Pfizer submitted its application on Nov. 20 for an emergency use authorization to the FDA Center for Biologics Evaluation and Research (CBER).
“The safety profile of a vaccine that’s going to be deployed in millions of people has to be incredibly clean,” said Dr. Peter Marks, who directs CBER. “We, as an agency, are one of the last agencies in the world that we still actually get the primary data. We don’t get summary data.”
CBER receives raw data on all participants in a vaccine trial, in addition to volumes of information on every aspect of the vaccine.
“The company can do its analysis on the patients, and we have the ability because we have the data to do our own analyses and make sure they match up,” Marks said.