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) rushed the approval of COVID-19 vaccines and boosters to accommodate 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,” the legislators wrote in a March 10 letter (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 asserted.
As first reported in January, the emails in question showed that, in 2021, the FDA’s Office of Vaccines Research and Review (OVRR) was being pressured by agency officials to speed up its review of the Pfizer vaccine despite the concerns of some staff members.
In their letter, the lawmakers noted that, initially, the FDA had announced a target date of January 2022 for the review to be completed.
“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 no longer works at the FDA, had warned that a “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.”
Citing their authority to conduct oversight on the matter, the Republicans requested that “all documents and communications” related to the cited exchange be turned over to the committee by March 24, and that transcribed interviews be scheduled with Gruber, former OVRR Deputy Director Philip Krause, FDA Center for Biologics Evaluation and Research Director Peter Marks, and FDA Principal Deputy Commissioner Janet Woodcock.
Previously, Woodcock noted in a briefing that Pfizer’s vaccine application was reviewed in an “unprecedented timeline,” but asserted that “our efforts to move as quickly as possible have in no way sacrificed scientific standards or the integrity of our process.”