Researchers Find Pfizer Excluded Clinical Trial Deaths From FDA COVID Vaccine EUA Request

Delayed reporting of the subject deaths into the Case Report Forms (CRFs) obscured the cardiac adverse event signal and allowed Pfizer/BioNTech’s request for EUA to proceed unchallenged, according to the study.

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10/19/2023

The forensic analysis showed trial subjects vaccinated with Pfizer’s COVID-19 vaccine experienced a 3.7 times increase in cardiovascular deaths compared to placebo controls and that this “significant adverse event signal” was not disclosed by Pfizer when the FDA was evaluating its vaccine for emergency use. Additionally, researchers identified numerous instances where Pfizer/BioNTech attributed potential vaccine-associated deaths to other causes and undermined vaccine safety data.

Altered Pfizer Data Favored Vaccine Approval

Pfizer altered their data at a critical decision point to favor EUA approval, study co-author Corinne Michels, Professor Emerita at Queens College in New York told The Epoch Times in an email. According to the study, Pfizer had a Nov. 14, 2020, data cutoff for its COVID-19 vaccine EUA application. In its filing, the company presented data showing four deaths in the placebo arm of its clinical trial and two deaths in the vaccine arm, which inflated the positive impact of the vaccine on death outcomes.

Pfizer’s “narrative descriptions of the deaths” show that it knew at least two deaths (#11141050 and #11201050) occurred in the vaccine arm of its clinical trial before the EUA data cutoff. However, Pfizer did not report the deaths in its data filing for EUA despite clear evidence it had been notified immediately of the deaths, according to Professor Emerita Michels.

Furthermore, all nonserious and severe adverse events that occur during the “active collection period” that begins after obtaining informed consent from the participant are recorded in the adverse event section of the CRF, and the investigator is to “record on the CRF all directly observed and all spontaneously reported AEs [adverse events] and SAEs reported by the participant.”

As part of its protocol, Pfizer was to record deaths in the CRFs used to capture clinical trial data and submit the CRFs with its data file to the FDA. Instead, Pfizer delayed recording the deaths despite having knowledge that they had occurred.

According to the researchers, because Pfizer delayed recording participant deaths in their case report file and did not use the “actual date of death,” these deaths were “not discoverable at a critical juncture of the EUA approval process, and the cardiac event signal was obscured.”

“If Pfizer/BioNTech had reported the actual date of death instead of the date the deaths were recorded in the Case Report Forms, Subjects #11141050 and #11201050 would have been included in the EUA application,” Professor Emerita Michels said. “Given this scenario, there would have been four vaccinated and four placebo subjects who died prior to the November 14th data cutoff date and whose deaths should have been included in the EUA application.”

“The delay in notification of the two critical patient deaths (#11141050 and #11201050) has to be investigated,” Dr. Kunadhasan said. “The patients’ families did the right thing and informed the clinical site immediately. They deserve answers, as do all of us.”

According to the study, if the accurate number of deaths Pfizer had knowledge of were included in its data package and presented during the FDA’s EUA Authorization Request meeting, it would have at least shown an equal number of deaths in the vaccine and placebo arms of the clinical trial and thus, no benefit of vaccination. 

The Epoch Times contacted Pfizer for comment but has not received a response.