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A bombshell analysis of clinical trial data concluded mRNA COVID shots do more harm than good, estimating 289,000 vaccine-related U.S. deaths in 2021 alone. Yet within weeks, the incendiary findings vanished amid fierce backlash
In a stunning development first reported by Dr. Mercola, a peer-reviewed study briefly published in the journal Cureus concluded that COVID-19 mRNA vaccines caused significantly more harm than good, estimating that the shots led to nearly 14 deaths for every life saved from the disease.1 However, the incendiary paper by Mead et al. was retracted just weeks after publication, raising questions about the validity of the research and sparking accusations of censorship.
The now-withdrawn study, titled "COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign," called for an immediate global moratorium on the use of mRNA COVID vaccines.1 The international team of authors asserted that the shots carried an "unacceptably high harm-to-reward ratio."2 Applying what they characterized as conservative estimates, including a number needed to vaccinate (NNV) of 119 and an infection fatality rate of 0.23%, the authors calculated that around 52,000 vaccinations would be required to prevent a single COVID-19 fatality.2 However, when potential vaccine-related deaths were accounted for, they estimated that "for every life saved, there were nearly 14 times more deaths caused by the modified mRNA injections."2
To reach these conclusions, the researchers conducted an in-depth re-analysis of data from the phase 3 clinical trials for Pfizer-BioNTech's BNT162b2 and Moderna's mRNA-1273 vaccines.3,4 These registrational trials, which collectively enrolled over 73,000 participants, were the basis for the U.S. Food and Drug Administration's emergency use authorization of the mRNA shots in December 2020.3,4 The new analysis identified several shortcomings in the design and reporting of the founding trials. These include the lack of safety data beyond a median of just two months follow-up, the trials' focus on relative rather than absolute risk reduction, and the narrow emphasis on reducing mild symptomatic disease rather than preventing severe illness, hospitalization, or death.1
To estimate population-level impacts, Mead and colleagues extrapolated from the trials' reported serious adverse event rates. They factored in the FDA's own statements acknowledging that such events are vastly underreported, using conservative underreporting factors of 10-30%.5,6 Applying these adjustments to U.S. adverse event figures, the authors estimated that approximately 289,789 deaths (95% CI 229,319-344,319) were caused by COVID mRNA vaccination in 2021 alone.2 Comparing these potential vaccine-induced fatalities to lives saved, based on the clinical trials' data and infection fatality rates, yielded the paper's headline conclusion of 14 deaths caused for every life saved.
In discussing their findings, the authors argued that "the risk-benefit imbalance substantiated by the evidence to date contraindicates further booster injections"1 and called for the shots' immediate removal from childhood vaccination schedules until proper safety studies are conducted. They criticized the "unethical and unconscionable"1 practice of administering inadequately tested vaccines to children who face negligible risk of dying from COVID-19 but a documented 2.2% risk of potentially permanent heart inflammation following mRNA vaccination.7,8
Almost immediately after publication, the paper provoked fierce backlash and accusations of spreading misinformation. Within two weeks, the journal's editors had retracted it, citing "a significant number of concerns" that purportedly could not be remedied.9 The study's lead author, Nathaniel Mead, told Children's Health Defense that he anticipated the retraction, as the "evidence-informed paper was an all-out indictment of the COVID-19 vaccine enterprise."9 He suggested the withdrawal reflected industry efforts to suppress findings critical of mass vaccination, stating "Once a major counter-narrative paper gets published and its findings begin to garner lots of attention, the Bio-Pharma stakeholders exert immense pressure on the publisher to retract the paper."9
Cardiologist Peter McCullough, another of the study's authors, denounced the retraction as a "stunning act of scientific censorship."10 While the journal provided no specific details about the supposed flaws warranting withdrawal, some observers have noted that the researchers' harm-benefit conclusions rely heavily on debatable assumptions about underreporting of vaccine adverse events. However, even critics of the paper have acknowledged that the clinical trials and post-authorization studies were not designed to assess impacts on overall mortality.11,12 Other research has also raised concerns that mRNA vaccination may cause more total deaths than it prevents, especially in younger age groups at low risk of severe COVID-19.13,14
Regardless of the study's ultimate merits, its rapid retraction highlights the charged atmosphere surrounding any challenge to the safety and necessity of universal COVID-19 vaccination. The episode illustrates the difficulty of conducting an open scientific debate on such a politicized and emotionally fraught issue. At minimum, the paper's short-lived findings underscore the urgent need for more rigorous and transparent evaluation of the population-level impacts of mass deployment of novel mRNA vaccine technology.
For more information on the underreported adverse effects of vaccines, as well as issues with their purported efficacy, visit our database on the subject here.
References
1. M. Nathaniel Mead et al., "COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign," Cureus 16, no. 1 (January 24, 2024): e52876, https://doi.org/10.7759/
2. Mead et al., "COVID-19 mRNA Vaccines."
3. Fernando P. Polack et al., "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine," New England Journal of Medicine 383, no. 27 (December 10, 2020): 2603–15, https://doi.org/10.1056/
4. Lindsey R. Baden et al., "Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine," New England Journal of Medicine 384, no. 5 (February 4, 2021): 403–16, https://doi.org/10.1056/
5. "Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020," FDA briefing document (U.S. Food and Drug Administration, December 10, 2020), https://www.fda.gov/media/
6. "COMIRNATY (COVID-19 Vaccine, mRNA)," FDA summary basis for regulatory action (U.S. Food and Drug Administration, November 8, 2021), https://www.fda.gov/media/
7. Tracy Beth Høeg et al., "SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis," MedRxiv, August 30, 2021, https://doi.org/10.1101/2021.
8. Katie A. Sharff et al., "Risk of Myopericarditis Following COVID-19 mRNA Vaccination in a Large Integrated Health System: A Comparison of Completeness and Timeliness of Two Methods," MedRxiv, December 27, 2021, https://doi.org/10.1101/2021.
9. Michael Nevradakis, "Lead Author of Peer-Reviewed Research Re-Examining Pfizer and Moderna mRNA Vaccine Trials Calls for Immediate Withdrawal of COVID Shots," The Defender, Children's Health Defense, March 2, 2024, https://
10. Nevradakis, "Lead Author of Peer-Reviewed Research."
11. Cindy Harper, "Here's the Catch in That Study Saying COVID Vaccines Cause More Harm Than Good," Medika Life, March 10, 2024, https://medika.life/heres-the-
12. Victoria Male, "Comparing All-Cause Mortality Between Vaccine Group and Placebo Group Should Be Standard for COVID-19 Vaccine Trials," The BMJ Opinion (blog), January 14, 2023, https://blogs.bmj.com/bmj/
13. Peter C. Gøtzsche and Maryanne Demasi, "Serious Harms of Covid-19 Vaccines: A Systematic Review," Working Paper, December 27, 2022, https://papers.ssrn.com/sol3/
14. Peter Doshi et al., "Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials: A Systematic Review and Meta-Analysis," Vaccine 40, no. 40 (September 22, 2022): 5798–5805, https://doi.org/10.1016/j.
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