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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].
- “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.’ . . . . 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. . . .”
- “. . . . 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 . . .”
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:
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:
- 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. . . .”
- 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.
- 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. . . .”
- 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. . . .”
- 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. . . .”
- 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. . . .”
- 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. . . .”
- 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. . . .”
- 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”).
- ” . . . . 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 policymakers, the 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. . . .”
- ” . . . 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”:
- “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.
- 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:
- 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. . . .”
- 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. . . .”
- 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.
- Again, the chairman of Trump’s “Warp Speed” vaccine development program–Moncef Slaoui–was in charge of Moderna’s product development operation.
- Moderna’s trial with mice was positive with regard to generating antibody levels high enough to prevent ADE.
- 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.
- 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.
- 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.
- 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. . . .”
- 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. . . .”
- 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.
- 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].
- “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.’ . . . . 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. . . .”
- “. . . . 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 . . .”
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. . . .”
. . . . 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:
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.
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:
- 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. . . .”
- 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.
- 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. . . .”
- 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. . . .”
- 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. . . .”
- 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. . . .”
- 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. . . .”
- 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. . . .”
- 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.’ . . . .”
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”).
- ” . . . . 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 policymakers, the 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. . . .”
- ” . . . 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. . . .”
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. . . .”
7d. The federal government’s extreme focus on remdesivir has been shaped, in large measure, by the influence of “Scientists to Stop COVID-19”:
- “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.
- 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. . . .”
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:
- 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. . . .”
- 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. . . .”
- 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. . . .”
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. . . .”
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].
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. A 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. . . .”
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. . . .