FDA Dismisses Two New Studies That Claim New COVID-19 Omicron Boosters Are Ineffective

The FDA’s vaccine chief, Dr. Peter Marks, said that more thorough and “well-controlled” studies are expected in the near future. Photo credit: JhvePhoto / Shutterstock.com, licensed.

WASHINGTON, D.C. – The Food and Drug Administration (FDA) is dismissing the findings of two new studies that both claim that new COVID-19 boosters shots tailored for Omicron are not any more effective against the variant than the original batch of vaccines that were released, with the agency saying that they did not reach any “meaningful conclusions” because they were too small in scope.

The two studies, carried out by scientists at Columbia University and Harvard University, concluded that updated bivalent boosters displayed roughly the same exact degree of efficacy – and in some cases even less – against the Omicron BA.5 subvariant as the first vaccines released earlier in the pandemic, according to Associate Professor at the University of Michigan’s School of Public Health, Aubree Gordon.

“The main finding is that we did not see broader immunity generated by the bivalent booster compared to the original monovalent booster,” she said.

The studies come just after updated COVID-19 boosters have been released by Pfizer/BioNTech and Moderna one month ago, but the conclusions of both Columbia and Harvard researchers have been downplayed by the FDA’s vaccine chief, Dr. Peter Marks, who said that more thorough and “well-controlled” studies are expected in the near future.


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“It is important to note that even the data from these initial small studies indicate that the bivalent vaccines are generally at least as good or better as the original vaccines in generating an immune response, particularly to BA.4/BA.5 and other newer variants,” Marks said. “FDA continues to encourage eligible individuals to consider receiving an updated vaccine to help protect against the currently circulating Covid-19 variants and the wave of Covid-19 that appears to be coming.”

Marks also supposed that even if the new boosters were only marginally better, that would nonetheless be a boon for the health of U.S. citizens.

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