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

• 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.

8.11.2.3. Visit 3 – 1-Month Follow-up Visit (After Vaccination 2): (28 to 35 Days After
Visit 2)
• Record AEs as described in Section 8.3.

• Review the participant’s reactogenicity e-diary data. 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.

• 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.

• For participants who are HIV-positive, record HIV viral load and CD4 count results
from the most recent test performed since Visit 1 (if any).

• Discuss contraceptive use as described in Section 10.4.

• Collect a blood sample (approximately 20 mL for participants ≥16 years of age, and
approximately 10 mL for participants in the 12- to 15-year age stratum) for
immunogenicity testing.

• Ask the participant or his/her parent(s)/legal guardian, as appropriate, to contact the
site staff or investigator if a medically attended event (eg, doctor’s visit, emergency
room visit) or hospitalization occurs.

• Ask the participant or his/her parent(s)/legal guardian, as appropriate, to contact the
site staff or investigator (this could be via the COVID-19 illness e-diary) immediately
if the participant experiences any respiratory symptoms as detailed in Section 8.13.

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

• Complete the source documents.

• The investigator or an authorized designee completes the CRFs.

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