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

• For participants not in the reactogenicity subset, issue a thermometer to monitor for
fever (for COVID-19 surveillance) and provide instructions on its use.

• Explain the e-diary technologies available for this study (see Section 8.14), and assist
the participant or his/her parent(s)/legal guardian, as appropriate, in downloading the
study application onto the participant’s own device or issue a provisioned device if
required.

• For participants in the reactogenicity subset, provide instructions on
reactogenicity e-diary completion and 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.

• For all participants, provide instructions on COVID-19 illness e-diary completion
and ask the participant or his/her parent(s)/legal guardian, as appropriate, to
complete the COVID-19 illness e-diary if the participant is diagnosed with
COVID-19 or has possible new or increased symptoms, and when he/she receives
a reminder, at least weekly. See Section 8.14 for further details.

• 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 he or she 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.

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