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
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.
Read the last one again:
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
That means if A got the shot (study intervention), then has a casual meeting with B, who is married to C (conceiving wife), then the investigator has to report it to Pfizer Safety within 24 hours.
Why?
Because it sheds. And they are afraid it will get to D, the unborn baby.
https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf
Page 67
8.3.5.1. Exposure During Pregnancy
An EDP occurs if:
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred.
Read the last one again:
That means if A got the shot (study intervention), then has a casual meeting with B, who is married to C (conceiving wife), then the investigator has to report it to Pfizer Safety within 24 hours.
Why?
Because it sheds. And they are afraid it will get to D, the unborn baby.
Please read it yourself. It starts on page 67,
I don't think they're afraid of it getting to the baby. I think that's their intention.