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

• Measure the participant’s body temperature.

• Perform urine pregnancy test on WOCBP as described in Section 8.2.6.

• Discuss contraceptive use as described in Section 10.4.

• Ensure that the participant meets none of the temporary delay criteria as described in
Section 5.5.

• Unblinded site staff member(s) will dispense/administer 1 dose of study intervention
into the deltoid muscle of the preferably nondominant arm. Please refer to the IP
manual for further instruction on this process.

• Blinded site staff must observe the participant for at least 30 minutes after study
intervention administration for any acute reactions. Record any acute reactions
(including time of onset) in the participant’s source documents and on the AE page of
the CRF, and on an SAE form as applicable.

• The participant should continue to adhere to the normal visit schedule but must be
followed for nonserious AEs for 1 month and SAEs for 6 months after the second
dose of BNT162b2. This will require AEs to be elicited either by unscheduled
telephone contact(s) and/or in-person visit(s).

6.7. Intervention After the End of the Study

No intervention will be provided to study participants at the end of the study.

7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention

In rare instances, it may be necessary for a participant to permanently discontinue study
intervention (definitive discontinuation). Reasons for definitive discontinuation of study
intervention may include the following: AEs; participant request; investigator request;
pregnancy; protocol deviation (including no longer meeting all the inclusion criteria, or
meeting 1 or more exclusion criteria). In general, unless the investigator considers it unsafe
to administer the second dose, or the participant does not wish to receive it, it is preferred
that the second dose be administered. Note that a positive SARS-CoV-2 NAAT result
without symptoms does not meet exclusion criterion 5 and should not result in
discontinuation of study intervention, whereas a COVID-19 diagnosis does meet exclusion
criterion 5 and should result in discontinuation of study intervention (see Section 8.15).

Note that discontinuation of study intervention does not represent withdrawal from the study.
Per the study estimands, if study intervention is definitively discontinued, the participant will
remain in the study to be evaluated for safety, immunogenicity, and efficacy. See the SoA
for data to be collected at the time of discontinuation of study intervention and follow-up for
any further evaluations that need to be completed.

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