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# FDA Confirms Pfizer 95% Covid Vaccine Efficacy
- URL: https://www.fdaweb.com/fda-confirms-pfizer-95-covid-vaccine-efficacy/
- Published: 2020-12-08T12:00:00.000Z
- Updated: 2026-09-14T16:39:21.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148249

Just-released FDA advisory committee [briefing information](https://www.fda.gov/media/144245/download?ref=fdaweb.com) is suggesting that it could be easy sailing for a Pfizer-BioNTech Emergency Use Authorization (EUA)submission for their Covid-19 vaccine. On 12/10, FDA will convene its Vaccines and Related Biological Products Advisory Committee to review and discuss the submitted data.

The briefing document confirms earlier reported results that demonstrated 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 advisory committee meeting is intended to provide recommendations on whether:

- based on the totality of scientific evidence available, it is reasonable to believe that the Pfizer-BioNTech Covid-19 vaccine may be effective in preventing COVID-19 in individuals 16 years of age and older, and
- the known and potential benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its known and potential risks for use in individuals 16 years of age and older.

Panel members will also discuss what additional studies should be conducted after EUA issuance to gather further data on the safety and effectiveness of this vaccine.