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

In the event of discontinuation of study intervention, it must be documented on the
appropriate CRF/in the medical records whether the participant is discontinuing further
receipt of study intervention or also from study procedures, posttreatment study follow-up,
and/or future collection of additional information.

7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at his/her own request. Reasons for
discontinuation from the study may include the following:

• Refused further follow-up;

• Lost to follow-up;

• Death;
• Study terminated by sponsor;

• AEs;
• Participant request;

• Investigator request;
• Protocol deviation.

If a participant does not return for a scheduled visit, every effort should be made to contact
the participant. All attempts to contact the participant and information received during
contact attempts must be documented in the participant’s source document. In any
circumstance, every effort should be made to document participant outcome, if possible.

The investigator or his or her designee should capture the reason for withdrawal in the CRF
for all participants.

If a participant withdraws from the study, he/she may request destruction of any remaining
samples taken and not tested, and the investigator must document any such requests in the
site study records and notify the sponsor accordingly.

If the participant withdraws from the study and also withdraws consent (see Section 7.2.1)
for disclosure of future information, no further evaluations should be performed and no
additional data should be collected. The sponsor may retain and continue to use any data
collected before such withdrawal of consent.

Lack of completion of all or any of the withdrawal/early termination procedures will not be
viewed as protocol deviations so long as the participant’s safety was preserved.

7.2.1. Withdrawal of Consent

Participants who request to discontinue receipt of study intervention will remain in the study
and must continue to be followed for protocol-specified follow-up procedures. The only
exception to this is when a participant specifically withdraws consent for any further contact

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