A team of researchers analyzing Pfizer’s clinical trial data has accused the pharmaceutical giant of concealing deaths during its COVID-19 vaccine trials.
Among the allegations is the failure to disclose the death of a Kansas participant who was part of the BNT162b2 vaccine trial. The death reportedly occurred 41 days after the participant received their second vaccine dose.
The accusations stem from a detailed report led by Dr. Jeyanthi Kunadhasan, an anesthetist and perioperative physician, and a member of the DailyClout research team.
The team alleges that Pfizer’s reporting practices during the critical juncture leading to the FDA’s Emergency Use Authorization (EUA) for the vaccine were flawed, with significant delays in documenting serious adverse events, including deaths.
“The Polack paper disclosed six deaths — two in the BNT162b2 arm, and four in the Placebo arm. In the journal article and the EUA approval documentation[9], the six deaths covered the period of July 27, 2020, through November 14, 2020,” Dr. Kunadhasan wrote in a letter sent to Kansas Attorney General Kris Kobach, who filed a lawsuit against Pfizer.
“This letter will demonstrate that Pfizer-BioNTech possessed records showing that eight deaths, four in the BNT162b2 arm and four in the Placebo arm, should have been disclosed by Pfizer to the FDA. In addition, the two undisclosed deaths presented a cardiac event signal in the clinical trial’s BNT162b2 recipients. One of the undisclosed deaths in the vaccinated arm of the trial occurred in Kansas,” she added.
Subject 11141050, a 63-year-old Kansas woman, participated in Pfizer’s clinical trial at a research site in Newton, Kansas.
Despite her pre-existing conditions, including hypertension and depression, she met the trial’s inclusion criteria and received her second vaccine dose on September 8, 2020. She passed away on October 19, 2020, with the cause of death determined to be sudden cardiac arrest.
According to the letter:
Subject 11141050 was mildly overweight, with a BMI of 27. She was postmenopausal, had depression, hypertension, osteoporosis, rheumatoid arthritis and sleep apnoea. Her medications included trazodone (since 01 January 2005) and sertraline (since 01 July 2020) for depression; pregabalin (since 01 January 2005) and baclofen (since 01 January 2018) for degenerative disc disease; as well as amlodipine (since 01 January 2010) and hydralazine (since 01 February 2020) for hypertension.
After completing the screening process and appropriate tests, she received her first dose of BNT162b2 on the 18th of August 2020 and the second dose on the 8th of September 2020. She presented for the one-month follow-up, post dose two, on 7th of October 2020 and had appropriate follow-up tests done then. There is no documentation of any untoward clinical events during these visits.
She died 41 days after receiving BNT162b2 dose 2 on the 19th of October 2020, and only 12 days after her planned follow-up visit. The emergency contact informed the clinical site of the death on October 19th, 2020.
The researchers allege that there was a 37-day delay in officially documenting her death, a violation of Pfizer’s own clinical trial protocols, which mandate immediate reporting of serious adverse events.
Moreover, her death and autopsy findings were not disclosed during the Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting on December 10, 2020, when the FDA evaluated Pfizer’s data for EUA approval.
According to the letter:
When we look at the table below, which is adapted from the “Forensic Analysis of the 38 Subject deaths in the 6-Month Interim Report of the Pfizer /BioNTech BNT162b2 mRNA Vaccine Clinical Trial”) (Michels et al., 2023), we can see, up to the data cutoff date of November 14, 2020, there were 11 deaths (six deaths in the Vaccinated arm of the study and five in the Placebo arm) in contrast to the six deaths publicly disclosed at the VRBPAC meeting and in the Polack article.
There was seemingly a capture rate of 33% (two reported deaths out of six deaths) in the Vaccinated arm versus an 80% capture rate in the Placebo arm (four reported deaths out of five deaths).
To determine how the discrepancies in reported deaths occurred, my fellow researchers and I started with the premise that, as of November 14, 2020, Pfizer-BioNTech was not informed of any deaths during the trial. The only way in which that could be validly disproved was demonstrating, through publicly available records, that Pfizer-BioNTech had knowledge of the deaths.
By painstakingly going through each of the patient’s notes released by the FDA and publicly available on the Public Health and Medical Professionals for Transparency (PHMPT) website, we identified the six dead subjects, whose deaths were reported in the initial Polack publication as well as at the VRBPAC meeting on December 10, 2020.
They are vaccinated subjects 11621327 and 10071101, as well as the unvaccinated subjects 11521085, 12313972, 10661350, and 10811194. Their deaths occurred prior to November 14, 2020, and there was documentation of their deaths prior to November 14, 2020, in their respective CRFs.
The two BNT162b2 subjects whose deaths were included in the EUA submission:
The four placebo subjects whose deaths were included in the EUA submission:
Having established that Pfizer-BioNTech used the data entry of the notification of death in the CRF as the only data point that determined whether a death was reported, our investigation of the public records at that time could not provide answers as to why the other deaths were not reported.
Dr. Aseem Malhotra, a highly esteemed, award-winning consultant cardiologist based at the HUM2N Clinic, London, wrote on X, “Pfizer covered up vaccine deaths research team alleges. This is exactly why I coined the term ‘psychopathic determinants of health’ Evidence points towards a crime against humanity by a psychopathic entity AKA corporate capitalism – major overhaul of economic system needed.”
You can read the full letter at DailyClout.
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