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Pfizer-BioNTech delayed reporting vaccine-associated deaths among BNT162b2 clinical trial participants until after the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the product.
The vaccine makers also failed to account for a large number of subjects who dropped out of the trial.
Together, these strategies kept regulators and the public ignorant of a 3.7-fold increase in cardiac deaths among subjects who received the vaccine, according to analysis in the International Journal of Vaccine Theory, Practice, and Research.
The authors of the paper described it as a “forensic analysis,” defined by the U.S. National Institute for Standards and Technology as “the use of scientific methods or expertise to investigate crimes or examine evidence that might be presented in a court of law.”
What the analysis shows
Corinne Michels, Ph.D., retired distinguished professor of biology at Queens College, New York, led the DailyClout Pfizer/BioNTech Documents Investigations Team on what the authors claim was the first independent examination of original data from the Pfizer-BioNTech COVID-19 mRNA vaccine (BNT162b2) clinical trial.
Investigators looked at each of the 38 deaths occurring between July 27, 2020, the start of phase 2/3 of the Pfizer-BioNTech vaccine trial, and March 13, 2021, the end date culminating in Pfizer-BioNTech’s 6-month interim report.
This trial phase involved 44,060 subjects. Half received a dose of BNT162b2, half got a placebo consisting of an inactive sterile salt solution.
The trial was unusual because at week 20 after the FDA issued the EUA for the vaccine, trial subjects in the placebo group were allowed to switch to the vaccinated group and receive their first BNT162b2 shot.
Switching from the placebo to the vaccinated group — or “unblinding” — normally occurs when the benefit of the drug is so great that not treating subjects becomes unethical. For example, investigators might consider unblinding a cancer trial if at some point all untreated patients deteriorated or died but all treated patients improved.
Unblinding conditions may be specified in the study design, but they usually involve input or review from medical ethicists.
Of 20,794 unblinded placebo subjects in the Pfizer trial, 19,685 received at least one dose of BNT162b2.
Normally the decision to unblind a vaccine trial would be based on the product’s safety and effectiveness in reaching certain endpoints or objectives. Endpoints for a drug to prevent viral infections might be a positive test or self-reported COVID-19 illness (the “case” numbers that drove much of COVID-19 policy), illness requiring hospitalization or death.
But, perhaps unexpectedly, after 33 weeks the data revealed no significant difference between deaths in the vaccinated and placebo groups for the initial 20-week placebo-controlled portion of the trial.
After week 20, after most former placebo subjects had received the vaccine, deaths among those in the vaccine group continued unabated.
The authors revealed “inconsistencies” between data presented in Pfizer-BioNTech’s 6-month interim report and subsequent publications by Pfizer-BioNTech trial site administrators:
“Most importantly, we found evidence of an over 3.7-fold increase in the number of deaths due to cardiac events in the BNT162b2 vaccinated individuals compared to those who received only the placebo.”
This means that 79% of relevant deaths were not recorded in time to be included in Pfizer’s regulatory paperwork.
By not including relevant subject deaths in the case report, Pfizer obscured cardiac adverse event signals, allowing the EUA to proceed unchallenged.
How did Pfizer get around legal, ethical obligations?
The Pfizer-BioNTech data, obtained through a Freedom of Information Act lawsuit, uncovered four additional deaths in the vaccine group and one more in the placebo group — but Pfizer failed to include these data in their FDA submission despite an explicit study design requirement to do so.
These data, and how they differ from what Pfizer-BioNTech reported in their applications, are summarized in Table 3 of Michels’ study.
One case involved a 63-year-old woman who died 41 days after receiving the shot, but whose death only entered the data pool 37 days later. Another was a 58-year-old woman whose death 72 days after vaccination went unreported for 26 days.
Had Pfizer-BioNTech met their legal and ethical obligation to report all serious adverse events their data would have shown equal deaths in placebo and vaccine groups — which would have shown no clear benefit for the vaccine.
How were they able to skirt those obligations?
For one, they were able to hide behind the the 2005 Public Readiness and Emergency Preparedness (PREP) Act, which provided an almost impenetrable liability shield for vaccine manufacturers for “medical countermeasures” in response to any “public health emergency.”
Second, because COVID-19 was viewed as a national health emergency, regulators abandoned the established, patient-centered, safety-based approval process requiring years of preclinical animal testing — and Pfizer-BioNTech unsurprisingly went along.
Timing of death reports raises questions
Michels also raised issues regarding total death reports and their timing.
Since the death total from both study groups, 38, appeared “surprisingly low” to study authors — particularly during a pandemic — they undertook their own analysis based on population mortality expectations at the time.
Assuming that age-adjusted death rates for the study subjects were similar to those of the general population, they estimated that 222 subjects should have died from July 27, 2020, to March 13, 2021. The reported number, 38, is just 18% of the expected number.
Michels explained this by the large number, 4.2% of “discontinued subjects.” The most concerning of these were subjects “lost to follow-up,” which means missing scheduled visits or other required activities.
Pfizer-BioNTech tried to reach these subjects via phone, certified mail or through their emergency contact but despite their efforts could not account for 395 subjects who had dropped out.
The authors wrote:
“These are not insignificant numbers and could easily account for the low number of deaths reported in this safety period of the trial. Given the importance of knowing the status of each trial subject, there should have been greater effort to locate these individuals.
“Additionally, Pfizer/BioNTech was responsible for oversight of the trial sites. Sites with excessive numbers of lost to follow-up should have been evaluated for performance.”
Michels was also concerned over how certain trial centers had many dropped-out subjects while others had none or just a few.
Ninety-six of 153 trial sites (63%) reported 0 or 1 subjects lost to follow-up and 34 (22%) reported 2-5 dropouts. But four sites reported more than 20 subjects lost to follow-up, amounting to about 5% of all trial subjects.
Since the vaccine makers were responsible for trial site oversight, the authors wrote, “Sites with excessive numbers of lost to follow-up should have been evaluated for performance.”
Finally, based on the data, it appears Pfizer-BioNTech was in no hurry to enter death reports before the EUA submission deadline, particularly for the BNT162b2 group.
Of the 38 reported deaths only one case was added on the day the subject died. Delays of 20+ and 30+ days were common.
One death took 72 days to find its way into the database, and all were entered as occurring on the reporting day, not on the actual date of death.
Of the eight subjects in the vaccine group that should have been reported by Dec. 10, 2020, the EUA application cutoff, the average reporting delay was 17.5 days for subjects in the vaccine group, but just 5.9 days for deaths among subjects in the placebo group.
