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THE PFIZER TRIAL REPORT - COULD VACCINES SHED?

This sounds like a nightmare dystopian medical disaster, yet the Pfizer Trials paper itself suggests such possibilities.





PFIZER TRIAL REPORT


These are some excerpts from the Pfizer trial paper named:

A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

QUOTE:


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. Page 67

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

  • Spontaneous abortion including miscarriage and missed abortion;

  • Neonatal deaths that occur within 1 month of birth should be reported, without regard to causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs when the investigator assesses the infant death as related or possibly related to exposure to the study intervention.....

8.3.5.2. Exposure During Breastfeeding An exposure during breastfeeding occurs if:

  • A female participant is found to be breastfeeding while receiving or after discontinuing study intervention.

  • A female is found to be breastfeeding while being exposed or having been exposed to study intervention (ie, environmental exposure). An example of environmental exposure during breastfeeding is a female family member or healthcare provider who reports that she is breastfeeding after having been exposed to the study intervention by inhalation or skin contact. The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred. The information must be reported using the Vaccine SAE Report Form. When exposure during breastfeeding occurs in the setting of environmental exposure, the exposure information does not pertain to the participant enrolled in the study, so 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. An exposure during breastfeeding report is not created when a Pfizer drug specifically approved for use in breastfeeding women (eg, vitamins) is administered in accord with authorized use. However, if the infant experiences an SAE associated with such a drug, the SAE is reported together with the exposure during breastfeeding.... " END QUOTE



The full report is worth a read. If you have little time start at 8.3.5



DOWNLOAD THE PFIZER DOCUMENT BELOW

210530 - PFIZER key doc - C4591001_Clinical_Protocol_Nov2020_Pfizer_BioNTech
.pdf
Download PDF • 1.05MB




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