ignor­ing it. Civ­i­liza­tion does­n’t even appear to be all that alarmed about a nuclear holo­caust any­more despite more nations pos­sess­ing these weapons than ever and despite the inevitabil­i­ty that such tech­nol­o­gy is going to get cheap­er and more acces­si­ble and even­tu­al­ly fall into the hands of ter­ror­ists groups at some point in the future. These kinds of nuclear dooms­day sce­nar­ios are inevitable if we con­tin­ue down this path and yet hard­ly any­one cares. So what about the threat of a viral holo­caust? Is the world ready to start seri­ous­ly pon­der­ing the MAD­ness of bio­log­i­cal war­fare research too? SARS-CoV­‑2 is just like a light appe­tiz­er com­pared to what could be com­ing. Imag­ine super-Ebo­la. How hard will it be to cre­ate super-Ebo­la with all of the knowl­edge we’re col­lec­tive­ly acquir­ing about how virus­es work?

    And unlike nuclear weapons research, there’s actu­al­ly a rea­son to car­ry out the kind of dual use research on virus with both offen­sive and defen­sive appli­ca­tions. That’s the whole premise behind these inter­na­tion­al col­lab­o­ra­tions on virol­o­gy research: it’s need­ed to help address future nat­ur­al pan­demics. So while human­i­ty could sur­vive just fine if we all agreed to stop nuclear weapons tech­nol­o­gy research, there is a real pub­lic health need to under­stand virus­es. And once we get that knowl­edge, it can be abused. And abused remark­ably eas­i­ly com­pared to nuclear tech­nol­o­gy.

    We real­ly are in anoth­er MAD­ness sit­u­a­tion. This time it’s with virus­es but the under­ly­ing dynam­ic is sim­i­lar: we’re doomed if we do and we’re doomed if we don’t. So how do we cre­ate a world where indi­vid­ual nations aren’t doomed if they aren’t per­pet­u­al­ly prepar­ing for war and yet all of this inher­ent­ly ‘dual use’ tech­nol­o­gy is still allowed to be devel­oped and exists? Can human­i­ty achieve some sort post-war sta­tus where dual use tech­nol­o­gy is read­i­ly avail­able for war-like uses but isn’t actu­al­ly used? If war is ‘pol­i­tics by oth­er means’, are we able to devel­op a shared polit­i­cal cul­ture that pre­cludes war? Is that even pos­si­ble? We have no idea at this point but we won’t find out until we start ask­ing our­selves if a post-war glob­al polit­i­cal cul­ture can even exist. So per­haps glob­al response to the cur­rent pan­dem­ic should include us col­lec­tive­ly tak­ing the time to ask our­selves if we can pos­si­bly imag­ine exist­ing with­out per­pet­u­al­ly prepar­ing to destroy each oth­er. There’s nev­er real­ly a bad time to ask that ques­tion. Heck, any viable future civ­i­liza­tion would prob­a­bly have that ques­tion — and the need to keep ask­ing and answer­ing it affir­ma­tive­ly — as one of its basic foun­da­tions. Still, now seems like an extra good time to ask if we can pos­si­bly stop try­ing to destroy each oth­er.

    Posted by Pterrafractyl | May 26, 2020, 3:45 pm
  8. @Pterrafractyl–

    Excel­lent work!

    I think it should be men­tioned in this con­text that the clo­sure of USAMRIID at Ft. Det­rick in ear­ly August of 2019 for safe­ty vio­la­tions war­rants clos­er scruti­ny.

    It has dis­ap­peared down the mem­o­ry hole.

    USAMRIID has part­nered with the Wuhan Insti­tute of Virol­o­gy “since the mid-1980’s”: http://wbm.whu.edu.cn/English/Departments/Departments/Institute_of_Medical_Virology.htm

    Also worth men­tion­ing is that USAID is a fre­quent cut-out for U.S. intel­li­gence.

    Note, also, that Whit­ney Webb not­ed the DARPA links to the Wuhan lab com­plex in her paper.

    The Covid-19 out­break was not the only “bio-event” to bedev­il Chi­na recent­ly:
    https://spitfirelist.com/for-the-record/ftr-1118-update-on-the-coronavirus-outbreak/?preview_id=74094&preview_nonce=0b0a9fe931&preview=true

    ” . . . . Just for infor­ma­tion

    In the past two years (dur­ing the trade war) Chi­na has suf­fered sev­er­al pan­demics:

    Feb­ru­ary 15, 2018: H7N4 bird flu. Sick­ened at least 1,600 peo­ple in Chi­na and killed more than 600. Many chick­ens killed. Chi­na needs to pur­chase US poul­try prod­ucts.
    June, 2018: H7N9 bird flu. Many chick­ens killed. Chi­na needs to pur­chase US poul­try prod­ucts.
    August, 2018: out­break of African swine flu. Same strain as Rus­sia, from Geor­gia. Mil­lions of pigs killed. Chi­na needs to pur­chase US pork prod­ucts.
    May 24, 2019: mas­sive infes­ta­tion of army­worms in 14 province-lev­el regions in Chi­na, which destroy most food crops. Quick­ly spread to more than 8,500 hectares of China’s grain pro­duc­tion. They pro­duce aston­ish­ing num­bers of eggs. Chi­na needs to pur­chase US agri­cul­tur­al prod­ucts – corn, soy­beans.
    Decem­ber, 2019: Coro­n­avirus appear­ance puts China’s econ­o­my on hold.
    Jan­u­ary, 2020:China is hit by a “high­ly path­o­gen­ic” strain of bird flu in Hunan province. Many chick­ens died, many oth­ers killed. Chi­na needs to pur­chase US poul­try prod­ucts.
    The stan­dard adage is that bad luck hap­pens in threes, not six­es.”

    Fun­da­men­tal, as well, to the dis­cus­sion and alto­geth­er absent from the sci­en­tif­ic and med­ical analy­sis is the POLITICAL context–overt trade war being waged by the U.S., desta­bi­liza­tion efforts fund­ed by the Nation­al Endow­ment for Democ­ra­cy in Hong Kong and the Uighur com­mu­ni­ty in Chi­na; and alle­ga­tions of cyber-espi­onage by a U.S. Cyber Com­mand that fails to men­tion that CIA cyber weapons have the engi­neered capa­bil­i­ty of sim­u­lat­ing Chi­nese offen­sive cyber weapon­ry.

    We should also recall the pres­ence of Ukrain­ian Nazis in Hong Kong–Azov Bat­tal­ion ele­ments and Pravy Sek­tor. They, in turn, were oper­at­ing on behalf of EU-fund­ed NGOs.

    Some­how, Azov Bat­tal­ion and Pravy Sek­tor just don’t sound like a “pro-Democ­ra­cy” move­ment.

    This is fun­da­men­tal to the over­all analy­sis and is NOT fac­tored into account.

    Keep up the great work,

    Dave

    Posted by Dave Emory | May 26, 2020, 5:08 pm

Post a comment