Activity

‘They’ (Pfizer, Moderna, Astrazenca, etc) have know about this from the beginning.
“intervention by inhalation or skin contact”
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001
( https://media.tghn.org/medialibrary/2020/11/C4591001_Clinical_Protocol_Nov2020_Pfizer_BioNTech.pdf )

(Pages 67 – 68)

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.
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
Page 68
• 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.
• 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.