Former FDA Scientists Dispute Need for Booster Vaccines

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Both Marion Gruber and Phillip Krause, FDA officials, co-authored a document disputing the need for COVID-19 boosters for most people.

Marion Gruber and Phillip Krause, two FDA officials who announced they would be leaving the agency after clashing with Biden over the need for booster vaccines, were among 18 authors of a paper published in The Lancet (1) on Sept. 13, 2021 disputing the need for booster vaccines for most people.

The current administration has firmly backed booster vaccines, with the Department of Human Health and Services recently stating that they believed booster vaccines would be needed. However, others, such as World Health Organization Director-General Tedros Adhanom Ghebreyesus, have pushed back against those calling for immediate booster shots, stating that it is more pressing to increase vaccine coverage in underserved countries.

The contention of Gruber, Krause, and the other authors of the paper, “Considerations in Boosting COVID-19 Vaccine Immune Responses”, centers on the assertion that there is no substantiated scientific backing for boosters for most people. According to the paper, initial findings from randomized trials have shown strong efficacy of the vaccines.

The authors of the paper showed concern that booster vaccines might result in unintended, adverse effects in recipients, which could also cause increased vaccine mistrust in the general population. Similarly, they worry that public opinion on the efficacy of the vaccine will be undermined by calls for a booster less than a year after release.

“Although the idea of further reducing the number of COVID-19 cases by enhancing immunity in vaccinated people is appealing, any decision to do so should be evidence-based and consider the benefits and risks for individuals and society,” stated Krause et al. in the paper.


“If boosters (whether expressing original or variant antigens) are ultimately to be used,” continued Krause et al. “There will be a need to identify specific circumstances in which the direct and indirect benefits of doing so are, on balance, clearly beneficial. Additional research could help to define such circumstances.”


P. Krause et al., The Lancet. io. online, DOI:10.1016/S0140-6736(21)02046-8(Sept. 13, 2021).