Far from being "safe and effective," in the clinical trials, more people who received the Pfizer "vaccine" DIED than those who were in the placebo group. The "vaccine" was NEVER shown to save lives.
Pfizer concealed at least 2 deaths in the “vaccine” arm of their clinical trial that should have been revealed BEFORE the FDA granted an Emergency Use Authorization on December 11, 2020.
BLINDED PLACEBO-CONTROLLED PERIOD TO EUA APPLICATION DATA COLLECTION CUT-OFF
Pfizer submitted the Emergency Use Application on November 20, 2020 with the following data (THEY LIED):
The cutoff period for data collection was November 14, 2020, at which time the DEATH TOLL was far different than what Pfizer claimed in their Application for Emergency Use Authorization.
Pfizer hid vaccine deaths, research team alleges
During the clinical trials for its COVID-19 vaccine, pharmaceutical giant Pfizer appears to have hidden two deaths.
According to Dr. Jeyanthi Kunadhasan, an anesthetist and perioperative physician in Australia; who was part of the team, the study protocol required that any “death or serious adverse effect” had to be reported within 24 hours. In the Kansas case that did not happen for 37 days.
The Kansas case was a 63-year-old woman who had her first dose of the Pfizer mRNA vaccine on August 18, 2020, and a second dose on September 8, 2020. She died on October 19, 2020, and her emergency contact immediately informed the clinical site — Alliance for Multispecialty Research LLC, in Newton, Kansas. Thirty-seven days later, on November 25, 2020 — 11 days after the data reporting cutoff date — the death was finally recorded in a “case report form.”
Five days after the emergency use application was submitted to the Food and Drug Administration by Pfizer.
The participant’s death was not reported in the trial results in the prestigious New England Journal of Medicine or to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which approved the EUA.
The second hidden death was a 58-year-old woman in Georgia.
She received her first dose on August 4, 2020, and a second on August 27, 2020. The woman died in her sleep on November 7, 2020, and her husband immediately informed the clinical site. The death was not added to the data for 26 days and first followed up on December 3, 2020 — again well after the Nov. 14 data cutoff date.
The reports shown to [the Vaccines and Related Biological Products Advisory Committee] VRBPAC and in the New England Journal of Medicine stated there were only six deaths in the trial, four in the placebo group and two in the vaccinated group, supposedly showing that the vaccine worked and reduced the risk of death.
However there were actually four in each group.
The bottom line?
Kunadhasan believes Pfizer knew the vaccine didn’t work and could cause heart problems — even before it was approved.
Letter to Texas Attorney General Ken Paxton: Vaccinated Deaths in Pfizer’s COVID Vaccine Clinical Trial Not Disclosed to FDA with EUA Data.
I wish to highlight two undisclosed deaths of American trial participants in the BNT162b2-vaccinated arm of Pfizer’s clinical trial. Pfizer’s nondisclosure of these deaths occurred before Pfizer’s data cut-off date for its EUA submission to the FDA. (Michels et al., 2023)
Polack et al. released their findings, “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine,” on December 10, 2020, one day before the FDA issued Pfizer’s [Emergency Use Authorization] EUA.
Polack, Fernando, et al. “Safety and Efficacy of the BNT162B2 Mrna Covid-19 Vaccine.” New England Journal of Medicine, nejm.org, 10 Dec. 2020, www.nejm.org/doi/full/10.1056/NEJMoa2034577
The Polack paper disclosed six deaths — two in the BNT162b2 arm and four in the placebo arm. Both the journal article and the EUA approval documentation showed the six deaths during the period of July 27, 2020, till November 14, 2020.
This letter will demonstrate that Pfizer-BioNTech had records showing eight deaths, four in the BNT162b2 arm and four in the placebo arm, that Pfizer should have been disclosed to the FDA.
The September 2023 Pfizer-BioNTech data released by the FDA introduced a document named “125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf,”
which included information revealing that Pfizer-BioNTech was, in fact, informed of two additional deaths in the BNT162b2 arm of the trial well before the EUA data cut-off date, and that Pfizer-BioNTech did not disclose those deaths to the FDA.
If the deaths had been disclosed in the EUA submission, they would have shown that the BNT162b2 mRNA COVID vaccine intervention did not reduce deaths.
Subject 11141050 from Alliance for Multispecialty Research LLC , Newton, Kansas, in the vaccinated arm of the study, died on October 19, 2020. Contrary to Pfizer-BioNTech’s clinical trial protocol, neither Polack et al., nor the EUA submission documentation, nor the VRBPAC meeting on December 10, 2020, disclosed this patient’s death.
The death occurred well before the data cut-off date of November 14, 2020.
The public lacks access to any of the original clinical trial records, specifically Pfizer Safety’s Vaccine SAE Reporting Form for subjects. However, from the patient narratives (Pfizer, 2023, p. 71), it is evident that the emergency contact confirmed on the day of death (October 19, 2020) that the subject had died.
As this death occurred well before the data cut-off date of November 14, 2020, and was known to Pfizer on November 25, 2020, there was ample opportunity to disclose this subject’s death, and possibly the autopsy results, at the December 10, 2020, VRBPAC meeting.
Subject 11201050, from Meridian Clinical Research LLC, Savannah, Georgia, died on November 7, 2020. The patient narratives explicitly state that the clinical site received notification of the subject’s death on November 7, 2020, from her husband.(Pfizer 2023, p. 75). This information is further supported by documentation found in that patient’s CRF clearly stating that the death notification occurred on November 7, 2020.[21]
Given these established facts, it is puzzling that the death of this subject was not included with the other data to the FDA when seeking EUA. Moreover, it was not disclosed by the clinical trial investigators to the regulators during the December 10, 2020, VRBPAC meeting (Vaccines and Related Biological Products Advisory Committee, 2020). This is particularly perplexing as the death occurred and was acknowledged as known before the November 14, 2020, data cut-off date.
We have documentation in the publicly available Pfizer clinical trial documents that confirms the patients’ loved ones promptly communicated the subjects’ deaths to the clinical trial sites. However, in violation of legal requirements, the regulatory authorities were apparently not informed of these deaths within the specified time frame. The critical time period under scrutiny is the issuance of the EUA on December 11, 2020, which relied upon the clinical trial data collected through November 14, 2020.
During the December 10, 2020, VRBPAC meeting, one reason cited for vaccine approval was “the known and potential benefits of the vaccine outweigh the known and potential risks of the vaccine when used for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older” (Vaccines and Related Biological Products Advisory Committee, 2020).
Notably, the omission of the two deaths from the vaccinated arm of the study at this critical juncture of EUA issuance raises substantial concerns about the overall safety reporting of Pfizer’s clinical trial.
The brilliant Dr Jeyanthi Kunadhasan testifies before an Australian Senate Committee that in Pfizer’s own clinical trial there were more deaths in the vaccinated group than the placebo group.
SUMMARY OF DEATHS IN 6-MONTH REPORTING PERIOD: July 27, 2020 to March 13, 2021
Deaths reported among those who received the Pfizer BNT162b2 “vaccine”:
There were a total of 19 deaths among those who received 2 injections of BNT162b2.
There were also 2 additional deaths among those who were originally in the placebo group but then received 2 injections plus a booster after the clinical trial was unblinded.
PLEASE NOTE:
There were actually 8 deaths that occurred among those who received the Pfizer “vaccine” before the FDA granted an Emergency Use Authorization on December 11, 2020, but only two of the deaths were reported by Pfizer in their EUA application (see Pfizer document above and 1# and 3# below).
There were 17 Deaths in the placebo arm of the clinical trial:
CONCLUSIONS
The C4591001 placebo-controlled randomized clinical trial of 22,030 vaccinated and 22,030 placebo subjects was the world’s only opportunity for an unbiased evaluation of the Pfizer/BioNTech BNT162b2 vaccine.
Unblinding of placebo subjects starting in Week 20 terminated the placebo-controlled clinical trial, thereby ending all unbiased evaluation of possible adverse event signals.
The mRNA-LNP platform is novel, not previously phase 2/3 tested in humans, and the toxicity of PP-Spike protein was unknown. Taken together, a 20-weeks placebo-controlled clinical trial is NOT sufficient to identify any except for the most common safety concerns.
The number of all-cause deaths is NOT decreased by BNT162b2 vaccination.
Of the 38 deaths reported in the 6-Month Interim Report of Adverse Events, 21 BNT162b2 vaccinated subjects died compared to 17 placebo subjects.
Delayed reporting of the subject deaths into the Case Report Form, which was in violation of the trial protocol, allowed the EUA to proceed unchallenged.
The number of subject deaths was 17% of the expected number, based on age-adjusted US mortality. One possible explanation could lie in the 395 subjects that were “Lost to Follow- up”.
There was a 3.7-fold increase in cardiac events in subjects who received the BNT162b2 vaccine versus the placebo.
Of the 15 subjects who were Sudden Adult Deaths (SAD) or Found Dead (FD), 12 died of a cardiac event, 9 of whom were vaccinated.
The cardiac adverse event signal was obscured by delays in reporting the accurate date of subject death that was known to Pfizer/BioNTech in the subject’s Narrative Report.
Early cancer signal? We observe that there were 2 deaths from metastatic cancer in the vaccine group while only 1 in the placebo group. Could this indicate an early signal that identifies accelerated outcomes for exisiting cancers or the new phenomenon of "turbo-cancers"? In our research, we find evidence of this possible signal in our research on malignant neoplasms deaths in the UK. The analysis of deaths for all malignant neoplasms can be found here, and the analysis of individual malignant neoplasm causes (including cancers without site specification), here.
Road traffic accidents? We observe that there were 2 deaths from road traffic accidents in the vaccine group while none in the placebo group. Is this a signal or spurious event?
Sepsis-related deaths? We observe that there were 3 sepsis-related deaths in the vaccine group while none in the placebo group. Is this a signal or spurious event?
All-cause mortality signal? We observe that there were 21 [19?] deaths in the vaccine group while 17 in the placebo group, corresponding to excess deaths around 23% [11.7%?]. Is this an early signal that corroborates the excess mortality we observe in the nations we've investigated? (link to our excess mortality analysis)
The data used to back up the claim that the efficacy of the Pfizer “vaccine” was 95% was clearly manipulated.
Pfizer claimed that only 8/18198 people who received the BNT162b2 “vaccine” were diagnosed with COVID-19.
Please read footnote “c.”
The time period of the data collection period started “from 7 days after Dose 2.”
This means that for 28 days after receiving the first injection (21 days between injection #1 and injection #2, plus 7 days after Dose 2) any participant who had symptoms of COVID-19 was not counted.
Out of 10,439 “vaccinated” participants in the clinical trial who became “ILL with Any Covid-19 Symptoms,” is it possible that only 8 participants were diagnosed with COVID-19, or has this data been manipulated?
References:
Pfizer Application for Emergency Use Authorization (November 20, 2020)
A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
A Phase 1 2 3 Placebo Controlled Randomized Observer Blind Dose Finding Study
Find out what was in the documents that Pfizer and Moderna tried to keep hidden from the public.
The US Food and Drug Administration (FDA) attempted to delay the public release of Pfizer’s COVID-19 vaccine safety data for 75 years, despite approving the injection after only 108 days of safety review on December 11th, 2020.
On January 6, 2022 United States District Judge Mark Pittman of the United States District Court in the Northern District of Texas ordered the release of the Pfizer clinical trial documents (55,000 pages per month). They released 12,000 pages by the end of January, 2022.
FDA must disclose more COVID-19 vaccine records, US judge rules
A federal judge has ordered the U.S. Food and Drug Administration to publicly disclose more information underpinning its authorization of COVID-19 vaccines, after failing to persuade the court to end the public records lawsuit.
In a ruling, on Friday, U.S. District Judge Mark Pittman in Fort Worth, Texas, ordered the agency to produce its “emergency use authorization” file to a group of scientists who wanted to see licensing information that the FDA relied on to approve the Pfizer-BioNTech coronavirus vaccine.
“The COVID-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer vaccine,” wrote Pittman.
The lawsuit, filed in late 2021, attracted attention after the FDA said it could take decades to process and disclose records to Public Health and Medical Professionals for Transparency, the group that brought the case.
The Covid-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer Vaccine.
It is ORDERED that the FDA shall produce the responsive EUA file on or before June 30, 2025.
This nonprofit, made up of public health professionals, medical professionals, scientists, and journalists exists solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines. The organization takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses.
3,200 medical professionals, lawyers and scientists make up the investigatory group that wrote the papers after reading every FDA dump throughout 2022 and 2023 until the final dump was made.
I claim no copyright of any kind whatsoever, over any of my work, ever. Everyone is encouraged to copy any and all of it, in part, or in full, and use it for whatever purposes they wish. In fact, I would be delighted if someone were to copy this entire body of work. I encourage everyone to duplicate and mirror it in its entirety. I also encourage everyone to adapt and utilize the information in whatever manner they deem appropriate. No citation or other reference is requested or required. It would actually bring me great joy to see this information multiply exponentially and "go viral".
Grateful You are straight talking to us.
Ellen
Monterey Peninsula
CA
I am thankful there are people like you willing and capable to do the work necessary to bring these horrific crimes to light.