Letter to Texas Attorney General Ken Paxton from Dr. Jeyanthi Kunadhasan: Vaccinated Deaths in Pfizer’s COVID Vaccine Clinical Trial Not Disclosed to FDA with EUA Data.

Jan 06, 2024

Originally Published on DailyClout.

Dr. Jeyanthi Kunadhasan

Team 3

DailyClout

P.O. Box 24

Millerton, NY 12546

The Honourable Ken Paxton

Attorney General of Texas
(469) 247-2360
P.O. Box 3476
McKinney, Texas 75070

RE: Undisclosed Deaths in C4591001 Trial at the Vaccine and Related Biological Products Advisory Committee (VRBPAC) on December 10, 2020.

Dear Attorney General Paxton:

I am Dr. Jeyanthi Kunadhasan, an anesthetist and perioperative physician in Australia. As a member of the DailyClout Pfizer research volunteers, I investigated 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 vaccine. Additionally, I serve as Treasurer of the Australian Medical Professionals Society.[2]

I co-authored Pfizer reports 42 [3] and 76 [4], available on dailyclout.io. Additionally, I contributed as 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] This analysis of the Pfizer’s COVID vaccine represents the inaugural examination of the original trial data by a group unaffiliated with clinical trial sponsor.

Your lawsuit against Pfizer has drawn my attention, And 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)

As you know, the clinical trial data reportedly supporting the safety and efficacy of the BNT162b2 mRNA vaccine has been published twice. Polack et al. released their findings, “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine,” [6] on December 10, 2020, one day before the FDA issued Pfizer’s EUA. Subsequently, on September 15, 2021, Stephen J. Thomas, MD, et al. published, “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.”[7] The Polack publication in the New England Journal of Medicine 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. Both the journal article and the EUA approval documentation[8] 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. Additionally, the two undisclosed deaths indicated a cardiac event signal in the clinical trial’s BNT162b2 recipients. (Michels et al., 2023)

Pfizer’s clinical trial protocol required prompt reporting – immediately upon awareness and, under no circumstances, to exceed 24 hours – of serious adverse events (SAE) , via the Vaccine SAE Reporting Form, to Pfizer Safety.[9] Investigators were responsible for documenting all directly observed and spontaneously reported adverse events, including serious adverse events reported by participants, into the patient's Case Report Form (CRF). In the unfortunate event of a death, the next of kin or emergency contact had the responsibility to promptly inform the clinical trial site, distinguishing it from the self-reporting process for other adverse events. The clinical trial site’s swift notification about an SAE to the trial sponsor, BioNTech in this instance, played a crucial role in meeting legal obligations and ethical responsibilities concerning participant safety and the study intervention under clinical investigation. BioNTech, as the sponsor, bore the legal duty to quickly notify both the local regulatory authority and other regulatory agencies about the safety of the study intervention under clinical investigation. Compliance with country-specific regulatory requirements for safety reporting to the regulatory authority, Independent Review Boards (IRBs)/Ethics Committees (ECs), and investigators was also obligatory.

Examining 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), reveals that as of the data cut-off date of November 14, 2020, a total of 11 deaths (six deaths in vaccinated arm of the study and five in the placebo arm) were recorded. This stands in contrast to the six deaths publicly disclosed at the VRBPAC meeting and in the Polack article. The capture rate seems to be 33% in the vaccinated arm (two reported deaths out of six) and 80% in the placebo arm (four reported deaths out of five).

To unravel the discrepancies in reported deaths, my co-authors and I initiated our investigation with the assumption that, as of November 14, 2020, Pfizer-BioNTech had no knowledge of any deaths during the trial. The only way to convincingly disprove this was to demonstrate, through publicly available records, that Pfizer-BioNTech had knowledge of the deaths. By examination of these records, we were able to show Pfizer-BioNTech indeed possessed knowledge of these deaths. Meticulously scrutinizing each patient’s notes accessible on the Public Health and Medical Professionals for Transparency (PHMPT) website, we identified the six deceased subjects, whose deaths were reported in the initial Polack publication and at the VRBPAC meeting on December 10, 2020. These subjects include vaccinated patients 11621327 and 10071101 along with the unvaccinated subjects 11521085, 12313972, 10661350, and 10811194. Their deaths occurred prior to November 14, 2020, and the documentation of their deaths was available in their respective Case Report Forms (CRFs) prior to November 14, 2020.

Below are two BNT162b2 subjects whose deaths were included in the EUA submission:

[10], [11]

Below are the four placebo subjects whose deaths were included in the EUA submission:

[12], [13], [14], [15]

The examination of the CRFs for the remaining 32 deaths did not reveal any additional notifications of death prior to the November 14, 2020, data cut-off date. (Reference Appendix A.) Our investigation confirmed that Pfizer-BioNTech relied on the data entry of the death notification in the CRF as perhaps the sole determinant used to include a death as reportable. However, our investigation of publicly available records at that time could not elucidate why the other deaths were not reported.

Nonetheless, the September 2023 Pfizer-BioNTech data released by the FDA introduced a document named “125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf,”[16] 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[17] from Alliance for Multispecialty Research LLC , Newton, Kansas[18], 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[19], 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. The narrative documents further state that the subject had an autopsy, determining the cause of death to be “sudden cardiac death.”

Upon reviewing this subject’s Case Report Form (CRF), I found the specific diagnosis “sudden cardiac death“ was mentioned on December 9, 2020.[20] On page 71 of this subjects’ CRF, the date of death notification was November 25, 2020. Since the clinical site had been informed by the emergency contact on the day the patient died, we know there was a 37-day delay in recording this death in the CRF, violating Pfizer’s trial protocol. 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.

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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]

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.

https://phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1120-11201050.pdf, p. 74

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. Beyond the ethical issues raised, which I have highlighted, there are legal obligations to promptly report deaths to local regulatory authorities, a practice essential for ensuring trial subjects’ safety.

The public does not have access to records that would demonstrate the actual notifications of death for the other undisclosed deaths that occurred before November 14, 2020 — specifically, two BNT162b2-vaccinated subjects (11521497 and 10891073) and placebo subject 11561124. It is currently not possible to determine if there were any additional errors in reporting during this period. Compelling Pfizer-BioNTech and the clinical trial sites to provide all available information is essential to establish the facts and a correct timeline.

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. 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.

Sincerely,

Dr. Jeyanthi Kunadhasan

MD (UKM), MMed (AnaesUM), FANZCA MMED (Monash)

c/o DailyClout.io

Appendix A

Footnotes

[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] 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.

[7] 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.

[8] 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.

[9] 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.

[10] Pfizer Site 1162 Atlanta Center for Medical Research. “125742_S1_M5_CRF_c4591001-1162-11621327.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 June 2023, phmpt.org/wp-content/uploads/2023/06/125742_S1_M5_CRF_c4591001-1162-11621327.pdf.

[11] Pfizer Site 1007 Cincinnati Children’s Hospital Medical Center. “125742_S1_M5_CRF_c4591001-1007-10071101.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 June 2022, phmpt.org/wp-content/uploads/2022/06/125742_S1_M5_CRF_c4591001-1007-10071101.pdf.

[12] Pfizer Site 1152 California Research Foundation. “125742_S1_M5_CRF_c4591001-1152-11521085.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 3 July 2023, phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1152-11521085.pdf.

[13] Pfizer Site 1231 Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich. “125742_S1_M5_CRF_c4591001 1231 12313972.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 June 2023, phmpt.org/wp-content/uploads/2023/06/125742_S1_M5_CRF_c4591001-1231-12313972.pdf.

[14] Pfizer Site 1066 Solaris Clinical Research. “125742_S1_M5_CRF_c4591001 1066 10661350.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 May 2023, phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1066-10661350.pdf.

[15] Pfizer Site 1231 Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich. “125742_S1_M5_CRF_c4591001-1231-12313972.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 June 2023, phmpt.org/wp-content/uploads/2023/06/125742_S1_M5_CRF_c4591001-1231-12313972.pdf.

[16] 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.

[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, 128.

[18] Pfizer. “C4591001 Comprehensive List of All Clinical Sites.” Public Health and Medical Professionals for Transparency, phmpt.org, 17 Nov. 2021, phmpt.org/wp-content/uploads/2021/11/5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf.

[19] 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.

[20] 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.

[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.

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