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

6.3.4. Breaking the Blind

The IRT will be programmed with blind-breaking instructions. In case of an emergency, the
investigator has the sole responsibility for determining if unblinding of a participant’s study
intervention assignment is warranted. Participant safety must always be the first
consideration in making such a determination. If the investigator decides that unblinding is
warranted, the investigator should make every effort to contact the sponsor prior to
unblinding a participant’s vaccine assignment unless this could delay further management of
the participant. If a participant’s vaccine assignment is unblinded, the sponsor must be
notified within 24 hours after breaking the blind. The date and reason that the blind was
broken must be recorded in the source documentation and CRF.

The study-specific IRT reference manual and IP manual will provide the contact information
and further details on the use of the IRT system.

6.4. Study Intervention Compliance
When participants are dosed at the site, they will receive study intervention directly from the
investigator or designee, under medical supervision. The date and time of each dose
administered in the clinic will be recorded in the source documents and recorded in the CRF.
The dose of study intervention and study participant identification will be confirmed at the
time of dosing by a member of the study site staff other than the person administering the
study intervention.

6.5. Concomitant Therapy

The following concomitant medications and vaccinations will be recorded in the CRF:

• All vaccinations received from 28 days prior to study enrollment until the 6-month
follow-up visit (Visit 8 for Phase 1 participants, and Visit 4 for Phase 2/3
participants).

• Prohibited medications listed in Section 6.5.1 will be recorded, to include start and
stop dates, name of the medication, dose, unit, route, and frequency.

• In addition, for participants enrolled in Phase 1, all current medication at baseline will
be recorded, to include start date, name of the medication, dose, unit, route, and
frequency.

6.5.1. Prohibited During the Study
Receipt of the following vaccines and medications during the time periods listed below may
exclude a participant from the per-protocol analysis from that point onwards, and may
require vaccinations to be discontinued in that participant; however, it is anticipated that the
participant would not be withdrawn from the study (see Section 7). Medications should not
be withheld if required for a participant’s medical care.

Unless considered medically necessary, no vaccines other than study intervention should be
administered within 28 days before and 28 days after each study vaccination. One exception

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