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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
Page 67
In general, follow-up information will include a description of the event in sufficient detail to
allow for a complete medical assessment of the case and independent determination of
possible causality. Any information relevant to the event, such as concomitant medications
and illnesses, must be provided. In the case of a participant death, a summary of available
autopsy findings must be submitted as soon as possible to Pfizer Safety.
Further information on follow-up procedures is given in Appendix 3.
8.3.4. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal
obligations and ethical responsibilities towards the safety of participants and the safety of a
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other
regulatory agencies about the safety of a study intervention under clinical investigation. The
sponsor will comply with country-specific regulatory requirements relating to safety
reporting to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory
requirements and sponsor policy and forwarded to investigators as necessary.
An investigator who receives SUSARs or other specific safety information (eg, summary or
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the
study and will notify the IRB/EC, if appropriate according to local requirements.
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the study intervention under study during pregnancy or breastfeeding and
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator
awareness.
8.3.5.1. Exposure During Pregnancy
An EDP occurs if:
• A female participant is found to be pregnant while receiving or after discontinuing
study intervention.
• A male participant who is receiving or has discontinued study intervention exposes a
female partner prior to or around the time of conception.
• A female is found to be pregnant while being exposed or having been exposed to
study intervention due to environmental exposure. Below are examples of
environmental exposure during pregnancy:
• A female family member or healthcare provider reports that she is pregnant after
having been exposed to the study intervention by inhalation or skin contact.