Coronavirus Vaccine Gets Approval Recommendation By FDA Committee

WASHINGTON, DC — The Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee has recommended emergency use approval of the coronavirus vaccine developed by pharmaceutical company Pfizer and its German partner BioNTech.

The committee voted was 17-4 in favor of approval after several hours of discussion on Thursday, according to multiple reports. There was one abstention.

The vaccine still needs to be approved by the full FDA before it can be distributed to any Americans. The FDA is expected to act soon, possibly within hours, to grant full approval, according to The Washington Post.

The panel voted "yes" to this question:

“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?”

That endorsement came despite questions about allergic reactions in two people who received the vaccine earlier this week when Britain became the first country to begin dispensing the Pfizer-BioNTech shot.

Despite all the remaining unknowns, in an emergency, “the question is whether you know enough,” said panel member Dr. Paul Offit of Children’s Hospital of Philadelphia, who concluded that the shot's potential benefits outweigh its risks.

Pfizer has said clinical trials show its vaccine is about 95 percent effective. It has already been approved for use in the United Kingdom and Canada. The U.S. is now likely to soon follow.

"Our team has done their initial analysis, and we do feel that preliminarily that the success criteria have been met," FDA Commissioner Dr. Stephen Hahn told CNN before the committee meeting.

Watch a replay of the committee hearing in the video player above or on the PBS NewsHour YouTube channel.

The Associated Press contributed reporting.