House Republicans Allege Biden Admin May Have ‘Wrongly Compressed’ Covid-19 Vaccine Approval Process

On Thursday, 10 House Republicans sent a letter to the FDA alleging that full FDA approval of the Covid-19 vaccine may have been fast-tracked in a way that cut corners. The House Select Subcommittee on the Coronavirus Pandemic said it will increase oversight in response.

The letter was signed by all the Republican members of the Subcommittee as well as Representative Lisa McClain (R., Mich.), chairwoman of the House Subcommittee on Health Care and Financial Services. “It appears the Biden Administration may have bypassed, wrongly compressed, and possibly compromised the longstanding process for awarding a full biologics approval to a vaccine,” read the letter, adding that the fast-tracking “may not have been to save lives, but concernedly to provide cover for implementing and enforcing vaccine mandates across the country.”

Though the members of Congress only mention the Biden administration, the Trump administration also regarded the speedy production and distribution of Covid therapeutics to be a priority. The public-private partnership to do so entitled Operation Warp Speed was broadly viewed as a major success of the U.S. pandemic response, with the first vaccine being authorized the same year the pandemic began. Axios reported in January that the program was coming to an unofficial end.

The Thursday letter relied heavily 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 full approval process. After a July 2021 meeting, Gruber expressed concern about expediting the approval process for Pfizer’s Biologics Licensing Application (BLA) in comments that were 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 said the FDA had publicly stated the goal for approval was January 2022, but a goal of September 2021 was stated in private. September was four months earlier than the expedited goal expressed publicly and eight months earlier than standard review, the letter read.

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,” as the members of Congress put it.

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.

“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,” argued the Republican members of Congress. “This is unconscionable.”

They added that their current oversight follows on their previous inquiry into the administration’s Covid-19 booster rollout, which the Subcommittee’s Republicans also viewed as potentially improper. Gruber and her colleague Phil Krause departed the agency in 2021 and their decision to do so was driven in part by the White House getting ahead of the FDA on booster shots, according to Axios.

In response to oversight efforts, public health experts have recommended that members of Congress proceed with caution so as to not undermine public confidence in vaccines.

A spokeswoman for the FDA told National Review that the agency has received the letter and will respond to the Subcommittee directly.

The members of Congress also requested documents from the agency and asked several former and current FDA officials to sit for transcribed interviews.