FDA May Need More Time to Review COVID-19 Booster Shot Plan

(PresidentialWire.com)- Last Tuesday, citing frustrations with the Biden Administration’s plan to push COVID booster shots without FDA approval, two senior FDA officials resigned from their positions.

Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and Phil Krause, deputy director, were at odds with the FDA’s top vaccine official Peter Marks for letting the CDC and the Advisory Committee on Immunization Practices make decisions that should be handled by the Food & Drug Administration.

Gruber and Krause believe that the administration’s plan for boosters was jumping the gun and that Marks should have pushed for the FDA to have more autonomy in the decision making.

On Thursday, FDA acting commissioner Dr. Janet Woodcock, along with CDC Director Dr. Rochelle Walensky warned the White House that they may need more time to review the data before the Biden Administration can move forward on introducing COVID-19 booster shots.

The White House had wanted to begin offering booster shots later this month.

According to a White House spokesman, the administration had “always said we would follow the science.” But considering two FDA officials objected enough to the booster shot plan to resign calls that assertion into question.

The push to require COVID booster shots is in response to the declining efficacy of the FDA-approved Pfizer vaccine which now the administration only said reduces the likelihood of hospitalization and death.

In mid-August, the Biden administration released a joint statement from HHS, Walensky and Woodcock which concluded that a booster shot “will be needed to maximize vaccine-induced protection.” The statement said that these booster shots, to be received 8 months after an individual’s second dose, will be available beginning the week of September 20.

But rather than the booster dose recommendations being determined by the FDA, the CDC’s Advisory Committee on Immunization Practices will make the call.

After Gruber and Krause submitted their resignations, infectious Disease expert Paul Offit of the University of Pennsylvania, who serves on the FDA’s vaccine advisory committee, told Politico that this is the administration’s booster plan, not the FDA’s plan. Offit added that the Biden administration “backed themselves up against the wall” in prematurely promoting booster shots.