Republicans Press FDA for Testimony on Rushed COVID-19 Vaccine Approvals

Republicans on the House Select Subcommittee on the Coronavirus Pandemic are seeking answers after recently released emails indicated that the U.S. Food and Drug Administration (FDA) had Rushed to approve COVID-19 vaccines, boosters, and other vaccines that can be used to comply with vaccine mandates.

“According to new internal U.S. Food and Drug Administration (FDA) communications, it appears the Biden Administration may have bypassed, compressed, and possibly compromised the longstanding process for awarding a full biologics approval to a vaccine,” In a March 10th letter, the legislators (PDF) to FDA Commissioner Robert Califf.

“This effort may not have been to save lives, but concernedly to provide cover for implementing and enforcing vaccine mandates across the country,” They were charged.

According to emails first reported in January of this year, it was revealed that FDA’s Office of Vaccines Research and Review had been pressured by officials to speed up the review of Pfizer vaccine.

The lawmakers pointed out that the FDA initially had not announced a reopening of the program. target date For the review to be complete, it will take place in January 2022.

“However, while the FDA publicly said its goal for approval was January 2022, its privately stated goal was September 15, 2021—four months earlier than the expedited goal and eight months earlier than standard review,” They wrote. “Further, according to Dr. Marion Gruber, the former director of the FDA’s Office of Vaccines Research and Review (OVRR), the Biden administration wanted to cut more corners to approve the vaccine even faster.”

Gruber, who is no longer employed at the FDA, warned that there were risks. “hyper-accelerated” review could undermine public confidence in both the vaccine and the FDA—particularly given concerns about myocarditis in young men and teens—and noted that FDA leadership had pointed to vaccine mandates as a reason for haste.

“This email points to evidence that the Biden Administration chose to sideline experts and fast track full approval of the COVID-19 vaccine, sacrificing thoroughness and veracity, to establish a precedent for vaccine mandates,” The legislators wrote. “This is unconscionable.”

The Republicans asked that they be allowed to exercise their oversight authority over the matter. “all documents and communications” The committee should receive information related to the cited exchange by March 24. Gruber, ex-OVRR Deputy Director Philip Krause and FDA Center for Biologics Evaluation and Research Director Peter Marks and Janet Woodcock, will schedule interviews with Gruber.

Previously, Woodcock noted in a briefing that Pfizer’s vaccine application was reviewed in an “unprecedented timeline” But he claimed that “our efforts to move as quickly as possible have in no way sacrificed scientific standards or the integrity of our process.”