FDA promises to 'rapidly' finalize emergency use authorization of COVID-19 vaccine

PHILADELPHIA (KYW Newsradio) -- The Food and Drug Administration will be granting emergency use authorization of the Pfizer coronavirus vaccine. The United States is now a step closer to having a coronavirus vaccine available for the public for the first time.

In a statement released early Friday morning FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, the Director of the FDA’s Center for Biologics Evaluation and Research, said the agency, “will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”

The announcement came a day after a panel of experts voted to recommend the vaccine be approved. After an all-day remote meeting that featured presentations from FDA and CDC experts along with top Pfizer officials, the Vaccines and Related Biological Products Advisory Committee voted 17 to 4, with one abstention, that the benefits of the vaccine outweighed the risks for use in those who are at least 16 years old.

"When you put forward a product like this, it's not because you know everything. You never know everything. But certainly we seem to know enough now to say that the benefits of this vaccine clearly outweigh any theoretical risks," Dr. Paul Offit, a member of the committee, told KYW Newsradio Friday morning, explaining why he voted yes.

During the meeting, Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, raised concerns with FDA and Pfizer officials about a few health care workers in the United Kingdom who had severe allergic reactions after they received the vaccine during the country’s rollout earlier in the week. Health officials say it’s not clear what in the vaccine triggered the reaction.

U.K. regulators, who are also investigating another possible case, changed guidance to say those with severe allergic reactions to a vaccine, medicine or food should not get the shot.

Offit is worried that too many people in the U.S. would avoid the vaccine unnecessarily.

"I think we need to drill down on this. There may be some people who have an allergic reaction to the so-called lipid nanoparticle, which is like a little fatty droplet in which that mRNA is encased. And I think we need to look a little more carefully, just find out how real it is and how common it is," Offit said.

FDA officials said they were communicating with their U.K. counterparts to get more information about the cases. They said they had fact sheets prepared for doctors and potential patients that warn against getting the vaccine if they are allergic to any of the vaccine ingredients.

Pfizer says the vaccine is 95% effective, and the vast majority of those in their clinical trials who had side effects had mild ones, including fatigue, headache and soreness at the injection site.

Offit said he expects the vaccine to be available here early next week.

"The CDC will probably meet on Sunday, likely also approve the use, and then it would be rolling out by no later than Monday," Offit said.

Among the first Americans who are expected to get vaccinated are health care workers and nursing home residents.