A group of researchers are calling into question Pfizer's and BioNTech's early trial data on its original COVID-19 vaccine after a forensic analysis revealed significant inconsistencies between data in the companies' six-month interim report and publications authored by Pfizer/BioNTech trial site administrators.
The preprint, published on Sept. 4, showed trial subjects vaccinated with Pfizer's COVID-19 vaccine experienced a 3.7 times increase in cardiovascular deaths compared to placebo controls--a "significant adverse event signal" not disclosed by Pfizer when the vaccine was authorized for emergency use. In addition, the analysis found numerous instances where Pfizer/BioNTech attributed potential vaccine-associated deaths to other causes and undermined vaccine safety data.
Clinical Trial ‘Cause of Death' Unsupported by Documentation
Researchers assessed data from Pfizer's original phase two/three clinical trial involving 44,060 subjects equally divided into two groups. One group received a dose of Pfizer's COVID-19 vaccine, and the other received a placebo. As part of their analysis, researchers reviewed the cause of death forms (CRFs) of 38 trial subjects who died during the study period from July 27, 2020, to March 13, 2021, the end date of the clinical trial.
They found that 14 of the 38 deaths--more than one-third of deaths--resulted from cardiovascular events, accounting for the difference between the 21 deaths in the vaccination arm compared to the 17 deaths in the placebo arm. In numerous cases, researchers found that documentation did not support the cause of death diagnosis or allow one to rule out the possibility of a cardiovascular event with an autopsy.
"In general, our review of the CRFs found them to be lacking in detail and extremely difficult to interpret and develop a good timeline of events," researchers wrote. "Often, a subject's pre-trial clinical history was absent. Absent also were results of the extensive array of medical testing carried out at the pre-trial screening and at other regularly scheduled visits."
Absent test results included complete blood counts, metabolic tests, pregnancy tests, COVID-19 tests, a comprehensive list of active medications, and other tests that would have provided clarity on a subject's overall health. Although more detailed clinical data on the trial subjects exists, the researchers said it is being withheld. Given the limitations of what Pfizer provided, the researchers said the information in the CRFs was often insufficient to support the investigator's conclusions regarding the cause of death.
The researchers also noted frequent communications between Pfizer/BioNTech physicians and trial site medical staff about the CRFs, some of which were over 400 to 900 pages.
Pfizer Used Earlier Data Cutoff and Unblinded Control Group
According to the analysis, Pfizer excluded the 38 deaths from information provided to the U.S. Food and Drug Administration (FDA) during its December 2020 meeting where its vaccine advisory panel was considering whether to authorize the Pfizer/BioNTech vaccine for emergency use.
When Pfizer/BioNTech submitted its application for Emergency Use Authorization (EUA) on Nov. 20, 2020, to the FDA, the application described clinical trial results using a cutoff date of November 14, 2020, even though the end date of the trial was March 13, 2021. Researchers said the earlier cutoff date concealed mortality data from the clinical trial.
"Both Pfizer presenters and the FDA committee failed to ask for and review deaths that occurred in the clinical trial participants after the data cutoff. As a result, they missed a more than three-fold increased risk of cardiovascular death with the Pfizer-BioNTech COVID-19 vaccine," cardiologist Dr. Peter McCullough told The Epoch Times in an email.
"If the FDA presentation with core slides had been presented with accurate, updated data, the Pfizer COVID-19 vaccine should not have been approved because of safety concerns," he added.
Twenty weeks into the clinical trial on Dec. 11, 2020, Pfizer's COVID-19 vaccine received EUA from the FDA, and the agency allowed Pfizer to unblind its control group. Unblinding occurs when study participants are told whether they received a vaccine or a placebo, and placebo subjects are permitted to get vaccinated. All but a few chose to receive the vaccine.