Flawed preprint based on autopsies inadequate to demonstrate that COVID-19 vaccines caused 74% of those deaths

On 5 July 2023, a manuscript titled “A systematic review of autopsy findings in deaths after COVID-19 vaccination” was uploaded to the Social Science Research Network (SSRN), a preprint server associated with The Lancet. The review analyzed autopsy reports of people vaccinated against COVID-19, concluding that 73.9% of those deaths were “directly due to or significantly contributed to by COVID-19 vaccination”.

The authors’ list included several names well-known for having spread COVID-19 misinformation in the past, including Harvey Risch, Roger Hodkinson, and William Makis. The last author is cardiologist Peter McCullough, whose false claims about COVID-19 vaccines eventually led The American Board of Internal Medicine to recommend revoking his board certification in October 2022.

It is noteworthy that six of the nine authors of the review are affiliated with The Wellness Company. McCullough is the chief scientific officer of this company, which markets supplements that allegedly protect against “vaccine injury”.

The review was removed from the SSRN server only one day after being uploaded. The explanation given by the Lancet group was that “the study’s conclusions are not supported by the study methodology”. However, the preprint has since been uploaded to Zenodo, where it accumulated over 180,000 views as of 28 July 2023.

The removal led several outlets and websites, such as the Daily Sceptic, Natural News, and InfoWars, to accuse the Lancet of “censorship” for supposedly removing a study showing that COVID-19 vaccines caused deaths. Screenshots of these articles and interviews with McCullough also made the rounds on Instagram, Facebook, Twitter, and TikTok, receiving hundreds of thousands of views and interactions.

However, that claim is inaccurate because the review isn’t a study but preliminary work that was never peer-reviewed or published in a scientific journal. More importantly, the review’s methodology is flawed, rendering it inadequate for establishing a causal link between COVID-19 vaccines and deaths, as we will show below.

The review is a preprint, not a published study as claimed

Contrary to online claims, the review isn’t a published study but a preprint, which is a scientific manuscript that hasn’t been evaluated by other experts (peer review).

Since 2018, the Lancet group has collaborated with the SSRN preprint server as a platform for scientific advance and discussion of unpublished research. But a disclaimer on the group’s website warns that preprints “are not Lancet publications or necessarily under review with a Lancet journal”. Therefore, presenting this preprint as “a Lancet article” is inaccurate.

The SSRN website also clarifies that preprints “should not be used for clinical decision making or reporting of research to a lay audience without highlighting that they are preliminary research and have not been peer-reviewed”.

Indeed, peer review is a crucial step in scientific publication because it helps ensure that the methodology used in a study is adequate and the conclusions well-supported by the data presented. In contrast, preprints like the one published in SSRN lack this quality control.

The preprint shows signs of potential serious biases

The preprint states that the aim was to identify potential causal relationships between COVID-19 vaccination and death. To do this, the authors searched for autopsy studies on people who died after receiving a COVID-19 vaccine. They identified 134 studies of which 44, comprising a total of 325 autopsies, met their inclusion criterion. Then, three physicians reviewed all the cases to determine which deaths could be directly attributed to COVID-19 vaccination.

Based on the information available, they concluded that 73.9% (240) of the deaths, most of them occurring within one week following vaccination, “were attributable to fatal vaccine injury syndrome”.

The first red flag is the use of the term “vaccine injury syndrome” in the preprint. While “vaccine injury” is sometimes used to refer to side effects of vaccination, “vaccine injury syndrome” is a term that has been pushed specifically by anti-vaccine groups and fringe organizations such as Front Line COVID-19 Critical Care Alliance to refer to adverse events with no proven causal link to vaccination, like sudden deaths and cancer.

The second issue is the selection of the studies included in the review. The authors excluded the majority (90) of the studies identified in their search. While 25 of them were excluded because they hadn’t conducted an autopsy or didn’t report vaccination status, 55 studies were excluded without clearly stating the reasons for doing so. This is important because including or excluding such a large number of studies could greatly alter the results, and therefore shouldn’t be done without scientific justification.

According to the Methods section, the authors included “All autopsy studies that include COVID-19 vaccines as a possible cause of death”. This vague definition, along with the unclear exclusion criterion, raises the question of whether there was bias in the way the studies were selected. For instance, it’s unclear if the authors excluded otherwise reliable studies simply because their inclusion would have given rise to results that are incompatible with the authors’ own views on COVID-19 vaccine safety.

This is all the more a concern, in light of the fact that the three physicians who reviewed the autopsies and decided which deaths were caused by vaccination were Hodkinson, Makis, and McCullough. As we explained above, all three have spread misinformation about COVID-19 and vaccines in the past, calling into question the objectivity of their analysis.

In particular, Makis claimed without evidence that COVID-19 vaccines were responsible for the deaths of 80 Canadian doctors. Reuters explained in a fact-check that at least 12 of those deaths were actually due to chronic illnesses, while four more resulted from accidents. Furthermore, no evidence suggests that COVID-19 vaccines increase mortality risk, as Health Feedback explained in earlier reviews.

Jonathan Laxton, a general internist and assistant professor of medicine at the University of Manitoba, pointed out several other issues in the preprint, including a misattributed affiliation and the citation of a retracted study, in a Twitter thread.

The methodology of the preprint is flawed, leading to poorly-founded conclusions

The fact that a person dies after COVID-19 vaccination isn’t sufficient in itself to draw conclusions about the safety of the vaccines. The reason for this is that, while a temporal association between vaccination and death is necessary to demonstrate causality, it isn’t sufficient on its own.

That is why case reports are generally inadequate for assessing causal associations, as Mitchell Levine, a professor of medicine and health research methods at McMaster University, explained to Logically Facts. Levine said that, to draw any meaningful conclusions, the preprint would at least need to compare the findings in the autopsies of vaccinated people to a control, unvaccinated group. However, the preprint showed no attempt to do so.

Instead, it proceeded to speculate on the supposed mechanisms by which COVID-19 vaccines cause harm, focusing on the alleged “deleterious effects” of the spike protein induced by vaccination.

Health Feedback evaluated earlier claims by McCullough linking the spike protein induced by vaccination with long COVID, other medical conditions, and deaths and found them to be inaccurate and incorrect. McCullough even proposed a way to counter these alleged harmful effects from vaccination. This consisted of using a supplement with no proven effectiveness that his company sells to “detoxify” from the spike protein.

Some evidence suggests that the spike protein produced during SARS-CoV-2 infection can be toxic to organs like the heart. However, this effect can’t be directly extrapolated to the spike protein induced by COVID-19 vaccines, which is different from that of the virus and produced in much smaller amounts. In fact, the evidence available indicates that the spike protein produced through vaccination is generally safe.

While certain COVID-19 vaccines have been associated with some serious side effects, including heart inflammation and blood clotting, these are very rare. This argues against a generalized toxic effect of vaccination. That said, the biological mechanisms by which the vaccine might cause these side effects remain under investigation^[1], and our current understanding about the effects of the spike protein might evolve with emerging research.

Studies show that COVID-19 vaccination doesn’t increase risk of death

The preprint’s discussion went on claiming that “The large number of COVID-19 vaccine induced deaths evaluated in this review is consistent with multiple papers that report excess mortality after vaccination”.

In support of this claim, the authors cited a retracted study and a preprint (again, not peer-reviewed or published in a scientific journal) by Pantazatos and Seligmann that has also been criticized for its methodological flaws.

Contrary to what the autopsy preprint suggested, reports of death following vaccination are scarce, as the CDC website explains. Furthermore, the hypothesis that COVID-19 vaccines cause or increase the risk of death is inconsistent with the results from peer-reviewed studies showing that vaccinated people don’t die at a higher rate than unvaccinated people^[2,3].

Many factors other than vaccination can influence a person’s risk of death. For example, the mean age of death in the autopsies evaluated in the preprint was 70.4 years. Being of older age and underlying health conditions increase a person’s risk of death regardless of vaccination status. However, neither of these potential confounding factors was taken into account in the analysis.

Older adults also have the highest vaccine coverage in many countries, including the U.S. and many European countries, with rates close to or over 90%. In this scenario, it is expected that most deaths occur among vaccinated people. But this fact doesn’t imply that the vaccines were the cause.

In short, the preprint’s narrative directly contradicts the large body of evidence showing that COVID-19 vaccines are safe and only rarely cause serious side effects. This potential risk is very small and doesn’t outweigh the benefits of vaccination.

Conclusion

Contrary to online claims, the autopsy review co-authored by McCullough isn’t “a Lancet study” but a preprint that hasn’t been peer-reviewed or published in any scientific journal. Furthermore, the preprint contains multiple methodological flaws, including potential biases and the failure to account for confounding factors, that render its results and conclusions unreliable.

Safety surveillance and epidemiological data show that COVID-19 vaccines don’t increase the risk of death. Serious side effects from the vaccines are rare and outweighed by the benefits of being protected against the disease.

READ MORE

In a LinkedIn post, Mathijs Binkhorst, a pediatrician at the Radboud University Medical Center, re-analyzed the results of the autopsy studies included in the preprint. Based on the conclusions of the authors of the original studies, Binkhorst found that only 59 (18,1%) of the cases were possibly or likely related to the COVID-19 vaccine. The remaining 267 (81,9%) were unlikely, uncertainly, or not related to vaccination. Therefore, contrary to what the preprint claimed, the vast majority of those deaths can’t be attributed to vaccination.

Binkhorst also explained that, while every death is tragic, these cases need to be seen in context; the studies’ data came from 14 countries, which administered more than 2,000 million vaccine doses in the period covered by the preprint. Most of the people deceased were 70 years and older and had underlying health conditions. These characteristics made them more vulnerable to COVID-19 complications, which the vaccine could help prevent.

UPDATED (14 August 2023):

We updated our review to include a link to a debunk by pediatrician Mathijs Binkhorst under the Read More section.

REFERENCES

• 1 – Yonker et al. (2023) Circulating Spike Protein Detected in Post–COVID-19 mRNA Vaccine Myocarditis. Circulation.
• 2 – Xu et al. (2021) COVID-19 Vaccination and Non–COVID-19 Mortality Risk — Seven Integrated Health Care Organizations, United States, December 14, 2020–July 31, 2021. Morbidity and Mortality Weekly Report.
• 3 – Bilinski et al. (2022) COVID-19 and Excess All-Cause Mortality in the US and 20 Comparison Countries, June 2021-March 2022. JAMA.