PFIZER AND BIONTECH ON Friday became the first to file for an emergency use authorization with the Food and Drug Administration for their coronavirus vaccine candidate.
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally,” Pfizer CEO Albert Bourla said in a statement. “Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”
Health and Human Services Secretary Alex Azar said the FDA would make a decision “within weeks” at an event on drug pricing with President Donald Trump on Friday.
Pfizer said in a press release that it is filing the application based on data showing its vaccine has an efficacy rate of 95%.
Earlier this week, Bourla said the company reached a milestone in the safety data that was needed to submit the application. The FDA asked parties to follow at least half of the participants who received the vaccine in final trials for two months after they received their second dose to ensure safety.
The FDA is reportedly planning a meeting for its advisory committee in December to consider approval of the vaccine.
“We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible,” Bourla said.