1/The @US_FDA just released its scientific analysis of the safety/efficacy of @pfizer's #COVID19 #vaccine candidate in advance of this week's advisory committee meeting. https://www.fda.gov/media/144245/download

2/From the executive summary, as to efficacy: "In a mid-November analysis of 36,621 participants randomized 1:1 to vaccine or placebo who were included in the
per-protocol efficacy analysis population of participants without evidence of SARS-CoV-2 infection prior to 7 days..."

3/"...after completion of the vaccination regimen, efficacy in preventing confirmed COVID-19 occurring at least 7 days after the second dose of vaccine was 95.0%,
with 8 COVID-19 cases in the vaccine group and 162 COVID-19 cases in the placebo group."

4/As to subgroups: "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."

5/As to safety: "Safety data from approximately 38,000 participants ≥16 years of age randomized 1:1 to vaccine
or placebo with a median of 2 months of follow up after the second dose suggest a favorable
safety profile,..."

6/"...with no specific safety concerns identified that would preclude issuance of an EUA."

7/Open questions: "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,..."

8/"...although available data for these outcomes did not allow for firm conclusions."

Stay tuned--much to come out of this week's meeting. #COVID19 #vaccine

In the meantime, please review the document. It is filled with informative data.