House Republicans Allege FDA ‘Cut Corners’ in Covid-19 Vaccine Approval Process
On Thursday, 10 House Republicans sent a letter to the FDA alleging that the Covid-19 vaccine approval process was fast-tracked in a way that cut corners. The House Select Subcommittee on the Coronavirus Pandemic will increase oversight in response.
The letter was signed by all the Republicans members of the Subcommittee as well as Representative Lisa McClain (R., Mi.), chairwoman of the House Subcommittee on Health Care and Financial Services. In addition to alleging that the approval process cut corners, the letter alleges the fast-tracking “may not have been to save lives, but concernedly to provide cover for implementing and enforcing vaccine mandates across the country.”
The letter heavily relied on an email to colleagues from Dr. Marion Gruber, who was director of the FDA’s Office of Vaccines Research and Review at the time of the approval process.
After a July 2021 meeting, Gruber expressed concern about expediting the approval process for Pfizer’s Biologics Licensing Application (BLA) in comments quoted in the letter.
“The review requires a thorough evaluation and FDA’s own analysis of the safety, effectiveness[,] and manufacturing information submitted to support licensure of this vaccine,” wrote Gruber.
“A review that is hyper-accelerated beyond the already very rapid September 15 target date and as a consequence, may be less thorough than our typical review seems more likely to undermine confidence in the vaccine (and, indeed, in FDA’s credibility) than to increase it,” she added.
Republicans claimed the FDA had publicly stated the goal for approval was January 2022, but a goal of September 2021 was being pushed in private. September was four months earlier than the expedited goal expressed publicly and eight months earlier than standard review, the letter read.
Gruber was quoted as expressing concerns about evidence linking the vaccine to the development of myocarditis, especially in young men.
“Dr. Krause and I pointed out the very important regulatory issues that still need to be settled by the time we take action on this BLA—including the pediatric plan—which is becoming increasingly complex in light of increasing evidence of association of this vaccine and development of myocarditis (especially in young males, but also included in the BLA indication),” she wrote.
House Republicans construed a portion of Gruber’s email as the doctor stating “that FDA officials were pushing for a quick approval in order to provide states and, eventually, the federal government, the ability to mandate these vaccines.”
The relevant part of Gruber’s email read: “You expressed your concern about the rising COVID-cases [sic] in the US and globally, largely caused by the Delta variant and stated your opinion that, absent a license, states cannot require mandatory vaccination.”
National Review contacted Gruber to ask whether lawmakers accurately characterized her email and in particular the above portion concerning vaccine mandates, but she did not respond by press time.
The Subcommittee’s Republicans called the Biden administration’s behavior “unconscionable” and said their current oversight follows on their past inquiry into the administration’s Covid-19 booster rollout, which the Subcommittee’s Republicans also viewed as improperly expedited.
A spokeswoman for the FDA told National Review that it has received the letter and will respond to the Subcommittee directly.
