FDA Director Dr. Peter Marks Admits Expediting Approval of Pfizer COVID Vaccine, Potentially to Meet Mandate Deadlines
The Select Subcommittee on the Coronavirus Pandemic held a pivotal hearing on Thursday titled “Assessing America’s Vaccine Safety Systems, Part One,” where the Director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, faced intense questioning over the rapid approval of the Pfizer-BioNTech COVID-19 vaccine.
The hearing, overseen by Chairman Rep. Brad Wenstrup (R-Ohio), probed the effectiveness of the vaccine safety reporting system, as well as the compensation process for vaccine-related injuries.
During the hearing, Rep. James Comer questioned Dr. Marks regarding the timeline for Pfizer’s vaccine approval.
Dr. Marks admitted that the original deadline was set for January 18, 2022, but due to the alleged sharp increase in COVID-19 deaths led to a push for faster approval.
Even with reservations from Dr. Philip Krause, former Deputy Director of the Office of Vaccines Research and Review, and Dr. Marion Gruber, director of the FDA’s vaccines office, regarding the rushed timeline, Dr. Marks claimed that his decision to expedite the approval was free from external influences, and taken in response to the public health crisis.
The hearing revealed that Dr. Marks and former FDA Commissioner Janet Woodcock had relieved Dr. Krause and Dr. Gruber from their roles in the vaccine’s approval process after they expressed hesitation about the expedited time frame.
When questioned, Dr. Marks confirmed his awareness of an association between the vaccine and myocarditis, particularly in young men.
Dr. Marks also confirmed discussions regarding myocarditis, particularly in young men, as a safety concern associated with the vaccine. Despite these concerns, the vaccine was ultimately approved on August 23, 2021, just one day before the military mandate for vaccination was issued.
Dr. Marks: “There was an acknowledgement that an approval could allow vaccine mandates to occur…Once you have a licensed vaccine, a mandate could be placed.”
Comer: “Did you express your desire to approve the vaccine by August 20th?”
Marks: “I did.”
Comer: “And it was ultimately approved on August 23rd, correct?”
Dr. Marks: “Correct.”
Comer: “Just for the record, the military mandate was issued on the 24th. That is interesting timing.”