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

Population Description
Dose 1 all-available For Phase 1 only: all randomized participants who receive at
immunogenicity least 1 dose of the study intervention with at least 1 valid and
determinate immunogenicity result after Dose 1 but before
Dose 2.
Dose 2 all-available All randomized participants who receive at least 1 dose of the
immunogenicity study intervention with at least 1 valid and determinate
immunogenicity result after Dose 2.
Evaluable efficacy All eligible randomized participants who receive all
vaccination(s) as randomized within the predefined window
and have no other important protocol deviations as determined
by the clinician.
All-available efficacy 1. All randomized participants who receive at least
1 vaccination.
2. All randomized participants who complete 2 vaccination
doses.
Safety All randomized participants who receive at least 1 dose of the
study intervention.

9.4. Statistical Analyses

The SAP will be developed and finalized before database lock for any of the planned
analyses in Section 9.5.1. It will describe the participant populations to be included in the
analyses and the procedures for accounting for missing, unused, and spurious data. This
section provides a summary of the planned statistical analyses of the primary, secondary, and
tertiary/exploratory endpoints.

9.4.1. Immunogenicity Analyses
Immunogenicity samples will be drawn for all participants. Immunogenicity analyses will be
based upon results from appropriately sized subsets of samples, according to the purpose.

The statistical analysis of immunogenicity results will be primarily based on the evaluable
immunogenicity populations as defined in Section 9.3. Serology data after a postbaseline
positive SARS-CoV-2 test result will not be included in the analysis based on the evaluable
immunogenicity populations.

An additional analysis will be performed based on the all-available populations if there is a
large enough difference in sample size between the all-available immunogenicity population
and the evaluable immunogenicity population. Participants will be summarized according to
the vaccine group to which they were randomized.

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