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A U.S. House of Representatives subcommittee is investigating whether the Biden administration improperly pressured U.S. health regulators to accelerate approval of Pfizer’s COVID-19 vaccine in 2021.
Rep. Brad Wenstrup (R-Ohio), chairman of the Select Subcommittee on the Coronavirus Pandemic, renewed a request he previously submitted in September 2023 for information after recent congressional testimony raised more questions about the vaccine approval timeline.
In a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf Thursday, Wenstrup cited testimony from a Feb. 15 hearing in which Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, suggested the agency faced pressure to quickly approve the Pfizer vaccine to facilitate federal vaccine mandates.
During the hearing, Marks stated, “There was an acknowledgment that an approval could allow vaccine mandates to occur.”
According to its press release, the subcommittee uncovered previous documents revealing that “scientists warned Dr. Marks and other FDA officials on numerous occasions about the dangers of rushing the COVID-19 vaccine approval process” but that the FDA had “seemingly disregarded the warnings” and dismissed the scientists who raised the concerns.
One of those concerns, raised by Dr. Marion Gruber and Dr. Phillip Krause and noted in documents previously reviewed by the subcommittee, related to a “pediatric plan to study an increased risk of myocarditis and pericarditis in adolescents” before Pfizer’s vaccine could be approved, the letter stated.
Gruber was director of the FDA’s Office of Vaccines Research and Review (OVRR) until October 2021. Krause served as deputy director of OVRR until November 2021. They both resigned reportedly over disagreements with the Biden administration’s rush to approve the COVID-19 booster shots.
According to Wenstrup, on Aug. 9, 2021, U.S. Defense Secretary Lloyd Austin said he would “make COVID-19 vaccines mandatory no later than mid-September, or immediately upon the U.S. Food and Drug Administration (FDA) licensure, whichever comes first.”
Wenstrup said this statement could have increased pressure on Biden administration officials to expedite approval of the vaccine, which took place just two weeks later.
On Aug. 24, 2021, the day after the FDA approved the vaccine, Austin issued the memorandum mandating the COVID-19 vaccine for all service members, Wenstrup noted.
Wenstrup gave the FDA until March 14 to provide requested communications related to the approval process and to schedule transcribed interviews with Marks and former FDA Commissioner Janet Woodcock.
