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

• Perform a clinical assessment. If the clinical assessment indicates that a physical
examination is necessary to comprehensively evaluate the participant, perform a
physical examination and record any findings in the source documents and, if
clinically significant, record on the medical history CRF.

• Measure the participant’s height and weight.

• 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.

• Record nonstudy vaccinations as described in Section 6.5.

• Ensure and document that all of the inclusion criteria and none of the exclusion
criteria are met.

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

• Record AEs as described in Section 8.3.

• 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.

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

• Obtain the participant’s randomization number and study intervention allocation
number using the IRT system. Only an unblinded site staff member may obtain this
information.

• 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.

• For participants in the reactogenicity subset, issue a measuring device to measure
local reactions at the injection site and a thermometer for recording daily
temperatures and provide instructions on their use.

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