'Safe and Effective': Pfizer Excluded Clinical Trial Deaths From FDA COVID Vaccine EUA Request

Altered Pfizer Data Favored Vaccine Approval

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By Megan Redshaw October 21, 2023

To obtain emergency use authorization (EUA) for its COVID-19 vaccine, Pfizer and BioNTech submitted a data package in 2020 to the U.S. Food and Drug Administration (FDA) so the agency could evaluate the safety and efficacy of its vaccine. A recently published peer-reviewed study by the DailyClout Pfizer/BioNTech Documents Investigations Team suggests Pfizer excluded known deaths in the vaccine arm of its clinical trial from its data filing and withheld information from the agency that could have resulted in a denial of EUA.

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.

As reported by The Epoch Times prior to the study's publication in the International Journal of Vaccine Theory, Practice, and Research, a group of researchers conducted a forensic analysis of Pfizer/BioNTech's early COVID-19 vaccine trial data and found significant inconsistencies between data in the companies’ six-month interim report and publications authored by Pfizer/BioNTech trial site administrators.

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.

On Dec. 10, 2020, one day prior to the FDA granting EUA for Pfizer’s COVID-19 vaccine, Dr. Susan Wollersheim, a clinical reviewer with the FDA’s Center for Biologics Evaluation and Research, presented data showing only two vaccine deaths during the clinical trial and four placebo deaths, which was used to support the claim that Pfizer’s COVID-19 vaccine if authorized, would save lives.

However, Pfizer documents obtained by the Public Health and Medical Professionals for Transparency through a Freedom of Information Act lawsuit and analyzed by the researchers show four additional deaths in the vaccine arm of the clinical trial and an additional death in the placebo arm, none of which were included in the FDA’s presentation on the efficacy and safety of Pfizer/BioNTech’s COVID-19 vaccine.

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.

Pfizer’s clinical trial protocol states, "All SAEs [serious adverse events] occurring in a participant during the active collection period as described in Section 8.3.1 are reported to Pfizer Safety on the Vaccine SAE Report Form immediately upon awareness and under no circumstance should this exceed 24 hours."

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 trial protocol, Serious Adverse Events (SAEs) are supposed to have been reported within 24 hours into the Case Report Form upon being notified,” study co-author Dr. Jeyanthi Kunadhasan told The Epoch Times in an email. “Death is the most serious SAE. Had the FDA been in receipt of the data in a timely manner, they would have had to ponder the approval of a drug, of which the first four deaths in the vaccinated arm were in patients in their mid-50s and mid-60s being found dead.”

'Cardiac Event Signal' Was Obscured

The Pfizer documents show the first known but excluded death involved a 63-year-old female who experienced sudden cardiac death on Oct. 19, 2020, which was 41 days after receiving her second Pfizer dose. The death was reported to Pfizer on Oct. 19, and an autopsy confirmed she experienced “sudden cardiac death.” Yet the woman’s death was not reported on the CRFs until Nov. 25, 2020, which was 37 days after the patient’s death.

The second death occurred in a 58-year-old female who died from cardiac arrest on Nov. 7, 2020, which was 72 days after receiving her second Pfizer dose. Yet Pfizer did not enter the death into the CRF until Dec. 3, 2020, which was 26 days after the patient died—despite being informed by her husband of her death on the day she died.

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."

Of these deaths, four deaths were due to cardiac events in vaccinated subjects compared with two in the placebo group. While the numbers are small, they represent a twofold increase in cardiac events in vaccinated participants. 

“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.

Source: theepochtimes.com

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