Pfizer’s Vaccine Meets EUA Thresholds, Could Be Authorized This Weekend

An FDA Emergency Use Authorization (EUA) could come as soon as this weekend for Pfizer/BioNTech’s COVID-19 vaccine, with the vaccine advisory committee set to meet tomorrow to discuss the agency’s 53-page analysis concluding that the two-dose regimen met its strict EUA requirements.

The analysis looks to be strongly in favor of an EUA for Pfizer/BioNTech’s BNT162b2, which demonstrated 95 percent efficacy in late-stage trials (DID, Nov. 19). The agency’s evaluation found that the data provided by Pfizer in its EUA submission fulfilled the recommendations outlined in the agency’s emergency authorization guidance for COVID-19 vaccines and met its effectiveness thresholds, according to the briefing document released ahead of the advisory panel meeting.

The double-dose regimen of the vaccine was highly effective in preventing infection at least seven days after completing vaccination, while a single shot was effective in reducing the risk of COVID-19 and severe COVID-19, the FDA concluded. The agency noted, however, that while the data suggest “some protection against COVID-19 disease following one dose,” it does not show if there is longer-term protection extending beyond three weeks after a single dose.

“The time of observation is limited by the fact that most of the participants received a second dose after three weeks,” the agency said. “The trial did not have a single-dose arm to make an adequate comparison.”

The briefing document cited “no specific safety concerns … that would preclude issuance of an EUA.” Side effects, including injection site reactions, headaches and fatigue, were common, but their prevalence was not alarming to the FDA, as vaccines often cause mild adverse events in patients.

Though the FDA will make the final call on authorization, it will take the committee’s recommendation into consideration. Center for Biologics Evaluation and Research (CBER) Director Peter Marks has said previously a decision would come “days to weeks” after the meeting, stressing the need “to do it right.”

Specifically, the committee will discuss whether the vaccine’s benefits outweigh its risks and if it is effective at preventing COVID-19 in patients aged 16 years and older, as well as what additional studies should be done following authorization. — James Miessler