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

• Remind the participant to bring the e-diary to the next visit.

• Complete the source documents.

• The investigator or an authorized designee completes the CRFs.

• 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.

8.11.1.5. Visit 4 – 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.

• 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.

• Review hematology and chemistry laboratory results and record any AEs in
accordance with Appendix 2.

• Measure vital signs (body temperature, pulse rate, and seated blood pressure), and, if
indicated by any change in the participant’s health since the previous visit, perform a
physical examination, evaluating any clinically significant abnormalities within the
following body systems: general appearance; skin; head, eyes, ears, nose, and throat;
heart; lungs; abdomen; musculoskeletal; extremities; neurological; and lymph nodes.

• 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.

• Obtain 2 nasal (midturbinate) swabs (collected by site staff). One will be tested (if
possible at the site, otherwise at the central laboratory) within 24 hours and
vaccination will only proceed if it is NAAT-negative for SARS-CoV-2 genomes.
The second will be sent to the central laboratory for potential later testing.

• Ensure and document that all of the inclusion criteria and none of the exclusion
criteria are met. If not, the participant should not receive further study intervention

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