8.3.5. 妊娠中または授乳中の曝露、および職業的曝露 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.
EDPは以下の様な時に起きる。An EDP occurs if: • A female participant is found to be pregnant while receiving or after discontinuing study intervention. 女性の被験者がワクチンの治験中、あるいは治験中断後に妊娠に気づいた時。
• A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception. 男性の被験者がワクチンの治験中、あるいは治験を中断した後に女性パートナーの妊娠前後に暴露させた時。
• 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: 女性が暴露中に妊娠または治験中の環境からの曝露で妊娠した場合。
環境からの曝露(environmental exposure)には以下がある。
• 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. 女性の家族、または医療従事者が、被験者（ワクチンを打った人）から吸入、あるいは皮膚接触によって曝露したとき。
•A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 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).
• If EDP occurs in a participant or a participant’s 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 will be collected after the start of study intervention and until 6 months after the last dose of study intervention.参加者または参加者のパートナーでEDPが発生した場合、SAEが発生したかどうかに関係なく、調査員はこの情報をワクチンSAEレポートフォームおよびEDP補足フォームでファイザーセーフティに報告する必要があります。妊娠の詳細は、治験の開始後、6ヶ月まで収集されます。
• If EDP occurs in the setting of environmental exposure, the investigator must report information to Pfizer Safety using the Vaccine SAE Report Form 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 investigator site file.環境曝露の設定でEDPが発生した場合、調査員はワクチンSAEレポートフォームとEDP補足フォームを使用してファイザーセーフティに情報を報告する必要があります。ばく露情報は研究に登録された参加者に関係しないため、情報はCRFに記録されません。しかしながら、 記入済みのワクチンSAEレポートフォームのコピーは、治験責任医師のサイトファイルに保持されます。
8.3.5.2. Exposure During Breastfeeding
とあり、ワクチンを接種した後に母乳育児中だった人は報告すること。（内容省略）
8.3.5.3. Occupational Exposure
職業上の曝露
“An occupational exposure occurs when a person receives unplanned direct contact with the study intervention, which may or may not lead to the occurrence of an AE. Such persons may include healthcare providers, family members, and other roles that are involved in the trial participant’s care.”
The investigator must report occupational exposure to Pfizer Safety within 24 hours of the investigator’s awareness, regardless of whether there is an associated SAE.
