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

• 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 or his/her parent(s)/legal guardian, as appropriate, has a
measuring device to measure local reactions at the injection site and a thermometer
for recording daily temperatures.

• Ensure the participant or his/her parent(s)/legal guardian, as appropriate, remains
comfortable with the chosen e-diary platform, confirm instructions on e-diary
completion, and, if the participant is part of the reactogenicity subset, ask the
participant or his/her parent(s)/legal guardian, as appropriate, to complete the
reactogenicity e-diary from Day 1 to Day 7, with Day 1 being the day of vaccination.

• If the participant is part of the reactogenicity subset, ask the participant or his/her
parent(s)/legal guardian, as appropriate, to contact the site staff or investigator
immediately if the participant 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 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.

• Remind the participant or his/her parent(s)/legal guardian, as appropriate, to bring the
e-diary to the next visit.

• Complete the source documents.

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