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

to this is that seasonal and pandemic influenza vaccine can be given at least 14 days after, or
at least 14 days prior to, the administration of study intervention.

Receipt of chronic systemic treatment with known immunosuppressant medications, or
radiotherapy, within 60 days before enrollment through conclusion of the study.

Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days is
prohibited from 28 days prior to enrollment to Visit 7 for Phase 1 participants, and Visit 3 for
Phase 2/3 participants).

Receipt of inhaled/nebulized corticosteroids from 28 days prior to enrollment to Visit 7
(1-month follow-up visit) for Phase 1 participants.

Receipt of blood/plasma products or immunoglobulins within 60 days before enrollment
through conclusion of the study.

Receipt of any other (nonstudy) coronavirus vaccine at any time prior to or during study
participation is prohibited.

Prophylactic antipyretics and other pain medication to prevent symptoms associated with
study intervention administration are not permitted. However, if a participant is taking a
medication for another condition, even if it may have antipyretic or pain-relieving properties,
it should not be withheld prior to study vaccination.

6.5.2. Permitted During the Study

The use of antipyretics and other pain medication to treat symptoms associated with study
intervention administration or ongoing conditions is permitted.

Medication other than that described as prohibited in Section 6.5.1 required for treatment of
preexisting stable conditions is permitted.

Inhaled (except in Phase 1 participants – see Section 6.5.1), topical, or localized injections of
corticosteroids (eg, intra-articular or intrabursal administration) are permitted.

6.6. Dose Modification
This protocol allows some alteration of vaccine dose for individual participants and/or dose
groups from the currently outlined dosing schedule. For reasons of reactogenicity,
tolerability, or safety, the IRC may recommend to reduce the second dose of study
intervention and/or increase the interval between doses.

If, due to a medication error, a participant receives 1 dose of BNT162b2 at Visit 1 and 1 dose
of placebo at Visit 2 (or vice versa), the participant should be offered the possibility to
receive a second dose of BNT162b2 at an unscheduled visit. In this situation:

• Obtain informed consent for administration of the additional dose.

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