番茄社区

WASHINGTON -- Pfizer/BioNTech's mRNA vaccine candidate was authorized for prevention of COVID-19 illness in individuals age 16 and older, becoming the first vaccine to earn that distinction, the

The emergency use authorization allows the vaccine to be distributed in the U.S., with the agency noting clear evidence the vaccine may be effective in preventing COVID-19 and the benefits outweigh the risk in this population.

But the process was not without its share of drama, with the earlier on Friday that FDA Commissioner Stephen Hahn, MD, was told by the White House that he had to authorize this vaccine on Friday or resign.

Despite the accelerated timeline, safety was a key theme throughout the FDA's statement, with the agency stating, "in making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information."

"Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research.

President Trump about the Pfizer/BioNTech vaccine authorization shortly after it was announced.

This vaccine is a two-dose regimen, to be administered three weeks apart. The agency noted the most common adverse events were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever; more people experienced reactions following the second dose.

In addition to the press release announcing the authorization, the FDA released the and fact sheets for and .

The CDC's Advisory Committee on Immunization Practices is to discuss the vaccine and possibly include it in the adult and child immunization schedule.

Data from the pivotal phase II/III clinical trial recently published in the found vaccine efficacy 7 days after the second vaccine dose was 95% (95% CI 90.3%-97.6%). It was 66% (three cases in the control group; one in the vaccine group) against severe COVID-19 at least 7 days after the second dose, albeit with a wide and nonsignificant confidence interval (95% CI -124.8% to 96.3%) given the small number of events.

Interestingly, the FDA noted data are not available to make a determination about how long the vaccine will protect someone from COVID-19, nor is there evidence the vaccine blocks transmission.

On Thursday, the FDA's Vaccines and Related Biological Products Advisory Committee voted 17-4-1 to recommend the vaccine for an EUA, despite concerns by a minority of members about the paucity of data in individuals ages 16-17.

Moderna's similar vaccine , and quick authorization of that product would be no surprise.

Comment