Republicans have accused the Biden administration of pushing to shorten the approval process of Pfizer’s COVID-19 vaccine to implement mandates nationwide, according to a letter from the House Select Subcommittee on the Coronavirus Pandemic to FDA Commissioner Robert Califf. The letter cited internal FDA communications revealing the administration may have tried to bypass, wrongly compress, and compromise the process for granting a full biologics approval to a vaccine.
Lawmakers leading the charge allege that the Biden administration’s attempt may not have been to save lives, but to provide cover for enforcing vaccine mandates across the country. The issue revolves around the shortened approval timeline for Pfizer’s Biologics License Application from 10 months standard review time to six months. The FDA had publicly stated in May 2021 that the goal for approval was January 2022, but Republicans accuse the administration of pushing for the goal for FDA approval to be September 2021, four months shorter. Republicans claim 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.”
According to the letter, the shortened approval timeline was “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.”
In July 2021, Dr. Gruber, the Director of the Office of Vaccines Research and Review (OVRR), was alleged to have also been worried about the potential side effects of the COVID-19 vaccine. While these concerns were not announced to the public, and those who theorized that long-term and serious side effects of these vaccines may become an issue, the Biden administration and Democrat lawmakers decided to condemn skeptics as “conspiracy theorists.”
Dr. Gruber would write in 2021 July of 2021, saying:
“We too are concerned about the rising COVID-19 cases in the US, [sic] however, our concern is that 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.”
The Republicans also claim that the Biden administration’s push to fast-track the vaccine approval may have damaged the FDA’s credibility, as Dr. Gruber’s email may suggest, as well as the FDA may have downplayed concerns about the development of myocarditis in young males who received the vaccines.
In addition, they have demanded related documents and communications no later than March 24. This accusation follows a letter from last Congress demanding information about “potential political interference with the FDA’s booster shot approval process.” The FDA said it has received the letter and will respond directly to the subcommittee.