Biologics

Panel Backs Pfizer Covid-19 Vaccine

FDA’s Vaccines and Related Biological Products Advisory Committee has voted to recommend an Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine. Panel members voted 17 to 4 that: based on the totality of scientific evidence available, the benefits of the vaccine outweigh its risks for use in individuals 16 years of age and older.

The majority of panel members agreed with the briefing information released in advance of the meeting that clinical trial data demonstrated that the vaccine’s efficacy was 95% in preventing confirmed Covid-19 occurring at least seven days after the second dose of the vaccine. This was parsed out in eight Covid-19 cases in the vaccine group and 162 Covid-19 cases in the placebo group.

“Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe Covid-19,” FDA says. “Secondary efficacy analyses suggested benefit of the vaccine in preventing severe Covid-19, in preventing Covid-19 following the first dose, and in preventing Covid-19 in individuals with prior SARS-CoV-2 infection, although available data for these outcomes did not allow for firm conclusions.” On the safety side, data suggest a “favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA,” it says.

The panel also discussed severe reactions that have been reported in the UK after they began immunizations this week. During an Alliance for a Stronger FDA conference call 12/9, CBER director Peter Marks said the agency plans to warn patients who’ve had previous severe reactions after being vaccinated about such risks with Pfizer-BioNTech’s Covid-19 vaccine if granted an EUA (see earlier story). “We'll continue to keep the public informed and I think we have to help people understand that we're going to see some side effects with these vaccines, and that's normal,” Marks said. “But to the extent that we mitigate these and avoid vaccinating people who might be at a very high risk and that's the kind of way we mitigate risk.”

Asked how soon an EUA decision will be made, Marks said it will be days to up to a week to render a decision after the advisory committee’s recommendation.

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