House investigators are probing whether the Biden administration pressured the Food and Drug Administration to fast-track approval for a leading COVID-19 jab required to implement and enforce vaccine mandates.
granted the application priority review the next month, and set a “public goal” of January 2022 for approving the vaccine, while privately setting a goal of approving the shot by Sept. 15, 2021.
Dr. Gruber wrote to colleagues on July 19, 2021, warning that the review timeline “cannot be compressed further” beyond the September deadline, noting that the timeline was less than half of that normally allocated for priority review applications.officials had opined that “absent a license, states cannot require mandatory vaccination” while raising concerns about the rise in COVID-19 cases.
“We too are concerned about the rising COVID-19 cases in the U.S., 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 than to increase it,” Dr. Gruber wrote.
The lawmakers say the email “points to evidence” that the Biden administration sidelined experts and sacrificed “thoroughness and veracity” in approving the vaccine.press release announcing the approval of the vaccine for those 16 and older, the agency said all approved vaccines “undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products.”
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine.” Dr. Peter Marks, the director of’s Center for Biologics Evaluation and Research, said in a statement. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.
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