The U.S. Food and Drug Administration intends to make a decision on approving Pfizer’s coronavirus vaccine within a few weeks of the key meeting scheduled for December 10, according to the agency’s official.
“It’s going to be a matter of weeks. It could be days to weeks,” Dr. Peter Marks, director of the FDA’s Center for Biological Assessment and Research, said on Wednesday. “It may be in days, but our goal is to make it happen in a few weeks.”
– I cannot say exactly whether an emergency permit should be issued, because we have to do it correctly. Obviously, we’re going to be doing this as soon as possible, ”Marks added at the Vaccinate His Family group-sponsored event.
The FDA’s Advisory Committee on Vaccines and Related Biological Products, a panel of independent experts, is scheduled to meet on Dec. 10 to discuss Pfizer’s application for an emergency use license.
So far, Pfizer is the only company to request an EUA from the FDA. Submission to the FDA was based on the results of a Phase 3 clinical trial of the Pfizer vaccine, which began on July 27 in the United States and enrolled more than 43,000 volunteers.
The final analysis of the study found that the coronavirus vaccine was 95% effective in preventing infections, even in older adults, and did not cause serious safety concerns, Pfizer and BioNTech said.
The vaccine cannot be shipped until the FDA has issued the EUA, according to a presentation by the U.S. Center for Disease Prevention and Control.
Marks ’schedule is different from President Donald Trump’s offer on Thursday. “The vaccines will be delivered literally – starting next week or the following week,” Trump said in his virtual Thanksgiving address to U.S. troops.
According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, vaccinations in the United States will begin “toward the end of December.”