A team of researchers analyzing Pfizer’s clinical trial data has accused the pharmaceutical giant of concealing deaths during its COVID-19 vaccine trials.
Among the allegations is the failure to disclose the death of a Kansas participant who was part of the BNT162b2 vaccine trial. The death reportedly occurred 41 days after the participant received their second vaccine dose.
The accusations stem from a detailed report led by Dr. Jeyanthi Kunadhasan, an anesthetist and perioperative physician, and a member of the DailyClout research team.
The team alleges that Pfizer’s reporting practices during the critical juncture leading to the FDA’s Emergency Use Authorization (EUA) for the vaccine were flawed, with significant delays in documenting serious adverse events, including deaths.
“The Polack paper disclosed six deaths — two in the BNT162b2 arm, and four in the Placebo arm. In the journal article and the EUA approval documentation[9], the six deaths covered the period of July 27, 2020, through November 14, 2020,” Dr. Kunadhasan wrote in a letter sent to Kansas Attorney General Kris Kobach, who filed a lawsuit against Pfizer.
“This letter will demonstrate that Pfizer-BioNTech possessed records showing that eight deaths, four in the BNT162b2 arm and four in the Placebo arm, should have been disclosed by Pfizer to the FDA. In addition, the two undisclosed deaths presented a cardiac event signal in the clinical trial’s BNT162b2 recipients. One of the undisclosed deaths in the vaccinated arm of the trial occurred in Kansas,” she added.
Subject 11141050, a 63-year-old Kansas woman, participated in Pfizer’s clinical trial at a research site in Newton, Kansas.
Despite her pre-existing conditions, including hypertension and depression, she met the trial’s inclusion criteria and received her second vaccine dose on September 8, 2020. She passed away on October 19, 2020, with the cause of death determined to be sudden cardiac arrest.
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