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

9.5.1. Analysis Timing

Statistical analyses will be carried out when the following data are available:

• Complete safety and immunogenicity analysis approximately 1 month after Dose 2
for Phase 1.

• Safety data through 7 days after Dose 2 and immunogenicity data through 1 month
after Dose 2 from the first 360 participants enrolled (180 to active vaccine and 180 to
placebo, stratified equally between 18 to 55 years and >55 to 85 years) in Phase 2/3.

• Safety data through 1 month after Dose 2 from at least 6000 participants enrolled
(3000 to active vaccine and 3000 to placebo) in Phase 2/3. Additional analyses of
safety data (with longer follow-up and/or additional participants) may be conducted if
required for regulatory purposes.

• IAs for efficacy after accrual of at least 62, 92, and 120 cases and futility after accrual
of at least 62 and 92 cases.

• Safety data through 1 month after Dose 2 and noninferiority comparison of
SARS-CoV-2 neutralizing titers in participants 12 to 15 years of age compared to
those in participants 16 to 25 years of age, 1 month after Dose 2.

• Descriptive analysis of immunogenicity and safety of “Process 1” and “Process 2”
material, 1 month after Dose 2.

• Complete safety and immunogenicity analysis approximately 6 months after Dose 2
for all participants in Phase 2/3.

• Complete efficacy and persistence-of-immunogenicity analysis after complete data
are available or at the end of the study.

All analyses conducted on Phase 2/3 data while the study is ongoing will be performed by an
unblinded statistical team.

9.6. Data Monitoring Committee or Other Independent Oversight Committee

This study will use an IRC, a DMC, and a group of internal case reviewers. The IRC is
independent of the study team and includes only internal members. The DMC is independent
of the study team and includes only external members. The IRC and DMC charters describe
the role of the IRC and DMC in more detail.

The responsibilities of the IRC are only in Phase 1 and will include:

• Review of safety data to permit dose escalations in the 18- to 55-year age cohort

• Review of safety data in the case of a stopping rule being met

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