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https://www.politico.com/news/2021/09/13/fda-covid-vaccine-boosters-research-paper-511638
The Biden admin are not listening to their own top scientists. The FDA's directory of the vaccine research and safety and the deputy director are both saying that there is no evidence suggesting that boosters are needed, and are resigning over Biden's plan to roll out boosters to all-Americans. They also have concerns that there is not sufficient safety data, and warn against serious side-effects like myocarditis and Guillain-Barré syndrome.
Why is the Biden administration rushing out boosters despite his own top scientists telling him not to?
https://www.thelancet.com/pb-assets...213&utm_content=158920213&utm_source=hs_email
UPDATE: FDA advisory committee votes 16-2 against boosters.
Two senior U.S. vaccine regulators who are leaving the FDA came out against giving Covid-19 booster shots to the general population now in a research paper published Monday that concludes current science on vaccine efficacy doesn't support giving third shots to most Americans.
The paper, co-authored by Marion Gruber and Philip Krause and published in The Lancet, deals a blow to the FDA and to the Biden administration just days before an external agency panel is set to review the case for doling out Pfizer-BioNTech boosters. The scientists recently announced plans to retire this fall, decisions one former agency official said stemmed in part from frustration with the administration's booster plan.
The main argument: The paper, which summarizes available trial data and peer-reviewed studies to date on the Covid vaccines, argues that despite waning immunity, the shots' efficacy "is substantially greater against severe disease than against any infection" and sufficiently protective for the general population.
"Even in populations with fairly high vaccination rates the unvaccinated are still the major drivers of transmission and are themselves at the highest risk of serious disease," wrote the authors, which also include World Health Organization scientists.
Even if booster shots were shown to lower the risk of serious disease, they said, existing supplies would be better off deployed to unvaccinated corners of the world, rather than boosting vaccinated populations, to head off the development of more variants.
"Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics," they wrote.
The authors note that boosting may still be needed in the future if protection from the initial shots wanes, or if a variant forms that evades that protection. They also acknowledge the possible benefit of immediately boosting immunocompromised patients who may not have mounted a sufficient immune response to their initial vaccine series.
Now is the time to study variant-based boosters while the primary vaccines continue to be effective, they said, noting the similar strategy used to plan annual flu shot formulations.
The Biden admin are not listening to their own top scientists. The FDA's directory of the vaccine research and safety and the deputy director are both saying that there is no evidence suggesting that boosters are needed, and are resigning over Biden's plan to roll out boosters to all-Americans. They also have concerns that there is not sufficient safety data, and warn against serious side-effects like myocarditis and Guillain-Barré syndrome.
Why is the Biden administration rushing out boosters despite his own top scientists telling him not to?
https://www.thelancet.com/pb-assets...213&utm_content=158920213&utm_source=hs_email
UPDATE: FDA advisory committee votes 16-2 against boosters.
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