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

• Review of safety and/or immunogenicity data to:

• Allow groups of participants of 65 to 85 years of age to proceed

• Select vaccine candidate/dose level(s) to proceed into Phase 2/3. Data supporting
the selection, including results for both binding antibody levels and neutralizing
titers, and the ratio between them, will also be submitted to the FDA for review

• Review of any available safety and/or immunogenicity data generated during the
course of this study, or the BioNTech study conducted in Germany, to determine:

• Whether any groups may not be started

• Whether any groups may be terminated early

• Whether any groups may be added with dose levels below the lowest stated dose
or intermediate between the lowest and highest stated doses

• Contemporaneous review of all NAAT-confirmed COVID-19 illnesses in Phase 1

The DMC will be responsible for ongoing monitoring of the safety of participants in the
study according to the charter. This may include, but is not limited to:

• Contemporaneous review of related AEs up to 1 month after completion of the
vaccination schedule

• Contemporaneous review of all SAEs up to 6 months after completion of the
vaccination schedule

• Contemporaneous review of all NAAT-confirmed COVID-19 illnesses in Phase 1

• At the time of the planned IAs, and ad hoc if requested by the unblinded team, review
of cases of COVID-19 for an adverse imbalance of cases of COVID-19 and/or severe
COVID-19 between the vaccine and placebo groups

The recommendations made by the DMC to alter the conduct of the study will be forwarded
to the appropriate Pfizer personnel for final decision. Pfizer will forward such decisions,
which may include summaries of aggregate analyses of safety data, to regulatory authorities,
as appropriate.

Three blinded case reviewers (medically qualified Pfizer staff members) will review all
potential COVID-19 illness events. If a NAAT-confirmed case in Phase 2/3 may be
considered severe, or not, solely on the basis of “significant acute renal, hepatic, or
neurologic dysfunction,” the blinded data will be reviewed by the case reviewers to assess
whether the criterion is met; the majority opinion will prevail.

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