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FTR #1134 Bio-Psy-Op Apocalypse Now, Part 9: Covid-19 Updates

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FTR #1134 This pro­gram was record­ed in one, 60-minute seg­ment [6]

Intro­duc­tion: As indi­cat­ed by the title of the pro­gram, this broad­cast updates var­i­ous arti­cles and book excerpts con­cern­ing Covid-19.

A Dai­ly Mail Online [UK] [7]arti­cle sets forth two bogus papers con­tend­ing that the SARS CoV‑2 virus was genet­i­cal­ly engi­neered by the Chi­nese as a bioweapon in a lab­o­ra­to­ry and that it “escaped.” Note the cham­pi­oning of one of the papers by a for­mer head of MI6 and the author­ship of the sec­ond by The Epoch Times, the paper of the Falun Gong cult. Linked to CIA, Steve Ban­non’s anti-Chi­na milieu and the Trump admin­is­tra­tion, the orga­ni­za­tion is a fas­cist mind con­trol cult dis­cussed in numer­ous shows, includ­ing FTR #‘s 1089 [8] and 1090 [9]

  1. “A for­mer MI6 chief was yes­ter­day accused by Gov­ern­ment offi­cials of ped­dling ‘fan­ci­ful claims’ that coro­n­avirus [10] was acci­den­tal­ly cre­at­ed in a Chi­nese lab­o­ra­to­ry. British secu­ri­ty agen­cies believe Covid-19 is not a man-made virus and is ‘high­ly like­ly’ to have occurred nat­u­ral­ly and spread to humans through ani­mals. And Health Sec­re­tary Matt Han­cock [11] has said there is ‘no evi­dence’ to back up the the­o­ry that it orig­i­nat­ed in a lab­o­ra­to­ry. But Sir Richard Dearlove, who was head of the MI6 from 1999 to 2004, cit­ed a recent report claim­ing the dis­ease was acci­den­tal­ly man­u­fac­tured by Chi­nese sci­en­tists.
  2. “ ‘I do think that this start­ed as an acci­dent,’ Sir Richard told The Dai­ly Telegraph’s ‘Plan­et Nor­mal’ pod­cast. ‘It rais­es the issue: if Chi­na ever were to admit respon­si­bil­i­ty, does it pay repa­ra­tions? I think it will make every coun­try in the world rethink how it treats its rela­tion­ship with Chi­na.’ He added: ‘Look at the sto­ries... of attempts by the [Bei­jing] lead­er­ship to lock down any debate about the ori­gins of the pan­dem­ic and the way peo­ple have been arrest­ed or silenced.’ . . . . The paper – co-authored by Pro­fes­sor Angus Dal­gleish, a renowned oncol­o­gist and vac­cine researcher who works at St George’s Hos­pi­tal, Uni­ver­si­ty of Lon­don, and Birg­er Sorensen, a Nor­we­gian virol­o­gist – con­tains none of the stark alle­ga­tions that orig­i­nal­ly stunned its review­ers.
  3. “The ini­tial paper that trig­gered wild rumours failed strin­gent tests of ver­i­fi­ca­tion and is under­stood to have been reject­ed in April by emi­nent inter­na­tion­al jour­nals such as Nature and the Jour­nal of Virol­o­gy. Bio­med­ical experts from the Fran­cis Crick Insti­tute and Impe­r­i­al Col­lege Lon­don are said to have refut­ed its con­clu­sions. Then one of the paper’s co-authors, Dr John Fredrik Moxnes, chief sci­en­tif­ic advis­er to the Nor­we­gian mil­i­tary, asked for his name to be with­drawn. This week, after numer­ous rewrites, the paper was pub­lished by the Quar­ter­ly Review of Bio­physics Dis­cov­ery. And those orig­i­nal world-shak­ing con­clu­sions have now with­ered to innu­en­do. No accu­sa­tion of Chi­nese manip­u­la­tion appears. . . .”
  4. “. . . . Back in April, a slick­ly pro­duced inves­tiga­tive doc­u­men­tary, Track­ing Down The Ori­gin Of The Wuhan Coro­n­avirus, was released online. It claimed con­clu­sive proof that the Covid-19 virus had been cre­at­ed as a bio­log­i­cal ‘weapon of mass destruc­tion’ in a Chi­nese lab. . . .”
  5. “At first sight, it seemed a shock­ing­ly con­vinc­ing piece of jour­nal­ism. On behalf of this news­pa­per, I cross-checked every claim: The experts it cit­ed and the fac­tu­al evi­dence unearthed. I also researched the back­grounds of its mak­ers. I then approached some of the world’s best inde­pen­dent sci­en­tif­ic author­i­ties to ask their opin­ion. They all agreed – this entic­ing­ly spicy sto­ry just did­n’t stand up.”
  6. “It had been pro­duced by a US based anti-Chi­nese gov­ern­ment media organ­i­sa­tion called the Epoch Times. Its ‘experts’ were vet­er­an hard-Right­ists. Most damn­ing­ly, its sci­en­tif­ic ‘facts’ were twist­ed out of shape.So much, then, for the Chi­nese-man­u­fac­tured coro­n­avirus con­spir­a­cy . . .”

Steve Ban­non is at the epi­cen­ter [12] of the anti-Chi­na effort and–to no one’s sur­prise–nev­er real­ly left [13] the Trump White House.

When assess­ing Ban­non as a polit­i­cal ani­mal, one should nev­er for­get that among the impor­tant ide­o­log­i­cal influ­ences on him is Julius Evola, an Ital­ian fas­cist who found Mus­soli­ni too mod­er­ate and ulti­mate­ly took his cues from the Nazi SS, who were financ­ing his work by the end of World War II.

” . . . . Don­ald Trump’s light­ning-rod 2016 cam­paign boss [14] and for­mer White House chief strate­gist who was ban­ished from the West Wing in 2017 has qui­et­ly crept back into 1600 Penn­syl­va­nia Ave., reestab­lish­ing ties to staffers, par­tic­u­lar­ly with regard to his pet issues of Chi­na and immi­gra­tion. . . . Anoth­er for­mer admin­is­tra­tion offi­cial told The Post that Ban­non nev­er real­ly left the White House after he was fired, main­tain­ing con­tacts and keep­ing up reg­u­lar chan­nels of com­mu­ni­ca­tions with offi­cials there. . . .”

In addi­tion, as dis­cussed in FTR #‘s 1111 and 1112 [15], Ban­non is part of a net­work that includes J. Kyle Bass and Tom­my Hicks, Jr. This nexus involves asym­met­ri­cal invest­ing with regard to the Hong Kong and Chi­nese economies and the inter-agency gov­ern­men­tal net­works involved in both overt and covert anti-Chi­na poli­cies imple­ment­ed by Team Trump. As will be seen below, they also are net­work­ing with the mis-named “Sci­en­tists to Stop Covid-19.” In that regard, they are also help­ing steer pol­i­cy that con­trols devel­op­ment of treat­ment and vac­cines for Covid-19. The man­age­ment of drug and vac­cine devel­op­ment, in turn, dou­bles back to mar­ket-dri­ving invest­ment dynam­ics.

An inter­est­ing sum­ma­tion of char­ac­ter­is­tics of a “delib­er­ate” epi­dem­ic are eval­u­at­ed against the find­ing that New York City was the epi­cen­ter of the U.S. Covid-19 out­break: 

Bit­ten: The Secret His­to­ry of Lyme Dis­ease and Bio­log­i­cal Weapons by Kris New­by; Harper­Collins [HC]; Copy­right 2019 by Kris New­by; ISBN 9780062896728; p. 185. [16]

Poten­tial epi­demi­o­log­i­cal clues to a delib­er­ate epi­dem­ic:

Clue no. 1–A high­ly unusu­al event with large num­bers of casu­al­ties: Check!

Clue no. 2–Higher mor­bid­i­ty or mor­tal­i­ty than is expect­ed. Check!

Clue no. 3–Uncommon dis­ease. Check!

Clue no. 4–Point-source out­break. Check!

Clue no. 5–Multiple epi­demics. Check! (Glob­al pan­dem­ic)

                      –Z. F. Dem­bek, et al., “Dis­cern­ment Between Delib­er­ate and Nat­ur­al Infec­tious Dis­ease Out­breaks”

The pre­vail­ing view of the Covid-19 out­break con­tends that the Amer­i­can out­break spread out­ward [17] from New York City. The strain of SARS CoV‑2 that appeared in New York came, in turn, from Europe. 

This does­n’t make sense. There were con­firmed cas­es of the virus on the West Coast that did not come from New York. A Euro­pean strain of the virus trans­mit­ted to New York City would have come in via air. In such an event, there would have been a well-doc­u­ment­ed out­break of Covid-19 among flight atten­dants, who oper­ate in close con­tact with pas­sen­gers in cramped cir­cum­stances, as well as expe­ri­enc­ing jet lag, which com­pro­mis­es the immune sys­tem.

Next, we review an aspect of the 2001 anthrax attacks [18]. We high­light­ed the 2001 anthrax attacks in con­nec­tion with the Covid-19 out­break in New York City in FTR #1128 [19].

We note that the Anthrax attacks appear to have oper­at­ed in over­lap­ping con­texts, includ­ing jus­ti­fi­ca­tion for the war in Iraq. 

The 2001 anthrax attacks appear to have served as a provo­ca­tion that jus­ti­fied a ten-fold increase in spend­ing for bio­log­i­cal war­fare devel­op­ment. The num­ber of BSL‑4 labs (hav­ing dual civil­ian and mil­i­tary use) increased from two in 2001, to a dozen in 2007.

This increase occurred while Don­ald Rums­feld was George W. Bush’s sec­re­tary of defense. He went to that posi­tion from being Chair­man of the Board of Direc­tors for Gilead Sci­ences, the man­u­fac­tur­er of remde­sivir.

We will delve into the pol­i­tics of the anthrax attacks in the future.

In the con­text of the above arti­cle, note that the Nation­al Insti­tutes of Health have also part­nered with CIA and the Pen­ta­gon, as under­scored by an arti­cle [20] about a BSL‑4 lab at Boston Uni­ver­si­ty. Note that Europe and the U.S. have twelve BSL4 labs apiece. Tai­wan has two. Chi­na has one:

  1. As the arti­cle notes, as of 2007, the U.S. had “more than a dozen” BSL4 labs–China com­mis­sioned its first as of 2017. a ten­fold increase in fund­ing for BSL4 labs occurred because of the anthrax attacks of 2001. Those attacks might be seen as some­thing of a provo­ca­tion, spurring a dra­mat­ic increase in “dual use” biowar­fare research, under the cov­er of “legit­i­mate” medical/scientific research. In FTR #1128 [19], we hypoth­e­sized about the milieu of Stephen Hat­fill and apartheid-linked inter­ests as pos­si­ble authors of a vec­tor­ing of New York City with Sars COV2: ” . . . . Before the anthrax mail­ings of 2001, the Unit­ed States had just two BSL4 labs—both with­in the razor-wire con­fines of gov­ern­ment-owned cam­pus­es. Now, thanks to a ten­fold increase in funding—from $200 mil­lion in 2001 to $2 bil­lion in 2006—more than a dozen such facil­i­ties can be found at uni­ver­si­ties and pri­vate com­pa­nies across the coun­try. . . .”
  2. The Boston Uni­ver­si­ty lab exem­pli­fies the Pen­ta­gon and CIA pres­ence in BSL‑4 facil­i­ty “dual use”: ” . . . . But some sci­en­tists say that argu­ment obscures the true pur­pose of the cur­rent biode­fense boom: to study poten­tial bio­log­i­cal weapons. ‘The uni­ver­si­ty por­trays it as an emerg­ing infec­tious dis­ease lab,’ says David Ozonoff, a Boston Uni­ver­si­ty epi­demi­ol­o­gist whose office is right across the street from the new BSL4 facil­i­ty. ‘But they are talk­ing about study­ing things like small pox and inhala­tion anthrax, which pose no pub­lic health threat oth­er than as bioweapons.’ . . . The orig­i­nal NIH man­date for the lab indi­cat­ed that many groups—including the CIA and Depart­ment of Defense—would be allowed to use the lab for their own research, the nature of which BU might have lit­tle con­trol over. . . .”

Piv­ot­ing to dis­cus­sion and review of the polit­i­cal, finan­cial and cor­po­rate con­nec­tions to the devel­op­ment of med­i­c­i­nal treat­ments for, and vac­cines to pre­vent, Covid-19, we recap details rel­e­vant to the extra­or­di­nary tim­ing of a 4/29 announce­ment of favor­able results for a tri­al of remde­sivir. That announce­ment drove equi­ties mar­kets high­er and was ben­e­fi­cial to the stock of Gilead Sci­ences.

We present a Stat News [21] arti­cle on the inter­nal delib­er­a­tions behind the deci­sions to mod­i­fy the NIAID study. Of par­tic­u­lar sig­nif­i­cance is the DSMB delib­er­a­tion. Note the time­line of the DSMB delib­er­a­tion, com­bined with the announce­ment on 4/29 that drove the mar­kets high­er.

  1. The deci­sion was made to cut it short before the ques­tion of remdesivir’s impact on mor­tal­i­ty could be answered: ” . . . .The Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases has described to STAT in new detail how it made its fate­ful deci­sion: to start giv­ing remde­sivir to patients who had been assigned to receive a place­bo in the study, essen­tial­ly lim­it­ing researchers’ abil­i­ty to col­lect more data about whether the drug saves lives — some­thing the study, called ACTT‑1, sug­gests but does not prove. In the tri­al, 8% of the par­tic­i­pants giv­en remde­sivir died, com­pared with 11.6% of the place­bo group, a dif­fer­ence that was not sta­tis­ti­cal­ly sig­nif­i­cant. A top NIAID offi­cial said he had no regrets about the deci­sion. ‘There cer­tain­ly was una­nim­i­ty with­in the insti­tute that this was the right thing to do,’ said H. Clif­ford Lane, NIAID’s clin­i­cal direc­tor. . . .”
  2. In addi­tion, patients sched­uled to receive place­bo received remde­sivir, instead. ” . . . . Steven Nis­sen, a vet­er­an tri­al­ist and car­di­ol­o­gist at the Cleve­land Clin­ic, dis­agreed that giv­ing place­bo patients remde­sivir was the right call. ‘I believe it is in society’s best inter­est to deter­mine whether remde­sivir can reduce mor­tal­i­ty, and with the release of this infor­ma­tion doing a place­bo-con­trolled tri­al to deter­mine if there is a mor­tal­i­ty ben­e­fit will be very dif­fi­cult,’ he said. ‘The ques­tion is: Was there a route, or is there a route, to deter­mine if the drug can pre­vent death?’ The deci­sion is ‘a lost oppor­tu­ni­ty,’ he said. . . .”
  3. Steven Nis­sen was not alone in his crit­i­cism of the NIAID’s deci­sion. ” . . . .Peter Bach, the direc­tor of the Cen­ter for Health Pol­i­cy and Out­comes at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, agreed with Nis­sen. ‘The core under­stand­ing of clin­i­cal research par­tic­i­pa­tion and clin­i­cal research con­duct is we run the tri­al rig­or­ous­ly to pro­vide the most accu­rate infor­ma­tion about the right treat­ment,’ he said. And that answer, he argued, should ide­al­ly have deter­mined whether remde­sivir saves lives. The rea­son we have shut our whole soci­ety down, Bach said, is not to pre­vent Covid-19 patients from spend­ing a few more days in the hos­pi­tal. It is to pre­vent patients from dying. ‘Mor­tal­i­ty is the right end­point,’ he said. . . .”
  4. Not only was the admin­is­tra­tion of remde­sivir instead of place­bo pri­or­i­tized, but the NIAID study itself was atten­u­at­ed! ” . . . . But the change in the study’s main goal also changed the way the study would be ana­lyzed. Now, the NIAID decid­ed, the analy­sis would be cal­cu­lat­ed when 400 patients out of the 1,063 patients the study enrolled had recov­ered. If remde­sivir turned out to be much more effec­tive than expect­ed, ‘inter­im’ analy­ses would be con­duct­ed at a third and two-thirds that num­ber.The job of review­ing these analy­ses would fall to a com­mit­tee of out­side experts on what is known as an inde­pen­dent data and safe­ty mon­i­tor­ing board, or DSMB. . . .”
  5. The per­for­mance of the DSMB for the remde­sivir study is note­wor­thy: ” . . . . But the DSMB for the remde­sivir study did not ever meet for an inter­im effi­ca­cy analy­sis, Lane said. All patients had been enrolled by April 20. The data for a DSMB meet­ing was cut off on April 22. The DSMB met and, on April 27, it made a rec­om­men­da­tion to the NIAID. . . .”
  6. The DSMB meet­ing on 4/27 deter­mined the switch from place­bo to remde­sivir. Of para­mount impor­tance is the fact that this was JUST BEFORE the 4/29 announce­ment that drove the mar­kets high­er and the same day on which key Trump aide–and for­mer Gilead Sci­ences lob­by­ist Joe Gro­gan resigned! ” . . . . . That deci­sion, Lane said, led the NIAID to con­clude that patients who had been giv­en place­bo should be offered remde­sivir, some­thing that start­ed hap­pen­ing after April 28. . . .”
  7. Dr. Ethan Weiss gave an accu­rate eval­u­a­tion of the NIAID study: ” . . . . ‘We’ve squan­dered an incred­i­ble oppor­tu­ni­ty to do good sci­ence,’ [Dr. Ethan] Weiss said. ‘If we could ever go back and do some­thing all over, it would be the infra­struc­ture to actu­al­ly learn some­thing. Because we’re not learn­ing enough.’ . . . .”

The remark­able han­dling of the NIAID study, the tim­ing of the announce­ment of the alto­geth­er lim­it­ed suc­cess of the atten­u­at­ed tri­al and the rise in equi­ties as a result of the announce­ment may be best under­stood in the con­text of the role played [22] in Trump pan­dem­ic deci­sion-mak­ing by an elite group of bil­lion­aires and scientists–including con­vict­ed felon Michael Milken (the “junk bond king”).

  1. ” . . . . Call­ing them­selves ‘Sci­en­tists to Stop COVID-19,’ the col­lec­tion of top researchers, bil­lion­aires and indus­try cap­tains will act as an ‘ad hoc review board’ for the tor­rent of coro­n­avirus research, ‘weed­ing out’ flawed data before it reach­es pol­i­cy­mak­ersthe Wall Street Jour­nal [23] report­ed on Mon­day. They are also act­ing as a go-between for phar­ma­ceu­ti­cal com­pa­nies seek­ing to build a com­mu­ni­ca­tion chan­nel with Trump admin­is­tra­tion offi­cials. The group . . . . has advised Nick Ayers, an aide to Vice Pres­i­dent Mike Pence [24], as well as oth­er agency heads, in the past month. Pence is head­ing up the White House coro­n­avirus task force. . . .”
  2. ” . . . The brainy bunch is led by Thomas Cahill, a 33-year-old doc­tor who became a ven­ture cap­i­tal­ist . . . . Cahill’s clout comes from build­ing con­nec­tions through his invest­ment firm, New­path Part­ners, with Sil­i­con Valley’s Peter Thiel, the founder of Pay­Pal, and bil­lion­aire busi­ness­men Jim Palot­ta and Michael Milken. . . .”

Note that Peter Thiel played a dom­i­nant role in bankrolling New­path Part­ners, and the oth­er finan­cial angel who ele­vat­ed Cahill–Brian Sheth–intro­duced him to Tom­my Hicks, Jr., [25]the co-chair­man of the RNC. In FTR #‘s 1111 [15] and 1112 [15], we looked at Hicks’ net­work­ing with Steve Ban­non asso­ciate J. Kyle Bass, as well as his role in the inter-agency net­works dri­ving the anti-Chi­na effort.

” . . . . At the helm of the effort: The 33-year-old and very-much-under-the-radar ven­ture cap­i­tal­ist Tom Cahill, who leads life sci­ences-focused New­path Part­ners. Cahill com­plet­ed his M.D. and PhD at Duke Uni­ver­si­ty a mere two years ago before land­ing at blue-chip invest­ment firm Rap­tor Group through a friend. He went on to found New­path with some $125 mil­lion after impress­ing well-con­nect­ed names like ven­ture cap­i­tal­ist Peter Thiel and Vista Equi­ty Part­ners co-founder Bri­an Sheth. . . . It was through Sheth, for exam­ple, that Sci­en­tists to Stop Covid-19 con­nect­ed with the co-chair­man of the Repub­li­can Nation­al Com­mit­tee, Thomas Hicks Jr. . . .”

The fed­er­al gov­ern­men­t’s extreme focus on remde­sivir has been shaped, in large mea­sure [26], by the influ­ence of “Sci­en­tists to Stop COVID-19”:

  1. “Sci­en­tists to Stop Covid-19” is shep­herd­ing remde­sivir: ” . . . . Sci­en­tists to Stop COVID-19 rec­om­mends that in this phase, the U.S. Food and Drug Admin­is­tra­tion (FDA) should work to coor­di­nate with Gilead phar­ma­ceu­ti­cals to focus on expe­dit­ing the results of clin­i­cal tri­als of remde­sivir, a drug iden­ti­fied as a poten­tial treat­ment for COVID-19. The group also rec­om­mends admin­is­ter­ing dos­es of the drug to patients in an ear­ly stage of infec­tion, and notes remde­sivir will essen­tial­ly be a place­hold­er until a more effec­tive treat­ment is pro­duced.
  2. The group is doing so by atten­u­at­ing the reg­u­la­to­ry process for coro­n­avirus drugs: “Gov­ern­ment enti­ties and agen­cies appear to adhere to the rec­om­men­da­tions out­lined by the group, with the Jour­nal report­ing that the FDA and the Depart­ment of Vet­er­ans Affairs (VA) have imple­ment­ed some of the sug­ges­tions, name­ly relax­ing drug man­u­fac­tur­er reg­u­la­tions and require­ments for poten­tial coro­n­avirus treat­ment drugs. . . .”

We con­clude dis­cus­sion of the remde­sivir machi­na­tions with a piece about the tim­ing [27] of the announce­ment of Grogan’s depar­ture.

” . . . . Gro­gan has served as the direc­tor of the White House Domes­tic Pol­i­cy Coun­cil since Feb­ru­ary 2019, over­see­ing a broad array of pol­i­cy issues includ­ing health care and reg­u­la­tion. . . . Gro­gan was one of the orig­i­nal mem­bers of the White House coro­n­avirus task force launched in late Jan­u­ary. . . . Gro­gan worked as a lob­by­ist for drug com­pa­ny Gilead Sci­ences before join­ing the Trump admin­is­tra­tion. . . .”

The depar­ture was announced in the Wall Street Jour­nal on the morn­ing of Wednes­day, April 29, the same day we got our first pub­lic reports of the NIAID clin­i­cal tri­al of remde­sivir that was pos­i­tive enough to show it short­ened the time to recov­ery and the same day the FDA grant­ed remde­sivir emer­gency use sta­tus. 

Note, again, the tim­ing of the DSM­B’s actions, as well as the influ­ence of “Sci­en­tists to Stop Covid-19.”

In FTR #1130 [28], we not­ed that Mon­cef Slaoui–formerly in charge of prod­uct devel­op­ment for Moderna–was cho­sen to head Trump’s “Oper­a­tion Warp Speed.” He will be work­ing with Four-Star Gen­er­al Gus­tave Per­na, cho­sen by Chair­man of the Joint Chiefs of Staff Gen­er­al Mark Mil­ley.

Even after agree­ing to sell his Mod­er­na stock, Mon­cef Slaoui’s invest­ments raise alarm­ing ques­tions [29]–note that he is a “ven­ture cap­i­tal­ist” and a long­time for­mer exec­u­tive at Glaxo-Smithk­line:

  1. The cir­cum­stances of his appoint­ment will per­mit him to avoid scruti­ny: ” . . . . In agree­ing to accept the posi­tion, Dr. Slaoui did not come on board as a gov­ern­ment employ­ee. Instead, he is on a con­tract, receiv­ing $1 for his ser­vice. That leaves him exempt from fed­er­al dis­clo­sure rules that would require him to list his out­side posi­tions, stock hold­ings and oth­er poten­tial con­flicts. And the con­tract posi­tion is not sub­ject to the same con­flict-of-inter­est laws and reg­u­la­tions that exec­u­tive branch employ­ees must fol­low. . . .”
  2. He will retain a great deal of Glaxo-Smithk­line stock: ” . . . . He did not say how much his GSK shares were worth. When he left the com­pa­ny in 2017, he held about [500,000 in West­ern Print Edi­tion] 240,000 shares and share equiv­a­lents, accord­ing to the drug company’s annu­al report and an analy­sis by the exec­u­tive com­pen­sa­tion firm Equi­lar. . . .”
  3. Fur­ther analy­sis of Slaoui’s posi­tion deep­ens con­cern about the integri­ty of the process: ” . . . . ‘This is basi­cal­ly absurd,’ said Vir­ginia Can­ter, who is chief ethics coun­sel for Cit­i­zens for Respon­si­bil­i­ty and Ethics in Wash­ing­ton. ‘It allows for no pub­lic scruti­ny of his con­flicts of inter­est.’ Ms. Can­ter also said fed­er­al law barred gov­ern­ment con­trac­tors from super­vis­ing gov­ern­ment employ­ees. . . . Ms. Can­ter, a for­mer ethics lawyer in the Oba­ma and Clin­ton admin­is­tra­tions, the Secu­ri­ties and Exchange Com­mis­sion and oth­er agen­cies, point­ed out that GSK’s vac­cine can­di­date with Sanofi could wind up com­pet­ing with oth­er man­u­fac­tur­ers vying for gov­ern­ment approval and sup­port. ‘If he retains stock in com­pa­nies that are invest­ing in the devel­op­ment of a vac­cine, and he’s involved in over­see­ing this process to select the safest vac­cine to com­bat Covid-19, regard­less of how won­der­ful a per­son he is, we can’t be con­fi­dent of the integri­ty of any process in which he is involved,’ Ms. Can­ter said.In addi­tion, his affil­i­a­tion with Medicxi could com­pli­cate mat­ters: Two of its investors [30] are GSK and a divi­sion of John­son & John­son, which is also devel­op­ing a poten­tial vac­cine. . . .”

Next, we turn to Mod­er­na’s ani­mal tri­al [31] for the mes­sen­ger RNA vac­cine it is devel­op­ing. There are sev­er­al con­sid­er­a­tions to be weighed in con­nec­tion with the Mod­er­na vac­cine.

  1. Again, the chair­man of Trump’s “Warp Speed” vac­cine devel­op­ment program–Moncef Slaoui–was in charge of Mod­er­na’s prod­uct devel­op­ment oper­a­tion.
  2. Mod­er­na’s tri­al with mice was pos­i­tive with regard to gen­er­at­ing anti­body lev­els high enough to pre­vent ADE.
  3. Anti­body Depen­dent Enhance­ment (ADE), [32]  is a phe­nom­e­na where low lev­els of inef­fec­tive anti­bod­ies latch onto the virus and exac­er­bate an over­ac­tive immune response that leads to the dead­liest symp­toms likes cytokine-storms. This dan­ger was seen with SARS and attempts to cre­ate a SARS vac­cine so it’s a rea­son­able fear with SARS-CoV­‑2.
  4. The Phase III [33] (human) tri­al is going to be start­ed in July, involv­ing 30,000 peo­ple. Alarm­ing­ly, those 30,000 peo­ple will all be receiv­ing the exact same dosage, 100 micro­grams, and that means the phase III tri­al won’t be test­ing sub-opti­mal dosages. The big Phase III tri­al won’t be test­ing for ADE in humans. 
  5. We may have a night­mare sit­u­a­tion where polit­i­cal pres­sure gives undo weight to ani­mal safe­ty results, leapfrog­ging over the neces­si­ty of test­ing for side effects. 
  6. The ani­mal tri­als have been severe­ly crit­i­cized: ” . . . . ‘This is the barest begin­ning of pre­lim­i­nary infor­ma­tion,’ said Dr. Gre­go­ry Poland, an immu­nol­o­gist and vac­cine researcher at the Mayo Clin­ic who has seen the paper, which has yet to under­go peer-review. Poland said the paper was incom­plete, dis­or­ga­nized and the num­bers of ani­mals test­ed were small. . . . Poland, who was not involved with the research, said the paper leaves out ‘impor­tant para­me­ters’ that could help sci­en­tists judge the work. . . .”
  7. We MIGHT cre­ate a vac­cine that pro­tects those who get a strong immune response while endan­ger­ing those with sub-pro­tec­tive responses–a “eugenic” vac­cine.
  8. ” . . . . ‘This is the barest begin­ning of pre­lim­i­nary infor­ma­tion,’ said Dr. Gre­go­ry Poland, an immu­nol­o­gist and vac­cine researcher at the Mayo Clin­ic who has seen the paper, which has yet to under­go peer-review. Poland said the paper was incom­plete, dis­or­ga­nized and the num­bers of ani­mals test­ed were small. . . . Poland, who was not involved with the research, said the paper leaves out ‘impor­tant para­me­ters’ that could help sci­en­tists judge the work. . . .”
  9. The phase II clin­i­cal tri­als on humans are still under­way and won’t be com­plet­ed before Novem­ber.  Phase III is going to be get­ting under­way in July. The Human clin­i­cal tri­als are already under­way at the same time the ani­mal safe­ty tri­als have yet to be com­plet­ed.
  10. Side effects can take a while to man­i­fest.

We pro­vid­ed detailed crit­i­cal com­ments on Mod­er­na’s Phase I tri­al in FTR #1132 [34].

We con­clude with a New York Times [35] arti­cle sets forth a “Vac­cine Octo­ber Sur­prise” sce­nario for this fall.

” . . . . In a des­per­ate search for a boost, he could release a coro­n­avirus vac­cine that has not been shown to be safe and effec­tive as an Octo­ber sur­prise. Oct. 23, 2020, 9 a.m., with 10 days before the elec­tion, Fox New releas­es a poll show­ing Pres­i­dent Trump trail­ing Joe Biden by eight per­cent­age points. Oct. 23, 2020, 3 p.m., at a hasti­ly con­vened news con­fer­ence, Pres­i­dent Trump announces that the Food and Drug Admin­is­tra­tion has just issued an Emer­gency Use Autho­riza­tion for a coro­n­avirus vac­cine. Mr. Trump declares vic­to­ry over Covid-19, demands that all busi­ness­es reopen imme­di­ate­ly and pre­dicts a rapid eco­nom­ic recov­ery. Giv­en how this pres­i­dent has behaved, this incred­i­bly dan­ger­ous sce­nario is not far-fetched. In a des­per­ate search for a polit­i­cal boost, he could release a coro­n­avirus vac­cine before it had been thor­ough­ly test­ed and shown to be safe and effec­tive. . . .”

1. A Dai­ly Mail Online [UK] [7]arti­cle sets forth two bogus papers con­tend­ing that the SARS CoV‑2 virus was genet­i­cal­ly engi­neered by the Chi­nese as a bioweapon in a lab­o­ra­to­ry and that it “escaped.” Note the cham­pi­oning of one of the papers by a for­mer head of MI6 and the author­ship of the sec­ond by The Epoch Times, the paper of the Falun Gong cult. Linked to CIA, Steve Ban­non’s anti-Chi­na milieu and the Trump admin­is­tra­tion, the orga­ni­za­tion is a fas­cist mind con­trol cult dis­cussed in numer­ous shows, includ­ing FTR #‘s 1089 [8] and 1090 [9]

  1. “A for­mer MI6 chief was yes­ter­day accused by Gov­ern­ment offi­cials of ped­dling ‘fan­ci­ful claims’ that coro­n­avirus [10] was acci­den­tal­ly cre­at­ed in a Chi­nese lab­o­ra­to­ry. British secu­ri­ty agen­cies believe Covid-19 is not a man-made virus and is ‘high­ly like­ly’ to have occurred nat­u­ral­ly and spread to humans through ani­mals. And Health Sec­re­tary Matt Han­cock [11] has said there is ‘no evi­dence’ to back up the the­o­ry that it orig­i­nat­ed in a lab­o­ra­to­ry. But Sir Richard Dearlove, who was head of the MI6 from 1999 to 2004, cit­ed a recent report claim­ing the dis­ease was acci­den­tal­ly man­u­fac­tured by Chi­nese sci­en­tists.
  2. “ ‘I do think that this start­ed as an acci­dent,’ Sir Richard told The Dai­ly Telegraph’s ‘Plan­et Nor­mal’ pod­cast. ‘It rais­es the issue: if Chi­na ever were to admit respon­si­bil­i­ty, does it pay repa­ra­tions? I think it will make every coun­try in the world rethink how it treats its rela­tion­ship with Chi­na.’ He added: ‘Look at the sto­ries... of attempts by the [Bei­jing] lead­er­ship to lock down any debate about the ori­gins of the pan­dem­ic and the way peo­ple have been arrest­ed or silenced.’ . . . . The paper – co-authored by Pro­fes­sor Angus Dal­gleish, a renowned oncol­o­gist and vac­cine researcher who works at St George’s Hos­pi­tal, Uni­ver­si­ty of Lon­don, and Birg­er Sorensen, a Nor­we­gian virol­o­gist – con­tains none of the stark alle­ga­tions that orig­i­nal­ly stunned its review­ers.
  3. “The ini­tial paper that trig­gered wild rumours failed strin­gent tests of ver­i­fi­ca­tion and is under­stood to have been reject­ed in April by emi­nent inter­na­tion­al jour­nals such as Nature and the Jour­nal of Virol­o­gy. Bio­med­ical experts from the Fran­cis Crick Insti­tute and Impe­r­i­al Col­lege Lon­don are said to have refut­ed its con­clu­sions. Then one of the paper’s co-authors, Dr John Fredrik Moxnes, chief sci­en­tif­ic advis­er to the Nor­we­gian mil­i­tary, asked for his name to be with­drawn. This week, after numer­ous rewrites, the paper was pub­lished by the Quar­ter­ly Review of Bio­physics Dis­cov­ery. And those orig­i­nal world-shak­ing con­clu­sions have now with­ered to innu­en­do. No accu­sa­tion of Chi­nese manip­u­la­tion appears. . . .”
  4. “. . . . Back in April, a slick­ly pro­duced inves­tiga­tive doc­u­men­tary, Track­ing Down The Ori­gin Of The Wuhan Coro­n­avirus, was released online. It claimed con­clu­sive proof that the Covid-19 virus had been cre­at­ed as a bio­log­i­cal ‘weapon of mass destruc­tion’ in a Chi­nese lab. . . .”
  5. “At first sight, it seemed a shock­ing­ly con­vinc­ing piece of jour­nal­ism. On behalf of this news­pa­per, I cross-checked every claim: The experts it cit­ed and the fac­tu­al evi­dence unearthed. I also researched the back­grounds of its mak­ers. I then approached some of the world’s best inde­pen­dent sci­en­tif­ic author­i­ties to ask their opin­ion. They all agreed – this entic­ing­ly spicy sto­ry just did­n’t stand up.”
  6. “It had been pro­duced by a US based anti-Chi­nese gov­ern­ment media organ­i­sa­tion called the Epoch Times. Its ‘experts’ were vet­er­an hard-Right­ists. Most damn­ing­ly, its sci­en­tif­ic ‘facts’ were twist­ed out of shape.So much, then, for the Chi­nese-man­u­fac­tured coro­n­avirus con­spir­a­cy . . .”

“Spy chief in coro­n­avirus storm: Down­ing Street hits out at for­mer MI6 boss Richard Dearlove’s ‘fan­ci­ful’ claims that Covid-19 was made in a lab” by Lar­isa Brown; The Dai­ly Mail; 6/4/2020. [7]

A for­mer MI6 chief was yes­ter­day accused by Gov­ern­ment offi­cials of ped­dling ‘fan­ci­ful claims’ that coro­n­avirus [10] was acci­den­tal­ly cre­at­ed in a Chi­nese lab­o­ra­to­ry.

British secu­ri­ty agen­cies believe Covid-19 is not a man-made virus and is ‘high­ly like­ly’ to have occurred nat­u­ral­ly and spread to humans through ani­mals.

And Health Sec­re­tary Matt Han­cock [11] has said there is ‘no evi­dence’ to back up the the­o­ry that it orig­i­nat­ed in a lab­o­ra­to­ry.

But Sir Richard Dearlove, who was head of the MI6 from 1999 to 2004, cit­ed a recent report claim­ing the dis­ease was acci­den­tal­ly man­u­fac­tured by Chi­nese sci­en­tists.

‘I do think that this start­ed as an acci­dent,’ Sir Richard told The Dai­ly Telegraph’s “Plan­et Nor­mal” pod­cast.

‘It rais­es the issue: if Chi­na ever were to admit respon­si­bil­i­ty, does it pay repa­ra­tions? I think it will make every coun­try in the world rethink how it treats its rela­tion­ship with Chi­na.’ He added: ‘Look at the sto­ries... of attempts by the [Bei­jing] lead­er­ship to lock down any debate about the ori­gins of the pan­dem­ic and the way peo­ple have been arrest­ed or silenced.’

Sir Richard cit­ed a report by Pro­fes­sor Angus Dal­gleish, from St George’s Hos­pi­tal, Uni­ver­si­ty of Lon­don, and Nor­we­gian virol­o­gist Birg­er Sorensen, which claims the virus was man­u­fac­tured in a lab­o­ra­to­ry, say­ing the study was a ‘very impor­tant con­tri­bu­tion to a debate which is now start­ing about how the virus evolved and how it got out and broke out as a pan­dem­ic.’

The study claims to have iden­ti­fied ‘insert­ed sec­tions’ on the sur­face of the Covid-19 virus that were ‘sig­nif­i­cant­ly dif­fer­ent’ from any oth­er sim­i­lar bug they had stud­ied.

But the Prime Min­is­ter’s spokesman slapped down Sir Richard’s com­ments, say­ing: ‘We’ve seen no evi­dence the virus is man-made.’ And a Gov­ern­ment offi­cial added: ‘These are fan­ci­ful claims. World lead­ing sci­en­tists in the UK, US and the World Health Organ­i­sa­tion have said numer­ous times... the virus was nat­ur­al in its ori­gin and like­ly moved into the human pop­u­la­tion through nat­ur­al trans­fer from ani­mals – not through a spe­cif­ic acci­dent or man-made inci­dent.’ . . . .

. . . . Back in April, a slick­ly pro­duced inves­tiga­tive doc­u­men­tary, Track­ing Down The Ori­gin Of The Wuhan Coro­n­avirus, was released online. It claimed con­clu­sive proof that the Covid-19 virus had been cre­at­ed as a bio­log­i­cal ‘weapon of mass destruc­tion’ in a Chi­nese lab.

At first sight, it seemed a shock­ing­ly con­vinc­ing piece of jour­nal­ism.

On behalf of this news­pa­per, I cross-checked every claim: The experts it cit­ed and the fac­tu­al evi­dence unearthed. I also researched the back­grounds of its mak­ers.

I then approached some of the world’s best inde­pen­dent sci­en­tif­ic author­i­ties to ask their opin­ion. They all agreed – this entic­ing­ly spicy sto­ry just did­n’t stand up.

It had been pro­duced by a US based anti-Chi­nese gov­ern­ment media organ­i­sa­tion called the Epoch Times. Its ‘experts’ were vet­er­an hard-Right­ists. Most damn­ing­ly, its sci­en­tif­ic ‘facts’ were twist­ed out of shape.

So much, then, for the Chi­nese-man­u­fac­tured coro­n­avirus con­spir­a­cy... Well, not quite. Around the time I was research­ing the film, I became aware of rumours emerg­ing about a ‘block­buster’ piece of bio­log­i­cal sci­ence by British and Nor­we­gian inves­ti­ga­tors to be pub­lished in a rep­utable jour­nal.

Experts who were sent the paper for ‘peer review’ pri­or to pub­li­ca­tion were astound­ed because it claimed to have estab­lished ‘beyond rea­son­able doubt that Covid-19 is an engi­neered virus’.

The authors alleged the Covid-19 virus had ‘unique fin­ger­prints’ that could not have evolved nat­u­ral­ly, and were ‘indica­tive of pur­po­sive manip­u­la­tion’.

In oth­er words, some­one had man­u­fac­tured this virus. Who exact­ly? The paper report­ed­ly con­clud­ed Covid-19 should cor­rect­ly be called the ‘Wuhan virus’.

When the paper was final­ly pub­lished this week, it sparked glob­al head­lines, large­ly thanks to for­mer head of MI6, Sir Richard Dearlove. In a news­pa­per pod­cast inter­view he claimed the research was smok­ing-gun evi­dence the virus pan­dem­ic had ‘start­ed as an acci­dent’ when a man-made virus escaped from a Chi­nese lab.

The paper – co-authored by Pro­fes­sor Angus Dal­gleish, a renowned oncol­o­gist and vac­cine researcher who works at St George’s Hos­pi­tal, Uni­ver­si­ty of Lon­don, and Birg­er Sorensen, a Nor­we­gian virol­o­gist – con­tains none of the stark alle­ga­tions that orig­i­nal­ly stunned its review­ers.

The ini­tial paper that trig­gered wild rumours failed strin­gent tests of ver­i­fi­ca­tion and is under­stood to have been reject­ed in April by emi­nent inter­na­tion­al jour­nals such as Nature and the Jour­nal of Virol­o­gy. Bio­med­ical experts from the Fran­cis Crick Insti­tute and Impe­r­i­al Col­lege Lon­don are said to have refut­ed its con­clu­sions.

Then one of the paper’s co-authors, Dr John Fredrik Moxnes, chief sci­en­tif­ic advis­er to the Nor­we­gian mil­i­tary, asked for his name to be with­drawn. This week, after numer­ous rewrites, the paper was pub­lished by the Quar­ter­ly Review of Bio­physics Dis­cov­ery. And those orig­i­nal world-shak­ing con­clu­sions have now with­ered to innu­en­do. No accu­sa­tion of Chi­nese manip­u­la­tion appears.

The rewrit­ten paper describes the virus as a ‘chimera’ – this means it con­tains the viral genet­ic mate­r­i­al of more than one virus. This may occur nat­u­ral­ly when two virus­es infect a liv­ing crea­ture at the same time.

It is the rea­son lead­ing inves­ti­ga­tors believe that the Covid-19 virus acquired its pan­dem­ic pow­ers by jump­ing between species.

The oth­er def­i­n­i­tion of a ‘chimera virus’ is one that has been cre­at­ed in a lab as a bioweapon, but the pub­lished paper only vague­ly implies foul play. In con­clu­sion, the paper argues that: ‘A com­pre­hen­sive analy­sis of the aeti­ol­o­gy of the tar­get virus is pre­req­ui­site, not option­al’. ‘Aeti­ol­o­gy’ is defined in med­ical terms as ‘the cause or ori­gin’. In oth­er words, Pro­fes­sor Dal­gleish and his col­league are demand­ing to know where Covid-19 came from. . . .

2. Steve Ban­non is at the epi­cen­ter [12] of the anti-Chi­na effort and–to no one’s surprise–never real­ly left the Trump White House.

When assess­ing Ban­non as a polit­i­cal ani­mal, one should nev­er for­get that among the impor­tant ide­o­log­i­cal influ­ences on him is Julius Evola, an Ital­ian fas­cist who found Mus­soli­ni too mod­er­ate and ulti­mate­ly took his cues from the Nazi SS, who were financ­ing his work by the end of World War II.

” . . . . Don­ald Trump’s light­ning-rod 2016 cam­paign boss [14] and for­mer White House chief strate­gist who was ban­ished from the West Wing in 2017 has qui­et­ly crept back into 1600 Penn­syl­va­nia Ave., reestab­lish­ing ties to staffers, par­tic­u­lar­ly with regard to his pet issues of Chi­na and immi­gra­tion. . . . Anoth­er for­mer admin­is­tra­tion offi­cial told The Post that Ban­non nev­er real­ly left the White House after he was fired, main­tain­ing con­tacts and keep­ing up reg­u­lar chan­nels of com­mu­ni­ca­tions with offi­cials there. . . .”

“Steve Ban­non Is Qui­et­ly Creep­ing Back into the White House” by Jon Levine; The New York Post; 5/9/2020. [13]

. . . . Don­ald Trump’s light­ning-rod 2016 cam­paign boss [14] and for­mer White House chief strate­gist who was ban­ished from the West Wing in 2017 has qui­et­ly crept back into 1600 Penn­syl­va­nia Ave., reestab­lish­ing ties to staffers, par­tic­u­lar­ly with regard to his pet issues of Chi­na and immi­gra­tion.

“He does have rela­tion­ships there. No ques­tion about it,” a per­son with knowl­edge of the sit­u­a­tion told The Post. “You know who runs the trade and Chi­na pol­i­cy work in the White House. You know who runs the immi­gra­tion side of things, those are the peo­ple Steve is talk­ing to.” . . . .

. . . . Anoth­er for­mer admin­is­tra­tion offi­cial told The Post that Ban­non nev­er real­ly left the White House after he was fired, main­tain­ing con­tacts and keep­ing up reg­u­lar chan­nels of com­mu­ni­ca­tions with offi­cials there. . . .

3. An inter­est­ing sum­ma­tion of char­ac­ter­is­tics of a “delib­er­ate” epi­dem­ic are eval­u­at­ed against the find­ing that New York City was the epi­cen­ter of the U.S. Covid-19 out­break: 

Bit­ten: The Secret His­to­ry of Lyme Dis­ease and Bio­log­i­cal Weapons by Kris New­by; Harper­Collins [HC]; Copy­right 2019 by Kris New­by; ISBN 9780062896728; p. 185. [16]

Poten­tial epi­demi­o­log­i­cal clues to a delib­er­ate epi­dem­ic:

Clue no. 1–A high­ly unusu­al event with large num­bers of casu­al­ties: Check!

Clue no. 2–Higher mor­bid­i­ty or mor­tal­i­ty than is expect­ed. Check!

Clue no. 3–Uncommon dis­ease. Check!

Clue no. 4–Point-source out­break. Check!

Clue no. 5–Multiple epi­demics. Check! (Glob­al pan­dem­ic)

                      –Z. F. Dem­bek, et al., “Dis­cern­ment Between Delib­er­ate and Nat­ur­al Infec­tious Dis­ease Out­breaks”

4. The pre­vail­ing view of the Covid-19 out­break con­tends that the Amer­i­can out­break spread out­ward from New York City. The strain of SARS CoV‑2 that appeared in New York came, in turn, from Europe. 

This does­n’t make sense. There were con­firmed cas­es of the virus on the West Coast that did not come from New York. A Euro­pean strain of the virus trans­mit­ted to New York City would have come in via air. In such an event, there would have been a well-doc­u­ment­ed out­break of Covid-19 among flight atten­dants, who oper­ate in close con­tact with pas­sen­gers in cramped cir­cum­stances, as well as expe­ri­enc­ing jet lag, which com­pro­mis­es the immune sys­tem.

“Trav­el From New York City Seed­ed U.S. Out­breaks” by Bene­dict Carey and James Glanz; The New York Times; 5/7/2020. [17]

New York City’s coro­n­avirus [36] out­break grew so large by ear­ly March that the city became the pri­ma­ry source of new infec­tions in the Unit­ed States, new research reveals, as thou­sands of infect­ed peo­ple trav­eled from the city and seed­ed out­breaks around the coun­try.

The research indi­cates that a wave of infec­tions swept from New York City through much of the coun­try before the city began set­ting social dis­tanc­ing lim­its to stop the growth. That helped to fuel out­breaks in Louisiana, Texas, Ari­zona and as far away as the West Coast.

The find­ings are drawn from geneti­cists’ track­ing sig­na­ture muta­tions of the virus, trav­el his­to­ries of infect­ed peo­ple and mod­els of the out­break by infec­tious dis­ease experts. . . .

5. We note that the Anthrax attacks appear to have oper­at­ed in over­lap­ping con­texts, includ­ing jus­ti­fi­ca­tion for the war in Iraq. 

The 2001 anthrax attacks appear to have served as a provo­ca­tion that jus­ti­fied a ten-fold increase in spend­ing for bio­log­i­cal war­fare devel­op­ment. The num­ber of BSL‑4 labs (hav­ing dual civil­ian and mil­i­tary use) increased from two in 2001, to a dozen in 2007.

This increase occurred while Don­ald Rums­feld was George W. Bush’s sec­re­tary of defense. He went to that posi­tion from being Chair­man of the Board of Direc­tors for Gilead Sci­ences, the man­u­fac­tur­er of remde­sivir.

We will delve into the pol­i­tics of the anthrax attacks in the future.

We high­light­ed the 2001 anthrax attacks in con­nec­tion with the Covid-19 out­break in New York City in FTR #1128 [19].

“The Mes­sage in the Anthrax” by Don Fos­ter; Van­i­ty Fair; Octo­ber 2003; pp. 188–200. [18]

. . . . Patrick’s B.g. sam­ple was puri­fied to a tril­lion spores per gram — near the the­o­ret­i­cal lim­it — and bet­ter than any­thing ever pro­duced by Iraq, South Africa, or the Sovi­et Union. An untrained eye could not dif­fer­en­ti­ate it from the anthrax pow­der that Patrick had pro­duced in 1959. The pur­pose of the exer­cise at Dug­way, how­ev­er, was defen­sive: to pre­pare our nation for a bioter­ror attack.

In April 1999, Patrick told Fox News that in two years there will be an attack with a sophis­ti­cat­ed agent man­u­fac­tured over­seas. His pre­dic­tion was not far off the mark.

By Octo­ber 12, 2001, the press was report­ing that Bob Stevens (case 5 [37]), the 63-year old tabloid pho­to edi­tor at Amer­i­can Media Inc. in Boca Raton, Flori­da, who had mys­te­ri­ous­ly suc­cumbed to inhala­tion­al anthrax on Octo­ber 5, had been infect­ed at work. (Inhala­tion­al anthrax comes from breath­ing in spores, and is far dead­lier than the cuta­neous form of the dis­ease, which is usu­al­ly con­tract­ed through cuts and scratch­es in the skin.) Spores were found through­out the A.M.I. build­ing, with hot spots in the mail­room and on the vic­tim’s key­board. . . .

. . . . Pow­der sam­ples from both the Brokaw and Daschle let­ters were couri­ered to Fort Det­rick, head­quar­ters of the U.S. Army Med­ical Research Insti­tute of Infec­tious Dis­eases (USAMRIID), in Fred­er­ick, Mary­land. The USAMRIID sci­en­tists were alarmed by what they dis­cov­ered. It was the same stuff that had killed Bob Stevens, the tabloid pho­to edi­tor, in Flori­da: the Ames strain, used in the U.S. biode­fense pro­gram. The dis­tri­b­u­tion of Ames, reg­u­lat­ed by USAMRIID, was lim­it­ed to about a dozen labs under tight secu­ri­ty con­trols. More­over, the anthrax had been weaponized, refined to its most lethal par­ti­cle size of one to three microns. Most aston­ish­ing was its puri­ty: the pow­der had been con­cen­trat­ed to a tril­lion spores per gram. . . .

. . . . Sev­er­al of Amer­i­ca’s bioweaponeers have said, for the record, that the anthrax attack has an upside. The killings have forced long-await­ed F.D.A. approval of the Bio­port anthrax vac­cine facil­i­ty and prompt­ed increased fed­er­al spend­ing on biode­fense — by $6 bil­lion in 2003 alone. But the anthrax offend­er also divert­ed law-enforce­ment resources when we need­ed them most and wreaked hav­oc on the U.S. Postal Ser­vice. He has shown the world how to dis­rupt the Amer­i­can econ­o­my with min­i­mal expense, and how to kill with min­i­mal risk of being caught.

Now that it“s been done once, it seems like­ly to hap­pen again. . . .

6. In the con­text of the above arti­cle, note that the Nation­al Insti­tutes of Health have also part­nered with CIA and the Pen­ta­gon, as under­scored by an arti­cle [20] about a BSL‑4 lab at Boston Uni­ver­si­ty. Note that Europe and the U.S. have twelve BSL4 labs apiece. Tai­wan has two. Chi­na has one:

  1. As the arti­cle notes, as of 2007, the U.S. had “more than a dozen” BSL4 labs–China com­mis­sioned its first as of 2017. a ten­fold increase in fund­ing for BSL4 labs occurred because of the anthrax attacks of 2001. Those attacks might be seen as some­thing of a provo­ca­tion, spurring a dra­mat­ic increase in “dual use” biowar­fare research, under the cov­er of “legit­i­mate” medical/scientific research. In FTR #1128 [19], we hypoth­e­sized about the milieu of Stephen Hat­fill and apartheid-linked inter­ests as pos­si­ble authors of a vec­tor­ing of New York City with Sars COV2: ” . . . . Before the anthrax mail­ings of 2001, the Unit­ed States had just two BSL4 labs—both with­in the razor-wire con­fines of gov­ern­ment-owned cam­pus­es. Now, thanks to a ten­fold increase in funding—from $200 mil­lion in 2001 to $2 bil­lion in 2006—more than a dozen such facil­i­ties can be found at uni­ver­si­ties and pri­vate com­pa­nies across the coun­try. . . .”
  2. The Boston Uni­ver­si­ty lab exem­pli­fies the Pen­ta­gon and CIA pres­ence in BSL‑4 facil­i­ty “dual use”: ” . . . . But some sci­en­tists say that argu­ment obscures the true pur­pose of the cur­rent biode­fense boom: to study poten­tial bio­log­i­cal weapons. ‘The uni­ver­si­ty por­trays it as an emerg­ing infec­tious dis­ease lab,’ says David Ozonoff, a Boston Uni­ver­si­ty epi­demi­ol­o­gist whose office is right across the street from the new BSL4 facil­i­ty. ‘But they are talk­ing about study­ing things like small pox and inhala­tion anthrax, which pose no pub­lic health threat oth­er than as bioweapons.’ . . . The orig­i­nal NIH man­date for the lab indi­cat­ed that many groups—including the CIA and Depart­ment of Defense—would be allowed to use the lab for their own research, the nature of which BU might have lit­tle con­trol over. . . .”

“High-Stakes Sci­ence” by Jeneen Inter­lan­di; Newsweek; 12/05/2007. [20]

. . . . Before the anthrax mail­ings of 2001, the Unit­ed States had just two BSL4 labs—both with­in the razor-wire con­fines of gov­ern­ment-owned cam­pus­es. Now, thanks to a ten­fold increase in funding—from $200 mil­lion in 2001 to $2 bil­lion in 2006—more than a dozen such facil­i­ties can be found at uni­ver­si­ties and pri­vate com­pa­nies across the coun­try. . . .

. . . . But some sci­en­tists say that argu­ment obscures the true pur­pose of the cur­rent biode­fense boom: to study poten­tial bio­log­i­cal weapons. “The uni­ver­si­ty por­trays it as an emerg­ing infec­tious dis­ease lab,” says David Ozonoff, a Boston Uni­ver­si­ty epi­demi­ol­o­gist whose office is right across the street from the new BSL4 facil­i­ty. “But they are talk­ing about study­ing things like small pox and inhala­tion anthrax, which pose no pub­lic health threat oth­er than as bioweapons.” And when it comes to ter­ror­ism, Ozonoff says, more labs will only increase the threat of an attack. “There has been one seri­ous bioter­ror inci­dent,” he says. “That was anthrax, and it came from a biode­fense lab.” While the uni­ver­si­ty has repeat­ed­ly stat­ed that the new facil­i­ty will not house bioweapons research, that might not be a promise it can keep. The orig­i­nal NIH man­date for the lab indi­cat­ed that many groups—including the CIA and Depart­ment of Defense—would be allowed to use the lab for their own research, the nature of which BU might have lit­tle con­trol over. . . .

7a. Piv­ot­ing to dis­cus­sion and review of the polit­i­cal, finan­cial and cor­po­rate con­nec­tions to the devel­op­ment of med­i­c­i­nal treat­ments for, and vac­cines to pre­vent, Covid-19, we recap details rel­e­vant to the extra­or­di­nary tim­ing of a 4/29 announce­ment of favor­able results for a tri­al of remde­sivir. That announce­ment drove equi­ties mar­kets high­er and was ben­e­fi­cial to the stock of Gilead Sci­ences.

We present a Stat News [21] arti­cle on the inter­nal delib­er­a­tions behind the deci­sions to mod­i­fy the NIAID study. Of par­tic­u­lar sig­nif­i­cance is the DSMB delib­er­a­tion. Note the time­line of the DSMB delib­er­a­tion, com­bined with the announce­ment on 4/29 that drove the mar­kets high­er.

  1. The deci­sion was made to cut it short before the ques­tion of remdesivir’s impact on mor­tal­i­ty could be answered: ” . . . .The Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases has described to STAT in new detail how it made its fate­ful deci­sion: to start giv­ing remde­sivir to patients who had been assigned to receive a place­bo in the study, essen­tial­ly lim­it­ing researchers’ abil­i­ty to col­lect more data about whether the drug saves lives — some­thing the study, called ACTT‑1, sug­gests but does not prove. In the tri­al, 8% of the par­tic­i­pants giv­en remde­sivir died, com­pared with 11.6% of the place­bo group, a dif­fer­ence that was not sta­tis­ti­cal­ly sig­nif­i­cant. A top NIAID offi­cial said he had no regrets about the deci­sion. ‘There cer­tain­ly was una­nim­i­ty with­in the insti­tute that this was the right thing to do,’ said H. Clif­ford Lane, NIAID’s clin­i­cal direc­tor. . . .”
  2. In addi­tion, patients sched­uled to receive place­bo received remde­sivir, instead. ” . . . . Steven Nis­sen, a vet­er­an tri­al­ist and car­di­ol­o­gist at the Cleve­land Clin­ic, dis­agreed that giv­ing place­bo patients remde­sivir was the right call. ‘I believe it is in society’s best inter­est to deter­mine whether remde­sivir can reduce mor­tal­i­ty, and with the release of this infor­ma­tion doing a place­bo-con­trolled tri­al to deter­mine if there is a mor­tal­i­ty ben­e­fit will be very dif­fi­cult,’ he said. ‘The ques­tion is: Was there a route, or is there a route, to deter­mine if the drug can pre­vent death?’ The deci­sion is ‘a lost oppor­tu­ni­ty,’ he said. . . .”
  3. Steven Nis­sen was not alone in his crit­i­cism of the NIAID’s deci­sion. ” . . . .Peter Bach, the direc­tor of the Cen­ter for Health Pol­i­cy and Out­comes at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, agreed with Nis­sen. ‘The core under­stand­ing of clin­i­cal research par­tic­i­pa­tion and clin­i­cal research con­duct is we run the tri­al rig­or­ous­ly to pro­vide the most accu­rate infor­ma­tion about the right treat­ment,’ he said. And that answer, he argued, should ide­al­ly have deter­mined whether remde­sivir saves lives. The rea­son we have shut our whole soci­ety down, Bach said, is not to pre­vent Covid-19 patients from spend­ing a few more days in the hos­pi­tal. It is to pre­vent patients from dying. ‘Mor­tal­i­ty is the right end­point,’ he said. . . .”
  4. Not only was the admin­is­tra­tion of remde­sivir instead of place­bo pri­or­i­tized, but the NIAID study itself was atten­u­at­ed! ” . . . . But the change in the study’s main goal also changed the way the study would be ana­lyzed. Now, the NIAID decid­ed, the analy­sis would be cal­cu­lat­ed when 400 patients out of the 1,063 patients the study enrolled had recov­ered. If remde­sivir turned out to be much more effec­tive than expect­ed, ‘inter­im’ analy­ses would be con­duct­ed at a third and two-thirds that num­ber.The job of review­ing these analy­ses would fall to a com­mit­tee of out­side experts on what is known as an inde­pen­dent data and safe­ty mon­i­tor­ing board, or DSMB. . . .”
  5. The per­for­mance of the DSMB for the remde­sivir study is note­wor­thy: ” . . . . But the DSMB for the remde­sivir study did not ever meet for an inter­im effi­ca­cy analy­sis, Lane said. All patients had been enrolled by April 20. The data for a DSMB meet­ing was cut off on April 22. The DSMB met and, on April 27, it made a rec­om­men­da­tion to the NIAID. . . .”
  6. The DSMB meet­ing on 4/27 deter­mined the switch from place­bo to remde­sivir. Of para­mount impor­tance is the fact that this was JUST BEFORE the 4/29 announce­ment that drove the mar­kets high­er and the same day on which key Trump aide–and for­mer Gilead Sci­ences lob­by­ist Joe Gro­gan resigned! ” . . . . . That deci­sion, Lane said, led the NIAID to con­clude that patients who had been giv­en place­bo should be offered remde­sivir, some­thing that start­ed hap­pen­ing after April 28. . . .”
  7. Dr. Ethan Weiss gave an accu­rate eval­u­a­tion of the NIAID study: ” . . . . ‘We’ve squan­dered an incred­i­ble oppor­tu­ni­ty to do good sci­ence,’ [Dr. Ethan] Weiss said. ‘If we could ever go back and do some­thing all over, it would be the infra­struc­ture to actu­al­ly learn some­thing. Because we’re not learn­ing enough.’ . . . .”

“Inside the NIH’s con­tro­ver­sial deci­sion to stop its big remde­sivir study” by Matthew Her­p­er; Stat News; 05/11/2020 [21]

7b. The remark­able han­dling of the NIAID study, the tim­ing of the announce­ment of the alto­geth­er lim­it­ed suc­cess of the atten­u­at­ed tri­al and the rise in equi­ties as a result of the announce­ment may be best under­stood in the con­text of the role played [22] in Trump pan­dem­ic deci­sion-mak­ing by an elite group of bil­lion­aires and scientists–including con­vict­ed felon Michael Milken (the “junk bond king”).

  1. ” . . . . Call­ing them­selves ‘Sci­en­tists to Stop COVID-19,’ the col­lec­tion of top researchers, bil­lion­aires and indus­try cap­tains will act as an ‘ad hoc review board’ for the tor­rent of coro­n­avirus research, ‘weed­ing out’ flawed data before it reach­es pol­i­cy­mak­ersthe Wall Street Jour­nal [23] report­ed on Mon­day. They are also act­ing as a go-between for phar­ma­ceu­ti­cal com­pa­nies seek­ing to build a com­mu­ni­ca­tion chan­nel with Trump admin­is­tra­tion offi­cials. The group . . . . has advised Nick Ayers, an aide to Vice Pres­i­dent Mike Pence [24], as well as oth­er agency heads, in the past month. Pence is head­ing up the White House coro­n­avirus task force. . . .”
  2. ” . . . The brainy bunch is led by Thomas Cahill, a 33-year-old doc­tor who became a ven­ture cap­i­tal­ist . . . . Cahill’s clout comes from build­ing con­nec­tions through his invest­ment firm, New­path Part­ners, with Sil­i­con Valley’s Peter Thiel, the founder of Pay­Pal, and bil­lion­aire busi­ness­men Jim Palot­ta and Michael Milken. . . .”

“Sci­en­tists, bil­lion­aires team up to aid White House in coro­n­avirus bat­tle” by Mark Moore; New York Post; 04/28/2020 [22]

7c. Note that Peter Thiel played a dom­i­nant role in bankrolling New­path Part­ners, and the oth­er finan­cial angel who ele­vat­ed Cahill–Brian Sheth–introduced him to Tom­my Hicks, Jr., the co-chair­man of the RNC. In FTR #‘s 1111 [15] and 1112 [15], we looked at Hicks’ net­work­ing with Steve Ban­non asso­ciate J. Kyle Bass, as well as his role in the inter-agency net­works dri­ving the anti-Chi­na effort.

” . . . . At the helm of the effort: The 33-year-old and very-much-under-the-radar ven­ture cap­i­tal­ist Tom Cahill, who leads life sci­ences-focused New­path Part­ners. Cahill com­plet­ed his M.D. and PhD at Duke Uni­ver­si­ty a mere two years ago before land­ing at blue-chip invest­ment firm Rap­tor Group through a friend. He went on to found New­path with some $125 mil­lion after impress­ing well-con­nect­ed names like ven­ture cap­i­tal­ist Peter Thiel and Vista Equi­ty Part­ners co-founder Bri­an Sheth. . . . It was through Sheth, for exam­ple, that Sci­en­tists to Stop Covid-19 con­nect­ed with the co-chair­man of the Repub­li­can Nation­al Com­mit­tee, Thomas Hicks Jr. . . .”

“The ven­ture cap­i­tal­ist at the cen­ter of the coro­n­avirus fight” BY LUCINDA SHEN; For­tune; 04/28/2020 [25]

7d. The fed­er­al gov­ern­men­t’s extreme focus on remde­sivir has been shaped, in large mea­sure, by the influ­ence of “Sci­en­tists to Stop COVID-19”:

  1. “Sci­en­tists to Stop Covid-19” is shep­herd­ing remde­sivir: ” . . . . Sci­en­tists to Stop COVID-19 rec­om­mends that in this phase, the U.S. Food and Drug Admin­is­tra­tion (FDA) should work to coor­di­nate with Gilead phar­ma­ceu­ti­cals to focus on expe­dit­ing the results of clin­i­cal tri­als of remde­sivir, a drug iden­ti­fied as a poten­tial treat­ment for COVID-19. The group also rec­om­mends admin­is­ter­ing dos­es of the drug to patients in an ear­ly stage of infec­tion, and notes remde­sivir will essen­tial­ly be a place­hold­er until a more effec­tive treat­ment is pro­duced.
  2. The group is doing so by atten­u­at­ing the reg­u­la­to­ry process for coro­n­avirus drugs: “Gov­ern­ment enti­ties and agen­cies appear to adhere to the rec­om­men­da­tions out­lined by the group, with the Jour­nal report­ing that the FDA and the Depart­ment of Vet­er­ans Affairs (VA) have imple­ment­ed some of the sug­ges­tions, name­ly relax­ing drug man­u­fac­tur­er reg­u­la­tions and require­ments for poten­tial coro­n­avirus treat­ment drugs. . . .”

“Elite group of sci­en­tists and bil­lion­aires are work­ing togeth­er to fight the coro­n­avirus pan­dem­ic” by Alexan­dra Kel­ley; The Hill; 04/28/2020 [26]

7e. We con­clude dis­cus­sion of the remde­sivir machi­na­tions with a piece about the tim­ing of the announce­ment of Grogan’s depar­ture.

” . . . . Gro­gan has served as the direc­tor of the White House Domes­tic Pol­i­cy Coun­cil since Feb­ru­ary 2019, over­see­ing a broad array of pol­i­cy issues includ­ing health care and reg­u­la­tion. . . . Gro­gan was one of the orig­i­nal mem­bers of the White House coro­n­avirus task force launched in late Jan­u­ary. . . . Gro­gan worked as a lob­by­ist for drug com­pa­ny Gilead Sci­ences before join­ing the Trump admin­is­tra­tion. . . .”

The depar­ture was announced in the Wall Street Jour­nal on the morn­ing of Wednes­day, April 29, the same day we got our first pub­lic reports of the NIAID clin­i­cal tri­al of remde­sivir that was pos­i­tive enough to show it short­ened the time to recov­ery and the same day the FDA grant­ed remde­sivir emer­gency use sta­tus. 

Note, again, the tim­ing of the DSM­B’s actions, as well as the influ­ence of “Sci­en­tists to Stop Covid-19.”

“Top Trump pol­i­cy advis­er Joe Gro­gan to leave post” by Mor­gan Chal­fant; The Hill; 04/29/2020 [27]

8a. In FTR #1130 [28], we not­ed that Mon­cef Slaoui–formerly in charge of prod­uct devel­op­ment for Moderna–was cho­sen to head Trump’s “Oper­a­tion Warp Speed.” He will be work­ing with Four-Star Gen­er­al Gus­tave Per­na, cho­sen by Chair­man of the Joint Chiefs of Staff Gen­er­al Mark Mil­ley.

Even after agree­ing to sell his Mod­er­na stock, Mon­cef Slaoui’s invest­ments raise alarm­ing ques­tions [29]–note that he is a “ven­ture cap­i­tal­ist” and a long­time for­mer exec­u­tive at Glaxo-Smithk­line:

  1. The cir­cum­stances of his appoint­ment will per­mit him to avoid scruti­ny: ” . . . . In agree­ing to accept the posi­tion, Dr. Slaoui did not come on board as a gov­ern­ment employ­ee. Instead, he is on a con­tract, receiv­ing $1 for his ser­vice. That leaves him exempt from fed­er­al dis­clo­sure rules that would require him to list his out­side posi­tions, stock hold­ings and oth­er poten­tial con­flicts. And the con­tract posi­tion is not sub­ject to the same con­flict-of-inter­est laws and reg­u­la­tions that exec­u­tive branch employ­ees must fol­low. . . .”
  2. He will retain a great deal of Glaxo-Smithk­line stock: ” . . . . He did not say how much his GSK shares were worth. When he left the com­pa­ny in 2017, he held about [500,000 in West­ern Print Edi­tion] 240,000 shares and share equiv­a­lents, accord­ing to the drug company’s annu­al report and an analy­sis by the exec­u­tive com­pen­sa­tion firm Equi­lar. . . .”
  3. Fur­ther analy­sis of Slaoui’s posi­tion deep­ens con­cern about the integri­ty of the process: ” . . . . ‘This is basi­cal­ly absurd,’ said Vir­ginia Can­ter, who is chief ethics coun­sel for Cit­i­zens for Respon­si­bil­i­ty and Ethics in Wash­ing­ton. ‘It allows for no pub­lic scruti­ny of his con­flicts of inter­est.’ Ms. Can­ter also said fed­er­al law barred gov­ern­ment con­trac­tors from super­vis­ing gov­ern­ment employ­ees. . . . Ms. Can­ter, a for­mer ethics lawyer in the Oba­ma and Clin­ton admin­is­tra­tions, the Secu­ri­ties and Exchange Com­mis­sion and oth­er agen­cies, point­ed out that GSK’s vac­cine can­di­date with Sanofi could wind up com­pet­ing with oth­er man­u­fac­tur­ers vying for gov­ern­ment approval and sup­port. ‘If he retains stock in com­pa­nies that are invest­ing in the devel­op­ment of a vac­cine, and he’s involved in over­see­ing this process to select the safest vac­cine to com­bat Covid-19, regard­less of how won­der­ful a per­son he is, we can’t be con­fi­dent of the integri­ty of any process in which he is involved,’ Ms. Can­ter said.In addi­tion, his affil­i­a­tion with Medicxi could com­pli­cate mat­ters: Two of its investors [30] are GSK and a divi­sion of John­son & John­son, which is also devel­op­ing a poten­tial vac­cine. . . .”

“Trump’s Vac­cine Chief Has Vast Ties to Drug Indus­try, Pos­ing Pos­si­ble Con­flicts” by Sheila Kaplan, Matthew Gold­stein and Alexan­dra Steven­son; The New York Times; 5/21/2020. [29]

8b. Next, we turn to Mod­er­na’s ani­mal tri­al for the mes­sen­ger RNA vac­cine it is devel­op­ing.

Mice were giv­en Mod­er­na’s vac­cine in a range of dos­es, includ­ed dos­es expect­ed to elic­it sub-pro­tec­tive response. Recall that the inter­ac­tion of COVID-19 with sub-pro­tec­tive immune respons­es (so low lev­els of anti­bod­ies that can’t pre­vent the dis­ease) is one of the key safe­ty issues to test giv­en the pos­si­bil­i­ty of Anti­body Depen­dent Enhance­ment (ADE), a phe­nom­e­na where low lev­els of inef­fec­tive anti­bod­ies latch onto the virus and exac­er­bate an over­ac­tive immune response that leads to the dead­liest symp­toms likes cytokine-storms. This dan­ger was seen with SARS and attempts to cre­ate a SARS vac­cine so it’s a rea­son­able fear with SARS-CoV­‑2 [32]

They’re still con­duct­ing The phase II clin­i­cal tri­als with peo­ple and phase III is going to be get­ting under­way in July. But that’s part of what’s kind of alarm­ing about the sit­u­a­tion: the Human clin­i­cal tri­als are already under­way at the same time the ani­mal safe­ty tri­als have yet to be com­plet­ed. The phase II tri­al is going to fol­low peo­ple for the next year so it won’t be com­plet­ed before Novem­ber. Side effects can take a while to man­i­fest.

We may have a night­mare sit­u­a­tion where polit­i­cal pres­sure gives undo weight to ani­mal safe­ty results, leapfrog­ging over the neces­si­ty of test­ing for side effects. 

We MIGHT cre­ate a vac­cine that pro­tects those who get a strong immune response while endan­ger­ing those with sub-pro­tec­tive responses–a “eugenic” vac­cine. 

” . . . . ‘This is the barest begin­ning of pre­lim­i­nary infor­ma­tion,’ said Dr. Gre­go­ry Poland, an immu­nol­o­gist and vac­cine researcher at the Mayo Clin­ic who has seen the paper, which has yet to under­go peer-review. Poland said the paper was incom­plete, dis­or­ga­nized and the num­bers of ani­mals test­ed were small. . . . Poland, who was not involved with the research, said the paper leaves out ‘impor­tant para­me­ters’ that could help sci­en­tists judge the work. . . .”

“Mod­er­na COVID-19 vac­cine appears to clear safe­ty hur­dle in mouse study” by Julie Steen­huy­sen; Reuters; 06/12/2020 [31].

 A series of stud­ies in mice of Mod­er­na Inc’s COVID-19 lent some assur­ance that it may not increase the risk of more severe dis­ease, and that one dose may pro­vide pro­tec­tion against the nov­el coro­n­avirus, accord­ing to pre­lim­i­nary data released on Fri­day.

Pri­or stud­ies on a vac­cine for SARS – a close cousin to the new virus that caus­es COVID-19 – sug­gests vac­cines against this type of virus might have the unin­tend­ed effect of caus­ing more severe dis­ease when the vac­ci­nat­ed per­son is lat­er exposed to the pathogen, espe­cial­ly in indi­vid­u­als who do not pro­duce an ade­quate­ly strong immune response.

Sci­en­tists have seen this risk as a hur­dle to clear before vac­cines can be safe­ly test­ed in thou­sands of healthy peo­ple.

While the data released by the U.S. Nation­al Insti­tutes of Aller­gy and Infec­tious Dis­ease (NIAID) and Mod­er­na offered some assur­ance, the stud­ies do not ful­ly answer the ques­tion.

“This is the barest begin­ning of pre­lim­i­nary infor­ma­tion,” said Dr. Gre­go­ry Poland, an immu­nol­o­gist and vac­cine researcher at the Mayo Clin­ic who has seen the paper, which has yet to under­go peer-review.

Poland said the paper was incom­plete, dis­or­ga­nized and the num­bers of ani­mals test­ed were small.

The authors said they have sub­mit­ted the work to a top-tier jour­nal. Moderna’s vac­cine is in mid­stage test­ing in healthy vol­un­teers. Mod­er­na said on Thurs­day it plans to begin final-stage tri­als enrolling 30,000 peo­ple in July.

In the ani­mal stud­ies, mice received one or two shots of a vari­ety of dos­es of Moderna’s vac­cine, includ­ing dos­es con­sid­ered not strong enough to elic­it a pro­tec­tive immune response. Researchers then exposed the mice to the virus.

Sub­se­quent analy­ses sug­gest “sub-pro­tec­tive” immune respons­es do not cause what is known as vac­cine-asso­ci­at­ed enhanced res­pi­ra­to­ry dis­ease, a sus­cep­ti­bil­i­ty to more severe dis­ease in the lungs.

“Sub­pro­tec­tive dos­es did not prime mice for enhanced immunopathol­o­gy fol­low­ing (expo­sure),” Dr. Bar­ney Gra­ham of the Vac­cine Research Cen­ter at NIAID and col­leagues wrote in the man­u­script, post­ed on the bioRx­iv web­site.

Fur­ther test­ing sug­gest­ed the vac­cine induces anti­body respons­es to block the virus from infect­ing cells.

The vac­cine also appeared to pro­tect against infec­tion by the coro­n­avirus in the lungs and noses with­out evi­dence of tox­ic effects, the team wrote.

They not­ed the mice that received just one dose before expo­sure to the virus sev­en weeks lat­er were “com­plete­ly pro­tect­ed against lung viral repli­ca­tion,” sug­gest­ing a sin­gle vac­ci­na­tion pre­vent­ed the virus from repli­cat­ing in the lungs.

“At first glance, it looks promis­ing in induc­ing neu­tral­iz­ing anti­body pro­tec­tion in mice,” Dr. Peter Hotez, a researcher at Bay­lor Col­lege of Med­i­cine said in an email. He had not reviewed the paper in detail.

Poland, who was not involved with the research, said the paper leaves out “impor­tant para­me­ters” that could help sci­en­tists judge the work. . . .

8c. The Phase III [33] tri­al is going to be start­ed in July, involv­ing 30,000 peo­ple. Alarm­ing­ly, those 30,000 peo­ple will all be receiv­ing the exact same dosage, 100 micro­grams, and that means the phase III tri­al won’t be test­ing sub-opti­mal dosages. The big Phase III tri­al basi­cal­ly won’t be test­ing ADE in humans.

The Phase II tri­al is ongo­ing, but will not be com­plet­ed before Novem­ber.

We pro­vid­ed detailed crit­i­cal com­ments on Mod­er­na’s Phase I tri­al in FTR #1132 [34].

“Mod­er­na Plans To Start Phase 3 Test­ing of its COVID-19 Vac­cine Can­di­date in July” by Alice Park; Time; 06/11/2020 [33]

On June 11, biotech com­pa­ny Mod­er­na announced [38] it had final­ized plans for phase 3 test­ing of its COVID-19 vac­cine can­di­date. The late-stage tri­al will include 30,000 par­tic­i­pants and is expect­ed to begin in July.

The tri­al will test just one dose lev­el of the vac­cine, 100 micro­grams, giv­en in two shots. . . . 

The phase 2 study is ongo­ing, and is enrolling 600 healthy peo­ple who will be fol­lowed for a year after their injec­tions. This stage will con­tin­ue to look at the vaccine’s safe­ty as well as col­lect fur­ther data on its effec­tive­ness. This study will include more peo­ple who might be a high risk of expo­sure to COVID-19, such as health care work­ers and res­i­dents in long-term care facil­i­ties.

In June, Mod­er­na became one of five vac­cine devel­op­ers [39] cho­sen to be part of Pres­i­dent Trump’s Oper­a­tion Warp Speed [40] pro­gram to speed devel­op­ment of a COVID-19 vac­cine. The selec­tion qual­i­fies Mod­er­na to receive fed­er­al gov­ern­ment fund­ing to con­tin­ue devel­op­ment of vac­cine, con­duct tests, as well as scale up man­u­fac­tur­ing to meet the goal of begin­ning to inoc­u­late 300 mil­lion peo­ple begin­ning ear­ly next year. Mod­er­na said it plans to deliv­er 500 mil­lion to 1 bil­lion dos­es a year begin­ning in 2021.

8d. New York Times arti­cle sets forth a “Vac­cine Octo­ber Sur­prise” sce­nario for this fall.

” . . . . In a des­per­ate search for a boost, he could release a coro­n­avirus vac­cine that has not been shown to be safe and effec­tive as an Octo­ber sur­prise. Oct. 23, 2020, 9 a.m., with 10 days before the elec­tion, Fox New releas­es a poll show­ing Pres­i­dent Trump trail­ing Joe Biden by eight per­cent­age points. Oct. 23, 2020, 3 p.m., at a hasti­ly con­vened news con­fer­ence, Pres­i­dent Trump announces that the Food and Drug Admin­is­tra­tion has just issued an Emer­gency Use Autho­riza­tion for a coro­n­avirus vac­cine. Mr. Trump declares vic­to­ry over Covid-19, demands that all busi­ness­es reopen imme­di­ate­ly and pre­dicts a rapid eco­nom­ic recov­ery. Giv­en how this pres­i­dent has behaved, this incred­i­bly dan­ger­ous sce­nario is not far-fetched. In a des­per­ate search for a polit­i­cal boost, he could release a coro­n­avirus vac­cine before it had been thor­ough­ly test­ed and shown to be safe and effec­tive. . . .”

“Could Trump Turn a Vac­cine Into a Cam­paign Stunt?” by Ezekiel J. Emanuel and Paul A. Offit; The New York Times; 06/08/2020 [35]

In a des­per­ate search for a boost, he could release a coro­n­avirus vac­cine that has not been shown to be safe and effec­tive as an Octo­ber sur­prise.

Oct. 23, 2020, 9 a.m., with 10 days before the elec­tion, Fox New releas­es a poll show­ing Pres­i­dent Trump trail­ing Joe Biden by eight per­cent­age points.

Oct. 23, 2020, 3 p.m., at a hasti­ly con­vened news con­fer­ence, Pres­i­dent Trump announces that the Food and Drug Admin­is­tra­tion has just issued an Emer­gency Use Autho­riza­tion for a coro­n­avirus vac­cine. Mr. Trump declares vic­to­ry over Covid-19, demands that all busi­ness­es reopen imme­di­ate­ly and pre­dicts a rapid eco­nom­ic recov­ery.

Giv­en how this pres­i­dent has behaved, this incred­i­bly dan­ger­ous sce­nario is not far-fetched. In a des­per­ate search for a polit­i­cal boost, he could release a coro­n­avirus vac­cine before it had been thor­ough­ly test­ed and shown to be safe and effec­tive. . . .

. . . . By com­par­i­son, the Phase III effec­tive­ness tri­al for one rotavirus vac­cine, RotaTeq [41], to pre­vent diar­rhea involved about 70,000 infants from 2001 to 2004 and anoth­er rotavirus vac­cine tri­al, Rotar­ix [42], involved 63,000 infants, from 2003 to 2006.

Researchers are expect­ing that it will be like­ly to take at least anoth­er eight to 12 months to deter­mine whether these coro­n­avirus vac­cines are effec­tive. Sci­en­tists have to wait until a suf­fi­cient num­ber of patients are exposed to coro­n­avirus to see if the vac­cine real­ly reduces the infec­tion rate, as well as how many peo­ple devel­op uncom­mon side effects. For com­par­i­son [43], the effec­tive­ness tri­al for the rotavirus vac­cines took about four years and the human papil­lo­mavirus vac­cine stud­ies to pre­vent cer­vi­cal can­cer took sev­en years.

So could Mr. Trump real­ly pull an “Octo­ber Sur­prise” with a vac­cine less than five months from today? . . .

. . . . There is anoth­er sce­nario that is far more omi­nous: Three months after the N.I.H. tri­als begin in July — so, mid Octo­ber — stud­ies reveal many patients are devel­op­ing high lev­els of anti­bod­ies to the coro­n­avirus with­out severe side effects. As the White House did with its relent­less pro­mo­tion of hydrox­y­chloro­quine as a cure, it would bad­ger the F.D.A. to per­mit use of the vac­cine. More pres­sure would come from drug com­pa­nies, some of whom may spend up to $1 bil­lion on research and are intense­ly com­pet­ing for pres­tige and glo­ry. They are plan­ning to begin man­u­fac­tur­ing their vac­cine can­di­dates at-risk — that is, before com­plet­ed stud­ies show­ing their vac­cine is actu­al­ly effec­tive.

Cog­nizant of the fate of Rick Bright [44] — the head of the Bio­med­ical Advanced Research and Devel­op­ment Author­i­ty, who was sum­mar­i­ly demot­ed when he resist­ed the president’s wish­es to ramp up pur­chase of hydrox­y­chloro­quine — the F.D.A. could issue an Emer­gency Use Autho­riza­tion for one or more vac­cines. These autho­riza­tions only require that the F.D.A. finds it “rea­son­able to believe” that a vac­cine “may be effec­tive” in pre­vent­ing a life-threat­en­ing dis­ease for it to be put on the mar­ket, with­out being for­mal­ly licensed.

An emer­gency autho­riza­tion would allow Mr. Trump to hold his news con­fer­ence and declare vic­to­ry. But like Pres­i­dent George W. Bush’s “Mis­sion Accom­plished” procla­ma­tion, it has the poten­tial to be a trav­es­ty. Mil­lions of vac­cines could be dis­trib­uted with­out proof that the vac­cine can pre­vent dis­ease or trans­mis­sion.

No vac­cine since the 1950s has been approved and licensed with­out com­plet­ing large, prospec­tive, place­bo-con­trolled stud­ies of safe­ty and effec­tive­ness.

Even if a vac­cine gen­er­ates anti­bod­ies, it does not prove that the vac­cine is effec­tive at pre­vent­ing infec­tion; it only makes it more like­ly that the vac­cine would be effec­tive. Indeed, about half of the vac­cines for oth­er dis­eases that work and are on the mar­ket actu­al­ly lack clear immuno­log­i­cal cor­re­lates [45] for pro­tec­tion, mean­ing they are effec­tive but patients’ anti­bod­ies, immune cells or oth­er mark­ers do not iden­ti­fy whether a patient is pro­tect­ed. Even with the ini­tial tri­als, we are like­ly to have scant data on whether old­er peo­ple will mount an immune reac­tion and be pro­tect­ed.

Giv­ing peo­ple a false sense of being pro­tect­ed will most like­ly lead to seri­ous out­breaks of the dis­ease as peo­ple reduce their com­pli­ance with phys­i­cal dis­tanc­ing and oth­er pub­lic health mea­sures.

If only 20,000 par­tic­i­pants receive the vac­cine, seri­ous but rare side effects might be missed. If such harms even­tu­al­ly arise, it could fur­ther erode a frag­ile vac­cine con­fi­dence and threat­en the abil­i­ty to get enough peo­ple vac­ci­nat­ed to estab­lish herd immu­ni­ty. That would be a dis­as­ter. . . .

. . . . The F.D.A. must require more than the pro­duc­tion of anti­bod­ies to approve a vac­cine, even for an emer­gency autho­riza­tion, much less licens­ing. Only when the inde­pen­dent data safe­ty and mon­i­tor­ing board com­posed of physi­cians, researchers and bio­sta­tis­ti­cians reviews the accu­mu­lat­ed tri­al data to assess the safe­ty and effec­tive­ness of the vac­cines, should the F.D.A. be allowed to decide on approval. . . .