BioCentury
ARTICLE | Product Development

Bourla, FDA leaders say two-month follow-up key to timing for COVID-19 vaccine authorization

October 17, 2020 1:18 AM UTC

An open letter from Pfizer’s Albert Bourla and a commentary from FDA’s heads of vaccine research and review respectively spell out how FDA’s guidance is shaping the timeline for what could be the first COVID-19 vaccine authorized in the U.S., and justify the reasoning behind that criteria.

Both communications, published six days before an Oct. 22 FDA advisory committee on COVID-19 vaccines, highlight FDA’s requirement that sponsors provide at least two months of follow-up data after the final vaccine dose for half of the trial’s participants...