The New York Times reported- Dr. Janet Woodcock, acting commissioner of the FDA, and Dr. Rochelle Walensky, head of the CDC, urged caution and advised that their agencies needed more time before approving any further action regarding booster shots.
The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Research and Evaluation:
“The administration recently announced a plan to prepare for additional COVID-19 vaccine doses, or ‘boosters,’ this fall, and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses.
“The process for authorizing or approving the use of a booster dose of a COVID-19 vaccine involves each vaccine manufacturer submitting data pertaining to safety and effectiveness to the agency to support this use. The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency’s advisory committee to inform our decision-making. Should the data received from other manufacturers raise unique questions that would benefit from the committee’s input, the agency intends to consider additional public discussions.
“A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines. The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner.”
Additional Information:
Today, the U.S. Food and Drug Administration announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older.
The meeting will be held on Sept. 17, 2021, from 8:30 a.m. to 3:45 p.m. EST.
Senior FDA officials are stepping down over disagreements with white house regarding booster shots. Marion Gruber, the director of the agency’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, will leave this October and November.
Source FDA.gov
