Fauci: No Time for Clinical Trials for Updated COVID Boosters, ‘We Need to Get the Vaccine Out Now’￼
Dr. Anthony Fauci said there is no time to conduct clinical trials before making available newer COVID-19 booster shots.
“We don’t have time to do a clinical trial because we need to get the vaccine out now,” Fauci said on Canada’s CBC this week, claiming about 400 Americans are dying per day with COVID-19, and thousands of others are in hospitals with the disease.
Fauci justified his claim:
When you have an updated vaccine that serves as a boost as it were, and is directed against the dominant circulating strain that’s in society, you have every reason to believe that that is going to be better than having a vaccine that isn’t highly specific to the circulating strain. That hasn’t been proven in a clinical trial because we don’t have time to do a clinical trial, because we need to get the vaccine out now because we have such a situation throughout the world and certainly in the United States.
Fauci, the director of the National Institute of Allergy and Infectious Diseases who has also served as White House chief medical advisor, added:
We are moving towards a cadence that for most people, likely, will be requiring a yearly annual updating of a vaccine in order to account for what will be the inevitable waning of immunity.
Fauci said “more effort in communicating” was necessary to “get people to just appreciate what the evidence is and not conspiracy theory.”
“[W]hat the real evidence is, it points very strongly towards getting vaccinated and also keeping up with your boosters,” he added.
On August 31 the FDA announced its authorization of updated “bivalent” boosters for the Moderna and Pfizer COVID shots “for use as a single booster dose at least two months following primary or booster vaccination.”
“The bivalent vaccines, which we will also refer to as ‘updated boosters,’ contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.,” FDA said.
“The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older,” the federal health agency added. “The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.”
However, as Science reported, for the BA.4/BA.5 boosters, both Pfizer and Moderna submitted mouse data to support authorization of the shots:
They have not released those data publicly, although at the June FDA meeting, Pfizer presented preliminary findings in eight mice given BA.4/BA.5 vaccines as their third dose. Compared with the mice that received the original vaccine as a booster, the animals showed an increased response to all Omicron variants tested: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.
Science noted the “potential downside” of the decision by federal health authorities to authorize vaccines without data from human trials:
Authorizing updated vaccines without clinical data could lower public acceptance. “If a variant booster is going to reduce overall uptake, that’s a potential problem” that could offset the gains in protection from the new vaccine, says Deborah Cromer, a mathematical modeler at the Kirby Institute of the University of New South Wales.
John Moore, a Weill Cornell Medicine vaccine and virology expert, said, according to USA Today, “To rely only on mouse data (for authorization) would be unprecedented in my knowledge and would certainly raise eyebrows.”
“It doesn’t mimic the human situation,” he said, adding he expects the updated booster will likely only provide marginally increased protection from getting the infection.
“They’re offering the public a shiny toy and they say, ‘look, here’s a new shiny toy, go out and get boosted with it,’” he said. “What if the public realizes the shiny toy doesn’t come with battery included, will that reduce confidence in future vaccines?”
Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky, who recently announced a makeover of her agency intended to “restore public trust,” echoed Fauci’s sense of urgency to deliver the updated boosters quickly.
“If we wait for those data to emerge in human data, not just mice data, we will be using what I would consider to be a potentially outdated vaccine,” Walensky said on a radio broadcast of “Conversations on Health Care” in late August.
At the same time, Walensky urged anyone eligible at the time to obtain the current booster.
“We have now given over 600 million doses of this vaccine in this country so we have an extraordinary safety profile, probably unlike any we’ve seen with any vaccine in history,” she said.
Dr. Harvey Risch, professor emeritus of epidemiology at Yale School of Public Health, told The Epoch Times Fauci’s comments were “reckless” since the regulators had not rushed Pfizer and Moderna to update the vaccines previously, including when the Delta variant was dominant last year.
Regarding Walensky’s comments, Risch pointed out as well CDC’s COVID Data Tracker indicated BA.4.6 – which is not included in the updated boosters – has been growing in proportion most recently.
“By the time that a supposed new winter wave of infections would occur in late November or December, it will likely be BA.4.6 and the new booster will be outdated anyway,” he said.
In August, when Fauci announced he would be retiring from his position in December, Risch told Laura Ingraham, host of Fox News Channel’s The Ingraham Angle Fauci had committed three “cardinal sins” in running the White House’s COVID policy:
The first was that he worked actively to suppress early outpatient treatment with hydroxychloroquine. He labeled non-randomized, but controlled studies – he called them anecdotal. That’s a falsehood. Anecdotal means a study of one person or two or three and not dozens and hundreds of people. [A]nd, further on to that, is he was involved in stopping the one NIH study that was actually testing hydroxychloroquine, and he didn’t fund any further studies to look at hydroxychloroquine when there was a gaping need for early treatment. That was the first thing.
The second thing was his gain of function research that’s now established that it was gain of function research that he lambasted Senator Paul, saying you don’t know what you’re talking about. And in fact, Senator Paul was quite correct. And many scientists have affirmed that this has been gain of function research that Fauci funded it against the law, and yet, Fauci did it.
And the third thing were the lockdowns and the masking that, at all costs, he supported and forced on the population to the destruction of the huge economic and psychological destruction of large segments of the country for no scientific benefit.
Fauci’s and Walensky’s recent comments regarding the urgency to authorize updated boosters despite no human clinical trial data further underscore why a lack of trust in the federal health agencies exists.
Their justifications are added to those documented as having been made by other key players in the COVID-19 vaccine rollouts.
In October 2021, for example, Dr. Eric Rubin, a member of the Food and Drug Administration (FDA) independent advisory panel and also editor-in-chief of New England Journal of Medicine said, even as he voted to approve the Pfizer shot for children aged 5 to 11 years, its safety would remain unknown until after children receive the drug.
“We’re never gonna learn about how safe the vaccine is until we start giving it,” said Rubin. “That’s just the way it goes.”
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