The US Food and Drug Administration intends to make a decision about authorizing Pfizer’s coronavirus vaccine within a few weeks of a key meeting scheduled for Dec. 10, according to an agency official.
“It will be a matter of weeks. It could be from days to weeks,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Wednesday. “It’s possible it could be within days, but our goal is to make sure it’s certainly within a few weeks.”
“I can’t give you an exact date that we’re going to have an emergency use authorization issued because we have to do it right. Obviously we’re going to be working to do it as quickly as we possibly can,” Marks added during the event sponsored by the group Vaccinate Your Family.
The FDA’s Vaccines and Related Biological Products Advisory Committee, a panel of independent experts, is scheduled to meet Dec. 10 to discuss Pfizer’s application for emergency use authorization.
So far, Pfizer is the only company to apply for an EUA from the FDA. The submission to the FDA was based on results from the Phase 3 clinical trial of Pfizer’s vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers.
The final analysis from the trial found the coronavirus vaccine was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, Pfizer and BioNTech said.
The vaccine cannot be shipped until the FDA issues an EUA, according to a presentation by the US Centers for Disease Control and Prevention.
Marks’ timeline varies from one offered Thursday by President Donald Trump. “The vaccines are being delivered literally — they’ll start in the next week or the week after,” Trump said in a virtual Thanksgiving address to US troops.
Vaccinations will begin in the US “towards the latter part of December,” according to Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases.