FDA advisers recommend authorization of Pfizer/BioNTech coronavirus vaccine

Vaccine advisers to the US Food and Drug Administration voted Thursday to recommend the agency grant emergency use authorization to Pfizer and BioNTech’s coronavirus vaccine.

Seventeen members of the Vaccines and Related Biological Products Advisory Committee voted yes, four voted no and one abstained.

“The question is never when you know everything. It’s when you know enough and I think we know enough now to say that this appears to be our way out of this awful, awful mess,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the committee, told CNN’s Wolf Blitzer after the vote.

“That’s why I voted yes.”

Dr. James Hildreth, president and chief executive officer of Meharry Medical College, said he would have hoped more minorities had been enrolled in the clinical trials of the vaccine.

“I just feel that we need this vaccine and the benefits outweigh the risks,” Hildreth, a temporary voting member of the committee, told CNN.

Several committee members expressed concern about reports of allergic reactions in two people who were vaccinated in Britain, which authorized Pfizer’s vaccine ahead of the US.

FDA staff said that, as with any vaccines, paperwork would accompany the Pfizer vaccine to warn against administering it to anyone with a history of severe allergic reactions to vaccines or allergies to any of the ingredients of the vaccine.

An EUA is short of a full approval. Pfizer would have to file a separate application for full FDA approval for its vaccine. Plus, Thursday’s vote doesn’t mean the vaccine will be authorized immediately.

The FDA will now decide whether to accept the recommendation, but has signaled that it will issue the EUA for the vaccine.

“Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials,” the agency said in a statement after the vote.

“In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process. However, they know that they must carry out their mandate to protect the public health and to ensure that any authorized vaccine meets our rigorous standards for safety and effectiveness that the American people have come to expect,” FDA Commissioner Dr. Stephen Hahn said in the statement.

“The whole of the FDA—myself included—remains committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, Americans can have trust and confidence in receiving the vaccine for their families and themselves.”

Then, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices must meet to decide whether it recommends that the vaccine be deployed for use.

ACIP has a meeting scheduled for Friday, and expects to vote during a meeting scheduled for Sunday.

Operation Warp Speed officials say they will start shipping the vaccine within 24 hours of FDA authorization.

President-elect Joe Biden weighed in. “We are grateful to the scientists and researchers who developed this vaccine. And, we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science led us to this point,” Biden said in a statement.

The process starts all over again next week. VRPBAC is scheduled to meet again December 17 to discuss Moderna’s EUA application.