Team 1 and Team 3 did a deep dive into Pfizer’s Post Marketing Experience 5.3.6 document and provided a summary of findings

5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-Feb-2021
Report Prepared by: Worldwide Safety Pfizer’s proprietary and confidential
Safe & Effective?
Pfizer is hoping you do not read this because THIS MAY KILL YOU.
We are concerned with the unanswered questions and blatant disregard for human life embodied in the 5.3.6 document. I implore you to read it (available within). If nothing else, be aware of the vaccine facts and the attempts to cover up and mislead with statistical manipulation.
The original document was redacted, and the FDA tried to keep the information from the public for 75 years, Pfizer repeatedly stated there are no new safety or efficacy issues for concern that signals a risk vs benefit scenario.
DID YOU KNOW SERIES? (Version 7)
1. The Food and Drug Administration requested monthly updates on safety (p. 5) and sent them to other Health regulators (p. 16) unspecified.
2. Reports are submitted voluntarily based on market share of the drug (p. 5)
3. 1,223 deaths were reported (p. 7) within the first 90 days of the trial.
4. Table 3 safety concerns in the U.S. for PVP have 3 categories?
- a). Important Identified Risks
- b). Important Potential Risks
- c). Missing Information
Did other countries have different safety concerns? (p. 9)
PVP is Pharmacovigilance. The science and activities relate to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems.
5. There were 9 Anaphylaxis Deaths (p. 10) – categorized as Important Identified Risk in PVP
6. VAED and VAERD 75 of 101 cases were severe (p. 11) (nearly 75% reported severe) – categorized as Important Potential Risk in PVP
VAED is a Vaccine-associated enhanced disease – a rare phenomenon in which a (usually) more severe clinical presentation of an infection that would normally be seen in an unvaccinated person occurs in someone who has been vaccinated. Antibodies that have been generated from vaccination bind to a pathogen and aid in a virus getting more easily into cells than it would on its own. Vaccines that have been found to cause VAED are no longer in use
VAERD is Vaccine-Associated Enhanced Respiratory Disease
7. Vaccine effectiveness – Covid-19 infection is considered a potential lack of efficacy even if the vaccination course is not complete. (p. 13) – categorized as Missing information Table 6.
8. Cardiovascular related deaths 136 reported (p. 17)
9. Covid 19 related deaths were 136 reported
(p. 17) ie. Lack of efficacy number 7 above
10. Facial paralysis had 183 unresolved cases reported (p. 19)
11. 8 pages of possible AESIs of a 38-page document estimated to be over 1200 AEIs (pp. 30-38)
AESIs Adverse effects of special interest are considered more serious & require reporting, and are of particular concern to the entities running a trial because they are quite bad
12. Pfizer concluded No new safety signals or lack of efficacy throughout the document. (p. 13,15) and no new safety information (pp. 10,13,17,18,19,20,21,22,23,24) – That’s 10 or 12 pages!
13. Pfizer concluded the findings of these signal detection analyses are consistent with the known safety profile of the vaccine. (p. 28)
14. Summary and conclusion by Pfizer (p. 29) – Review of the available data for this cumulative PM experience confirms a favorable benefit:risk balance for BNT162b2

Leave a comment