>>18942064

TYB

Report 73: Pfizer Knew by November 2020 That Its mRNA COVID Vaccine Was Neither Safe Nor Effective. Here Is What Pfizer’s Employees and Contractors Knew and When They Knew It.

May 31, 2023

Introduction

Through the review of two documents – Pharmacovigilance Plan for Biologic License Application #125742 Of Covid-19 mRNA vaccine (nucleoside modified) (BNT162b2, PF-07302048) and 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162b2) Received Through 28-Feb-2021 – referred to below as “PV” and “5.3.6,” the contributors to this report came to understand Pfizer knows its product does not work and that it poses a danger to the public. In this report, they have demonstrated these admissions using Pfizer’s own words. When those documents are overlaid with the Emergency Use Authorization (EUA) from 2020 and the EUA from late 2021, it becomes apparent that the Company ignored safety signals and used weak statistics to justify product use. When these documents are viewed together, there is sufficient evidence to say Pfizer understood that there were problems with its mRNA COVID product before the original EUA was submitted in November 2020.

Abbreviations

PV = Pharmacovigilance Plan for Biologic License Application #125742 Of Covid-19 mRNA vaccine (nucleoside modified) (BNT162b2, PF-07302048). Date of Report: 28 July 2021, Version 1.1

EUA 2020 = Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum. Date of Document: 20 November 2020, Author: Marion F. Gruber, Ph.D., Director, CBER/OVRR

5.3.6 = Reissue of 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162b2) Received Through 28-Feb-2021. Approval Date: 30 April 2021.

EUA 5-11 = Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum. Date of Document: 06 October 2021, Author: Peter Marks, M.D., Ph. D., Director, CBER, and Acting Director, CBER/OVRR.

SOC = System Organ Class

AE = Adverse Event

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>>18942217

Executive Summary in chronological order:

• In November 2020 (EUA 2020), Pfizer dismissed safety signals in its clinical trial C4591001 (ages 16+). Moreover, although Pfizer considered any adverse event (AE) within six weeks of product use to be reasonably associated with the product (EUA 2020, p. 10), it dismissed the observed safety signals in EUA 2020, 5.3.6, PV, and EUA 5-11.

• In November 2020 (EUA 2020), Pfizer had a weak demonstration of efficacy based on very few occurrences (eight cases versus 162 cases). C4591001 was essentially invalid because investigators failed to confirm or deny 3,410 suspected COVID cases (1,594 vaccinated and 1,816 placebo). If COVID occurred in the thousands and investigators used only 170 cases for efficacy, their statistics did not reflect reality. Investigators then destroyed their clinical trial by unblinding and vaccinating all placebo cohort participants (PV, p. 13, pp. 18-19). In effect, this act terminated the trial. Pfizer acknowledged unblinding and vaccinating the placebo cohort would adversely affect the data (EUA 2020, p. 53). The company cut off data collection the day after placebo participants were vaccinated (EUA 5-11, p. 12).

• Through December 2020 to February 2021 (5.3.6) field reports, Pfizer observed AEs including deaths and permanent harms. Per Pfizer’s own standard of AEs within six weeks of product use being considered product-related (EUA 2020, p. 10), Pfizer de facto recognized its product caused AEs, because many of the AEs in 5.3.6 occurred within hours or days of product use.

• In its report dated July 28, 2021 (PV), Pfizer still planned to use C4591001 (a portion of which was due April 2023) to reach final conclusions on its mRNA COVID product’s efficacy and safety. The cut off of data collection on March 12, 2021, should be understood as Pfizer’s acknowledgement of the termination of its clinical trial. Pfizer attempted to substitute titer-based lab tests for efficacy, but later admitted lab titers do not represent disease protection (i.e., efficacy) (EUA 5-11, p. 13).

• In Pfizer’s July 2021 report (PV), Pfizer acknowledged pericarditis and myocarditis as risks of product use. Pfizer did not call it a dose-response, but it reported pericarditis and myocarditis risks as higher after dose #2 (PV, p. 50). Pfizer reported a similar dose-dependent pattern elsewhere (EUA 2020, p. 6, p. 42, p. 56; EUA 5-11, p. 46). All other AEs noted in the EUA 2020, from study C4591001, and AEs reported from the field in 5.3.6 were ignored. Additional studies listed by Pfizer in PV seem to not exist online.

• In October 2021 (EUA 5-11), efficacy was weakly demonstrated. Investigators did not draw upon C4591001 for support. Rather, they substituted titers for efficacy.

• In Pfizer’s October 2021 EUA 5-11 submission, Pfizer described a dose-response relationship between its product and AEs in both dosage and dose number. Investigators speculated that subclinical damages would manifest in the long-term. The implication is that continued doses with subclinical damages would eventually manifest as clinical damages. Pfizer admitted a young male subject’s AE, previously dismissed, was actually related to product use months after initial signal detection. This event represented a pattern of behavior: no matter what AE occurred, investigators concluded it was unrelated to Pfizer’s product.

• EUA 5-11 introduced unsupported points to push product use in children. Pfizer introduced claims on transmission prevention and attacked the unvaccinated. Investigators did not provide clinical trial evidence for support. The product did not have well-demonstrated benefits, so any risks (and there are many) immediately rendered a poor risk-benefit ratio.

https://truthsocial.com/@realSidneyPowell/posts/110471673232585291

https://dailyclout.io/report-73-pfizer-knew-what-pfizers-employees-and-contractors-knew-and-when-they-knew-it/

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Sidney Powell - Defending The Republic Newsletter

June 2, 2023

Good News Friday: 06/02/23

Dear Patriots,

How is it that a short week can be so darn tough?

Go forward into a summer weekend with some good news.

SPECIAL NOTE:

In our continuing battle against the lawfare launched against us for representing electors exercising their First Amendment right to petition the government by filing lawsuits after the 2020 election, Sidney argued in the Seventh Circuit in Chicago Wednesday.

You may listen to the entire argument HERE - https://defendingtherepublic.org/oral-argument-by-sidney-powell-in-feehan-v-evers-7th-circuit-court-of-appeals/

Governor Evers of WI is still trying to have Sidney and co-counsel sanctioned to stop other lawyers from ever raising the machine fraud issues again.

1- Protecting children from social media and bad mental health results is a fight worth having. We hope to see more schools hold these companies accountable.

Daily Wire

Tennessee School District Sues Social Media Companies Over Growing Mental Health Crisis Among Students

2- It gets little coverage but parents all over the country are stepping in to shield their children from the onslaught of grooming at school.

Daily Wire

Six Maryland Parents Sue School Board For Forcing Kids To Read ‘Pride’ Books

3- At least we will not have to be held hostage to this perverted content. Don’t you love that they ended this agreement in SECRET?

NY Post

BLM leader Patrisse Cullors secretly dumped from Warner Bros TV deal

4- Alabama Governor Kay Ivey protects women’s sports from men participation.

Office of the Governor of Alabama

Governor Ivey Takes Another Step to Protect Women’s Sports, Signs House Bill 261

5- Insanity stopped…. at least temporarily.

Newsmax

Pentagon Orders Air Force Base to Cancel Drag Show

6- Update on Yulia Hicks and her transplant surgery. She is doing well!

DailyWire

Mother Speaks Out After Yulia Hicks Undergoes Kidney Transplant Despite Alleged Duke Rejection Over COVID Vax

7- Do not relent. Keep up the pressure on all the boycotts.

John Nolte at Brietbart

May Ratings Collapse — Fox Loses Third of Viewers Without Tucker Carlson

https://truthsocial.com/@realSidneyPowell/posts/110474744209797012

https://defendingtherepublic.org/good-news-friday-06-02-23/