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

• Diarrhea;

• Vomiting.

2. Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other
nonstudy vaccine within 28 days, before study intervention administration.

3. Anticipated receipt of any seasonal or pandemic influenza vaccine within 14 days, or any
other nonstudy vaccine within 28 days, after study intervention administration.

4. Receipt of short-term (<14 days) systemic corticosteroids. Study intervention
administration should be delayed until systemic corticosteroid use has been discontinued
for at least 28 days. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or
eyes) corticosteroids are permitted.

6. STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed product(s),
placebo, medical device(s), or study procedure(s) intended to be administered to a study
participant according to the study protocol.

The study will evaluate a 2-dose (separated by 21 days) schedule of various different dose
levels of 2 investigational RNA vaccine candidates for active immunization against
COVID-19 in 3 age groups (18 to 55 years of age, 65 to 85 years of age, and ≥12 years of
age [stratified as 12-15, 16-55, or >55 years of age]).

These 2 investigational RNA vaccine candidates, with the addition of saline placebo, are the
3 potential study interventions that may be administered to a study participant:

• BNT162b1 (BNT162 RNA-LNP vaccine utilizing modRNA and encoding the RBD):
10 µg, 20 µg, 30 µg, 100 µg

• BNT162b2 (BNT162 RNA-LNP vaccine utilizing modRNA and encoding the P2 S):
10 µg, 20 µg, 30 µg

• Normal saline (0.9% sodium chloride solution for injection)

The vaccine candidate selected for Phase 2/3 evaluation is BNT162b2 at a dose of 30 µg.

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