Pfizer Did Not Disclose a Kansas Vaccinated “Sudden Cardiac Death” from Its COVID-19 Clinical Trial – Dr. Jeyanthi Kunadhasan’s Letter to Kansas Attorney General Kris Kobach
Dr. Jeyanthi Kunadhasan
Anaesthetist and Perioperative Physician
Pfizer Documents Analysis Project – Team 3
P.O. Box 24
Millerton, New York 12546
The Honourable Kris Kobach
Attorney General of Kansas
120 SW 10th Ave, 2nd Floor
Topeka, Kansas 66612
4th December 2024
RE: Undisclosed Vaccinated Death from Kansas in the C4591001 Trial at the Vaccine and Related Biological Products Advisory Committee (VRBPAC) on December 10, 2020
Dear Attorney-General Kobach:
My name is Dr. Jeyanthi Kunadhasan, and I am an anesthetist and perioperative physician in Australia. I am also a member of the DailyClout team of volunteers who are investigating the data, released on the Public Health and Medical Professionals for Transparency website[1], which formed the basis of the Food and Drug Administration’s Emergency Use Authorization (EUA) of Pfizer-BioNTech’s BNT162b2 mRNA COVID-19 vaccine. Additionally, I am Treasurer of the Australian Medical Professionals Society.[2]
I co-wrote the WarRoom/DailyClout Pfizer Documents Analysis reports 42[3] and 76[4], available on dailyclout.io. I am also a coauthor of “Forensic Analysis of the 38 Subject deaths in the 6-Month Interim Report of the Pfizer-BioNTech BNT162b2 mRNA Vaccine Clinical Trial,”[5] which is the first analysis of the Pfizer-BioNTech BNT162b2 mRNA vaccine original trial data by a group unaffiliated with the clinical trial sponsor.
I note with interest your lawsuit against Pfizer. I would like to draw your attention to an undisclosed participant death from Kansas that occurred the BNT162b2-vaccinated arm of Pfizer’s clinical trial as originally reported in War Room/DailyClout Report 89, ‘Researchers Find Pfizer Delayed Recording Vaccinated Deaths at Critical Juncture of EUA Process. Improper Delays in Reporting Deaths in the Vaccinated Led FDA to Misstate Vaccine’s Effectiveness, Influenced EUA Grant Decision.‘[6]
As you are aware, the findings of the clinical trial C4591001 reportedly supporting the safety and efficacy of the BNT162b2 mRNA vaccine, have been published twice. Polack et al. first published findings on December 10, 2020, one day prior to the FDA’s issuance of EUA, entitled, “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine”[7]. Then, on September 15, 2021, Stephen J. Thomas, MD, et al. published, “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.”[8] The Polack NEJM publication stated, “All the trial data were available to all the authors, who vouch for its accuracy and completeness and for adherence of the trial to the protocol, which is available with the full text of this article at NEJM.org. An independent data and safety monitoring board reviewed efficacy and unblinded safety data.” (Polack et al., 2020)
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. 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.
Pfizer’s clinical trial protocol required that serious adverse events (SAE) be reported immediately upon awareness, and under no circumstances to exceed 24 hours, to Pfizer Safety on the Vaccine SAE Reporting Form.[10] The protocol required site investigators to record into the patient’s Case Report Form (CRF) all directly observed, and all spontaneously reported adverse events and serious adverse events reported by the participant. In the case of a death, the next of kin/emergency contact was relied upon to inform a clinical trial site of a participant’s death, unlike the self-reporting of other adverse events. Prompt notification to the trial sponsor, by the clinical trial site investigator, of an SAE was essential to meet legal obligations and ethical responsibilities regarding the safety of participants and the safety of a study intervention under clinical investigation. The sponsor, in this case BioNTech, had a legal responsibility to notify both the local regulatory authority and other regulatory agencies about the safety of the study intervention under clinical investigation. The sponsor was required to comply with country-specific regulatory requirements relating to safety reporting to the regulatory authority, Independent Review Boards (IRBs)/Ethics Committees (ECs), and investigators.
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.
However, the September 2023 Pfizer-BioNTech data released by the FDA provided a document titled, “125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf”[11] which 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. 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.
Subject 11141050, a then 63-year-old female subject, signed up for the Pfizer vaccine trial (C4591001) at the Alliance for Multispecialty Research LLC, in Newton, Harvey County, 67114 Kansas. The Principal Investigator at this site was Dr Richard Glover.[12]
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.[13]
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.[14] 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.[15]
This subject’s death was not disclosed in the Polack NEJM publication (Polack et al., 2020), nor at the VRBPAC meeting on December 10, 2020.[16] Pfizer-BioNTech’s own clinical trial protocol indicated that it should have been disclosed.
The death happened well before the data cutoff date of November 14, 2020. In the patient narratives (Pfizer, 2023, p. 71), one can see that the emergency contact confirmed on the day of death (19th October 2020) that the subject had died. The narrative documents further state that the subject had an autopsy, from which the cause of death was determined to be “sudden cardiac death.”
When I reviewed this subject’s Case Report Form (CRF), I found the particular diagnosis “sudden cardiac death” had been mentioned on December 9, 2020.[17] On page 71 of this subject’s CRF, the date of notification of death is November 25, 2020. Since the clinical site had been informed by the emergency contact on the day the patient died, we see that there was a 37-day delay in recording this death into the CRF, in contravention of Pfizer’s trial protocol. As this death occurred well before the data cutoff date of November 14, 2020, and was known on November 25, 2020, there was ample opportunity to disclose this subject’s death, and possibly the autopsy results, at VRBPAC’s December 10, 2020, meeting.
Per the autopsy, the patient died from ‘sudden cardiac death,’ with her known risk factors of hypertension and obesity putting her at high risk of cardiac-acute myocardial infarct. The clinical site staff entered the specific diagnosis of “sudden cardiac death” into her notes on December 9th, 2020, the day before the VRBPAC meeting on December 10th, 2020, which suggests that this hidden death also had autopsy results available at the critical juncture of consideration of the vaccine’s Emergency Use Authorization.
https://phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1114-11141050.pdf#page=128, p. 128.
To be eligible for inclusion in this clinical trial, participants had to be deemed healthy based on medical history, physical examination (if required), and the clinical judgement of the investigator. The protocol allowed healthy participants with pre-existing stable disease – defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the six weeks before enrolment – to participate in the clinical trial. This patient was medicated with two different antihypertensives and had encountered clinical trial personnel at least three times with no mention of any worryingly high blood pressure readings. In fact, I cannot find any blood pressure reading in her publicly available case notes. Consequently, I can only assume the patient’s high blood pressure, from which she had suffered since January 1st, 2010, was well-controlled when she was admitted to the trial.
The patient was 165cm tall and weighed 74.1kg. Hence, her BMI of 27.2 put her in the overweight category, not obese. Without reviewing autopsy results, it will be difficult to believe that such anthropometric readings put a person at high risk of sudden cardiac death.
https://www.phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1114-11141050.pdf, p. 10.
Further inquiry is needed into the clinical sponsor’s conclusion that this undisclosed death in the Vaccinated arm was not due to the vaccine. On what basis was this determination made? This patient has an autopsy result that is still not publicly available. This autopsy was not disclosed at the most critical juncture, prior to the drug’s authorisation. The results of this autopsy need to be made public for scrutiny by independent experts.
It is extremely important to know
- When the clinical site 1114 received notification of death, and whether there was timely notification to the clinical trial sponsor, Pfizer-BioNTech.
- When the autopsy was done, and who was informed of the results of sudden cardiac death and when.
- 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.
Below is a simple schematic diagram highlighting the important dates for this trial subject.
I further scrutinised the deaths and autopsies performed overall in the trial. The Vaccinated arm had 21 deaths, and only three of them (subjects 11141050, 11271112, and 11351033) had autopsies done.[18] One autopsy resulted in the diagnosis of sudden cardiac death (subject 11141050), and the other two reports are still not available. Ten of the 21 deaths in the vaccinated subjects occurred in those who were found dead or suffered sudden adult death.[19] Of those 10, only two (subjects 11141050 and 11271112) had autopsies done, with only one autopsy result provided (subject 11141050 – sudden cardiac death). The result of the autopsy for vaccinated subject 11271112 is still pending. There were 17 deaths in the placebo group, and only four (subjects 11521085, 11561124, 11681083, and 12314987) had autopsies. Of these, two (subjects 11561124 and 11681083) listed a cause of death. The other two results are still not available.
The autopsies, or rather lack of autopsies, in this trial become more pertinent considering the recently published systematic review of autopsy findings in deaths after COVID-19 vaccination. It found 73.9% of deaths were independently adjudicated as directly due to the vaccination, of which the primary cause of death included sudden cardiac death in 35%. [20]
I also want to highlight another undisclosed death of a vaccinated subject. 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]
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 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. Patients who volunteered for the clinical trial likely did so, at least in part, in service of humanity. The failure to disclose the patients’ deaths, despite timely notification by loved ones, constitutes a betrayal of their altruism and trust and deserves further investigation. It also raises considerable doubt about the reporting methods overall. These methods have led to medico-financial expenditure never seen in the world, and possibly on incorrect premises entirely.
Sincerely,
Dr Jeyanthi Kunadhasan
MD (UKM) MMed (AnaesUM) FANZCA MMED (Monash)
####
[1] “Pfizer 16+ Documents.” Public Health and Medical Professionals for Transparency, Food and Drug Administration, 17 Feb. 2021, phmpt.org/pfizer-16-plus-documents/.
[2] “Australian Medical Professionals’ Society: A Society for Australian Medical Professionals.” AMPS, AMPS, amps.redunion.com.au/. Accessed 31 Dec. 2023.
[3] Kunadhasan, Jeyanthi, et al. “Report 42: Pfizer’s EUA Granted Based on Fewer than 0.4% of Clinical Trial Participants. FDA Ignored Disqualifying Protocol Deviations to Grant Eua.” DailyClout, DailyClout, 26 Sept. 2022, dailyclout.io/report-41-the-170-clinical-trial-participants-who-changed-the-world-pfizer-ignored-protocol-deviations-to-obtain-emergency-use-authorization-for-its-covid-19-mrna-vaccine/.
[4] Kunadhasan, Jeyanthi, and Ed Clark. “Report 76: Pfizer Had Data to Announce Its COVID-19 Vaccine’s Alleged ‘Efficacy’ in October 2020. Why Did Pfizer Delay the Announcement until November 9, 2020, Six Days after the 2020 U.S. Presidential Election?” DailyClout, DailyClout, 10 July 2023, dailyclout.io/report-76-pfizer-had-necessary-data-to-announce-its-covid-19-vaccines-alleged-efficacy-in-october-2020-why-did-pfizer-delay/.
[5] Michels, Corinne, et al. “Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/Biontech Bnt162b2 Mrna Vaccine Clinical Trial.” International Journal of Vaccine Theory, Practice, and Research, International Journal of Vaccine Theory, Practice, and Research, 17 Oct. 2023, ijvtpr.com/index.php/IJVTPR/article/view/86.
[6] https://dailyclout.io/fda-granted-pfizer-eua-based-on-misrepresented-data/
[7] 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.
[8] Thomas, Stephen J., et al. “Safety and Efficacy of the BNT162B2 Mrna Covid-19 Vaccine through 6 Months.” New England Journal of Medicine, nejm.org, 15 Sept. 2021, www.nejm.org/doi/full/10.1056/NEJMoa2110345.
[9] Naik, Ramachandra, et al. “Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum.” FDA, fda.gov, 20 Nov. 2020, www.fda.gov/media/144416/download, p. 19.
[10] Pfizer. “A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS.” Public Health and Medical Professionals for Transparency, PHMPT.org, 1 Mar. 2022, phmpt.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf, p. 74.
[11] Pfizer. “125742_S1_M5_5351_c4591001-Interim-Mth6-Narrative-Sensitive.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 Sept. 2023, phmpt.org/wp-content/uploads/2023/09/125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf.
[13] https://phmpt.org/wp-content/uploads/2023/09/125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf, p. 69.
[14] https://phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1114-11141050.pdf, p. 23.
[15] https://phmpt.org/wp-content/uploads/2023/09/125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf, p. 71.
[16] Vaccines and Related Biological Products Advisory Committee. “Vaccines and Related Biological Products Advisory Committee December 10, 2020, Meeting Announcement.” U.S. Food and Drug Administration, fda.gov, 10 Dec. 2020, www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement.
[17] Pfizer. “125742_S1_M5_CRF_c4591001-1114-11141050.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 May 2023, phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1114-11141050.pdf, p. 128.
[18] https://dailyclout.io/wp-content/uploads/Follow-up-letter-Professor-Anthony-Lawler_17_5_24.pdf
[19] Michels, Corinne, et al. “Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/Biontech Bnt162b2 Mrna Vaccine Clinical Trial.” International Journal of Vaccine Theory, Practice, and Research, International Journal of Vaccine Theory, Practice, and Research, 17 Oct. 2023, ijvtpr.com/index.php/IJVTPR/article/view/86.
[20] Science, Public Health Policy and the Law. 2024. “A Systematic review of autopsy findings in deaths after COVID-19 Vaccination – Science, Public Health policy.” November 17, 2024. https://publichealthpolicyjournal.com/a-systematic-review-of-autopsy-findings-in-deaths-after-covid-19-vaccination/.
[21] Pfizer. “125742_S1_M5_CRF_c4591001-1120-11201050.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 May 2023, phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1120-11201050.pdf, p. 74.
Purchase Your Copy of The Pfizer Papers.
Become a DailyClout Member.
Subscribe to DailyClout so you never miss an update!
Dr. Jeyanthi Kunadhasan is an anesthetist and perioperative physician in Australia, and she was a Consultant Anaesthetist at a major regional Victorian public hospital in practice for more than 12 years. She has a clinical interest in Patient Blood Management and has spearheaded many initiatives that sustainably brought down the unnecessary transfusion rates in major surgeries, leading to improved patient outcomes and lower cost to the health system. Dr. Kunadhasan is member of the DailyClout research volunteers investigating Pfizer’s clinical trial documents and data.
One of our country’s most important freedoms is that of free speech.
Agree with this essay? Disagree? Join the debate by writing to DailyClout HERE.