FULL CLAIM: A “peer-reviewed” study showed that Pfizer had “altered” and “manipulated” the reporting of deaths that occurred in their clinical trial; an “accurate reporting” of mortality data would have shown that there is “no benefit of vaccination”
REVIEW
In October 2023, the Epoch Times claimed that an analysis of clinical trial data obtained from a Freedom of Information Act request revealed that not all deaths that occurred during the trial had been reported to the FDA. It also claimed that an “accurate reporting” of mortality data would have shown “no benefit of vaccination”.
However, this claim doesn’t explain correctly the vaccine benefits demonstrated by the clinical trial, which were instrumental in the FDA’s decision to authorize the vaccine for emergency use in December 2020. Furthermore, it glosses over the large amount of real-world data showing that COVID-19 vaccines are beneficial.
The Epoch Times also stated that Pfizer had “altered data” in order to withhold these deaths from the news of trial participant deaths from the FDA. But the outlet provided no evidence of that.
The Epoch Times’ claim is based on a research paper by Michels et al. published in October 2023, in which researchers looked at the mortality data from the Pfizer clinical trial released by the FDA. In this review, we’ll go over the results from Michels et al. and explain why the reanalysis doesn’t diminish the vaccine’s benefits as assessed by the FDA in its decision.
The analysis was published in an outlet associated with anti-vaccine interests
The Epoch Times defined Michels et al. as a “peer-reviewed study”. While the paper has undergone peer review by at least two members of the editorial board of the journal that published it, according to the journal’s website, the journal itself presents a few red flags with regards to its credibility.
Notably, several members of the editorial board are known to take an anti-vaccine stance.
The editor-in-chief of the International Journal of Vaccine Theory, Practice, and Research (IJVTPR) is John Oller, a linguist who published a paper claiming that the tetanus vaccine distributed in Kenya was laced with a contraceptive hormone. This false claim has been already repeatedly debunked, but has continued to persist for decades.
Christopher Shaw, the senior editor, co-authored the same paper on the tetanus vaccine in Kenya. Furthermore, he also published at least two papers, one in 2016 and one in 2017, linking certain vaccine ingredients to autism.
David Gorski, a professor of surgery and oncology at Wayne State University School of Medicine, previously detailed the flaws of both papers. The website Retraction Watch, which monitors news about the retraction of scientific studies, also reported that the 2016 paper was retracted because of “serious concerns regarding the scientific soundness of the article” while the 2017 paper was retracted for data manipulation.
Russell Blaylock and Stephanie Seneff, who are associate editors at IJVTPR, also have a history of propagating COVID-19 and vaccine disinformation in the past. Two other editors, Mary Holland and Brian Hooker, are respectively, general counsel and chief scientific officer of Children’s Health Defense, a prominent anti-vaccine organization with a track record of making false claims about vaccines.
Overall, the observations above strongly suggest that the International Journal of Vaccine Theory, Practice, and Research has a vested interest in publishing content that frames COVID-19 vaccines in a poor light. Interpreting the studies it publishes therefore requires due caution given its anti-vaccine bias.
What did Michels et al. do and what did they find?
The authors searched the FDA-released documents for details about deaths in participants of the Pfizer-BioNTech COVID-19 vaccine clinical trial in 2020.
This clinical trial enrolled more than 43,000 participants, divided into two groups. Participants in the vaccine arm received the COVID-19 vaccine, while the participants in the placebo arm received a saline solution[1]. The trial began on 27 July 2020 and data collected up to 14 November 2020 were sent to the FDA. On 10 December 2020, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the data available and voted in favor of authorizing the vaccine for emergency use.
Analyzing the 6-month interim report and the individual case report forms of each deceased participant, Michels et al. observed that some people died before the cutoff date of 14 November 2020, but their deaths were only registered to their case report form after that date. For instance, participant #11201050 died on 7 November 2020. But this information was only uploaded to its case report form on 3 December 2020.
This means that some deaths that had already occurred before the end of data collection weren’t included in the data sent to the FDA in preparation for its meeting on 10 December 2020. In total, four deaths in the vaccine arm and one death in the placebo arm weren’t reported on time.
The data presented to the VRBPAC mentioned two deaths in the vaccine arm of the trial, and four deaths in the placebo arm, which is exactly the number of people from each arm who died before the cutoff date and whose death was registered in the case report forms before that date. But if we take into account all the people who actually died before 14 November 2020, regardless of whether their death was reported on time, the count rises to five deaths in the vaccine arm, and four deaths in the placebo arm.
From this observation, the authors concluded that the delay in reporting obscured the fact that there was no reduction in all-cause mortality in the vaccine arm compared to the placebo arm. This is what made the Epoch Times conclude that the vaccine showed “no benefit”.
Michels et al. also claimed that the delay “allowed Pfizer/BioNTech to manipulate the reporting of the results”. This is also the interpretation given by the Epoch Times, as described earlier.
However, this interpretation is incorrect. In the following sections, we’ll explain why these figures don’t call into question the assessment of the vaccine’s benefits by the FDA.
The primary benefit the clinical trial sought to assess was a reduction in COVID-19 cases, not in all-cause mortality
The Epoch Times made it seem as if the clinical trial aimed to assess the effect of vaccination on all-cause mortality. This is incorrect. In fact, the trial was designed to assess the ability of the vaccine to reduce the risk of getting COVID-19. This is because the FDA required a vaccine efficacy against getting the disease of at least 50% for authorizing the vaccine candidates.
The research article reporting the clinical trial results clearly stated:
“The first primary endpoint was the efficacy of [the Pfizer-BioNTech vaccine] against confirmed Covid-19 with onset at least 7 days after the second dose in participants who had been without serologic or virologic evidence of SARS-CoV-2 infection up to 7 days after the second dose[1]”
A primary endpoint is the specific benefit of the vaccine candidate that the clinical trial was designed to assess. In this case, the primary endpoint was met, as the vaccine showed a 95% efficacy in reducing the risk of COVID-19[1].
Data from the clinical trial (section 6.3.4.2.3.3) also showed that the vaccine reduced the risk of severe COVID-19. However, the small number of severe cases during the trial limited the conclusiveness of this result.
Thus, the clinical trial showed that the vaccines offered a benefit, protection from getting COVID-19, which is exactly what the FDA had asked for.
If, as implied by the Epoch Times, all-cause mortality was the sole possible benefit, it is highly plausible that it would have been presented as such. Yet, the briefing document provided by Pfizer to the FDA described the number of deaths as “similar” between the vaccine and placebo arms in its section 6.3.3.2.1.2 and didn’t present the seemingly lower number of deaths in the vaccine arm as supporting evidence of the vaccine benefits.
The transcript of the FDA meeting on 10 December 2020, where the decision to authorize the vaccine was taken, also showed that the seemingly lower number of all-cause deaths in the vaccine arm wasn’t mentioned as a sign of vaccine benefit. The word “death” occurs in 47 instances in the transcript, most of it in relation to the number of COVID-19 deaths in the general population during the pandemic. A minority of instances related to the number of all-cause deaths in the clinical trial, but only in the context of summarizing the result from the trial.
At no point did members of the committee highlight the reduction in all-cause mortality as a vaccine benefit or as a reason to authorize the vaccine.
In summary, even if all the deaths that occurred before 14 November 2020 had been included, the vaccine would still have shown benefits in COVID-19 risk reduction. In other words, the committee decided to vote in favor of the authorization, not because there seemed to be fewer deaths in the vaccine arm but because the vaccine effectively reduced the risk of getting COVID-19.
Since the vaccine rollout, scientific studies have assessed the rate of all-cause mortality in large populations of vaccinated and unvaccinated individuals in real-life settings. A study of more than six million people in the U.S. found that the all-cause mortality rate was lower among vaccinated individuals[2]. A study of the entire population of Hungary also found that the all-cause mortality rate was lower among vaccinated people compared to unvaccinated people[3].
No available evidence indicates that the delays in reporting post-vaccination deaths were intentional
Both Michels et al. and the Epoch Times implied that Pfizer had knowingly avoided reporting post-vaccination deaths, by using words like “manipulate” or “altered”. However, neither of them provided evidence that Pfizer deliberately delayed reporting post-vaccination deaths.
In fact, this delay in recording a death occurred in both the vaccine arm and the placebo arm. The same delay can also be observed with deaths that occurred before the cutoff date of 14 November 2020 and those that occurred after that date.
Michels et al. did observe that the median duration of the delay was shorter in the placebo arm. This means that Pfizer was slower in reporting the deaths occurring among those who received the vaccine than the placebo. However, the delays vary greatly, from one day to several weeks, and Michels et al. didn’t report performing any statistical tests to determine if the difference in delays between the vaccine and placebo arms was statistically significant.
Conclusion
An analysis of Pfizer-BioNTech clinical trial data reported that some deaths may have been incorrectly unaccounted for when the FDA voted to authorize the Pfizer-BioNTech COVID-19 vaccine for emergency use.
However, the primary objective of the clinical trial was to assess the efficacy of the COVID-19 vaccine against symptomatic COVID-19, not against death. This was indeed shown in the trial, with the vaccine showing a 95% efficacy at reducing the risk of COVID-19. Therefore, the claim that the trial showed “no benefit” is inaccurate.
Moreover, no evidence was provided to support the claim that delays in reporting post-vaccination deaths were intentional, and such delays were also observed in the placebo arm. Moreover, published research on the general population so far has shown that all-cause mortality isn’t higher in people vaccinated against COVID-19.
REFERENCES
- 1 – Polack et al. (2020) Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. The New England Journal of Medicine
- 2 – Xu et al. (2023) A safety study evaluating non-COVID-19 mortality risk following COVID-19 vaccination. Vaccine
- 3 – Pálinkás et al. (2022) Effectiveness of COVID-19 Vaccination in Preventing All-Cause Mortality among Adults during the Third Wave of the Epidemic in Hungary: Nationwide Retrospective Cohort Study. Vaccines
