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

In the event that sponsor personnel confirm that a stopping rule is met, the following actions
will commence:

• The IRC will review all appropriate data.

• The stopping rule will PAUSE randomization and study intervention administration
for the impacted vaccine candidate all dose levels and age groups.

• The DMC will review all appropriate data.

• For all participants vaccinated, all other routine study conduct activities, including
ongoing data entry, reporting of AEs, participant reactogenicity e-diary completion,
blood sample collection, and participant follow-up, will continue during the pause.

A stopping rule is met if any of the following rules occur after administration of
investigational BNT162 vaccine; data from placebo recipients will not contribute to the
stopping rules. Reactogenicity e-diary data confirmed by the investigator as being entered by
the participant in error will not contribute toward a stopping rule.

The BNT162b RNA platform will be evaluated for contribution to stopping rules overall;
vaccine candidate dose levels within the platform and age groups will contribute to stopping
rules together. However, it is possible that the recommendations may include halting or
continuing randomization with any of the BNT162 vaccine candidates.

Stopping Rule Criteria for Each BNT162 Vaccine Candidate:

1. If any participant vaccinated with the BNT162 candidate (at any dose level) develops an
SAE that is assessed by the investigator as possibly related, or for which there is no
alternative, plausible, attributable cause.

2. If any participant vaccinated with the BNT162 candidate (at any dose level) develops a
Grade 4 local reaction or systemic event after vaccination (see Section 8.2.2) that is
assessed as possibly related by the investigator, or for which there is no alternative,
plausible, attributable cause.

3. If any participant vaccinated with the BNT162 candidate (at any dose level) develops a
fever >40.0°C (>104.0°F) for at least 1 daily measurement after vaccination
(see Section 8.2.2.4) that is assessed as possibly related by the investigator, or for which
there is no alternative, plausible, attributable cause.

4. If any 2 participants vaccinated with the BNT162 candidate (at any dose level) report the
same or similar severe (Grade 3) AE (including laboratory abnormalities) after
vaccination, assessed as possibly related by the investigator, or for which there is no
alternative, plausible, attributable cause.

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