FDA Review of Efficacy and Safety of Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Request

Advisory committee deck review

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3 open comments

Dr. Elena BrooksChange request · May 20, 2026, 12:14 PM

Please add a final review note that this December 10, 2020 public FDA deck is historical source material, not current medical guidance.

Deck title

Jordan DiazChange request · May 20, 2026, 12:36 PM

The efficacy summary should preserve the first primary endpoint detail: 8 vaccine cases vs 162 placebo cases, VE 95.0%, assessed from 7 days after Dose 2.

Primary efficacy analysis

Dr. Priya ShahChange request · May 20, 2026, 12:52 PM

For safety, mention the median follow-up was about 2 months and avoid implying causality for Bell's palsy; the slide says there was no clear basis to conclude causality at that time.

Unsolicited adverse events

Mara ChenResolved · May 20, 2026, 12:40 PM

Source page, FDA media download, title slide, and hash are verified for the bundled presentation.

FDA source

FDA Review of Efficacy and Safety of Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Request

fda-pfizer-biontech-covid19-vaccine-eua-review-2020.pdf