The Food & Drug Administration announced Friday that its committee on vaccines will meet Dec. 10th to review Pfizer’s request for emergency use authorization (EUA) of its Covid-19 vaccine.
This comes two days after Pfizer, with their German partner BioNTech, released promising final results that show their vaccine is 95% effective and protects elderly adults who are most at risk of dying. Pfizer had submitted the EUA request earlier in the day Friday.
An FDA spokesperson said the three-week window is necessary because “this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting, and to be prepared for a robust public discussion with the advisory committee members.”
Before the FDA’s Vaccines and Related Biological Products Advisory Committee meets next month, the agency intends to make background materials available to the public.
“While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible,” FDA Commissioner Stephen M. Hahn said Friday.
Pfizer also emphasized the need to quickly get regulatory approval as coronavirus infections soar globally.
“We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” Dr. Albert Bourla, Pfizer Chairman and CEO, said Wednesday.
“With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,” Bouria added.
Pfizer plans to produce 50 million vaccine doses this year and 1.3 billion doses in 2021.
If the FDA approves Pfizer’s vaccine for emergency use then it will likely be available first to frontline health care workers and the elderly, by the end of this year.
Moderna also released promising results this week that show its vaccine is 95% effective. The company is expected to file its own emergency use authorization request with the FDA soon.
The vaccines cannot be approved fast enough for concerned Americans as infections are climbing across the country right now.
The United States recorded 185,095 new coronavirus cases and 2,015 deaths Thursday, bringing the total to more than 11.5 million cases and 251,715 deaths.