Page 90 - pfizervax

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

but will remain in the study to be evaluated for safety, immunogenicity, and efficacy
(see Section 7.1).

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

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

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

• 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.

• Ensure the participant has a measuring device to measure local reactions at the
injection site and a thermometer for recording daily temperatures.

• Ensure the participant remains comfortable with his or her chosen e-diary platform,
confirm instructions on e-diary completion, and ask the participant to complete the
reactogenicity e-diary from Day 1 to Day 7, with Day 1 being the day of vaccination.

• 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:

• Fever ≥39.0°C (≥102.1°F).

• Redness or swelling at the injection site measuring greater than 10 cm
(>20 measuring device units).

• Severe pain at the injection site.

• Any severe systemic event.

• Ask the participant 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 to contact the site staff or investigator (this could be via the
COVID-19 illness e-diary) immediately if he or she experiences any respiratory
symptoms as detailed in Section 8.13.

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