Thank You Meryl Nass for Posting on CHAOS Newsletter.
Here is my comment to her substack that reads thusly: Comments Regarding Pfizer COVID-19 Vaccine Phase III Clinical Study, Which Led to the Product’s EUA; from a former FDA clinical reviewer, with valuable references to the law and FDA guidance documents.
Wow! Thank you for sharing this amazingly well written review of the malfeasance by Pfizer. I documents in a well summarized way why and how the Covid mRNA shots are not “safe and effective.” The author nails it on each point; I intend to use this to support the ban of Covid shots. Every state health authority and state attorney general needs to be put on notice that failure to stop the covid shots is complicity in advancing fraudulent medicine. This report cuts through the lies and shows beyond a doubt that the Covid Big Lie actually killed people, maimed others, and has left some with debilitating long term ill effects, from Chuck Fall.
Below is the opening and the conclusion to this excellent report. We in the medical / health freedom movement should use this information to make a targeted demand for a ban on Covid mRNA shots. Go to Meryl’s website for full report.
https://merylnass.substack.com/p/comments-regarding-pfizer-covid-19
From FDA reviewer:
Prior to the administration of the first doses of the Pfizer coronavirus “vaccine” in December 2020, the message was conveyed that it was 95% effective against infection, replication and spread of COVID-19, that it would protect against severe cases, hospitalization, and death, immunity would be long-lasting, and that good safety outcomes were ensured. However, a shallow dive into the study data which was made available to the public clearly indicates that there was no data to support any of these claims from the pivotal study upon which the authorization was based. In addition, the very definition of the term “vaccine” subsequently had to be changed in order to accommodate the substantial shortcomings of the treatment.
It is important to understand the critical importance of the ramifications of U.S. Food and Drug Administration (FDA) Phase 2/3 clinical outcomes regarding subsequent decision-making concerning drugs, biologics or medical devices under consideration for both authorization and subsequent approval. It should also be understood that the performance of a product during the clinical trial is assumed to be a reliable as well as accurate predictor of performance post-approval. Thus, given that the interpretation of the Pfizer clinical data is unambiguous and inarguable, its performance following authorization would not have been expected to vary much from the clinical study results upon which it was based. It is clear that the results of the examination of the FDA Briefing Document for the Pfizer-BioNTech BNT162b2 COVID-19 Vaccine Phase 2/3 clinical study C45910011, the basis for the Emergency Use Authorization (EUA), reveal a number of serious safety concerns which, when combined with the weak effectiveness outcomes, clearly demonstrate that the purpose of the Pfizer clinical study, and that of the EUA vaccine which followed, were NOT to protect the public health as it relates to COVID-19 and SARS-CoV-
- Conclusions
- The Pfizer Phase 2/3 clinical study, which led to the Pfizer COVID-19 vaccine EUA was not designed in the interest of protecting the public health, and because of this, its emergency use should never have been authorized. Any conclusions drawn or actions taken from the study outcomes have not been relevant with respect to the management of the SARS-CoV-2 situation. The only apparent benefit of the clinical study outcomes was in predicting the poor safety and effectiveness outcomes which have been observed following the EUA, e.g., increased mortality and cardiovascular complications.
- As anyone involved in clinical decision-making at FDA understands, benefit-risk assessment is the cornerstone of the regulatory review of human drugs, medical devices and biologics. That is, unless the benefit of a product exceeds its risk, there is no need to further consider product viability. In the case of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine, because those greater than age 75 with comorbidities (the at-risk population in the SARS-CoV-2 pandemic) comprised only 4% of the study population, no conclusions could be drawn regarding vaccine safety or effectiveness of this most critical group. Since FDA and Pfizer did not conduct an adequate evaluation of this most vulnerable group, this clearly indicates there was no intention of helping them, and more importantly, in protecting the public health. Therefore, as FDA violated their own October 6, 2020 EUA guidance document18 regarding the assurance of safety and efficacy, the EUA should not have been authorized, as it could not possibly have been concluded that benefit exceeded risk for the elderly with comorbidities.
- Following the authorization of the EUA, those who agreed to take the experimental vaccine were falsely led to believe that it provided long-lasting immunity, protection against viral infection and transmissibility, very strong vaccine effectiveness, diminished chances of hospitalization/ death, and ensured good safety outcomes. However, none of these claims were true. Instead, the study’s principal effectiveness outcome indicated only that there was no more than a 1% improvement in mild COVID-19 symptoms in favor of the Vaccinated compared to the Placebo subjects, in a population whose average subject was a 50-year old person with few or no comorbidities, as opposed to the older and much less healthy actual at-risk population.
- A critical thinker would have struggled with the elimination of the Placebo cohort which occurred at 6 months, as by deliberately preventing any future test vs control comparisons in the absence of control data, vaccine safety as predicted by the study outcomes will never be known. This intentional action violated the fundamental principles of good clinical practice and fundamental clinical trial design. On the other hand, the spirit of the elimination of the control group is not inconsistent with FDA’s decision to authorize the emergency use of the Pfizer vaccine in the first place.
- A critical thinker would have questioned the designation of the PCR test to identify COVID-19 positive subjects, as this test, in addition to being open to manipulation, was never designed to qualify subjects as COVID-19 positive. Thus, having employed this faulty methodology, instead of one proposed by experts, seems to have completely invalidated the study effectiveness outcomes, as poor as they were.
- The failure to discuss at the EUA meeting the 1% Absolute Risk Reduction, the actual treatment effectiveness, as opposed to just presenting the 95% Relative Risk Reduction, constituted a violation of FDA published guidelines as well as the ethical and legal obligation of informed consent for communicating risks and benefits to the public.
- Regarding safety outcomes, the ACIP conclusions after 2 months were “Severe local and systemic adverse reactions (grade ≥3, defined as interfering with daily activity) occurred more commonly in Vaccine recipients than in Placebo recipients,” with the GRADE evidence as type 2 (moderate certainty) for serious adverse events in those who were vaccinated. The 6-month data underscored these findings, as the Vaccinated group had 5,241 and 262 related adverse events and severe adverse events, compared to 1,322 and 150 in the Placebo group; there were 20 deaths associated with the Vaccinated cohort, compared to 14 who were in the Placebo group. Regarding reported causes of death associated with cardiovascular events, there were 9 deaths in the Vaccinated group, compared to 5 in the Placebo group.
- Following the authorization, it became obvious that most of the harms, including death, occurred soon after the administration of the COVID-19 vaccines. However, during the clinical trial, as well as following the authorization, one was only considered as Vaccinated two weeks following the second Pfizer vaccination. That is, those harms were, and continue to be, attributed to the Unvaccinated. This abhorrent action cleverly serves to cover up much of the injury which has occurred closely following vaccination.
- The numbers of “Suspected COVID-19 Cases” were similar between the Vaccine (1,594) and Placebo (1,816) groups, indicating very little difference between the two study cohorts in the clinical trial. Although further discussion would ostensibly have impacted the EUA decision, instead, it was completely ignored.
- The failure to discuss the reasons for the substantially greater number of Protocol Deviations in the Vaccinated group (311 vs 60 for the Unvaccinated), and whose data was not included in subsequent analysis, was a significant omission. Why was an explanation not provided? The omission of this critical discussion should have been sufficient to have placed the EUA on hold until adequate information was made available to enable an informed decision.
- From a safety perspective, it is clear that the performance of the Vaccine cohort was inferior to that of the Placebo control group. It is equally clear that the absolute risk reduction in COVID-19 cases provided by the Pfizer vaccine was minimal, and completely failed to represent the at-risk elderly-with-multiple-comorbidities population. Therefore, it should be apparent even to a layman, that there is no benefit to a reduction in cases if it comes at the cost of increased sickness and death.
- The decision-making by Pfizer in conjunction with FDA as related to the clinical study, and the subsequent actions taken, violated not only FDA regulations, but the fundamental principles of benefit/risk determination as well as the assurance of good clinical practice.19-24
- The FDA had attempted to delay the release of Pfizer’s COVID-19 vaccine safety and effectiveness clinical data for 75 years, despite having authorized the product after only 108 days of clinical review on December 11th, 2020.25 However, in early January 2022, Federal Judge Mark Pittman, after hearing testimony from the Public Health and Medical Professionals for Transparency, ordered the FDA to release 55,000 pages per month over the ensuing eight months.26 The released reports continue to be reviewed by Daily Clout.27 Daily Clout has written numerous reports using primary source Pfizer documents since they gained access to the data. For example, Report 84 revealed that there were more cardiovascular deaths in the vaccinated than in the unvaccinated cohort in Pfizer’s clinical trial. Furthermore, Pfizer did not report the 3.7-fold cardiovascular adverse events signal and also delayed reporting deaths so that it favored the vaccinated arm of the trial.28
To see full article with references: https://merylnass.substack.com/p/comments-regarding-pfizer-covid-19