COVID
Pfizer Failed to Disclose Deaths of Two Women in COVID Vaccine Clinical Trials
A researcher who analyzed FDA documents related to the emergency use authorization of Pfizer’s COVID-19 vaccine is demanding the autopsy report on a Kansas woman who died of cardiac arrest 41 days after receiving her second dose of the vaccine. Pfizer took 37 days, instead of the required 24 hours, to report the death.
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Pfizer-BioNTech did not disclose the deaths of two vaccinated participants in its COVID-19 vaccine clinical trials, according to a team of Daily Clout researchers who analyzed documents related to the Pfizer clinical trials.
The deaths occurred before the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the vaccine in December 2020. However, it wasn’t until September 2023, nearly three years later, that the FDA publicly released documents revealing the deaths of a 63-year-old Kansas woman and a 58-year-old Georgia woman who participated in the trials.
The revelations prompted Dr. Jeyanthi Kunadhasan — an Australian anesthesiologist and perioperative physician and one of the researchers analyzing the Pfizer documents on behalf of Daily Clout — to write to Kansas Attorney General Kris Kobach, requesting his office investigate the death of the 63-year-old Kansas woman.
“If the additional two deaths had been disclosed at the time of the EUA, it would have shown that the BNT162b2 mRNA COVID vaccine intervention provided no reduction in deaths,” Kunadhasan wrote in her letter.
In June, Kobach sued Pfizer, alleging the company misled the public by marketing its COVID-19 vaccine as “safe and effective” while concealing known risks — including myocarditis and pericarditis, failed pregnancies and deaths — and critical data on limited effectiveness.
In 2022, a federal court ordered the FDA to release the approximately 1.2 million pages of documents pertaining to the clinical trials for the Pfizer-BioNTech COVID-19 vaccine, after rejecting the FDA’s request for 75 years to release the records.
The documents Kunadhasan analyzed revealed that Pfizer had the opportunity to disclose the deaths before the Dec. 10, 2020, meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) — but did not do so.
Pfizer also did not disclose the deaths — both classified in the documents as “sudden cardiac death” unrelated to the victims’ vaccination — in a December 2020 New England Journal of Medicine paper touting the “safety and efficacy” of the Pfizer-BioNTech vaccine.
Kunadhasan told The Defender:
“The death highlighted in Kansas is significant as it occurred well within the reporting period considered for the EUA, and as my letter shows was not disclosed. There was every opportunity to disclose this death at the VRBPAC meeting.
“This death even had an autopsy, which I show was probably available before the VRBPAC meeting, and again was not disclosed.”
According to The Sentinel, “The fact that both participants died of heart attacks becomes more important when other studies showed risks of myocarditis and pericarditis — particularly after a second shot and particularly in young men under 25, but among other patients as well.”
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), told The Defender the actions of Pfizer and the FDA are “duplicitous at best.” He said:
“All death data for clinical trials needed not only to be made available to the FDA but also to the public. Otherwise, informed consent is completely missing, regardless of whether the product is EUA or [fully] approved.
“It is also particularly devious that Pfizer lied about a reduction in deaths in the vaccination arm when, with these data, the opposite was true.”
Naomi Wolf, Ph.D., CEO of Daily Clout and author of “The Pfizer Papers: Pfizer’s Crimes Against Humanity,” told The Defender the documents show that the “FDA covered up the unlawfully concealed deaths” of the trial participants and that these records “may well reveal a direct connection to the mRNA injection.”
“The details that Dr. Kunadhasan and her colleagues revealed about the death of this poor woman could theoretically allow Kobach to demand the autopsy reports and interview witnesses with information about her passing,” Wolf said.
Dr. Chris Flowers, a retired radiologist and member of the Daily Clout team that examined the Pfizer documents, told The Sentinel that the two undisclosed deaths should have been enough to halt the clinical trial.
“If you put it in context, yes, there’s a small number of deaths,” Flowers said. “Normally, the FDA calls a stop to those clinical trials until further investigation is done. And in many cases, [this] is sort of the death knell of that clinical trial.”
Noting that these deaths “would have at least made it more difficult” for the FDA to grant the Pfizer-BioNTech vaccine an EUA, Hooker said that “to release this information over two years later, after the obvious damage has been done, is criminal. Pfizer should be held accountable.”
Wolf said that while she’s “not an attorney, fraud, negligence and manslaughter come to mind.”
“This was one of the most important clinical trials in modern medical history,” Karl Jablonowski, Ph.D., senior research scientist at CHD, told The Defender. “The people in political power chose to ‘trust the science,’ and they were wrong to do so.”
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Undisclosed deaths may have led to FDA granting EUA ‘on incorrect premises’
In her letter, Kunadhasan said she wants to draw attention to “an undisclosed participant death from Kansas that occurred in the BNT162b2-vaccinated arm of Pfizer’s clinical trial.”
Kunadhasan pointed out that Daily Clout published a report about the two undisclosed deaths in October.
According to the documents Kunadhasan cited, the death of the Kansas woman occurred “well before the data cutoff date of November 14, 2020” and nearly a month before the December 2020 VRBPAC meeting.
She said there was a 37-day delay in reporting the results of the Kansas woman’s autopsy, which revealed “sudden cardiac death,” Kunadhasan noted.
“Notably, the omission of the deaths and autopsy report 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,” Kunadhasan stated in the letter.
Kunadhasan also told the attorney general that Pfizer’s clinical trial protocol required that serious adverse events be reported: “immediately upon awareness, and under no circumstances to exceed 24 hours … Pfizer-BioNTech’s own clinical trial protocol indicated that it should have been disclosed.”
Referring to the New England Journal of Medicine paper, Kunadhasan noted that the paper disclosed only six deaths — two among vaccinated clinical trial participants and four among participants in the placebo group.
FDA documents released in September 2023, however, “included information showing that Pfizer-BioNTech was, in fact, informed of two additional deaths in the BNT162b2 arm of the trial well before the EUA data cutoff and that those deaths were not disclosed to the FDA,” Kunadhasan wrote.
The documents showed that the 63-year-old Kansas woman signed up for the Pfizer-BioNTech trial at the Alliance for Multispecialty Research LLC, in Newton, Kansas. She received the two doses of the vaccine on Aug. 18, 2020, and Sept. 8, 2020, and “had appropriate follow-up tests” done on Oct. 7, 2020.
“There is no documentation of any untoward clinical events during these visits,” Kunadhasan wrote. But on Oct. 19, 2020, 41 days after her second dose and less than two weeks after her follow-up visit, the woman died. A subsequent autopsy found the cause of death to be “sudden cardiac death,” not related to the vaccine.
“It is extremely important to know … Why this death (which occurred well within the reporting period) and the autopsy results were not disclosed publicly at the December 10th, 2020, VRBPAC meeting,” Kunadhasan said in her letter.
The letter also highlighted the death of the 58-year-old Georgia woman, who received her two doses of the Pfizer-BioNTech COVID-19 vaccine on Aug. 4, 2020, and Aug. 27, 2020. She died in her sleep on Nov. 7, 2020. Kunadhasan noted that her death was “not added to the data for 26 days.”
Kunadhasan told The Defender these discrepancies prompted her letter to Kobach.
“As a doctor, the non-disclosure of a death and autopsy of a clinical trial participant is a profound betrayal of medical ethics. I hope Kobach pays attention to this, and there can be accountability for this Kansan,” Kunadhasan said.
“Kansans should contact Kobach for action in regards to this letter and other AGs should follow suit with investigating Pfizer’s crimes in their states,” Wolf said.
Kobach’s office did not respond to a request from The Defender for comment as of press time.
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Prominent cardiologist joins calls for suspension of mRNA COVID shots
Kunadhasan’s letter comes amid growing calls for a moratorium — or an outright ban — on the mRNA COVID-19 shots, and an independent investigation into their safety.
In an 11-page letter to U.K. regulators and health officials last week, cardiologist Dr. Aseem Malhotra joined these calls.
“There is overwhelming evidence that calls for the suspension of the COVID-19 mRNA vaccine (which, by technicality, is a genetic therapy) because of serious harms,” Malhotra wrote in the letter.
The letter was addressed to Charley Massey, CEO of the U.K.’s General Medical Council; Wes Streeting, the U.K.’s secretary of state for Health; Sir Christopher Whitty, the U.K.’s chief medical officer; and Lord Patrick Valance, the U.K.’s minister of state for Science Research and Innovation.
Malhotra wrote that these officials’ decision “to not support a pause and independent investigation of the safety of the vaccines is now untenable given accumulating evidence of harm and corrupt practices.”
The letter also referred to The Hope Accord — a petition Malhotra drafted earlier this year signed by over 64,000 people, including 1,900 medical doctors and over 2,000 scientists and academics.
The petition calls for the suspension of the mRNA COVID-19 vaccines, “comprehensive re-evaluation of the safety and efficacy of all COVID-19 vaccine products,” “immediate recognition and support for the vaccine-injured,” “restoration of ethical principles” and “addressing the root causes of our current predicament.”
Speaking on medical commentator John Campbell, Ph.D.’s YouTube show on Dec. 11, Malhotra said evidence supporting withdrawal of the vaccines is “overwhelming.”
Explaining why he wrote to U.K. officials, Malhotra told Campbell, “Sunlight is a very powerful disinfectant for malodorous health policy,” and said that there may be an explosion of people in the near future who are currently asymptomatic but who may develop vaccine-related conditions.
“We’ve got a lot of asymptomatic people in the population who I feel are at risk of heart attack, stroke and cancer. Until we get that addressed full on, more people are going to be harmed from a vaccine they took three years ago,” Malhotra said.
“My conscience will not allow me to stay quiet and just do this behind the scenes. As healthcare professionals, we need to address it because it’s not going away.”
“What we need to do is create almost a culture … where people aren’t afraid to admit that things have changed or they’ve got things wrong and they can change their mind,” Malhotra said.
Watch Campbell interview Malhotra here:
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