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

10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS

10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations

10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:

• Consensus ethical principles derived from international guidelines including the
Declaration of Helsinki and CIOMS International Ethical Guidelines;

• Applicable ICH GCP guidelines;

• Applicable laws and regulations, including applicable privacy laws.

The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents
(eg, advertisements) must be reviewed and approved by the sponsor and submitted to an
IRB/EC by the investigator and reviewed and approved by the IRB/EC before the study is
initiated.

Any amendments to the protocol will require IRB/EC approval before implementation of
changes made to the study design, except for changes necessary to eliminate an immediate
hazard to study participants.

The investigator will be responsible for the following:

• Providing written summaries of the status of the study to the IRB/EC annually or
more frequently in accordance with the requirements, policies, and procedures
established by the IRB/EC;

• Notifying the IRB/EC of SAEs or other significant safety findings as required by
IRB/EC procedures;

• Providing oversight of the conduct of the study at the site and adherence to
requirements of 21 CFR, ICH guidelines, the IRB/EC, European regulation 536/2014
for clinical studies (if applicable), and all other applicable local regulations.

10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable
regulatory authority in any area of the world, or if the investigator is aware of any new
information that might influence the evaluation of the benefits and risks of the study
intervention, Pfizer should be informed immediately.

In addition, the investigator will inform Pfizer immediately of any urgent safety measures
taken by the investigator to protect the study participants against any immediate hazard, and
of any serious breaches of this protocol or of ICH GCP that the investigator becomes aware
of.

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