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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

Endpoint Statistical Analysis Methods
second dose per 1000 person-years of follow-up in participants
without evidence of infection (prior to 7 days or 14 days after
receipt of the second dose) for the active vaccine group to the
placebo group

Ratios of confirmed COVID-19 illness (according to the
CDC-defined symptoms) from 7 days and from 14 days after the
second dose per 1000 person-years of follow-up in participants
with and without evidence of infection (prior to 7 days or 14 days
after receipt of the second dose) for the active vaccine group to the
placebo group

VE = 100 × (1 – IRR) will be estimated with confirmed COVID-19
illness according to the CDC-defined symptoms from 7 days or from
14 days after the second dose. The 2-sided 95% CI for VE will be
9
derived using the Clopper-Pearson method as described by Agresti.
Missing efficacy data will not be imputed.

9.4.3. Safety Analyses
Endpoint Statistical Analysis Methods
Primary Descriptive statistics will be provided for each reactogenicity endpoint
for each dose and vaccine group. Local reactions and systemic events
from Day 1 through Day 7 after each vaccination will be presented by
severity and cumulatively across severity levels. Descriptive
summary statistics will include counts and percentages of participants
with the indicated endpoint and the associated Clopper-Pearson 95%
CIs.

For Phase 1, descriptive statistics will be provided for abnormal
hematology and chemistry laboratory values at 1 and 7 days after
Dose 1 and 7 days after Dose 2, including grading shifts in
hematology and chemistry laboratory assessments between baseline
and 1 and 7 days after Dose 1, and before Dose 2 and 7 days after
Dose 2. Descriptive summary statistics will include counts and
percentages of participants with the indicated endpoint and the
associated Clopper-Pearson 2-sided 95% CIs.

AEs will be categorized according to the Medical Dictionary for
Regulatory Activities (MedDRA) terms. A 3-tier approach will be
used to summarize AEs in Phase 2/3. Under this approach AEs are
classified into 1 of 3 tiers: (1) Tier 1 events are prespecified events of
clinical importance and are identified in a list in the product’s safety

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