Reference:
U.S. Food and Drug Administration. (2020). Vaccines and related biological products advisory committee meeting December 10, 2020 FDA briefing document Pfizer-BioNTech COVID-19 vaccine. https://www.fda.gov/media/144246/download
Summary:
On December 10, 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed Pfizer-BioNTech’s COVID-19 vaccine, BNT162b2, which received an Emergency Use Authorization (EUA) request on November 20, 2020. The vaccine, based on a nucleoside-modified mRNA platform, demonstrated a 95% efficacy in preventing symptomatic COVID-19 in participants without prior infection, with safety data indicating a favourable profile among over 38,000 participants. The most common
adverse reactions included injection site pain, fatigue, and headache, primarily occurring within the first week post-vaccination. VRBPAC concluded that the benefits of the vaccine outweigh its risks for individuals aged 16 and older, recommending continued monitoring for long-term safety and efficacy data.