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

Type of Participant and Disease Characteristics:

2. Participants who are willing and able to comply with all scheduled visits, vaccination
plan, laboratory tests, lifestyle considerations, and other study procedures.

3. Healthy participants who are determined by medical history, physical examination
(if required), and clinical judgment of the investigator to be eligible for inclusion in the
study.

Note: Healthy participants with preexisting stable disease, defined as disease not
requiring significant change in therapy or hospitalization for worsening disease during
the 6 weeks before enrollment, can be included. Specific criteria for Phase 3 participants
with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV) can be found in Section 10.8.

4. Phase 2/3 only: Participants who, in the judgment of the investigator, are at higher risk
for acquiring COVID-19 (including, but not limited to, use of mass transportation,
relevant demographics, and frontline essential workers).

Informed Consent:

5. Capable of giving personal signed informed consent/have parent(s)/legal guardian
capable of giving signed informed consent as described in Appendix 1, which includes
compliance with the requirements and restrictions listed in the ICD and in this protocol.

5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:

Medical Conditions:

1. Other medical or psychiatric condition including recent (within the past year) or active
suicidal ideation/behavior or laboratory abnormality that may increase the risk of study
participation or, in the investigator’s judgment, make the participant inappropriate for the
study.

2. Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV).

3. History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s).

4. Receipt of medications intended to prevent COVID-19.

5. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT
result was not available) or microbiological (based on COVID-19 symptoms/signs and a
positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.

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