Dr. Jeyanthi Kunadhasan, WarRoom/DailyClout Researcher, Alerts the Therapeutic Goods Administration That Pfizer Had More Vaccinated Deaths Than Placebo Deaths in Its COVID Vaccine Clinical Trial
Dr. Jeyanthi Kunadhasan, an anaesthetist and perioperative physician in Australia and Treasurer of the Australian Medical Professionals’ Society, wrote to Dr. Tony Lawler, Deputy Secretary of Australia’s Therapeutic Goods Administration (TGA), on March 21, 2024, regarding the vaccinated deaths in Pfizer’s C4591001 COVID-19 vaccine clinical trial. Specifically, Dr. Kunadhasan explained in detail that Pfizer did not disclose all vaccinated deaths during the trial to Food and Drug Administration (FDA) when the company submitted data to support its application for emergency use authorization (EUA). Because Pfizer failed to be transparent with the FDA about the total number of vaccinated deaths during its trial, the Vaccine and Related Biological Products Advisory Committee (VRBPAC) was misinformed about the correct number of deaths in vaccinees when it met on December 10, 2020, to consider Pfizer’s COVID-19 drug for EUA. Based on an incomplete dataset, VRBPAC recommended that the FDA grant EUA to Pfizer for its novel, mRNA-based COVID treatment. Certainly, this information should be alarming to Dr. Lawler and TGA. Yet, his response indicated otherwise.
Dr. Kunadhasan received Dr. Lawler’s response on March 27, 2024, stating that TGA “…makes its own decision [about drugs] based on the Australian context.” He shockingly went on to say, “It is reassuring to note that, in this case, none of the deaths in the trial have been attributed to the vaccine and the initial conclusions remain valid. The accumulating published evidence over time continues to support the significant public health benefit of the safety and efficacy of mRNA vaccines, as well as an overwhelmingly favourable risk/benefit ratio.” Dr. Lawler suggested that Dr. Kunadhasan should direct her concerns to the FDA. It appears TGA leadership is not interested in ensuring Australians have access to and an understanding of the most accurate Pfizer trial data available.
On April 6, 2024, Dr. Kunadhasan responded to Dr. Lawler’s letter pointing out, “At the six-month data review, the TGA team investigating the C4591001 trial data would have discovered a gross misrepresentation in the data presented to the public up to the [EUA] data cut-off date of November 14th, 2020. Instead of the reported six deaths, with more deaths in the placebo arm (four deaths) compared to the vaccinated arm (two deaths), there were 11 deaths, with six deaths in the vaccinated arm compared to the five in the placebo arm.” In other words, during the trial, more participants died in the treatment arm than in the placebo arm. Additionally, she pointed out the potential breaches of Good Clinical Practice and questioned on what basis the determination was made by TGA that one of the “undisclosed death[s] in the vaccinated arm was not due to the vaccine.”
Dr. Kunadhasan concludes her April 6th letter to Dr. Lawler by saying, “I trust you agree that substantial safety reporting issues in this trial require further attention.” Indeed, the Pfizer trial’s many shortfalls, including significant safety issues, need to be highlighted so that such issues do not occur again in future trials happening under “public health emergency” circumstances. Should Dr. Lawler respond, DailyClout will post his letter.
Please read these three important letters below.
https://dailyclout.io/wp-content/uploads/AMPS_letter_TGA_March_21_2024.pdf
Kunadhasan reply to Professor Lawler_6_4_24
https://dailyclout.io/wp-content/uploads/Kunadhasan-reply-to-Professor-Lawler_6_4_24.pdf
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