FDA postpones meeting on Pfizer COVID-19 vaccine for younger children
The U.S. Food and Drug Administration announced on Friday that it is postponing the Vaccines and Related Biological Products Advisory Committee meeting that was originally scheduled for Tuesday, Feb. 15.
The move came after Pfizer presented the FDA with new data regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 vaccine in children ages six months to four years old.
In a statement, the FDA said: “As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision making for potential authorization.”
Postponing the meeting will give the federal agency time to engage in a transparent public discussion, as has been the case for prior COVID-19 vaccine decisions, the FDA said.
A new date for the meeting is forthcoming, the agency noted, after it has looked over data on a third dose in this specific age group from Pfizer's ongoing clinical trial.
In a press release, Pfizer said: “The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion.”