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“Political language…is designed to make lies sound truthful and murder respectable, and to give an appearance of solidity to pure wind.”
— George Orwell, 1946
EVERYTHING MR. EMORY HAS BEEN SAYING ABOUT THE UKRAINE WAR IS ENCAPSULATED IN THIS VIDEO FROM UKRAINE 24 [5]
ANOTHER REVEALING VIDEO FROM UKRAINE 24 [6]
Mr. Emory has launched a new Patreon site. Visit at: Patreon.com/DaveEmory [7]
FTR#1292 This program was recorded in one, 60-minute segment [8].
FTR#1293 This program was recorded in one, 60-minute segment. [9]
[10]Introduction: This description opens with an uncharacteristic qualification and apology: There are two elements of the titles of each of these programs that were not adequately explained in the broadcasts themselves, although they are implicit in the subject material.
The term “Northwoods Virus” is more completely presented in FTR#1215 [11]. Among the apparent goals of the “Covid Operation” that produced SARS CoV‑2 is the turning of American public opinion against China. Operation Northwoods was a plan hatched by the Join Chiefs of Staff in the early 1960’s to stage apparent terrorist incidents against American civilian and military personnel and infrastructure in order to manipulate public opinion in this country and generate sentiment for an invasion of Cuba.
The second program refers to the Biden Presidency as “Satanic,” because behind a studiously constructed façade of identity politics, “Team Biden” is pursuing an overtly warlike, imperialist agenda that was accurately characterized by writer Henry Miller in his novel Tropic of Cancer: “America is the very incarnation of doom, and she will lead the rest of the world into the Bottomless Pit.”
Perhaps the most insidious of Biden’s programs is his “Cancer Moonshot.”
Ominously, it may well be the successor to Richard Nixon’s “War on Cancer,” which did not defeat cancer, but did serve as the apparent platform for the development of biological warfare weapons, AIDS in particular.
Modeled after DARPA, headed by a DARPA alumna whose CV intersects with that Agency’s apparent involvement with the development of Covid-19 and with an acting director who is also a former employee of that benighted organization, this new “health agency [12]–ARPA‑H [13]”, this agency will employ new, synthetic biology technology.
Although that development is represented as humanitarian, the structure of the agency and the national security backgrounds of its leading personnel suggest strongly that this agency, too, will serve as a clandestine platform for the next generation of biological weaponry.
We begin FTR#1292 [8]with a reprise of the audio from a (now deleted) 55-second video of Dr. Jeffrey Sachs summarizing his two-year stewardship of The Lancet’s commission investigating the origins of SARS CoV‑2.
Sachs stated that he is “pretty convinced” it came from a U.S. biological laboratory.
Next, we recap a study [14] released by US National Academy of Sciences at the request of the Department of Defense about the threats of synthetic biology concluded that the techniques to tweak and weaponize viruses from known catalogs of viral sequences is very feasible and relatively easy to do.
One of the central points Mr. Emory has made about the genesis of the coronavirus concerns the legal principle of “consciousness of guilt.”
Going a long way toward proving consciousness of guilt are:
- The classification of information about the nature of the biological agents involved with the CDC’s closure [15] of the United States Army’s Medical Institute of Infectious Disease in early August of 2019 [15], on the eve of the pandemic.
- The behavior of Peter Daszak and colleagues in “gaming” [16]the Lancet statement on the “natural” origin of the coronavirus (Daszak’s EcoHealth Alliance–funded and advised by the national security establishment [17]–is implicated in the creation of the SARS COV‑2.) Note that the EcoHealth Alliance was synthesizing “novel coronaviruses” at this point in time, an important factor to remember when evaluating the Metabiota/Munich Re business model being presented in 2018. (See #4 presented below.)
- The reaction [16] of government officials to Trump administration figures into the origins of the virus, advising would be investigators that such inquiries would open a “can of worms,” or “a Pandora’s Box” because it would should light on U.S. funding of the projects.
- Metabiota–partnered with EcoHealth Alliance [18]–was networked with In-Q-Tel [19] (the intelligence community’s venture capital arm) and Munich Re to provide pandemic insurance. Their 2018 business model directly foreshadowed [20] the pandemic. “ . . . . Just two years earlier, the company had run a large set of scenarios forecasting the consequences of a novel coronavirus spreading around the globe. . . . Measures that decreased person-to-person contact, including social distancing, quarantine, and school closures, had the greatest cost per death prevented, most likely because of the amount of economic disruption caused by those measures . . . .” In 2018, as well, EcoHealth Alliance proposed a “novel coronavirus” [21] for synthesis by DARPA. Although there is no evidence that DARPA synthesized the virus, the U.S. did synthesize closely related viruses. With the genome of that novel virus having been published, it may well have been synthesized either by DARPA or someone else, given the contemporary technology. Again, this, also was in 2018.
- Many aspects of the SARS COV‑2 virus, including its curious FCS site and institutionalized obfuscation of aspects of the pandemic it caused suggest deliberate cover-up. Why would the NIH redact 290 pages of a document requested by an FOIA suit!! [20] Why were sequences of bat coronavirus genomes removed from public view [20].
The program features a recap of some of the more important articles in the long series on the coronavirus, followed by discussion of the Energy Department’s conclusion that the coronavirus escaped from a Chinese laboratory.
Excellent analysis presented by the Moon of Alabama [22]blog notes that the Wall Street Journa [23]l article breaking the “news” about the Energy Department’s conclusion was co-authored by Michael R. Gordon, who trumpeted the “Lab Leak” meme in the spring of 2021.
In a previous journalistic incarnation [24], Gordon helped generate enthusiasm for the invasion of Iraq by parroting the disinformation about Saddam Hussein having WMD’s.
Surprising to Moon of Alabama [22]but not to us is Edward Snowden’s endorsement of the Lab Leak Hypothesis.
Far from being the “hero” Snowden has made out to be, Snowden is an extreme right-winger, whose work on cyber-security appears to be the work of a conscious double agent. (We have covered Snowden’s escapades in numerous programs over the years, particularly FTR#’s 1078 [25]-1081 [26].)
For the convenience of the listener, we recap a 2001 article [27] discussing the all-encompassing scope of U.S. electronic snooping—an article that reveals the depth of Snowden’s duplicity.
In addition to touching on a story of a recently-released book [28] about the Coronavirus being synthesized as part of a U.S. biological warfare program, the program recaps the Biden administration’s creation of a “Medical DARPA.”
Following discussion of Moderna’s deliberate withholding [29]of data from regulators about its new bivalent mRNA vaccine, we note a study that indicates that new, deadly variants of Covid that could overwhelm the healthcare system are a distinct possibility.
Of great significance is analysis of a diplomatic breakthrough [30] engineered by China. Brokering a rapprochement between Iran and Saudi Arabia in the Middle East, China has helped to re-set the political landscape of the Middle East.
As noted by M.K. Bhadrakumar, the realignment may signal a demise of the dollar as the global reserve currency of choice. IF such a development ensues, it will prove devastating to America’s imperial status, curtailing the military industrial complex in particular.
Mr. Emory expresses his great fear that this will not be allowed to develop—the above-mentioned “Cancer Moonshot” and lethal, synthesized micro-organisms and pandemics will very likely be the American answer to the long-term economic and political implications of the Chinese diplomatic coup.
1a. We begin with a reprise of the audio from a (now deleted) 55-second video of Dr. Jeffrey Sachs summarizing his two-year stewardship of The Lancet’s commission investigating the origins of SARS CoV‑2.
Sachs stated that he is “pretty convinced” it came from a U.S. biological laboratory.
This same audio clip concludes FTR#1293.
1b. A study released by US National Academy of Sciences at the request of the Department of Defense about the threats of synthetic biology concluded that the techniques to tweak and weaponize viruses from known catalogs of viral sequences is very feasible and relatively easy to do:
The rapid rise of synthetic biology, a futuristic field of science that seeks to master the machinery of life, has raised the risk of a new generation of bioweapons, according a major US report into the state of the art. . . .
“ . . . Advances in the area mean that scientists now have the capability to recreate dangerous viruses from scratch; make harmful bacteria more deadly; and modify common microbes so that they churn out lethal toxins once they enter the body. . . In the report, the scientists describe how synthetic biology, which gives researchers precision tools to manipulate living organisms, ‘enhances and expands’ opportunities to create bioweapons. . . . Today, the genetic code of almost any mammalian virus can be found online and synthesised. ‘The technology to do this is available now,’ said [Michael] Imperiale. “It requires some expertise, but it’s something that’s relatively easy to do, and that is why it tops the list. . . .”
2a. Going a long way toward proving consciousness of guilt are:
- The classification of information about the nature of the biological agents involved with the CDC’s closure [15] of the United States Army’s Medical Institute of Infectious Disease in early August of 2019 [15], on the eve of the pandemic.
- The behavior of Peter Daszak and colleagues in “gaming” [16]the Lancet statement on the “natural” origin of the coronavirus (Daszak’s EcoHealth Alliance–funded and advised by the national security establishment–is implicated in the creation of the SARS COV‑2.)
- The reaction [16] of government officials to Trump administration figures into the origins of the virus, advising would be investigators that such inquiries would open a “can of worms,” or “a Pandora’s Box” because it would should light on U.S. funding of the projects.
- Metabiota–partnered with EcoHealth Alliance [18]–was networked with In-Q-Tel [19] (the intelligence community’s venture capital arm) and Munich Re to provide pandemic insurance. Their 2018 business model directly foreshadowed [20] the pandemic. “ . . . . Just two years earlier, the company had run a large set of scenarios forecasting the consequences of a novel coronavirus spreading around the globe. . . . Measures that decreased person-to-person contact, including social distancing, quarantine, and school closures, had the greatest cost per death prevented, most likely because of the amount of economic disruption caused by those measures . . . .” In 2018, as well, EcoHealth Alliance proposed a “novel coronavirus” [31] for synthesis by DARPA. Although there is no evidence that DARPA synthesized the virus, the U.S. did synthesize closely related viruses. With the genome of that novel virus having been published, it may well have been synthesized either by DARPA or someone else, given the contemporary technology. Again, this, also was in 2018.
- Many aspects of the SARS COV‑2 virus, including its curious FCS site and institutionalized obfuscation of aspects of the pandemic it caused suggest deliberate cover-up. Why would the NIH redact 290 pages of a document requested by an FOIA suit!! [20] Why were sequences of bat coronavirus genomes removed from public view [20].
2b.
- “Bats, Gene Editing and Bioweapons: Recent DARPA Experiments Raise Concerns Amid Coronavirus Outbreak” by Whitney Webb; The Last American Vagabond; 1/30/2020. [32]
- “Peter Daszak’s EcoHealth Alliance Has Hidden Almost $40 Million In Pentagon Funding And Militarized Pandemic Science” by Sam Husseini; Independent Science News; 12/16/2020. [33]
- “The Lab-Leak Theory: Inside the Fight to Uncover Covid-19’s Origins” by Katherine Eban; Vanity Fair; 6/3/2021. [16]
- “Munich Re & In-Q-Tel Select Metabiota to Gain Deeper Insights into Epidemic Risk and Global Preparedness for Infectious Diseases;” org; 8/22/2017. [34]
- “EXCLUSIVE: Hunter Biden DID help secure millions in funding for US contractor in Ukraine specializing in deadly pathogen research, laptop emails reveal, raising more questions about the disgraced son of then vice president” by JOSH BOSWELL; Daily Mail [UK]; 3/25/2022. [18]
- “We Can Protect the Economy From Pandemics. Why Didn’t We?” by Evan Ratliff; Wired; 06/16/2020 [20].
- “A call for an independent inquiry into the origin of the SARS-CoV‑2 virus” by Neil L. Harrison and Jeffrey D. Sachs; PNAS [Proceedings of the National Academy of Sciences]; 05/19/2022 [35]
. . . . China has also sought to deflect blame for the pandemic by spreading a conspiracy theory that the virus may have been the result of research at a U.S. military lab at Fort Detrick, Md. The claim, which was first made in March 2020 was repeated by a foreign ministry spokesman as recently as this month.
At the Energy Department, new intelligence prompted it to change its position from being undecided about how the virus emerged. Officials did not share that intelligence but said the agency made its conclusion with only “low confidence.” . . . . [Italics are Mr. Emory’s]
4.“This Debate Hasn’t Made Us Safer” by David Wallace-Wells; The New York Times; 3/5/2023. [38]
Bioterrorism expert and whistleblower alleges that CIA secretly collaborated in supporting unethical gain of function research that resulted in the manufacture of the COVID-19 virus, which was then leaked from the Wuhan Institute of Virology.
Dr. Andrew G. Huff is an Iraq War veteran and infectious disease epidemiologist with a Ph.D. from the University of Minnesota who, in September 2014, went to work for EcoHealth Alliance [39], an NGO that received over $118 million in grants from federal agencies [40] whose mission was to protect the public from infectious diseases.
In a new book, The Truth About Wuhan: How I Uncovered the Biggest Lie in History (New York: Skyhorse Press, 2022), Huff claims that his boss at EcoHealth Alliance, Dr. Peter Daszak, was working with the CIA and that beginning in 2012, he oversaw the development of the biological agent known as SARS-CoV‑2 that results in the disease COVID-19.
The development occurred through Gain-of-Function research funded by the United States Agency for International Development (USAID) and the National Institutes of Health (NIH).[1] [41]
According to Huff, Dr. Daszak and Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases from 1984 until his retirement in December 2022, along with other colleagues, “behaved like a pseudoscience mafia entrenched in the halls of the medical military industrial complex.”[2] [42]
They not only engineered the COVID-19 pandemic but “criminally conspired to smear” anyone who did not support their narrative—including Huff who was subjected to a campaign of FBI surveillance and harassment that nearly resulted in his death.
Engineering a Deadly Virus—and a Vaccine to Allegedly Combat It
One of the first tasks that Dr. Huff undertook while working at EcoHealth Alliance was to review an NIH proposal titled “Understanding the Risk of Bat Coronavirus Emergence,” written by Dr. Daszak with Zhengli Shi of the Wuhan Institute of Virology (WIV) and some other scientists.
The study had the support of “the grandfather of Gain-of-Function research,” Dr. Ralph Baric, a virologist at the University of North Carolina’s Gillings School of Public Health, which ranks third in NIH funding. (According to Huff, “Fauci has been [the school’s] de facto Don for decades.”[3] [43])
The proposal advocated for studying people in rural China who may have come into contact with bats that spread the Coronavirus among humans and to screen for the virus with the goal of being able to better predict Coronavirus transmission. It further aimed to develop new Coronavirus strains and perform experiments [44] that would enhance the ability of bat coronavirus to infect human cells and laboratory animals using techniques of genetic engineering.[4] [45]
This study fit the definition of Gain-of-Function research, whose aim is to “purposefully enhance the pathogenicity, infectivity, virulence, survivability or transmissibility of an infectious agent,” as Huff defines it, or put more simply, “make an infectious agent more dangerous.”[5] [46]
On October 17, 2014, the Obama administration declared a moratorium [47] on Gain-of-Function research related to influenza, Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) after an accident at the U.S. Center for Disease Control and Prevention (CDC).
Dr. Fauci subsequently outsourced [48] the Gain-of-Function research to China’s Wuhan lab and licensed the lab [49] to continue receiving U.S. government funding. The moratorium on Gain-of-Function research was lifted by the Trump administration in December 2017 [44], and Dr. Fauci sent $3.7 million from the National Institute of Allergy and Infectious Diseases to the Wuhan Institute of Virology to restart the coronavirus bat project.
By trying to make bats capable of infecting human cells, Huff came to believe that his employer was involved not only in unethical Gain-of-Function but also bioweapons research. Its end result was “the creation of SARS-CoV‑2,” which “causes the disease known as COVID-19.”[6] [50]
According to Huff, the infectious agent SARS-CoV‑2 and the COVID-19 mRNA vaccine—which Huff characterizes as gene therapy—were co-developed under the same research program.[7] [51]
Huff writes that EcoHealth Alliance used Dr. Baric’s work for testing experimental vaccines, treatments and therapeutics against the newly engineered SARS-CoV‑2 strain years before COVID-19 was known to the public to determine which countermeasures would be most effective at mitigating the disease in humanized mice.[8] [52] . . . .
6. Among those parroting the Energy Department’s line on the Wuhan “Lab Leak” meme is Edward Snowden. In, among other programs, FTR#‘s 1075 [53] through 1081 [26], we noted not only that the Internet was developed for “counterinsurgency purposes”
“Edward Snowden Signs On To Distribute U.S. Gov Propaganda;” Moon of Alabama; 2/27/2023. [22]
Edward, you are an idiot.
Edward Snowden @Snowden — 15:36 UTC · Feb 26, 2023 [54]
Do you remember the “institutional” and social media corpo response in the first half of 2020 when someone contradicted the consensus? They were punished for the “crime” of “disinformation.”
Corporations must never again be permitted to police speech.
wsj.com
WSJ News Exclusive | Lab Leak Most Likely Origin of Covid-19 Pandemic, U.S. Agency Now Says [55]
The Energy Department’s revised assessment of how the pandemic started is based on new intelligence.Moon of Alabama @MoonofA — 16:05 UTC · Feb 26, 2023 [56]
How is the U.S. Energy Department (which is the ‘intelligence’ here) qualified to make such conclusions? Is Michael A. Gordon, famous for Iraq WMD claims, an author qualified to write more than garbage?
Quoted Tweet
Edward Snowden @Snowden · 14h
Do you remember the “institutional” and social media corpo response in the first half of 2020 when someone contradicted the consensus? They were punished for the “crime” of “disinformation.”Corporations must never again be permitted to police speech.
https://wsj.com/articles/covid-origin-china-lab-leak-807b7b0a [57]—
chinahand @chinahand — 17:52 UTC · Feb 26, 2023 [58]
to recap the actual state of play: meaningless DoE report gets leaked to journos so credentialed cretins can assist USG in making anti-China hay. Gotta change the name to “less than zero media”
—
Caitlin Johnstone @caitoz — 11:35 UTC · Feb 27, 2023 [59]
It’s the same guy. IT’S THE SAME FUCKING GUY.
Quoted Tweet
Mark Ames @MarkAmesExiled — 13h
DC’s China War lobby dusting off their Iraq WMD tool to revive lab leak theory—
The new ‘report’:
Lab Leak Most Likely Origin of Covid-19 Pandemic, Energy Department Now Says [23]
U.S. agency’s revised assessment is based on new intelligence
By Michael R. Gordon and Warren P. Strobel
Updated Feb. 26, 2023 4:29 pm ETThe U.S. Energy Department has concluded that the Covid pandemic most likely arose from a laboratory leak, according to a classified intelligence report recently provided to the White House and key members of Congress.
...
The Energy Department made its judgment with “low confidence,” according to people who have read the classified report.
...
U.S. officials declined to give details on the fresh intelligence and analysis that led the Energy Department to change its position.
...
The National Intelligence Council, which conducts long-term strategic analysis, and four agencies, which officials declined to identify, still assess with “low confidence” that the virus came about through natural transmission from an infected animal, according to the updated report.—
Previously:
THREATS AND RESPONSES: THE IRAQIS; U.S. SAYS HUSSEIN INTENSIFIES QUEST FOR A‑BOMB PARTS [24]
By Michael R. Gordon and Judith Miller
Sept. 8, 2002More than a decade after Saddam Hussein agreed to give up weapons of mass destruction, Iraq has stepped up its quest for nuclear weapons and has embarked on a worldwide hunt for materials to make an atomic bomb, Bush administration officials said today.
In the last 14 months, Iraq has sought to buy thousands of specially designed aluminum tubes, which American officials believe were intended as components of centrifuges to enrich uranium. American officials said several efforts to arrange the shipment of the aluminum tubes were blocked or intercepted but declined to say, citing the sensitivity of the intelligence, where they came from or how they were stopped.
...
While there is no indication that Iraq is on the verge of deploying a nuclear bomb, Iraq’s pursuit of nuclear weapons has been cited by hard-liners in the Bush administration to make the argument that the United States must act now, before Mr. Hussein acquires nuclear arms and thus alters the strategic balance in the oil-rich Persian Gulf.
...
Hard-liners are alarmed that American intelligence underestimated the pace and scale of Iraq’s nuclear program before Baghdad’s defeat in the gulf war. Conscious of this lapse in the past, they argue that Washington dare not wait until analysts have found hard evidence that Mr. Hussein has acquired a nuclear weapon. The first sign of a ”smoking gun,” they argue, may be a mushroom cloud.
7. The year-long investigation concluded just before the 9/11/attacks. [The NSA/GCHQ vacuum cleaning predates 9/11–D.E.] The European Parliamentary commission concluded that many other European countries had the same capability.
[Notice when this was published–9/6/2001.–D.E.] . . . The United States-led spying system known as Echelon can monitor virtually every communication in the world — by e‑mail, phone or fax — that bounces off a satellite, the European Parliament was told. But in reporting on a yearlong study of the system that was prompted by concern that American companies were using data from the system to gain a competitive edge, Gerhard Schmid, a German member of the Parliament, said that many European countries had similar abilities . . .
8. It appears that the FDA, CDC, and Moderna all colluded to withhold data from these advisory panels the Moderna had already gathered indicating that the bivalent COVID boosters are possibly less effective at prevent an infection than the original mRNA vaccine formulation.
Yep, first the FDA held a day-long meeting on June 28 with a panel of independent experts about the new boosters. The president of Moderna was also invited to present to the panel and shared the results of a new Moderna study that had just been preprinted (non-peer reviewed) three days before the meeting. The study showed the new bivalent vaccine elicited higher antibody levels. But also higher infection rates. The higher antibody levels were excitedly shared to the panel. Nothing about the higher infection rates was shared.
So why didn’t the FDA share this info about higher infection rates with the panel? The FDA was aware of Moderna’s preprinted study, after all. We’ll we’re told that the FDA just didn’t have enough time to review it. That’s the excuse given for how Moderna’s president was allowed to selectively share results with the panel and the FDA leaving the panelists in the dark.
The FDA ultimately approved the bivalent boosters on August 31. The next day, the CDC held an independent panel of its own to review the new bivalent boosters. Again, people from Moderna were there to selectively present how the new boosters resulted in higher antibody levels while leaving out the data about the higher infection rates entirely. On September 13, the FDA finally published the data it based its approval on, including the infection data. So the FDA only publicly released the data from Moderna showing possibly lower efficacy for the new boosters only after the CDC’s panel gave its own stamp of approval without knowing about the lower efficacy findings.
So what was the CDC’s excuse for keeping the panel in the dark? Well, according to the CDC spokesperson, the “CDC was aware” of the data that would later be published in The New England Journal of Medicine. Also, they added that assessing infections was an “exploratory objective of the study,” which was “not designed to assess vaccine effectiveness.” It’s not exactly a compelling excuse. Finally, they pointed out that in assessing infections, “researchers used different durations and points in time among a very small group of people,” and because of the limitations of the data, it was not featured at the meeting. In other words, the Moderna study was poorly-powered crap.
Which is was by all indications. And that’s part of the story here: Moderna’s poorly-powered crap study was apparently fine for use when it increased the chances of the vaccines getting approved. But when it comes to the data showing reduced effectiveness we can just ignore it because of the poor statistical power. It’s all quite convenient. Convenient for Moderna and any Moderna super-fans that inhabit the federal regulatory bureaucracy. As Dr. Paul Offit, one of the independent experts who is now livid over this scandal, put it, his faith in the whole approval process has been shaken. Which should raise plenty of questions for the rest of us [29]:
Some vaccine advisers to the federal government say they’re “disappointed” and “angry” that government scientists and the pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year when the advisers discussed whether the shot should be authorized and made available to the public.
That data suggested the possibility that the updated booster might not be any more effective at preventing Covid-19 infections than the original shots.
The data was early and had many limitations, but several advisers told CNN that they were concerned about a lack of transparency.
US taxpayers spent nearly $5 billion on the new booster, which has been given to more than 48.2 million [60] people in the US.
“I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” said Dr. Paul Offit, a member of the Vaccines and Related Biological Products Advisory Committee, a group of external advisers that helps the FDA make vaccine decisions. “Decisions that are made for the public have to be made based on all available information – not just some information, but all information.”
At a meeting of this FDA advisory group in June and a meeting in September of a panel that advises the US Centers for Disease Control and Prevention, the experts were presented with reams of information indicating that the new vaccine worked better than the one already on shelves, according to a review of videos and transcripts of those meetings and slide presentations made by Moderna, CDC and FDA officials.
That data – called immunogenicity data – was based on blood work done on study participants to assess how well each vaccine elicited antibodies that fight off the Omicron strain of the virus that causes Covid-19.
The data that was not presented to the experts looked at actual infections: who caught Covid-19 and who did not.
It found that 1.9% of the study participants who received the original booster became infected. Among those who got the updated bivalent vaccine – the one that scientists hoped would work better – a higher percentage, 3.2%, became infected. Both versions of the shot were found to be safe.
This infection data was far from complete. The number of study subjects who became infected was very small, and both the patients and the researchers were aware of who was getting the original shot and who was getting the new booster.
Despite these imperfections, the data was included in a preprint study that was posted online in June, again in September in an FDA document and then later that month in a top medical journal – and advisers to the FDA and the CDC said the data should have been shared with them, too.
“It’s not a group of children. We understand how to interpret these results,” said Dr. Eric Rubin, a member of the FDA vaccine advisory committee.
The six FDA and CDC advisers interviewed by CNN said that this infection data wouldn’t have changed how they voted, because the data had such limitations, but it still should have been presented to them.
“There should always be full transparency,” said Dr. Arnold Monto, a professor of epidemiology at the University of Michigan School of Public Health and acting chair of the FDA advisers’ group. “These data should not be dismissed. They are early, but they indicate that we need to look at them and see what their value is.”
Dr. Pablo Sanchez, a member of the CDC’s panel, called the Advisory Committee on Immunization Practices, said that if the data “was looked at as part of the study, it should have been presented to the advisers prior to their decision.”
The FDA and the CDC convene their advisory board meetings and make presentations to the advisers. At last year’s meetings, Moderna executives made presentations, as well. The advisers then make their recommendations to the agencies, and the agencies decide whether to authorize the shots and recommend them to the public.
Moderna spokesman Christopher Ridley said in an email to CNN that the company shared the infection data with the FDA and posted the study manuscript before the agency’s panel meeting in June “in response to requests that we share an update from the ongoing study.”
That study preprint [61] was posted online June 25, three days before the FDA advisers met.
Michael Felberbaum, an FDA spokesman, told CNN in an email that “the FDA received the preprint less than a day prior to the advisory committee meeting,” and “the information was therefore not provided in an adequate timeframe for it to be included in the agency’s meeting materials, and generally the FDA only discusses data at advisory committee meetings that the agency has had the opportunity to substantively review.”
“Numerous studies support the finding that the COVID-19 vaccines remain the best defense against the most devastating consequences of COVID-19 such as hospitalization and death, and that the updated vaccines may help provide better protection against the currently circulating variants,” Felberbaum wrote.
He added that “throughout the pandemic, the FDA has remained as transparent as possible regarding its processes and decision-making regarding the COVID-19 vaccines” and that Moderna could have chosen to present the data at the FDA advisory committee meeting.
Kristen Nordlund, a CDC spokeswoman, said that “due to the many limitations involving this clinical data, it was not featured” in the CDC’s advisory committee discussion.
Emphasis on transparency
The advisers said there are three main reasons why it matters that the infection data was not presented to them.
One, they said, is the potential impact of their decision: If Americans were going to be getting these shots, all available data should be brought to the table for consideration.
Two, the advisory committee meetings are streamed live online, and regulatory agencies around the world use the information to help make decisions about vaccines in their countries.
Three, they stressed that transparency is important. The public doesn’t witness conversations among FDA officials or between agency officials and pharmaceutical company executives, but they do get to watch the advisory panels’ proceedings.
…
Infection data not included in presentations by FDA and Moderna
Last summer, as the FDA’s and CDC’s outside advisers considered the updated boosters, the stakes were high. They knew that in just a matter of months, winter would be approaching, and Covid rates could spike. They also knew the original vaccine was getting less effective with each new variant and that the addition of the Omicron strain in the updated booster might help battle the virus.
The FDA advisers [62] – 21 voting members, including infectious disease experts and vaccinologists from Stanford, the University of Pennsylvania and Harvard – met [63] for a full day on June 28.
Dr. Stephen Hoge, the president of Moderna, made a presentation [64] to the advisers and frequently referred to information from the preprint study that had been posted three days before. The study was funded by Moderna and led by company scientists, and it had not been subjected to peer review or published in a medical journal.
The data Hoge shared with the advisers demonstrated that blood tests on about 800 study participants indicated that the new bivalent booster was “superior” at increasing antibodies to the Omicron variant compared with the original vaccine.
Hoge did not mention another part of the study that cast a less-positive light on the updated shot.
In that part, the researchers gave some participants the existing vaccine and other participants the updated booster, and then they kept track of who became infected with Covid-19.
Among the hundreds of participants who received the original vaccine and showed no evidence of a prior Covid-19 infection, over the period of the small study, 1.9% became infected. Among the hundreds who received the new bivalent vaccine, a higher percentage, 3.2%, became infected. The preprint did not indicate whether these findings were statistically significant.
A 22-page FDA briefing document [65] given to the advisers did not mention this infection data.
Dr. Jerry Weir, director of the Division of Viral Products at the FDA’s Office of Vaccines Research and Review, also did not mention the infection data in his presentation [66] to the advisers.
At the end of the June 28 meeting, the FDA advisers voted 19–2 to recommend the inclusion of an Omicron variant for the Covid-19 booster vaccine. Offit, a professor of vaccinology at the Perelman School of Medicine at the University of Pennsylvania, and Dr. Henry Bernstein, a professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in New York, voted in opposition.
Over the next month, the US government announced agreements to purchase the bivalent booster from Pfizer [67] and Moderna [68]: a contract for $3.2 billion with Pfizer [69] and for $1.74 billion with Moderna [70].
Limitations of Moderna’s infection data
The infection data that wasn’t included in the Moderna and FDA presentations has several serious limitations, according to the six advisers who spoke to CNN.
First, the numbers were very small: The study analyzed only hundreds of patients, and only 16 became infected. None of them ended up in the emergency room or were hospitalized.
…
Second, participants were not randomly assigned to receive either the original or new vaccine, and the study was not double-blind, meaning the participants and the researchers knew who was receiving which shot. Lack of randomization and blinding can bias study results.
Third, the primary purpose of the study was not to study infection rates but to do immunogenicity analyses, taking blood from participants and examining their antibody responses to the vaccine.
…
“The primary objective of the study was to assess the safety and immunogenicity of the bivalent vaccine. The study was not randomized and did not control for infection risk between arms, making comparison of a relatively small number of cases problematic,” he wrote.
Nearly $5 billion for updated boosters
On August 31, about two months after the FDA advisers’ meeting, the agency authorized the Moderna bivalent vaccines. The Moderna infection data was included in the agency’s written decision [71], but it wasn’t posted online until September 13, according to Felberbaum, the FDA spokesman.
On September 1, the CDC advisers [72] – 14 voting members – met to consider whether to recommend the bivalent boosters for Americans to get in the fall. Several CDC scientists presented data [73] at that meeting but did not include the infection data.
Nordlund, the CDC spokeswoman, said in her email that the “CDC was aware” of the data that would later be published in The New England Journal of Medicine [74] but that assessing infections was an “exploratory objective of the study,” which was “not designed to assess vaccine effectiveness.” She added that in assessing infections, “researchers used different durations and points in time among a very small group of people,” and because of the limitations of the data, it was not featured at the meeting.
“CDC vaccine recommendations are made following an evaluation and presentation of high-quality vaccine efficacy or immunobridging data,” Nordlund wrote.
Dr. William Schaffner, a non-voting member of the CDC’s advisory committee, called Nordlund’s argument “very weak.”
“The data are limited, but they are informative, and I think one would have anticipated that a complete presentation would have included them,” said Schaffner, an infectious disease specialist at Vanderbilt University Medical Center.
Dr. Jacqueline Miller, a senior vice president at Moderna, presented [75] to the advisers. Like her colleague Hoge, the company president, she showed material suggesting that the bivalent vaccine was superior and did not show slides detailing the statistics about the infection rates, according to a copy of the slides she presented.
Several hours into the meeting, one of the CDC advisers, Dr. Sybil Cineas, an associate professor of medicine at the Warren Alpert Medical School of Brown University, asked Miller about cases of Covid-19 among study subjects who received the original vaccine versus the updated bivalent booster.
Miller said that among subjects with no evidence of prior infection, as well as those with evidence of prior infection, the disease incidence rates were 2.4% for the group who received the original vaccine and 2.5% for those who got the bivalent booster.
That data would be published two weeks later in The New England Journal of Medicine.
When she answered Cineas’ question, Miller did not mention other aspects of the infection data in the published study. That data indicated that among hundreds of participants with no previous Covid-19 infections, infection occurred in 1.9% of those who’d received the old vaccine and in 3.2% of those who’d received the new bivalent vaccine. She also did not mention breakdowns of whether participants were sick with Covid or had asymptomatic illnesses. The study, like the preprint, did not mention whether any of these findings were statistically significant.
At the end of the meeting, the CDC advisers voted 13–1 in favor of recommending the bivalent booster, with Sanchez, a professor of pediatrics at the Ohio State University College of Medicine, voting in opposition. CDC Director Dr. Rochelle Walensky signed off on the recommendation later that day, and the vaccines were made available to the public. Currently [76], they are the only booster available once someone has had their primary series of a Covid-19 vaccine.
More than six months after the FDA advisers met, Moderna still has not released data from a randomized Phase 3 trial comparing infections in participants who received the new booster with those who received the old shot. The company expects to release such results “shortly” with about 3,000 participants, according to Ridley.
Pfizer does not “currently have data on incidence of infection post bivalent booster. However, we continue to monitor real-world data and collect data from our own studies,” according to a statement from Jerica Pitts, senior director of global media relations.
Together, the new updated boosters from Pfizer and Moderna cost taxpayers nearly $5 billion. To put that in perspective, that’s about the size of the annual budget for the state of Delaware [77].
Former FDA scientist: No excuse for excluding infection data
A former FDA scientist who helped run the agency’s vaccine division told CNN that if he were still at the agency, he would have advocated for sharing the infection information with the advisers, even if it was made available only a short time before the meeting.
“I don’t think there’s any excuse for excluding it,” even with its imperfections, said Dr. Philip Krause, who served [78] as deputy director of the FDA’s Office of Vaccine Research and Review until he resigned in October 2021.
“The company’s failure to present this information at the [FDA advisers meeting] and the omission of discussion about the data at that meeting raises questions about the ability of the process to provide a full and transparent review of the data,” he added.
Krause said his main concern was preserving – or regaining – the public trust in the FDA.
“That’s the critical thing,” he said. “The FDA’s objective review of the data is what is providing the great, great value to the American people, because this way they know that somebody who doesn’t have a stake in the outcome has looked at the deepest possible level at these data.”
FDA and CDC vaccine advisers echoed Krause’s concerns about transparency.
“I think that as much data that’s available should be made public and available for discussion by advisory groups so that the public can see, yes, the available science has been evaluated as best as [possible] at that particular time,” said Bernstein, the member of the FDA advisory committee.
Bernstein added that he was disappointed that the data had not been presented to him and the other advisers.
Offit, the member from the University of Pennsylvania, said he was angry.
“I was angry to find out that there was data that was relevant to our decision that I didn’t get to see. Angry because they should trust us to make the decision based on all the data. These agencies, whether it’s the FDA or CDC, can’t make that decision for us. That’s the point of having an independent advisory committee,” he said.
‘It shook my faith’
About a month after the CDC advisers met, studies [79] were released from researchers at Harvard and Columbia suggesting that the new vaccines didn’t work any better than the original.
Those studies, which were very small and only in preprint and not in a medical journal, measured immune responses after people got the bivalent vaccine compared with the original version of the vaccine.
“We essentially see no difference” between the old boosters and the new about a month after the shot, said Dr. David Ho, a professor of microbiology and immunology at Columbia whose team authored one of the studies.
President Joe Biden and other administration officials continue to emphasize that the updated booster [80] is the best way to avoid hospitalization or death from Covid-19. But nearly four months after its release, only 15.4% of the US population age 5 and older has opted to get the shot, according to CDC data [60].
On January 26, the advisers are scheduled to meet [81] again to discuss future Covid-19 vaccination regimens.
Offit, the FDA vaccine adviser, said the Columbia and Harvard studies convinced him even more that the infection data and all the related caveats should have been given to the advisers from the beginning.
“This was not acceptable. I understand we’re in the middle of a pandemic. I understand we’re building the plane while it’s still in the air, but you can’t do this,” he said. “It did shake my faith. It shook my faith in how these decisions were being made.”
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Abstract
The strategy of relying solely on current SARS-CoV‑2 vaccines to halt SARS-CoV‑2 transmission has proven infeasible. In response, many public-health authorities have advocated for using vaccines to limit mortality while permitting unchecked SARS-CoV‑2 spread (“learning to live with the disease”). The feasibility of this strategy critically depends on the infection fatality rate (IFR) of SARS-CoV‑2. An expectation exists that the IFR will decrease due to selection against virulence. In this work, we perform a viral fitness estimation to examine the basis for this expectation. Our findings suggest large increases in virulence for SARS-CoV‑2 would result in minimal loss of transmissibility, implying that the IFR may vary freely under neutral evolutionary drift. We use an SEIRS model framework to examine the effect of hypothetical changes in the IFR on steady-state death tolls under COVID-19 endemicity. Our modeling suggests that endemic SARS-CoV‑2 implies vast transmission resulting in yearly US COVID-19 death tolls numbering in the hundreds of thousands under many plausible scenarios, with even modest increases in the IFR leading to unsustainable mortality burdens. Our findings highlight the importance of enacting a concerted strategy and continued development of biomedical interventions to suppress SARS-CoV‑2 transmission and slow its evolution.
The agreement announced on Friday in Beijing regarding the normalisation of diplomatic relations between Saudi Arabia and Iran and the reopening of their embassies is a historic event. It goes way beyond an issue of Saudi-Iranian relations. China’s mediation signifies that we are witnessing a profound shift of the tectonic plates in the geopolitics of the 21st century.
The joint statement issued on Friday in Beijing [83] begins by saying that the Saudi-Iranian agreement was reached “in response to the noble initiative of President Xi Jinping.” The dramatic beginning goes on to state that Saudi Arabia and Iran have expressed their “appreciation and gratitude” to Xi Jinping and the Chinese government “for hosting and sponsoring the talks, and the efforts it placed towards its success.”
The joint communique also mentioned Iraq and Oman for fostering the Saudi-Iranian dialogue during 2021–2022. But the salience is that the United States, which has been traditionally the dominant power in West Asian politics for close to eight decades, is nowhere in the picture.
Yet, this is about the reconciliation between the two biggest regional powers in the Persian Gulf region. The US retrenchment denotes a colossal breakdown of American diplomacy. It will remain a black mark in President Biden’s foreign policy legacy.
But Biden must take the blame for it. Such a cataclysmic failure is largely to be traced to his fervour to impose his neoconservative dogmas as an adjunct of America’s military might and Biden’s own frequent insistence that the fate of humankind hinges on the outcome of a cosmic struggle between democracy and autocracy.
China has shown that Biden’s hyperbole is delusional and it grates against realities. If Biden’s moralistic, ill-considered rhetoric alienated Saudi Arabia, his attempts to suppress Iran met with stubborn resistance from Tehran. And, in the final analysis, Biden literally drove both Riyadh and Tehran to search for countervailing forces that would help them to push back his oppressive, overbearing attitude.
The US’ humiliating exclusion from the centre stage of West Asian politics constitutes a “Suez moment” for the superpower, comparable to the crisis experienced by the UK in 1956, which obliged the British to sense that their imperial project had reached a dead end and the old way of doing things—whipping weaker nations into line as ostensible obligations of global leadership —was no longer going to work and would only lead to disastrous reckoning.
The stunning part here is the sheer brain power and intellectual resources and ‘soft power’ that China has brought into play to outwit the US. The US has at least 30 military bases in West Asia — five in Saudi Arabia alone — but it has lost the mantle of leadership. Come to think of it, Saudi Arabia, Iran and China made their landmark announcement on the very same day Xi Jinping got elected for a third term as president.
What we are seeing is a new China under the leadership of Xi Jinping trotting over the high knoll. Yet, it is adopting a self-effacing posture claiming no laurels for itself. There is no sign of the ‘Middle Kingdom syndrome,’ which the US propagandists had warned against.
On the contrary, for the world audience — especially countries like India or Vietnam, Turkey, Brazil or South Africa — China has presented a salutary example of how a democratised multipolar world can work in future — how it is possible to anchor big power diplomacy on consensual, conciliatory politics, trade and interdependence and advance a ‘win-win’ outcome.
Implicit in this is another huge message here: China as a factor of global balance and stability. It is not only Asia-Pacific and West Asia who are watching. The audience also includes Africa and Latin America — in fact, the entire non-Western world that forms the big majority of world community who are known as the Global South.
What the pandemic and the Ukraine crisis have brought to the surface is the latent geopolitical reality that the Global South rejects the policies of neo-mercantalism pursued by the West in the garb of ‘liberal internationalism.’
The West is pursuing a hierarchical international order. None other than the EU foreign policy chief Josep Borrell blurted this out in an unguarded moment recently with a touch of racist overtone when he said from a public platform that ‘Europe Is a garden. The rest of the world Is a jungle, and the jungle could Invade the garden.’
Tomorrow, China could as well be challenging the US hegemony over the Western Hemisphere. The recent paper by the Chinese Foreign Ministry titled ‘US Hegemony and Its Perils [84]’ tells us that Beijing will no longer be on the defensive.
Meanwhile, a realignment of forces on the world stage is taking place with China and Russia on one side and the US on the other. Doesn’t it convey a big message that on the very eve of the historic announcement in Beijing on Friday, the Saudi Arabian foreign minister Prince Faisal bin Farhan Al Saud landed suddenly in Moscow on a ‘working visit’ and went into a huddle with Foreign Minister Sergey Lavrov who was visibly delighted? (here [85], here [86] and here [87] )
Of course, we will never know what role Moscow would have played behind the scenes in coordination with Beijing to build bridges between Riyadh and Tehran. All we know that Russia and China actively coordinate their foreign policy moves. Interestingly, on March 6, President Putin had a telephone conversation [88] with Iran’s President Ebrahim Raisi.
Audacity of hope
To be sure, the geopolitics of West Asia will never be the same again. Realistically, the first sparrow of spring has appeared but the ice was melted for only three or four rods from the shore. Nonetheless, the sun’s rays give hope, signalling warmer days to come.
Conceivably, Riyadh won’t have any truck further with the diabolical plots hatched in Washington and Tel Aviv to resuscitate an anti-Iran alliance in West Asia. Nor is it in the realms of possibility that Saudi Arabia will be party to any US-Israeli attacks on Iran.
This badly isolates Israel in the region and renders the US toothless. In substantive terms, it scatters the Biden administration’s feverish efforts lately to cajole Riyadh to join Abraham Accords.
However, significantly, a commentary in Global Times [89] noted somewhat audaciously that the Saudi-Iranian deal “set a positive example for other regional hotspot issues, such as the easing and settlement of the Israeli-Palestinian conflict. And in the future, China could play an important role in building a bridge for countries to solve long-standing thorny issues in the Middle East just as what it did this time.”
Indeed, the joint communique issued in Beijing says, “The three countries [Saudi Arabia, Iran and China] expressed their keenness to exert all efforts towards enhancing regional and international peace and security.” Can China pull a habit out of the hat? Time will tell.
For the present, though, the Saudi-Iranian rapprochement will certainly have positive fallouts on the efforts toward a negotiated settlement in Yemen and Syria as well as on the political instability in Lebanon.
Besides, the joint communique emphasises that Saudi Arabia and Iran intend to revive the 1998 General Agreement for Cooperation in the Fields of Economy, Trade, Investment, Technology, Science, Culture, Sports, and Youth. All in all, the Biden administration’s maximum pressure strategy toward Iran has crashed and the West’s sanctions against Iran are being rendered ineffectual. The US’ policy options on Iran have shrunk. Put differently, Iran gains strategic depth to negotiate with the US.
The cutting edge of the US sanctions lies in the restrictions on Iran’s oil trade and access to western banks. It is entirely conceivable that a backlash is about to begin as Russia, Iran and Saudi Arabia — three top oil/gas producing countries start accelerating their search for payment mechanisms bypassing the American dollar.
China is already discussing such an arrangement with Saudi Arabia and Iran. China-Russia trade and economic transactions no longer use American dollar for payments. It is well understood that any significant erosion in the status of the dollar as ‘world currency’ will not only spell doom for the American economy but will cripple the US’ capacity to wage ‘forever wars’ abroad and impose its global hegemony.
The bottom line is that the reconciliation between Saudi Arabia and Iran is also a precursor to their induction as BRICS members in a near future. To be sure, there is a Russian-Chinese understanding already on this score. The BRICS membership for Saudi Arabia and Iran will radically reset the power dynamic in the international system.
Dr. Renee Wegrzyn is President Biden’s choice to lead the Advanced Research Projects Agency for Health, which is aimed at driving biomedical innovation.
President Biden, sketching out a vision for “bold approaches” to fighting cancer and other diseases, announced on Monday that he had selected Dr. Renee Wegrzyn, a Boston biotech executive with government experience, as the director of a new federal agency aimed at pursuing risky, far-reaching ideas that will drive biomedical innovation. [!—D.E.]
Mr. Biden made the announcement at the John F. Kennedy Presidential Library and Museum in Boston, on the 60th anniversary of the former president’s “moonshot” speech that ushered in an era of space travel. He used the occasion to reiterate his call to “end cancer as we know it” — the tag line for his own “cancer moonshot” initiative. . . .
. . . . Modeled after the Defense Advanced Research Projects Agency, the new agency is known as the Advanced Research Projects Agency for Health. (In the argot of Washington, where every agency has an acronym, the defense research agency is called DARPA and the health agency [12] is ARPA‑H [13].) . . . .
. . . . Dr. Wegrzyn is a vice president for business development at Ginkgo Bioworks and the head of innovation at Concentric by Ginkgo, the company’s initiative to advance coronavirus testing and track the spread of the virus. She also worked at DARPA and its sister agency, the Intelligence Advanced Research Projects Activity. . . .
. . . . The agency already has an acting deputy director, Adam H. Russell [91], also a DARPA alumnus, who has been laying the technical infrastructure and other groundwork to get the new agency off the ground. . . .
. . . . In addition to announcing his intent to appoint Dr. Wegrzyn, Mr. Biden issued an executive order on Monday establishing a biotechnology and biomanufacturing initiative intended to position the United States as a leader in the field and to center drug manufacturing in the country. [This is aimed at China–D.E.]. . .
12. https://en.wikipedia.org/wiki/Renee_Wegrzyn [92]
. . . . From 2003 to 2006, Wegrzyn worked as a post-doctoral research fellow at the European Molecular Biology Laboratory [93]. From 2006 to 2008, she worked as the assay development group leader for Adlyfe, a biotechnology company based in Quebec [94]. In 2009, she was a senior scientist at Meso Scale Discovery and in 2012, she was a fellow at the Johns Hopkins Center for Health Security [95]. From 2009 to 2016, she worked as a senior lead technologist at Booz Allen Hamilton [96]. From 2016 to 2020, she served as a program manager in the Biological Technologies Office [97] of DARPA [98], where she specialized in synthetic biology and biosecurity [99]. [This is the period during which DARPA [32] was doing the SARS CoV‑2 work—D.E.] 2018, she has been a senior advisor to the Nuclear Threat Initiative [100].[3] [101] In 2020, she joined Ginkgo Bioworks [102] as vice president of business development.[4] [103]” . . . .