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

8.13.1. Potential COVID-19 Illness Visit: (Optimally Within 3 Days After Potential
COVID-19 Illness Onset)

This visit may be conducted as an in-person or telehealth visit; a telehealth visit involves the
sharing of healthcare information and services via telecommunication technologies
(eg, audio, video, video-conferencing software) remotely, thus allowing the participant and
investigator to communicate on aspects of clinical care.

As a participant’s COVID-19 illness may evolve over time, several contacts may be required
to obtain the following information:

• Record AEs, as appropriate as described in Section 8.3. Note: Potential COVID-19
illnesses that are consistent with the clinical endpoint definition should not be
recorded as AEs. These data will be captured as efficacy assessment data only on the
relevant pages of the CRF, as these are expected endpoints.

• Record details of any of the prohibited medications specified in Section 6.5.1
received by the participant if required for his or her clinical care.

• If the visit is conducted in person, obtain a nasal (midturbinate) swab (collected by
site staff). Alternatively, if conducted by telehealth, instruct the participant to
self-collect a nasal (midturbinate) swab and ship for assessment at the central
laboratory.

• Collect COVID-19–related standard-of-care clinical and laboratory information. This
includes, but is not limited to:

• Symptoms and signs, including

• Clinical signs at rest indicative of severe systemic illness (RR ≥30 breaths per
minute, HR ≥125 beats per minute, SpO2 ≤93% on room air at sea level, or
PaO2/FiO2 <300 mm Hg)

• Evidence of shock (SBP <90 mm Hg, DBP <60 mm Hg, or requiring
vasopressors)

• Significant acute renal, hepatic, or neurologic dysfunction

• Respiratory failure (defined as needing high-flow oxygen, noninvasive
ventilation, mechanical ventilation, or ECMO)

• Clinical diagnosis

• Local laboratory SARS-CoV-2 test result(s). Note that if it is routine practice to
perform a repeat local SARS-CoV-2 test for any reason, then a repeat nasal
(midturbinate) swab should also be obtained and shipped for assessment at the
central laboratory.

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