A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine
candidate-selection, and efficacy study in healthy individuals.

The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose
level(s); Phase 2/3: an expanded cohort and efficacy part.

The study will evaluate the safety, tolerability, and immunogenicity of 3 different
SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate:

- As a 2-dose (separated by 21 days) schedule;

- At various different dose levels in Phase 1;

- As a booster;

- In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12
years of age [stratified as 12-15, 16-55 or >55 years of age]).

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

Participants who originally received placebo will be offered the opportunity to receive
BNT162b2 at defined points as part of the study.

In order to describe the boostability of BNT162, and potential heterologous protection
against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to
Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or
BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as
well as its immunogenicity.

The assessment of boostability will be further expanded in a subset of Phase 3 participants
at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and
potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the
South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3
participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg.

To further describe potential homologous and heterologous protection against emerging
SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve
(ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as
a 2-dose series, separated by 21 days.

To reflect current and anticipated recommendations for COVID 19 vaccine boosters,
participants in C4591001 who meet specified recommendations and have not already received
one, will be offered a third dose of BNT162b2 after their second dose of BNT162.