Letters to AGs

Attorney General Letters of evidence

Dr Jeyanthi Kunadhasan MD

AG Ken Paxton

Letter to Texas Attorney General Ken Paxton:

AG Paxton was leading a group of States in a lawsuit against Pfizer

Vaccinated Deaths in Pfizer’s COVID Vaccine Clinical Trial Not Disclosed to FDA with EUA Data

https://dailyclout.io/letter-to-texas-attorney-general-ken-paxton-vaccinated-deaths-in-pfizers-covid-vaccine-clinical-trial-not-disclosed-to-fda-with-eua-data/

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:

Subject ID	Actual Date of Death	Date Pfizer Had Knowledge of the Death	Did Pfizer Have Knowledge of the Death Prior to the 11/14/20 EUA Data Cut-Off?	Source for Pfizer’s Knowledge of the Death
11621327	13-SEP-20	24-SEP-20	YES	Subject’s Case Report File, 10/15/2020, page 123, 10/2/2020 07:36:13 page 122 notes that death was listed in Safety DB but missing in the CRF. Notification of death noted as 9/24/2020 on page 122.[10]
10071101	21-OCT-20	5-NOV-20	YES	Subject’s Case Report File, 11/5/2020 16:40:57 page 188, Nov-05-2020 16:39:49 page 196 of the CRF.[11]

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

Subject ID	Actual Date of Death	Date Pfizer Documented Knowledge of the death	Did Pfizer have knowledge prior to the 11/14/20 EUA Data Cut-Off?	Source for Pfizer’s Knowledge of the Death
11521085	26-Aug-20	27-Aug-20	YES	Subject’s Case Report File, Page 118 Aug-27-2020 09:33:16.[12]
12313972	28-Sep-20	01-Oct-20	YES	Subject’s Case Report File, Oct-01-2020 16:07:36 page 149-150, Oct-01-2020 16:08:33 page 156.[13]
10661350	3-Nov-20	10-Nov-20	YES	Subject’s Case Report File, Nov-10-2020 13:41:45 page 121, Nov-10-2020 13:41:02 page 122.[14]
10811194	4-Nov-20	11-Nov-20	YES	Subject’s Case Report File, Nov-11-2020 15:19:14 page 343, Nov-12-2020 07:51:29 mentions 11Nov202 as the date of notification of death.[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.

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)

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.

AG Kris Kobach (KS)

As a result of our findings of at least two HIDDEN DEATHS in the Pfizer Clinical Trial, and published in our peer-reviewed article of a Forensic Analysis of the Pfizer Clinical Trial, Dr JK wrote a letter to the State AGs of the affected subjects.

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

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

The Honourable Kris Kobach

Attorney General of Kansas

120 SW 10^th Ave, 2^nd 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 18^th of August 2020 and the second dose on the 8^th of September 2020. She presented for the one-month follow-up, post dose two, on 7^th 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 19^th 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 19^th, 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 (19^th 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/2023/09/125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf p. 71.

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 judgment 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 10^th, 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)

REFERENCES

[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.

[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.

[12] https://phmpt.org/wp-content/uploads/2021/11/5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf p. 18

[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.

[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/.

Georgia AG Chris Carr

Dr JK wrote another letter similar to that sent to Kris Kobach with the details of the subject from Georgia who died.

Letter to AG of Georgia highlighting details of the hidden vaccinated death from Georgia in the Pfizer Covid-19 Vaccine trial

The Honourable Christopher M. Carr

Attorney-General of Georgia

40 Capitol Square, SW
Atlanta, GA 30334

20^th January 2025

RE: The Importance of Undisclosed Vaccinated Death from Georgia in the C4591001 Trial at the Vaccine and Related Biological Products Advisory Committee (VRBPAC) on December 10, 2020

Dear Attorney-General Carr,

My name is Dr. Jeyanthi Kunadhasan, and I am an anesthetist and perioperative physician in Australia. I draw your attention to the events below because I think this information is highly relevant to the people of Georgia, and I hope you will be able to carry it forward because it seems to be indicative of some very serious problems.

I am a member of a team of volunteers who investigated the original data from the Pfizer clinical trial CA4591001. This data was to be suppressed for 75 years until a Federal lawsuit forced its release on the Public Health and Medical Professionals for Transparency website^[1]. This data formed the basis of the Food and Drug Administration’s Emergency Use Authorization (EUA) of Pfizer-BioNTech’s BNT162b2 mRNA COVID vaccine. Additionally, I am Treasurer of the Australian Medical Professionals Society.^[2]

I coauthored “Forensic Analysis of the 38 Subject deaths in the 6-Month Interim Report of the Pfizer-BioNTech BNT162b2 mRNA Vaccine Clinical Trial,”^[3] which is the first analysis of the Pfizer-BioNTech BNT162b2 mRNA vaccine original trial data by a group unaffiliated with the clinical trial sponsor. The information reported on here was revealed by our research presented in this journal article. Additionally, I authored Pfizer reports 42 ^[4] and 76 ^[5], available on Dailyclout.io.

I begin with an undisclosed trial-participant death from Georgia that occurred in the BNT162b2-vaccinated arm of Pfizer’s clinical trial as originally reported in War Room/Daily Clout 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, till 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 trials BNT162b2 recipients. One of the undisclosed deaths in the vaccinated arm of the trial occurred in Georgia.

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 would have been 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 had 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 6 deaths publicly disclosed at the VRBPAC meeting and 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, we 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 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 and 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.

Two BNT162b2 subjects whose deaths were included in the EUA submission:

Four placebo subjects whose deaths were included in the EUA submission:

However, the September 2023 Pfizer-BioNTech data released by the FDA provided a document named “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 deaths had been disclosed at the time of the EUA, they would have shown that the BNT162b2 mRNA COVID vaccine intervention provided no reduction in deaths.

Subject 11201050, a 58-year-old woman, signed up for the Pfizer vaccine trial (C4591001) at the Meridian Clinical Research, 340 Eisenhower Drive, Suite 1200, Savannah 31406, Georgia. The Principal Investigator for this site is Dr Paul Bradley.

Her comorbidities included chronic back pain (since 2015), hypertension (since 2017), anxiety (since 2018), and type 2 diabetes mellitus (since 2018). Concomitant medications included metformin (since 2017) for type 2 diabetes mellitus; lisinopril (since 2017) and clonidine (since 2018) both for hypertension; and lorazepam (since 2018) for anxiety. 12

She received Dose 1 of BNT162b2 on 04 Aug 2020 and Dose 2 on 27 Aug 2020 (Day 24). On Nov 7th, 2020 (72 days after Dose 2), her husband called the clinical site and notified them that the subject had died in her sleep. The subject’s husband reported that the night before her death, she had taken an unspecified muscle relaxant and diazepam (Valium) for her chronic back pain; these medications were previously used by the subject. No symptoms or illnesses leading to the subject’s death were reported. The subject was not seen in the hospital. The coroner was called to pronounce death; an autopsy was not performed. This is a strange incuriosity into the cause of death of a 58-year-old woman who has died in her sleep, especially one enrolled in a clinical trial of a novel therapeutic.

According to the husband, the cause in the death certificate was stated as “cardiac arrest.” According to the investigator, there was no reasonable possibility it could be due to the study intervention. Pfizer concurred with the investigator’s causality assessment.

https://phmpt.org/wp-content/uploads/2023/09/125742_S1_M5_5351_c4591001-interim- mth6-narrative-sensitive.pdf page 75

Her husband called the clinical site itself on November 7th to inform them of her death. In the patient’s CRF, the date of collection/notification of death is Nov 7th, 2020. (see screenshot below).

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

As such, this subject’s death should have been reported publicly in the VRBPAC meeting as well as the NEJM publication, as it had happened well within the reporting period prior to Nov 14th, 2020, and the clinical site documented it. Why wasn’t it?

Despite documenting receipt of her death on the day she died, the first entry elsewhere in her CRF regarding her death was on December 3rd, 2020.

https://phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1120- 11201050.pdf page 148-149.

As this was now after the data cutoff date, this was presumably the reason this death was not disclosed publicly. However, this is still prior to the December 10th VRBPAC meeting when the vaccine was approved. It seems as if the sponsor decided not to acknowledge this death, even though it occurred well within the reporting period concerned, with the clinical trial site acknowledging those facts. Other than obvious ethical issues raised, there are legal obligations to report deaths in a timely manner to local regulatory authorities to ensure safety of trial subjects.

Further inquiry is needed into –

the clinical trial investigator’s conclusion that this undisclosed death of a 58-year-oldwoman in the vaccinated arm was not due to the vaccine. As the patient did not have any autopsy done, what was the evidentiary basis upon which the clinical investigator and the sponsor rely upon to form this conclusion?
The process in which the clinical site acknowledges notification of death on November 7, 2020, but this death is not disclosed publicly either in the VRBPAC meeting or the NEJM publication. Did the clinical site promptly, within 24 hours, fill in the Vaccine SAE Reporting Form and inform the clinical sponsors Pfizer and BioN Tech as they should have as per legal and ethical requirements?
Why this clinical site took 26 days, evident in their own documentation, to follow up on such a serious adverse event such as death? Has there been adequate regulatory oversight into this clinical site?
When did Pfizer and BioNTech acknowledge receipt of this death? When did Pfizer and BioNTech inform the regulatory authorities of this clinical trial subject’s death? Pfizer BioNTech submitted their application for the EUA to the FDA on 20 November 2020.This Vaccine SAE Reporting Form is not currently publicly available, and compelling Pfizer/BioNTech and the clinical trial sites to provide all available information is the only way to establish the facts and timeline.Below is a simple schematic diagram highlighting the important dates for this trial subject.

I want to highlight another undisclosed death of a vaccinated subject in this trial that also happened in the reporting period under consideration for the EUA, which similarly was not publicly disclosed. Subject 11141050, from Alliance for Multispecialty Research LLC, Newton, Kansas died on October 19, 2020. Despite timely notification of death by the emergency contact, there was a 37-day delay to this death being officially recorded in that subject’s CRF. This subject did have an autopsy done, of which the cause of death was “sudden cardiac death”. There is evidence in this subject’s CRF that this autopsy result was available prior to the December 10, 2020, VRBPAC meeting where Pfizer’s Covid 19 vaccine first received the EUA.13

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.14 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.15 Of those 10, only two (subjects 11141050 and 11271112) had autopsies done, with only one result (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%. 16

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)

REFERENCES

^[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] 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

^[4] 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/

^[5] 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/

^[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_5351125742_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.
[12] https://phmpt.org/wp-content/uploads/2023/09/125742_S1_M5_5351_c4591001-interim-mth6-narrative- sensitive.pdf page 75

[13] https://dailyclout.io/pfizer-did-not-disclose-a-kansas-vaccinated-sudden-cardiac-death-from-its-covid-19- clinical-trial-dr-jeyanthi-kunadhasans-letter-to-kansas-attorney-general-kris-kobach/
[14] https://dailyclout.io/wp-content/uploads/Follow-up-lejer-Professor-Anthony-Lawler_17_5_24.pdf
[15] 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.

[16] 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/.

Attorney General Letters of evidence

Dr Jeyanthi Kunadhasan MD