Page 75 - pfizervax

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

8.2.6. Pregnancy Testing

Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least
25 mIU/mL. Pregnancy tests will be performed in WOCBP at the times listed in the SoA,
immediately before the administration of each vaccine dose. A negative pregnancy test result
will be required prior to the participant’s receiving the study intervention. Pregnancy tests
may also be repeated if requested by IRBs/ECs or if required by local regulations. In the
case of a positive confirmed pregnancy, the participant will be withdrawn from
administration of study intervention but may remain in the study.

8.3. Adverse Events and Serious Adverse Events

The definitions of an AE and an SAE can be found in Appendix 3.

AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or
the participant's parent(s)/legal guardian).

The investigator and any qualified designees are responsible for detecting, documenting, and
recording events that meet the definition of an AE or SAE and remain responsible to pursue
and obtain adequate information both to determine the outcome and to assess whether the
event meets the criteria for classification as an SAE or caused the participant to discontinue
the study intervention (see Section 7.1).

Each participant/parent(s)/legal guardian will be questioned about the occurrence of AEs in a
nonleading manner.

In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up
information in an expedited fashion.

8.3.1. Time Period and Frequency for Collecting AE and SAE Information

The time period for actively eliciting and collecting AEs and SAEs (“active collection
period”) for each participant begins from the time the participant/parent(s)/legal guardian
provides informed consent, which is obtained before the participant’s participation in the
study (ie, before undergoing any study-related procedure and/or receiving study
intervention), through and including Visit 7 for Phase 1 participants, and Visit 3 for Phase
2/3 participants. In addition, any AEs occurring up to 48 hours after each subsequent blood
draw must be recorded on the CRF.

SAEs will be collected from the time the participant/parent(s)/legal guardian provides
informed consent to approximately 6 months after the last dose of study intervention (Visit 8
for Phase 1 participants, and Visit 4 for Phase 2/3 participants).

Follow-up by the investigator continues throughout and after the active collection period and
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the
investigator and Pfizer concurs with that assessment.

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