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

• Complete the source documents.

• The investigator or an authorized designee completes the CRFs and an unblinded
dispenser/administrator updates the study intervention accountability records.

If the participant is part of the reactogenicity subset, the investigator or appropriately
qualified designee reviews the reactogenicity e-diary data online following vaccination to
evaluate participant compliance and as part of the ongoing safety review. Daily review is
optimal during the active diary period.

8.11.2.2. Visit 2 – Vaccination 2: (19 to 23 Days After Visit 1)

It is anticipated that the procedures below will be conducted in a stepwise manner; ensure
that procedures listed prior to administration of the vaccine are conducted prior to
vaccination.

• Record AEs as described in Section 8.3.

• If the participant is part of the reactogenicity subset, review the participant’s
reactogenicity e-diary data. Collect stop dates of any reactogenicity e-diary events
ongoing on the last day that the reactogenicity e-diary was completed and record stop
dates in the CRF if required.

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

• Discuss contraceptive use as described in Section 10.4.

• Record nonstudy vaccinations as described in Section 6.5.

• Record details of any of the prohibited medications specified in Section 6.5.1
received by the participant if required for his or her clinical care.

• Ensure and document that all of the inclusion criteria and none of the exclusion
criteria are met. If not, the participant may not receive further study intervention but
will remain in the study to be evaluated for safety, immunogenicity, and efficacy
(see Section 7.1).

• Measure the participant’s body temperature.

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

• Obtain a nasal (midturbinate) swab (collected by site staff).

• 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.

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