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8.3.5.Exposure During Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the study interventionunder 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 PregnancyAn EDP occurs if:
â¢A female participant is found to be pregnant while receiving or after discontinuingstudy intervention.
â¢A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception.
â¢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:
â¢A female family member or healthcare providerreports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact.ïŒPage 67ïŒ
â¢A male family member or healthcare providerwho has been exposed to the study intervention by inhalation or skin contactthen exposes his female partner prior to or around the time of conception.
The investigator must report EDP to Pfizer Safety within24 hours of the investigatorâs awareness, irrespective of whether an SAE has occurred.
The initial information submitted should include the anticipated date of delivery (see below for information related to termination of pregnancy).
â¢If EDP occurs in a participant or a participantâs partner, the investigator must report this information to Pfizer Safety on the Vaccine SAE Report Form and an EDP Supplemental Form, regardless of whether an SAE has occurred.Details of the pregnancy willbe collected after the start of study intervention and until 6 months after the last doseof study intervention.
â¢If EDP occurs in the setting of environmental exposure, the investigator must report information to Pfizer Safety using the Vaccine SAE ReportForm and EDP Supplemental Form. Since the exposure information does not pertain to the participant enrolled in the study, the information is not recorded on a CRF; however, a copy of the completed Vaccine SAE Report Form is maintained in the investigatorsite file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for all EDP reports with an unknown outcome.
The investigator will follow the pregnancy until completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a follow-up to the initial EDP Supplemental Form.
In the case of a live birth, the structural integrity of the neonate can be assessed at the time of birth. In the event of a termination, the reason(s) for termination should be specified and, if clinically possible, the structural integrity of the terminated fetus should be assessed by gross visual inspection (unless preprocedure test findings are conclusive for a congenital anomaly and the findings are reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly),the investigator should follow the procedures for reporting SAEs. Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs follows:
â¢Spontaneous abortion includingmiscarriage and missed abortion;
â¢Neonatal deaths that occur within 1month of birth should be reported, without regard to causality, as SAEs. In addition, infant deaths after 1month should be reported as SAEs when the investigator assesses the infant death as related or possibly relatedto exposure to the study intervention.ïŒPage 68ïŒ