Produced by: MOS Video Department
According to an earlier media report, after analyzing Pfizer’s “Clinical Protocol” study and investigation report regarding the company’s own mRNA CCP virus vaccine in Nov 2020, it was found that in Pfizer’s clinical trial document, scientists suggest the potential adverse event happen to the close contact of individuals who have been vaccinated with the trial mRNA CCP virus vaccine.
Pfizer’s scientists were concerned about “Exposure During Pregnancy” and “Occupational Exposure” to the people who have been vaccinated with the mRNA CCP virus vaccine participating in the clinical trial.
In the “Clinical Protocol” document, under section “8.3.5 Exposure During Pregnancy & Occupational Exposure”, Pfizer warns that,
“Exposure During Pregnancy” occurs when:
- A female participant is found to be pregnant while receiving or after discontinuing the vaccination.
- A male participant who is receiving or has discontinued the vaccination 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 the vaccinated due to environmental exposure.
- A female family member or healthcare provider reports that she is pregnant after having been exposed to the vaccinated by inhalation or skin contact.
An “Occupational Exposure” occurs when a person receives unplanned direct contact with the vaccinated, which may or may not lead to the occurrence of an adverse event (AE).
The direct contact includes:
- Healthcare providers
- Family members
- Other roles that are involved in the vaccination participant’s care
Pfizer instructed investigators to report the “exposures” to Pfizer Safety within 24 hours of the investigator’s awareness, regardless of whether there is an associated Vaccine Serious Adverse Event (SAE).
But since the information does not pertain to a participant enrolled in the mRNA CCP virus vaccine’s “Clinical Trial”, the information is not recorded on a Case Report Form (CRF) or the Vaccine Adverse Event Reporting System (VAERS). However, a copy of the completed Vaccine SAE Report Form is maintained in Pfizer’s investigator’s site file.
Posted by: 谐趣园
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