FDA expected to authorize Pfizer COVID vaccine in coming days.
The move would be a pivotal moment as public health officials predict the U.S. could face its worst public health crisis in history this winter.
The Food and Drug Administration (FDA) could authorize the Pfizer coronavirus vaccine as early as the end of this week. The FDA is scheduled to convene a meeting of its Vaccines and Related Biological Products Advisory Committee, known as VRBPAC, on Thursday to review the vaccine for emergency use authorization.
James Hildreth, a member of the committee, said Saturday that an authorization could come as early as Friday.
“If the FDA commissioner decides to issue approval, the EUA, on that day when the vote is taken, as early as Friday of next week we could see vaccinations happening across the country,” Hildreth told NBC’s Weekend Today on Saturday.
Pfizer submitted its Covid vaccine data to the FDA on Nov. 20. The company said a final analysis of its phase three clinical trial, which featured more than 43,000 participants, found the vaccine was 95% effective in preventing Covid and was safe to use. U.S. officials say they will distribute the vaccine within 24 hours of authorization.
Emergency use authorization means the FDA will allow some adults to receive the vaccine even as the agency continues to evaluate data. It isn’t the same thing as a full approval, which can typically take months.
If the Thursday meeting goes well and the advisory committee formally votes in favor, the FDA could announce its authorization “within days,” said Health and Human Services Secretary Alex Azar in an interview with ABC News.
Race against the clock
U.S. hospitals already have a higher load of Covid patients than ever before, and the outbreak is primed to set further records this week.
The authorization of the vaccine, which Pfizer produced alongside German drugmaker BioNTech, would mark a record-breaking time frame for a process that can normally take as many as ten years. The United Kingdom authorized the same vaccine for emergency use last week, becoming the first country in the world to do so.
Nevertheless, initial doses of the vaccine will be limited as manufacturing ramps up, with top U.S. health officials predicting it will take months to immunize everyone who wants to be vaccinated. The federal government has deals lined up with several drugmakers to buy some of their first doses.
The vaccine will likely be distributed in phases. A CDC panel on Tuesday voted 13-1 to give health-care workers and long-term care facility residents in the U.S. the first doses once the vaccine is cleared for public use. There are roughly 21 million health-care workers and 3 million long-term care facility residents in the United States.
U.S. officials say they should be able to distribute enough coronavirus vaccine doses to immunize 100 million people by the end of February.
Former Presidents Barack Obama, George W. Bush, and Bill Clinton have all said they would be willing to take the vaccine publicly as polls suggest many Americans are skeptical about getting vaccinated, according to a recent Gallup poll.
