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

Update as part of protocol amendment 3: as data have become available from this study and
the BNT162-01 study in Germany, it was decided:

• To not study the BNT162a1 and BNT162c2 vaccine candidates at this time, so these
candidates have been removed from the protocol; and

• That lower dose levels of BNT162b1 and BNT162b2 warrant consideration.
Therefore, a 20-µg dose level is formally included for both candidates.

Update as part of protocol amendment 4: the 50-µg dose level for BNT162b1 and BNT162b2
is removed and the 100-µg dose level for BNT162b2 is removed; similar dose levels of
BNT162b3 may be studied as for BNT162b1 and BNT162b2.

Update as part of protocol amendment 5: the vaccine candidate selected for Phase 2/3
evaluation is BNT162b2 at a dose of 30 µg. BNT162b3 will not be studied.

4.4. End of Study Definition

A participant is considered to have completed the study if he/she has completed all phases of
the study, including the last visit. Note that participants enrolled in Phase 1 in groups that do
not proceed to Phase 2/3 may be followed for fewer than 24 months (but no less than
6 months after the last vaccination).

The end of the study is defined as the date of last visit of the last participant in the study.

5. STUDY POPULATION

This study can fulfill its objectives only if appropriate participants are enrolled. The
following eligibility criteria are designed to select participants for whom participation in the
study is considered appropriate. All relevant medical and nonmedical conditions should be
taken into consideration when deciding whether a particular participant is suitable for this
protocol.

Prospective approval of protocol deviations to recruitment and enrollment criteria, also
known as protocol waivers or exemptions, is not permitted.

5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:

Age and Sex:

1. Male or female participants between the ages of 18 and 55 years, inclusive, and 65 and
85 years, inclusive (Phase 1), or ≥12 years (Phase 2/3), at randomization. Note that
participants <18 years of age cannot be enrolled in the EU.

• Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female
(Section 10.4.2) participants.

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