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

• Schedule an appointment for the participant to return for the next study visit.

• 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 and an unblinded
dispenser/administrator updates the study intervention accountability records.

• 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.

8.11.1.6. Visit 5 – 1-Week Follow-up Visit (Vaccination 2): (6 to 8 Days After Visit 4)

• Record AEs as described in Section 8.3.

• 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.

• Collect a blood sample (approximately 10 mL) for hematology and chemistry
laboratory tests as described in Section 10.2.

• 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.

• Discuss contraceptive use as described in Section 10.4.

• Collect a blood sample (approximately 50 mL) for immunogenicity testing.

• If the participant (select participants only, details will be provided by the sponsor)
consents, collect an additional 170 mL blood sample for exploratory COVID-19
research.

• Ask the participant to contact the site staff or investigator immediately if he or she
experiences any of the following from Day 1 to Day 7 after vaccination (where Day 1
is the day of vaccination) to determine if an unscheduled reactogenicity visit is
required:

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