Nov 2020 – Pfizer already knew its covid jab was neither safe nor effective

 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 • by Contributors: Loree Britt; Michelle Cibelli, RN, BSN; Barbara Gehrett, M.D.; Joseph Gehrett, M.D.; and Chris Flowers, M.D. | Editors: Amy Kelly, Chris Flowers, M.D., and David Shaw

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

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 in the vaccinated cohort versus 162 cases in the unvaccinated cohort). C4591001 may be invalid because investigators are unclear about 3,410 suspected COVID cases (1,594 vaccinated and 1,816 placebo). If COVID cases 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.

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.

EUA 2020 Regarding Efficacy 

Pfizer’s original efficacy claim was based upon ratios between very small numbers over a short period of time (six weeks), representing extremely weak evidence. The vaccinated group had eight COVID-19 cases, and the placebo group had 162 cases (EUA 2020, p. 20). Investigators used this simple ratio to determine high efficacy, as 162 is around 20 times greater than eight. Compare these occurrences against the 17,411 in the vaccine cohort and the 17,511 in the placebo cohort used for the statistical evaluation (EUA 2020, p. 23). Eight and 162 were infinitesimal. If an individual took the vaccine, it dropped their risk of a positive PCR test from 0.92% to 0.045% in a six-week period. To put it another way, one should consider the result as doses needed to treat the population. Investigators vaccinated about 17,500 individuals (35,000 doses) to prevent approximately 150 COVID cases. For the other 17,350, the benefit was effectively zero during the six weeks. For them, vaccination was only risk.

This analysis described the purest meaning of the investigators’ results. They arrived at a statistic derived under a narrow set of parameters, the most important of which was the very short-term nature of six weeks. In this context, the fraction of a percentage drop in COVID risk was inconsequential to the population. Pfizer failed to discuss the alternative conclusions based on few occurrences in a short time span. Pfizer would have understood that 35,000 doses to save about 150 cases was not practical for a public health intervention. This approximation of doses-needed-to-treat is just as valid as the efficacy claim in the context of a six-week period. It is the same result at which Pfizer arrived, drawn from the same evidence; however, it is rephrased in more practical language. A reasonable person would not take an experimental drug if the benefit was a 0.88% drop in COVID risk.

To create strength in statistical evaluation, the trial needed to run for two years to allow occurrences to build up in the placebo and experimental cohorts. Only then could valid conclusions be made. The result would either hold up and become stronger with time as vaccinated participants resisted disease over the long term, or investigators would find that COVID cases also accumulated in the vaccinated cohort just as they did in the placebo cohort. The practical reality was that this short-term cultivation of data was enough to perform a statistical math exercise only. Investigators did not demonstrate 95% efficacy over a year or longer period of time. If efficacy waned in the short-, middle-, or long-terms, it would not be captured by this preliminary analysis. For a short, preliminary, investigative trial with further follow-up planned, Pfizer’s conclusion was technically acceptable, despite issues, as long as the clinical trial continued, unaltered, to the planned 24-month completion date.

On page 41 (EUA 2020), the investigators reported there was a testing issue in their clinical trial, which could have affected even their preliminary efficacy assessment. There were suspected COVID cases numbering in the thousands that were not PCR-confirmed. The authors discussed this finding in the context of safety, discussing both reactogenicity and adverse events, but they did not provide commentary on efficacy.