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

parent(s)/legal guardian, as appropriate, is maintained to ensure that endpoint events are not
missed. This study will employ various methods, tailored to the individual participant, to
ensure that communication is maintained and study information can be transmitted securely.
Using appropriate technology, such as a study application, a communication pathway
between the participant or his/her parent(s)/legal guardian, as appropriate, and the study site
staff will be established. The participant or his/her parent(s)/legal guardian, as appropriate,
may be able to utilize his or her own devices to access this technology, or use a device
provided by the sponsor. Traditional methods of telephone communication will also be
available. The technology solution may facilitate the following:

• Contact with the investigator, including the ability of the participant or his/her
parent(s)/legal guardian, as appropriate, to report whether or not the participant has
experienced symptoms that could represent a potential COVID-19 illness (COVID-19
illness e-diary; see Section 8.13).

• An alert in the event that the participant is hospitalized.

• Visit reminders.

• Messages of thanks and encouragement from the study team.

• A platform for recording local reactions and systemic events (reactogenicity e-diary)
– see Section 8.2.2.

If a participant or his/her parent(s)/legal guardian, as appropriate, is not actively completing
either the reactogenicity or COVID-19 illness e-diary, the investigator or designee is required
to contact the participant or his/her parent(s)/legal guardian, as appropriate, to ascertain why
and also to obtain details of any missed events.

8.15. SARS-CoV-2 NAAT Results From Visits 1 and 2 and Potential COVID-19 Illness
Visits

Nasal (midturbinate) swabs for SARS-CoV-2 NAAT are obtained at:

• Visits 1 and 2: To determine whether a participant will be included in efficacy analyses
of those with no serological or virological evidence (up to 7 or 14 days after receipt of the
second dose, depending on the objective) of past SARS-CoV-2 infection.

• Potential COVID-19 illness visits: To determine whether symptoms experienced by the
participant fulfill the COVID-19 case definition.

Research laboratory–generated positive results from the Visit 1 and Visit 2 swabs, and all
results from the illness visit swabs, will be provided to the site once available, but this will
not be in real time and cannot be relied upon to direct clinical care. Therefore, the participant
should be directed to seek additional testing through his/her primary healthcare providers at a
licensed clinical laboratory when exhibiting potential COVID-19 symptoms or otherwise

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