Paper claiming ‘extensive’ harms of COVID-19 vaccines to be retracted

A journal is retracting a paper on the purported harms of vaccines against COVID-19 written in part by authors who have had similar work retracted before.

The article, “COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign,” appeared late last month in Cureus, which used to be a stand-alone journal but is now owned by Springer Nature. (It has appeared frequently in these pages.)

Graham Parker, Director of Publishing and Customer Success at Cureus, told Retraction Watch:

I can confirm we will be retracting it by the end of the week, as we have provided the authors with a deadline to reply and indicate whether they agree or disagree with the retraction.

The senior author on the work was Peter McCullough, a cardiologist at the Institute of Pure and Applied Knowledge who lost his board certification after the American Board of Internal Medicine found he had “provided false or inaccurate medical information to the public.”

Indeed, McCullough had already lost one paper, in Current Problems in Cardiology, from Elsevier, when he and his colleagues submitted their latest opus to Cureus. And SSRN, which hosts preprints for The Lancet, another Elsevier journal, had removed work by him and colleagues claiming large numbers of deaths from COVID-19 vaccines.  

A few days after the paper appeared, we asked John Adler Jr., the editor in chief of Cureus, if the track record of the authors concerned him. His response seemed to admit to the risk, but he also defended the journal’s vetting of the paper: 

Yes I am aware that many of these authors are skeptical zealots when it comes to the dangers of vaccines. Our editorial response was extra vigilance during the peer review process with 8 different reviewers weighing in on publication or not, including a few with strong statistics knowledge. Therefore, a credible peer review process was followed and the chips fell where they may. That is all I can say. If you or other readers were to note fatal flaws in this article now that it is published, i.e. failure to accurately report financial COIs [conflicts of interest], totally erroneous statistical analysis, fake data etc. we will of course re-evaluate at any time.

Adler then took a jab at other journals:  

The decision process Cureus made, contrasts sharply with Elsevier’s seeming editorial decision to just censor the article using ad hominem concerns.

In a Feb. 9, 2024 letter to the journal and the publisher, John P. Moore, a microbiologist at Weill Cornell Medicine in New York City, and Gregg Gonsalves, an epidemiologist at Yale School of Public Health, in New Haven, Conn., expressed their “serious concerns” about the article. Among their objections: 

The authors utterly lack relevant professional qualifications that would enable them to assess the scientific publications they draw on and/or attempt to criticize. The authors self-describe their affiliations under the rubric of “Independent Research”, or list private foundations, or in one case report an academic discipline unrelated to biology. In short, the authors cannot draw on years of training in biological science, but appear to be self-taught via the “University of Google”.

They continue:

The point here is that the Cureus review merely regurgitates claims about mRNA vaccines that have circulated on the internet and been debunked over and over again, including by fact-checking organizations (e.g., Factcheck.org, and the USA Today and Politico factcheck teams).

They conclude: 

By bringing this highly problematic review to your attention, we hope that you will conduct a thorough review of how it was accepted for publication in Cureus under the Springer Nature imprimatur. How appropriate was the peer review process? How did the editor act? Is the acceptance of this review symptomatic of a wider problem at the journal? Finally, if you share our views that this review is so flawed as to be dangerous to public health, you may well decide that it should be retracted.

Springer Nature had apparently been looking into the case already, and ended up agreeing with Moore, Gonsalves and other critics of the article. 

Steve Kirsch, a co-author of the paper, announced the retraction on his Substack over the weekend:

The paper I co-authored with 6 other authors will be retracted by the journal because the publisher won’t allow any paper that is counter-narrative to be published.

According to Kirsch’s post, Springer Nature’s inquiry found: 

a significant number of concerns with your article that in our view can’t be remedied with a correction. The concerns include, but are not limited to: 

  1. We find that the article is misrepresenting all-cause mortality data
  2. We find that the article appears to be misrepresenting VAERs data
  3. The article states that the Pfizer COVID-19 vaccine saved two lives and caused 27 deaths per 100,000 vaccinations, and the Moderna vaccine saved 3.9 lives and caused 10.8 deaths per 100,000 vaccinations, though there does not appear to be convincing evidence for this claim. 
  4. Incorrect claim: Vaccines are gene therapy products.
  5. The article states that vaccines are contaminated with high levels of DNA. Upon review we found that the cited references are not sufficient to support these claims. 
  6. The article states that SV40 promoter can cause cancer because SV40 virus can cause cancer in some organisms and inconclusively in humans. However, we find that this is misrepresenting the cited study (Li, S., MacLaughlin, F., Fewell, J. et al. Muscle-specific enhancement of gene expression by incorporation of SV40 enhancer in the expression plasmid. Gene Ther 8, 494–497 (2001). https://doi.org/10.1038/sj.gt.3301419 
  7. The article states that mRNA COVID-19 vaccines did not undergo adequate safety and efficacy testing, which the journal considers to be incorrect
  8. The article incorrectly states that spike proteins produced by COVID-19 vaccination linger in the body and cause adverse effects.

Waving the white flag, a bowed but unbroken Kirsch wrote: 

It doesn’t do any good to show them these reasons are all bogus. The laundry list of items is simply a placeholder to make it look like the journal is following the science.

Nothing we can say on appeal will make any difference.

The decision was made to retract the paper and facts don’t matter. It’s about supporting the narrative. When they write “in our view can’t be remedied with a correction” it means “don’t even bother arguing with us, your paper is retracted.”

For his part, Moore said:

The journal and publisher responded courteously and professionally to our letter, and I was pleased by the final outcome. They did what needed to be done.

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73 thoughts on “Paper claiming ‘extensive’ harms of COVID-19 vaccines to be retracted”

  1. Right, so given the rather long list of serious problems with the article, how is it possible that it was nonetheless passed by 8 (!) reviewers? Was their statistical expertise even relevant?

    Reply

    1. At the end of the second paragraph, this article links to a series showing that Cureus has had to retract many studies over the years: https://retractionwatch.com/category/by-journal/cureus/
      One of these articles, from 2015, states that Cureus is noted for not having a thorough review process.
      The authors probably knew this and submitted to this open source journal knowing the review would not be thorough.

      Reply

      1. Please answer the question. How did EIGHT reviewers totally miss all of the mistakes and misrepresentations allegedly contained in this paper and signed off on it so that it could be published. Again, EIGHT reviewers (EIGHT!) read and reviewed the paper and totally missed all of the problems. How in the world is that even possible. So how did it occcur.

        And don’t tell me how Cureus has a problem with their review process. Both Wiley and Elsevier have racked up quite the number of retractions over the years. Would you make the same claim about Wiley and Elsevier? Why or why not.

        https://retractionwatch.com/category/by-journal/wiley
        https://retractionwatch.com/category/by-journal/elsevier/

        In the end this is a paper that didn’t toe the ideological line on Covid-19 and Covid-19 vaccines and so had to go by hook or by crook. But it had to go. Disgusting that science is now conducted based upon political ideology. But here we are and there we go.

        Reply

        1. Do Cureus still follow their innovative disruptive paradigm of requiring authors to provide their own reviewers?

          Reply

        2. You may not be a regular reader of this blog, William, so let me inform you that two peer reviewers signed off on the ChatGPT giant rat dick paper.

          Reply

        3. I don’t know what point you are making about Wiley, or perhaps we should say Windawi, and Elsevier. Both are terrible in a variety of ways (personally, I don’t accept refereeing requests from either one, any more). But in this particular case their own shortcomings played no role.
          The questions you seem to be addressing to Retraction Watch strike me as similar to questions Retraction Watch routinely addresses to editors; however the confidentiality of the peer review process limits one’s prospects of getting answers, even if the editors were to take their jobs seriously. So I’d say you are barking up the wrong tree here.
          How, indeed. Inquiring minds would very much like to know. Though it begins with a lack of concern in upper management, presumably, and misaligned financial incentives.

          Reply

      2. We selected Cureus because of the online interactive features with comments. We made the right choice after we handled months of peer-reviewer comments and had two editors approve the paper before contracting, copyright, and publication. When the paper hit >330,000 views/reads/downloads in a month compared to an average Cureus paper of 2700, we knew are strategy of disseminating scientific data on the safety concerns and theoretical benefits of COVID-19 vaccination was successful. The retraction brought forward no new issues that were not handled during the peer review process. The retraction has caused even more attention to be drawn the the paper as people learn more about the harms of COVID-19 vaccination.

        Reply

        1. Yes, you’ve been quite clear that your concern is more about seeking attention and less about the validity of the study and its conclusions.

          Reply

        2. We selected Cureus because of the online interactive features with comments.

          “I wanted a vehicle where my committed supporters can register, leave comments about how great the paper is, and contribute to a high up-vote SIQ score.”

          I suppose that’s one way to do Science.

          Reply

  2. The last author’s affiliation is the Truth for Health Foundation which spreads dangerous misinformation and advocates for potentially harmful alternative treatments for COVID-19 and other diseases.

    Reply

    1. Dr. Peter McCullough, http://www.petermcculloughmd.com
      Chief Scientific Officer, The Wellness Company, http://www.twc.health
      President, McCullough Foundation, http://www.mcculloughfnd.org
      Author, Courage to Face COVID-19, http://www.couragetofacecovid.com
      Radio Show, http://www.americaoutloud.com/author/dr-peter-mccullough/
      Substack, petermcculloughmd.substack.com/

      Dr. McCullough is an internist, cardiologist, epidemiologist holding degrees from Baylor University, University of Texas Southwestern Medical School, University of Michigan, and Southern Methodist University. He manages common infectious diseases as well as the cardiovascular complications of both the viral infection and the injuries developing after the COVID-19 vaccine in Dallas TX, USA. Dr. McCullough has broadly published on a range of topics in medicine with > 1000 publications and > 685 citations in the National Library of Medicine. His works include “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” the first widely utilized treatment regimen for ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine. Subsequently he published the first detoxification approach titled “Clinical Rationale for SARS-CoV-2 Base Spike Protein Detoxification in Post COVID-19 and Vaccine Injury Syndromes” in the Journal of American Physicians and Surgeons. He has dozens of peer-reviewed publications on the infection and has commented extensively on the medical response to the COVID-19 crisis in TheHill, America Out Loud, and on FOX NEWS Channel. Dr. McCullough testified multiple times in the US Senate, European Parliament, Texas Senate Committee on Health and Human Services, Arizona Senate and House of Representatives, Colorado General Assembly, New Hampshire Senate, Pennsylvania Senate, and South Carolina Senate concerning many aspects of the pandemic response. Dr. McCullough has had years of dedicated academic and clinical efforts in combating the SARS-CoV-2 virus and in doing so, has reviewed thousands of reports, participated in scientific congresses, group discussions, press releases, and has been considered among the world’s experts on COVID-19.

      Reply

    2. You “utterly lack relevant professional qualifications that would enable [you] to assess the scientific publications [you] draw on and/or attempt to criticize”. I know this because “Factcheck.org, and the USA Today and Politico” told me so.

      Reply

        1. Misinformation is a propaganda term and has no place in clinical science where data are emerging. Dr. McCullough is a volunteer for Truth for Health Foundation among many organizations.

          Truth for Health Foundation™ is the Trade Name registered with the State of Arizona in 2021 (click here to view the Arizona certificate) for the original 501(c)(3) public charity incorporated in Arizona in 2007 under the name Straight Truth About Hormones Foundation, Inc. The Foundation was conditionally approved by the IRS as a non-profit in 2007, and the Foundation received its full IRS approval as a tax-exempt public charity January 19, 2008, EIN 20-8961711. (click here to view the IRS approval letter). The IRS regulations require that name changes be filed with IRS as part of the next Form 990 following the name change. Form 990 for 2021 will be filed on schedule in May 2022, and will include the name change registered with the State of Arizona in 2021 when the original Foundation was re-activated and services expanded.

          VISION

          We envision a world where people choose their path to live fully as human beings according to the physical and spiritual laws of life as God designed us.

          MISSION

          To provide truthful, balanced, medically sound, research-based information and cutting edge updates on prevention and treatment of common medical conditions, including COVID-19 and other infectious diseases, that affect health, quality of life and longevity.

          To present faith-based integrated approaches to medical treatment, health and healing services that encompass all dimensions making us human: physical, psychological/emotional, spiritual, social and environmental.

          To advocate and provide legal defense of basic human and civil rights related to preservation of life, the right to bodily integrity, health and quality of life, medical freedom, and securing the autonomy of the doctor-patient relationship and the ability to engage in unconstrained professional medical decision-making tailored to the needs of the individual person.

          CORE VALUES

          Truth for Health Foundation is a physician-founded 501(c)3 public charitable Foundation incorporated in the state of Arizona, USA. We are dedicated to following the Oath of Hippocrates to serve individual patients to the best of our ability and judgement and to uphold the highest standards of medical ethics.

          Foundation Officers, Directors, and Staff are grounded in Judeo-Christian principles of honesty, integrity, respect, kindness, compassion, humility and commitment to preserving God’s gift of Life as we serve our patients and communities.

          We strive to honor God and Jesus Christ in all we do as we conduct business, and to follow Biblical principles exemplified in Jesus’ Healing Ministry throughout the New Testament as we implement health programs for the people we serve.

          We are a Christian organization serving people of all faiths, as well as those who do not follow a faith tradition.

          Reply

          2. Dr. McCullough is a volunteer for Truth for Health Foundation among many organizations.

            Two questions come to mind.
            1. Does Dr McCullough always speak and write of himself in the third person? That could soon grow tiresome at home.
            2. Are there any officers of this “Truth for Health Foundation” who aren’t Peter McCullough?

  3. We have been notified of a threatened retraction of this paper based on false claims made by Tim Kersjes @TimKersjes head of research integrity, resolutions at Springer @springerpub He has overstepped the editors in this move in violation of the COPE: Committee on Publication Ethics Guidelines. There are no research ethics, validity, or integrity issues raised. Kersjes does not have a publication track record himself (0 listings in PUBMED) and is not qualified to judge our paper beyond what the editors have decided in their acceptance. The paper has > 300K views, reads, and downloads and stands as an authoritative review paper on the risks and theoretical benefits of COVID-19 vaccination. We will vigorously appeal this opinionated, ex post facto, arbitrary, and capricious decision by Kersjes. Peter A. McCullough, MD, MPH (694 listings in PUBMED) @stephanieseneff @JesslovesMJK @stkirsch https://pubmed.ncbi.nlm.nih.gov/38274635/

    Reply

    1. I don’t know that the Retraction Watch comments section has a method of authenticating commenter identities. If this is actually one of the authors of the paper, namely, Peter A. McCullough, MD, MPH®, it would be great if you could provide some evidence so readers know for sure, otherwise, the comment could be read as a parody.

      Reply

  4. At some point I think you have to address the criticisms, not just howl about how oppressed you are. Some of those criticisms are very specific and are matters of record. Either the paper you cite supports what you cited it for, or not. If it does, you could easily settle this by quoting the part that supports your point. Others are matters of logic. Either you can use VAERS this way or you can’t. People have made solid arguments on why you can’t: those need to be addressed.

    My personal evaluation is that if the authors go straight to “everyone is against us” and do not respond to concrete criticisms, it’s because they can’t.

    Reply

    2. To: Springer Nature Research Integrity Support
      From: M. Nathaniel Mead, BA, BSc, MSc, and Peter A. McCullough, MD, MPH
      Subject: RIG-12669 / Concerns regarding our recent article in Cureus
      Date: February 22, 2024
      To Whom It May Concern:
      We are writing in response to the threatened retraction and eight false claims made by Tim Kersjes and Springer Nature regarding our highly rated, heavily viewed and downloaded comprehensive review paper, “COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign,” published on 24 January 2024 in the journal Cureus. Mr. Kersjes currently serves as Head of Research Integrity, Resolutions for Springer Nature Research Integrity Group.
      The statements made by Kersjes are false, misleading, and unsupported by evidence. Several claims were also arbitrary and capricious. Most of the statements appear to be adapted, either directly or indirectly, from the numerous comments made by the well-known vaccine industry social media trolls, Jonathan Laxton and Matthew Dopler, comments that were inserted almost daily in the Cureus portal following our paper’s publication. Their sole purpose was to deliberately denigrate coauthors of the “Lessons Learned” paper while misleading, confusing, mocking and otherwise upsetting others participating in the Cureus post-publication forum online. As an example, one of Laxton’s statements in the Cureus portal reads as follows:
      “This is anti-vaccine gish-gallop that adds nothing useful to the literature. The majority of the authors have no expertise in this subject (Seneff, Rose, Kirsch). They wildly speculate on “anomalies” in the Pfizer trial even though data from the Moderna trial is similar with similar efficacy outcomes and the Clalit real-world study (Pfizer-funded) found a similar efficacy rate. They misrepresent all-cause mortality as COVID-19 would have to make up a very large amount of deaths to detect a difference in all-cause mortality between groups in a study of this size. They misrepresent VAERs data ignoring the number of doses given at once for COVID-19 and that the COVID vaccine is 2-3 doses and influenza 1. They present the Table 2 fallacy from the Cleveland Clinic study. This study never should have been published.” – Jonathan Laxton, MD
      This statement from Laxton is nonsense from a scientific standpoint. Following the libelous, defamatory comments about several of our paper’s coauthors, Laxton resorts to incoherent rambling and gibberish about the Pfizer and Moderna trials, followed by his citing a non-existent “Table 2 fallacy”; both comments may suggest an intellectual disability or some form of cognitive impairment. We have placed in bold the phrases that Kersjes clearly appropriated from Laxton in order to help devise the first two of eight statements in the retraction letter. Kersjes evidently borrowed these phrases without realizing that (a) his actions would be uncovered and exposed, and (b) neither Laxton nor Dopler have any training in epidemiology and biostatistics, hence the outright speciousness of their comments. Unfortunately for Kersjes, the groundless, misleading comments of both Laxton and Dopler contribute nothing of substance and instead only engender confusion and cognitive dissonance for the Cureus readership. Given that Kersjes has no training in the health sciences, it is not surprising that he fails to see through the inaccurate and fallacious nature of the numerous Laxton/Dopler comments.
      In sum, the false claims made by Kersjes reflect a breathtaking dearth of scientific understanding. All of Kersjes’s comments were accounted for and subsumed by the review process; more sophisticated and meaningful variations of these comments were raised by the original reviewers of the manuscript and were handled with edits in the paper during the review process. The Cureus editors found the responses satisfactory and fully accepted the paper. The manuscript has been contracted and copyrighted, and has had a record number of views, reads, and downloads over a one month period for Cureus. Nevertheless, we will now respond to each of Kersjes’s statements in turn.
      1) Kersjes claim: We find that the article is misrepresenting all-cause mortality data
      Response: In borrowing this comment from Laxton, Kersjes is offering an unfounded criticism. Three sources of ACM data were considered in our paper, and we accurately synopsized all three: the Benn et al. (2022), Aarstad and Kvitastein (2022), and Rancourt et al. (2023) analyses. The paper’s eight reviewers’ agreed with the way we presented these ACM data. All agreed that the Benn et al. analysis showed the mRNA vaccinations did not lead to a reduction in overall mortality. All agreed that the Aarstad and Kvitastein analysis of 31 European countries showed “(a) increases in ACM during the initial nine-month period of 2022 were positively correlated with increases in 2021 vaccination distribution; and (b) each percentage point increase in 2021 vaccination coverage was associated with a 0.105% increase (95%CI 0.075-0.134) in monthly mortality during 2022.” Reviewer Alpha (evidently chosen by Cureus) asked us to emphasize the Rancourt et al. 180-page analysis extensively showed booster rollouts synchronously followed by peaks in all-cause mortality, so we inserted that important statement as well.
      Citations
      #52. Benn CS, Schaltz-Buchholzer F, Nielsen S, et al.: Randomised clinical trials of COVID-19 vaccines: do adenovirus-vector vaccines have beneficial non-specific effects?. Lancet preprint. April. 5:2022. 10.2139/ssrn.4072489
      #254. Aarstad J, Kvitastein OA: Is there a link between the 2021 COVID-19 vaccination uptake in Europe and 2022 excess all-cause mortality?. Asian Pac J Health Sci. 2022, 2023:25-31. 10.21276/apjhs.2023.10.1.6
      #255. Rancourt DG, Baudin M, Hickey J, Mercier J: COVID-19 Vaccine-Associated Mortality in the Southern Hemisphere. Correlation Research in the Public Interest, Ontario, Canada; 2023.
      Our reanalysis of the postmarketing data provided to the FDA for the Pfizer trial data yielded a 31% higher ACM risk in the BNT162b2 group compared to the placebo group. The detailed explanation for this calculation can be found in the second to last paragraph in the section, “Revisiting the registrational trials”. This was thoroughly analyzed by all eight reviewers, with no objections. We clearly noted that the 31% increase was not a statistically significant finding, but still a trend in the wrong direction. The 31% increase and theoretical estimate of the timeframe that would be required to reach statistical significance (2.8 years) was independently confirmed by Masterjohn (citation #64).
      2) Kersjes claim: We find that the article appears to be misrepresenting VAERs data
      Response: Kersjes is making an oblique, unsubstantiated comment, again borrowing directly from Laxton’s comment above. Our two charts were based on documented queries to the Vaccine Adverse Events Reporting System (VAERS). There is no misrepresentation because the charts were generated directly from data supplied by these VAERS queries. In the last paragraph in the section “Quality control issues and process-related impurities”, our paper states the following: “Based on a query of the MedDRA code ‘Autoimmune disorder’ in the Vaccine Adverse Events Reporting System (VAERS), there was an 803% increase in autoimmune disorders per million doses administered when comparing the administration of Influenza vaccines from 2018 to 2020 with COVID-19 vaccinations from 2021 to 2023 (Figure 5) [173]. This represents an immense safety signal.” All eight reviewers agreed with this wording and interpretation.
      In the second paragraph of the Discussion, we offer this clear caveat about the use of VAERS: “Although invaluable as tools for detecting safety signals, national health surveillance databases such as VAERS and Yellow Card do not meet the rigorous standards set by controlled trials, further underscoring the necessity of this approach for the assessment of medical and public health interventions.” This is why we only cite VAERS as indicative of safety signals and concerning trends.
      Referring to Figure 7 in the Discussion, we offered the following interpretation and substantiation: “Figure 7 shows a graph based on myocarditis reports in VAERS Domestic Data as of September 29, 2023, which offers an indication of the gravity of this situation. All myocarditis reports are plotted according to age and dose (dose 1 (pink), dose 2 (green), and dose 3 (blue)). After dose two, there was a five-fold increase in myocarditis cases among 15-year-old males. Regardless of age, myocarditis cases were more frequent following dose two, which is suggestive of a causal link between myocarditis and the COVID-19 mRNA inoculations. The data depicted in the chart are further reinforced by a recent disproportionality analysis of VAERS data showing a statistically significant association between cardiovascular events and COVID-19 vaccinations [263].”
      All eight reviewers agreed with this concise, cogent presentation of the VAERS data. Note that we use the phrase “suggestive of a causal link”. We are not declaring a cause-and-effect relationship, only suggesting the possibility on a precautionary basis. The most compelling study of VAERS is the large disproportionality analysis by Yan et al.(2022), which is citation #48 in our paper. This study found very strong signals for myocardial infarction, pulmonary embolism, cardio-respiratory arrest, cerebral infarction, ischemic stroke, and cerebral hemorrhage associated with both mRNA vaccines.
      Citations
      #48. Yan MM, Zhao H, Li ZR, et al.: Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: gaining insight through the VAERS. Front Pharmacol. 2022, 13:921760. 10.3389/fphar.2022.921760
      #173. VAERS Reports Contradict Claim of No AEs in Frameshifting Context. (2023). Accessed: December 16, 2023: https://jessicar.substack.com/p/vaers-reports-contradict-claim-of.
      #263. Amir M, Latha S, Sharma R, Kumar A: Association of cardiovascular events with COVID-19 vaccines using vaccine adverse event reporting system (VAERS): a retrospective study. Curr Drug Saf. 2023, 10.2174/0115748863276904231108095255
      3) Kersjes claim: The article states that the Pfizer COVID-19 vaccine saved two lives and caused 27 deaths per 100,000 vaccinations, and the Moderna vaccine saved 3.9 lives and caused 10.8 deaths per 100,000 vaccinations, though there does not appear to be convincing evidence for this claim.
      Response: Kersjes is referring to Appendix 2, but he fails to understand that this is not a matter of evidence but biostatistical reasoning and calculation. The calculations were derived and presented as estimates based on conservative assumptions that are clearly explained and delineated in Appendix 2. The fact that Kersjes points to not enough “convincing evidence” to support this estimate suggests a fundamental lack of understanding of epidemiological principles, methods and procedures, much less how to place quantitative analyses in context. The calculation of number of lives saved per 100K vaccinations was in fact based on generous assumptions of benefit, utilizing data from the relatively healthy population recruited for the Pfizer trial. It was also based on conservative assumptions of risk based on the Fenton analysis of UK Yellow Card data.
      The epidemiological and biostatistical rationale for Appendix 2 is that any risk-benefit analysis must consider how much the presumed benefit in terms of reducing COVID-19-related mortality is offset by the potential increase in vaccine-induced mortality. Assessments of the safety profile of the Covid-19 modified mRNA injections warrant an objective, precautionary perspective. Any substantial upward trend in all-cause mortality within the intervention arm of the study population reflects poorly on the intervention and indicates an unacceptable safety risk to the general public. All eight reviewers agreed with this rationale and several applauded us for using it because they understood that, from a precautionary standpoint, our analytical approach was balanced and appropriate.
      4) Kersjes claim: Incorrect claim: Vaccines are gene therapy products.
      Response: Here Kersjes is making a simplistic and distorted interpretation of what we stated in our paper. The focus of the paragraph in question (see below) was on the terminology that has been in use for the 30 years preceding the pandemic. During that time, as we state in the paper, the terms gene therapy and mRNA vaccination were often used interchangeably [23]. The third to last paragraph in the Introduction reads as follows:
      Concerns about inadequate safety testing extend beyond the usual regulatory approval standards and practices. Although we employ the terms “vaccine” and “vaccination” throughout this paper, the COVID-19 mRNA products are also accurately termed gene therapy products (GTPs) because, in essence, this was a case of GTP technology being applied to vaccination [21]. European regulations mandate the inclusion of an antigen in vaccines, but these immunogenic proteins are not intrinsic to the mRNA vaccines [22]. The GTP vaccine platform has been studied for over 30 years as an experimental cancer treatment, with the terms gene therapy and mRNA vaccination often used interchangeably [23]. This is due to the mRNA products’ specific mode of action: synthetic mRNA strands, encapsulated within a protective lipid nanoparticle (LNP) vehicle, are translated within the cells into a specific protein that subsequently stimulates the immune system against a specific disease. Another accurate label would be prodrugs because these products stimulate the recipient’s body to manufacture the target protein [24]. As there were no specific regulations at the time of the rapid approval process, regulatory agencies quickly “adapted” the products, generalized the definition of “vaccine” to accommodate them, and then authorized them for EUA for the first time ever against a viral disease. However, the rationale for regulating these products as vaccines and excluding them from regulatory oversight as GTPs lacks both scientific and ethical justification [21]. (Note: Throughout this review, the terms vaccines and vaccinations will be used interchangeably with injections, inoculations, biologicals, or simply, products.)
      All eight reviewers agreed with the content of the above paragraph, as did the Cureus editors.
      Citations:
      #21. Banoun H: mRNA: vaccine or gene therapy? he safety regulatory issues. Int J Mol Sci. 2023, 24:10514. 10.3390/ijms241310514
      #22. Guerriaud M, Kohli E: RNA-based drugs and regulation: toward a necessary evolution of the definitions issued from the European Union legislation. Front Med (Lausanne). 2022, 9:1012497. 10.3389/fmed.2022.1012497
      #23. Van Lint S, Renmans D, Broos K, et al.: The ReNAissanCe of mRNA-based cancer therapy. Expert Rev Vaccines. 2015, 14:235-51. 10.1586/14760584.2015.957685
      #24. Cosentino M, Marino F: Understanding the pharmacology of COVID-19 mRNA vaccines: playing dice with the spike?. Int J Mol Sci. 2022, 23:10881. 10.3390/ijms231810881
      5) Kersjes claim: The article states that vaccines are contaminated with high levels of DNA. Upon review we found that the cited references are not sufficient to support these claims.
      Response: This is a mere hand-waving argument. The references were sufficient as we will now show. Yu et al. were the first to report the issue of batch variability [150]. Speicher et al. then reported DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada [151]. In an analysis of multiple vials of the bivalent Pfizer and Moderna mRNA products, McKernan et al. found “high levels of DNA contamination in both the monovalent and bivalent vaccines” that were “orders of magnitude higher than the EMA’s limit” of 330 nanograms of DNA per milligram of RNA [152]. The DNA process-related impurities also exceeded the safety limits of the FDA (10ng/dose). These data were then independently confirmed by Buckhaults and his genomics research team. They examined two batches of Pfizer mRNA vials and confirmed contamination with the plasmid DNA vector that had been used as the template for mRNA vaccine production [8,153]. At a South Carolina Senate hearing, Buckhaults reported having consistently sequenced substantial quantities of plasmid DNA, 200 billion DNA fragments per vial [153].
      We acknowledge that the research on process-related impurities (bacterial DNA fragments) is quite new and therefore controversial. Our discussion of process-related impurities was the very last section included in this narrative review, and it was inserted at the behest of reviewer alpha (again, ostensibly chosen by Cureus) in order to better address the manufacturing and quality control issues. All eight reviewers agreed that this was a serious issue and that, contrary to your assertion, the citations provided were sufficient. We understand that this is not an issue the vaccine enterprise wants to be made public, and it is alarming to see Springer Nature, the largest medical publisher in the world, evidently attempting to censor such information. DNA contamination has emerged as perhaps the most dangerous aspect of these experimental products because of the potential threat of integration into the human genome. Again, the precautionary principle should be honored if protection of public health is to be considered paramount.
      Citations:
      #150. Yu B, Taraban MB, Briggs KT: All vials are not the same: potential role of vaccine quality in vaccine adverse reactions. Vaccine. 2021, 39:6565-9. 10.1016/j.vaccine.2021.09.065
      #151. Speicher DJ, Rose J, Gutschi, Wiseman DM, McKernan K: DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: exploratory dose response relationship with serious adverse events [PREPRINT]. OSFPreprints. 2023, 10.31219/osf.io/mjc97
      #152. McKernan K, Helbert Y, Kane LT, McLaughlin S: Sequencing of bivalent Moderna and Pfizer mRNA vaccines reveals nanogram to microgram quantities of expression vector dsDNA per dose [PREPRINT]. OSFPreprints. 2023, 10.31219/osf.io/b9t7m
      #153. Senate H∂earing On Dangerous and Potentially Fatal Errors Within The Methods of Vaccine Distribution.. ( September 20, 2023.). Accessed: January 17, 2023: https://arvozylo.medium.com/senate-hearing-on-dangerous-and-potentially-fatal-errors-within-the-methods-of-vaccine-di….
      6) Kersjes claim: The article states that SV40 promoter can cause cancer because SV40 virus can cause cancer in some organisms and inconclusively in humans. However, we find that this is misrepresenting the cited study (Li, S., MacLaughlin, F., Fewell, J. et al. Muscle-specific enhancement of gene expression by incorporation of SV40 enhancer in the expression plasmid. Gene Ther 8, 494–497 (2001). https://doi.org/10.1038/sj.gt.3301419
      Response: Ironically, this statement from Kersjes is, in fact, misrepresenting our content. For citation 159, we stated the following: “In a 2001 study on somatic gene delivery to skeletal muscle cells, it was shown that incorporation of the SV40 enhancer into DNA plasmids could increase the level of exogenous gene expression by a factor of 20 [159].” The statement is perfectly accurate, and the Cureus editors and reviewers agreed with this interpretation. We are sorry if Kersjes has once again humiliated himself and his corporate superiors by exploiting or consulting with Dopler and/or Laxton to make this erroneous claim.
      Additionally, we cite several studies to support the potential causal connection between SV40 and cancer [155-158], again entirely relevant when considering the precautionary principle. Moreover, concerns around the SV40 sequence being present in the bacterial DNA were also cited in a 2023 Cureus article by Angues and Bustos, a paper focusing on the multi-hit hypothesis of oncogenesis.
      Citations
      #155.Vilchez RA, Butel JS: Emergent human pathogen simian virus 40 and its role in cancer. Clin Microbiol Rev. 2004, 17:495-508. 10.1128/CMR.17.3.495-508.2004
      #156. Rotondo JC, Mazzoni E, Bononi I, Tognon M, Martini F: Association between simian virus 40 and human tumors. Front Oncol. 2019, 9:670. 10.3389/fonc.2019.00670
      #157. Vilchez RA, Kozinetz CA, Arrington AS, et al.: Simian virus 40 in human cancers. Am J Med. 2003, 114:675-84. 10.1016/s0002-9343(03)00087-1
      #158. Qi F, Carbone M, Yang H, Gaudino G: Simian virus 40 transformation, malignant mesothelioma and brain tumors. Expert Rev Respir Med. 2011, 5:683-97. 10.1586/ers.11.51
      #159. Li S, MacLaughlin FC, Fewell JG, et al.: Muscle-specific enhancement of gene expression by incorporation of SV40 enhancer in the expression plasmid. Gene Ther. 2001, 8:494-7. 10.1038/sj.gt.3301419
      #160. Orient JM: Beyond negative evidence: Lessons from the disputes on DNA contamination of COVID-19 vaccines. J Am Phys Surg. 2023, 28:106-12.
      #219. Angues VR, Bustos PY: SARS-CoV-2 vaccination and the multi-hit hypothesis of oncogenesis. Cureus. 2023, 15:e50703. 10.7759/cureus.50703
      7) Kersjes claim: The article states that mRNA COVID-19 vaccines did not undergo adequate safety and efficacy testing, which the journal considers to be incorrect.
      Response: Once again, Kersjes provides no evidence to support this claim. This statement sounds like a broad-sweeping position statement being issued by the publisher and by the vaccine industry stakeholders, certainly not from the journal itself. We worked closely with the journal’s editors and they never once made such a comment, because they could see that the evidence and arguments we presented were sound.
      First, the serious adverse events, or SAEs, are all well-documented in our paper. Second, the registrational trials were far too short to able to assess safety (2-3 months, in contrast with the previous industry standard of 10-15 years). Third, the trials underreported and underestimated the SAEs, and these underestimations were only demonstrated later on (see Fraiman et al. and Michels et al. re-analyses). In order to help Kersjes see the error of his thinking, we recommend that he sift through and study all our paper’s 294 scientific citations in order to more clearly understand the serious nature of the situation. Only by studying these reports and analyses can you honestly come to recognize and comprehend the profoundly unsafe nature of these mRNA products. As the Dutch saying goes, “van fouten kun je leren”—you can learn from your mistakes.
      Examples can be found throughout our paper. Based on re-analyses of the data from Pfizer’s founding trial, Michels and colleagues found a nearly four-fold increase (OR 3.7, 95%CI 1.02-13.2, p = 0.03) in serious cardiac events (e.g., heart attack, acute coronary syndrome) in the vaccine group. Neither the original trial report nor Pfizer’s Summary Clinical Safety report acknowledged or commented on this crucial safety signal. Moreover, the Fraiman et al. re-analysis of the Pfizer trial found a significant 36% higher risk of serious adverse events (SAEs), which included deaths and many life-threatening conditions in the vaccinated participants [50]. Fraiman’s group also found a four-fold higher risk of serious adverse events of special interest (AESIs) compared to the risk of COVID-19 hospitalizations, while the Moderna trial demonstrated a more than 2-fold higher risk. For perspective, the official SAE rate for other vaccines is only 1-2 per million. The Fraiman team’s estimate based on the Pfizer trial data (1,250 SAEs per million) exceeds this benchmark by at least 600-fold. An independent risk-benefit analysis by Mörl et al. 2022 [51] showed that the Pfizer mRNA vaccine produced 25 times more SAEs than the number of severe COVID-19 cases prevented. As reported by Montano in 2021 [47], two large drug safety reporting systems in the US and Europe found 7.8 million vaccine-related adverse events among approximately 1.6 million individuals, with older age groups showing a higher frequency of death, hospitalizations, and life-threatening reactions. Signals were identified for heart attack, pulmonary embolism, cardio-respiratory arrest, cerebral infarction, and cerebral hemorrhage, with relative risk estimates ranging from approximately 1.5 to 8.5.
      In summary, this idea that the “mRNA COVID-19 vaccines did not undergo adequate safety and efficacy testing” is the central premise of our entire paper. It was the basis for our paper being considered by Cureus in the first place, and then eventually accepted following an exhaustive, lengthy review process. The fact that Kersjes is making this statement suggests that he and his Springer superiors are overriding the Cureus editors in this matter (and scapegoating the editors in the process). After extensive back-and-forth communications, revisions, and follow-up confirmation, the Cureus reviewers and editors concurred with our conclusions, which resulted in acceptance of the paper for publication.
      The following citations from our paper provide a sampling of studies, analyses, and evidence-based reviews that help drive home the seriously unsafe nature of these COVID-19 mRNA products:
      #47. Montano D: Frequency and associations of adverse reactions of COVID-19 vaccines reported to pharmacovigilance systems in the European Union and the United States. Front Public Health. 2021, 9:756633. 10.3389/fpubh.2021.756633
      #48. Yan MM, Zhao H, Li ZR, et al.: Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: gaining insight through the VAERS. Front Pharmacol. 2022, 13:921760. 10.3389/fphar.2022.921760
      #49. Classen B: US COVID-19 vaccines proven to cause more harm than good based on pivotal clinical trial data analyzed using the proper scientific endpoint, “all cause severe morbidity”. Trends Int Med. 2021, 1:1-6.
      #50. Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P: Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022, 40:5798-805. 10.1016/j.vaccine.2022.08.036
      #51. Mörl F, Günther M, Rockenfeller R: Is the harm-to-benefit ratio a key criterion in vaccine approval?. Front Med (Lausanne). 2022, 9:879120. 10.3389/fmed.2022.879120
      #54. Michels CA, Perrier D, Kunadhasan J, et al.: Forensic analysis of the 38 subject deaths in the 6- month interim report of the Pfizer/BioNTech BNT162b2 mRNA vaccine clinical trial. IJVTPR. 2023, 3:973-1009. 10.56098/ijvtpr.v3i1.85
      #57. Oster ME, Shay DK, Su JR, et al.: Myocarditis cases reported after mRNA-based COVID-19 vaccination in the US from December 2020 to August 2021. JAMA. 2022, 327:331-40. 10.1001/jama.2021.24110
      #58. Rees AR: Viruses, vaccines and cardiovascular effects. Br J Cardiol. 2022, 29:16. 10.5837/bjc.2022.016
      #59. Almas T, Rehman S, Mansour E, et al.: Epidemiology, clinical ramifications, and cellular pathogenesis of COVID-19 mRNA-vaccination-induced adverse cardiovascular outcomes: a state-of-the-heart review. Biomed Pharmacother. 2022, 149:112843. 10.1016/j.biopha.2022.112843
      #60. Gao J, Feng L, Li Y, et al.: A systematic review and meta-analysis of the association between SARS-CoV-2 vaccination and myocarditis or pericarditis. Am J Prev Med. 2023, 64:275-84. 10.1016/j.amepre.2022.09.002
      #61. Yasmin F, Najeeb H, Naeem U, et al.: Adverse events following COVID-19 mRNA vaccines: a systematic review of cardiovascular complication, thrombosis, and thrombocytopenia. Immun Inflamm Dis. 2023, 11:e807. 10.1002/iid3.807
      #62. Shiravi AA, Ardekani A, Sheikhbahaei E, Heshmat-Ghahdarijani K: Cardiovascular complications of SARS-CoV-2 vaccines: an overview. Cardiol Ther. 2022, 11:13-21. 10.1007/s40119-021-00248-0
      #63. Jeet Kaur R, Dutta S, Charan J, et al.: Cardiovascular adverse events reported from COVID-19 vaccines: a study based on WHO database. Int J Gen Med. 2021, 14:3909-27. 10.2147/IJGM.S324349
      #71. Gøtzsche PC, Demasi M: Serious harms of the COVID-19 vaccines: a systematic review [PREPRINT]. medRxiv. 2022, 10.1101/2022.12.06.22283145
      #139. Hulscher N, Alexander PE, Amerling R, et al.: A systematic review of autopsy findings in deaths after COVID-19 vaccinations. Zenodo. 2023, 10.5281/zenodo.8120770
      #140. Hulscher N, Hodkinson R, Makis W, McCullough PA: Autopsy findings in cases of fatal COVID-19 vaccine-induced myocarditis. ESC Heart Failure. 2024, 1-14. 10.1002/ehf2.14680
      #141. Schwab C, Domke LM, Hartmann L, et al.: Autopsy-based histopathological characterization of myocarditis after anti-SARS-CoV-2-vaccination. Clin Res Cardiol. 2023, 112:431-440. 10.1007/s00392-022-02129-5
      #142. Pathology Conference: Vaccine-induced spike protein production in the brain, organs etc., now proven [Webpage in German]. (2022). Accessed: October 16, 2023: https://report24.news/pathologie-konferenz-impfinduzierte-spike-produktion-in-gehirn-u-a-organen-nun-erwiesen/.
      #143. Reutlingen Autopsy/Histology Study: Side-effects from corona vaccinations [Webpage in German]. (2020). Accessed: October 16, 2023: https://corona-blog.net/2022/03/10/reutlinger-autopsie-histologie-studie-nebenwirkungen-und-todesfaelle-durch-die-cor….
      #144. Seneff S, Kyriakopoulos AM, Nigh G, McCullough PA: A potential role of the spike protein in neurodegenerative diseases: a narrative review. Cureus. 2023, 15:e34872. 10.7759/cureus.34872
      #207. Liu J, Wang J, Xu J, et al.: Comprehensive investigations revealed consistent pathophysiological alterations after vaccination with COVID-19 vaccines. Cell Discov. 2021, 7:99. 10.1038/s41421-021-00329-3
      #208. Collier JL, Weiss SA, Pauken KE, Sen DR, Sharpe AH: Not-so-opposite ends of the spectrum: CD8(+) T cell dysfunction across chronic infection, cancer and autoimmunity. Nat Immunol. 2021, 22:809-19. 10.1038/s41590-021-00949-7
      #209. Irrgang P, Gerling J, Kocher K, et al.: Class switch toward noninflammatory, spike-specific IgG4 antibodies after repeated SARS-CoV-2 mRNA vaccination. Sci Immunol. 2023, 8:eade2798. 10.1126/sciimmunol.ade2798
      #210. Uversky VN, Redwan EM, Makis W, Rubio-Casillas A: IgG4 antibodies induced by repeated vaccination may generate immune tolerance to the SARS-CoV-2 spike protein. Vaccines (Basel). 2023, 11:99. 10.3390/vaccines11050991
      8) Kersjes claim: The article incorrectly states that spike proteins produced by COVID-19 vaccination linger in the body and cause adverse effects.
      Response: Kersjes makes this false claim without citing any evidence. In our review, we cite numerous studies that contradict his claim regarding spike protein-induced adverse effects. For example, upon biopsy in young individuals hospitalized with COVID-19 vaccine myocarditis, Baumeier et al. found spike protein (s-protein) in the heart associated with the active inflammation of myocarditis. Several studies cited below found spike protein causing inflammation and damage in the heart, brain and other organs. Yonker et al. [202] observed that the S-protein persists in circulation in young adults who developed myocarditis post mRNA vaccination, but not in vaccinated individuals who did not develop myocarditis.
      As Parry et al. [180] document in great detail, the modified nature of the synthetic mRNA (pseudouridine mRNA) accounts for the prolonged mRNA persistence and spike protein production throughout the body. Röltgen et al. [236] found persistence of both vaccine mRNA and spike protein for the full 60 days duration of their study; the mRNA and free spike proteins were found in the cytoplasm and nuclei of germinal cells in axillary lymph nodes ipsilateral to deltoid muscle injection site. The persistence of these mRNA vaccine components is due to the fact that the synthetic mRNA is excessively stable over the course of months, while “natural” mRNA degrades rapidly. Trougakos et al. [25] surmise that “vaccination-mediated adverse effects (AEs) can be attributed to the unique characteristics of the S-protein itself (antigen) either due to molecular mimicry with human proteins or as an ACE2 ligand.”
      Again, Kersjes provides no evidence to support his claim and instead resorts to arbitrary hand-waving statements. We encourage him and his handlers at Springer to stop denying what the scientific evidence is showing to be the foundational basis for the SAEs that have been clearly demonstrated to be either caused or strongly associated with these experimental genetic injections.
      Citations
      24. Cosentino M, Marino F: Understanding the pharmacology of COVID-19 mRNA vaccines: playing dice with the spike?. Int J Mol Sci. 2022, 23:10881. 10.3390/ijms231810881
      25. Trougakos IP, Terpos E, Alexopoulos H, et al.: Adverse effects of COVID-19 mRNA vaccines: the spike hypothesis. Trends Mol Med. 2022, 28:542-54. 10.1016/j.molmed.2022.04.007
      142. Pathology Conference: Vaccine-induced spike protein production in the brain, organs etc., now proven [Webpage in German]. (2022). Accessed: October 16, 2023: https://report24.news/pathologie-konferenz-impfinduzierte-spike-produktion-in-gehirn-u-a-organen-nun-erwiesen/.
      175. Bellavite P, Ferraresi A, Isidoro C: Immune response and molecular mechanisms of cardiovascular adverse effects of spike proteins from SARS-CoV-2 and mRNA vaccines. Biomed. 2023, 11:451. 10.3390/biomedicines11020451
      180. Parry PI, Lefringhausen A, Turni C, Neil CJ, Cosford R, Hudson NJ, Gillespie J: ’Spikeopathy’: COVID-19 spike protein is pathogenic, from both virus and vaccine mRNA. Biomed. 2023, 11:2287. 10.3390/biomedicines11082287
      202. Yonker LM, Swank Z, Bartsch YC, et al.: Circulating spike protein detected in post- COVID-19 mRNA vaccine myocarditis. Circulation. 2023, 147:867-76. 10.1161/CIRCULATIONAHA.122.061025
      203. Baumeier C, Aleshcheva G, Harms D, et al.: Intramyocardial inflammation after COVID-19 vaccination: an endomyocardial biopsy-proven case series. Int J Mol Sci. 2022, 23:6940. 10.3390/ijms23136940
      Mr. Kersjes alludes to the journal’s Editors-in-Chief as the source of these publication concerns. This appears to be a duplicitous act of scapegoating. The assertion is wholly implausible, as we worked closely with the Cureus editors for several months, and they ultimately approved the paper for publication, following an intensive review process that lasted several months and included multiple editors and reviewers. Indeed, all of the above issues were previously raised and successfully addressed by the Cureus editors and reviewers, resulting in the final acceptance and publication of the paper after completing the peer review process.
      Careful inspection of the nature and manner of presenting these eight points for retraction makes it quite clear that Kersjes overrode the Cureus editors in criticizing the validity of our paper. Instead, he and his Springer superiors rely mainly on the unsubstantiated, misleading comments of the vaccine industry trolls, Laxton and Dopler. This is somewhat understandable, since Kersjes has no first-authored, peer-reviewed publications and no high-level scientific training, thus no capacity to judge or opine on the validity of the paper. He therefore cannot be considered a content expert on COVID-19 vaccine safety, and his questions indicate that he never once consulted with experts on COVID-19 vaccination. In short, Kersjes is unqualified to make an ex post facto decision on publication validity. The eight point list appears to be his personal attempt to scrub the permanent record on vaccine safety. Nevertheless, in offering the eight statements, Kersjes has violated the COPE guidelines. Any final decision regarding the retraction of the paper will have to be taken out of his hands since he is on the COPE committee, presenting a clear conflict of interest.
      We vigorously reject this opinionated, ex post facto, arbitrary, and capricious decision on the part of Kersjes and his Springer superiors. If this article is retracted, we will report Springer Nature and the Cureus editors (whose integrity we believe is being unfairly impugned in this matter) to be in violation of the COPE guidelines. We will then bring this matter to the attention of the Committee on Publication Ethics. Furthermore, we will contact the editorial board of Cureus to express our concerns, as we do not believe they had predatory intentions (i.e., deliberately accepting the paper in order to then retract it in a devious attempt to undermine its validity and credibility). Finally, we may also appeal to the U.S. Office of Research Integrity (ORI), which is part of the U.S. Department of Health and Human Services.
      In closing, we note that the average Cureus-promoted paper receives 2700 views in a year. Our “Lessons Learned” paper has received more than 320,000 views in a single month. Our Scholarly Impact Quotient (SIQ) rating is just under 9.3, therefore outstanding and indeed unprecedented, given that no previous Cureus paper has elicited this much attention, interest and enthusiasm in such a short period of time. We challenge the publisher to show us evidence to the contrary. If this paper is retracted, it will be in violation of the COPE Guidelines resulting in both the Journal, Kersjes, and Springer being reported to multiple organizations for violation of publication ethics, integrity, and breach of contract.
      ALL OF THE AUTHORS OF THIS PAPER REJECT THIS THREATENED RETRACTION.
      Sincerely,
      M. Nathaniel Mead MSc, lead author
      Peter A. McCullough MD, MPH, senior author (694 listings in PUBMED)
      Stephanie Seneff PhD
      Russ Wolfinger PhD
      Jessica Rose PhD
      Steve Kirsch MSc
      Kris Denhaerynck PhD
      Citation:
      Mead MN, Seneff S, Wolfinger R, Rose J, Denhaerynck K, Kirsch S, McCullough PA. COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign. Cureus. 2024 Jan 24;16(1):e52876. doi: 10.7759/cureus.52876. P

      Reply

  6. You are all part of the DARPA initiated censorship to stop information about mRNA vaccins that is not in line what governments/Pfizer/Moderna wants us to believe.

    If you are really interested: Your retractions arguments are all debunked here point-by-point. It is a shame that you think this is necessary. You use ad-hominem reasons to retract this. It is shameful.

    https://virusvaria.nl/de-inquisitie-van-retractionwatch/

    Please read. You can use the translation button to English in the upper-right corner.

    Reply

  7. So now that Cureus has decided to retract this article will they also be refunding any “Preferred Editing” fees that can run from an average of $340 USD per paper to $1,300 USD per paper if you don’t qualify for the free publishing that might have been charged? Or will they just pocket the money regardless of the retraction.

    And really, how sneaky are they. They don’t charge “article publishing fees” but only charge “Preferred Editing Fees” if the paper you submit doesn’t meet their “rigorous formatting and language requirements”. Wonder how many of those papers they publish actually qualify for the free publishing tier given they’ve got to make money for Springer Nature Group.

    Reply

    1. This is a good question. When selecting the target journal for a manuscript, one should look for a retraction policy that includes the repayment of fees, and not just for the presence of a comments thread where readers can praise the paper.

      Reply

    1. You left out the reference to “precious” and “children’s ice cream”. Lymph and blood are “bodily fluids”, if the LNPs spread through those, which has been observed – see https://academic.oup.com/cid/article/74/4/715/6279075 – “Here we provide evidence that circulating SARS-CoV-2 proteins are present in the plasma of participants vaccinated with the mRNA-1273 vaccine. We report antigen and serological data of the mRNA-1273 vaccine in 13 healthcare workers at the Brigham and Women’s Hospital. Ultrasensitive single-molecule array (Simoa) assays were used for the detection of SARS-CoV-2 antigens spike (S1–S2 unit), S1, and nucleocapsid and antibodies immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) against SARS-CoV-2 spike, S1, receptor binding domain (RBD), and nucleocapsid, as previously described [6, 7]. The ultralow detection limits of the Simoa assays enable detection of antigen and antibody production in the early stages postvaccination and quantification of changes in levels over the course of both vaccine injections.” Of course, the concentration of LNPs will be very low compared to that of the spike proteins produced by the vaccines, but the title is still (somewhat) accurate.

      Reply

  10. To: Springer Nature Research Integrity Support
    From: M. Nathaniel Mead, BA, BSc, MSc, and Peter A. McCullough, MD, MPH
    Subject: RIG-12669 / Concerns regarding our recent article in Cureus
    Date: February 22, 2024
    To Whom It May Concern:
    We are writing in response to the threatened retraction and eight false claims made by Tim Kerjses and Springer Nature regarding our highly rated, heavily viewed and downloaded comprehensive review paper, “COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign,” published on 24 January 2024 in the journal Cureus. Mr. Kerjses currently serves as Head of Research Integrity, Resolutions for Springer Nature Research Integrity Group.
    The statements made by Kerjses are false, misleading, and unsupported by evidence. Several claims were also arbitrary and capricious. Most of the statements appear to be adapted, either directly or indirectly, from the numerous comments made by the well-known vaccine industry social media trolls, Jonathan Laxton and Matthew Dopler, comments that were inserted almost daily in the Cureus portal following our paper’s publication. Their sole purpose was to deliberately denigrate coauthors of the “Lessons Learned” paper while misleading, confusing, mocking and otherwise upsetting others participating in the Cureus post-publication forum online. As an example, one of Laxton’s statements in the Cureus portal reads as follows:
    “This is anti-vaccine gish-gallop that adds nothing useful to the literature. The majority of the authors have no expertise in this subject (Seneff, Rose, Kirsch). They wildly speculate on “anomalies” in the Pfizer trial even though data from the Moderna trial is similar with similar efficacy outcomes and the Clalit real-world study (Pfizer-funded) found a similar efficacy rate. They misrepresent all-cause mortality as COVID-19 would have to make up a very large amount of deaths to detect a difference in all-cause mortality between groups in a study of this size. They misrepresent VAERs data ignoring the number of doses given at once for COVID-19 and that the COVID vaccine is 2-3 doses and influenza 1. They present the Table 2 fallacy from the Cleveland Clinic study. This study never should have been published.” – Jonathan Laxton, MD
    This statement from Laxton is nonsense from a scientific standpoint. Following the libelous, defamatory comments about several of our paper’s coauthors, Laxton resorts to incoherent rambling and gibberish about the Pfizer and Moderna trials, followed by his citing a non-existent “Table 2 fallacy”; both comments may suggest an intellectual disability or some form of cognitive impairment. We have placed in bold the phrases that Kerjses clearly appropriated from Laxton in order to help devise the first two of eight statements in the retraction letter. Kerjses evidently borrowed these phrases without realizing that (a) his actions would be uncovered and exposed, and (b) neither Laxton nor Dopler have any training in epidemiology and biostatistics, hence the outright speciousness of their comments. Unfortunately for Kerjses, the groundless, misleading comments of both Laxton and Dopler contribute nothing of substance and instead only engender confusion and cognitive dissonance for the Cureus readership. Given that Kerjses has no training in the health sciences, it is not surprising that he fails to see through the inaccurate and fallacious nature of the numerous Laxton/Dopler comments.
    In sum, the false claims made by Kerjses reflect a breathtaking dearth of scientific understanding. All of Kerjses’s comments were accounted for and subsumed by the review process; more sophisticated and meaningful variations of these comments were raised by the original reviewers of the manuscript and were handled with edits in the paper during the review process. The Cureus editors found the responses satisfactory and fully accepted the paper. The manuscript has been contracted and copyrighted, and has had a record number of views, reads, and downloads over a one month period for Cureus. Nevertheless, we will now respond to each of Kerjses’s statements in turn.
    1) Kerjses claim: We find that the article is misrepresenting all-cause mortality data
    Response: In borrowing this comment from Laxton, Kerjses is offering an unfounded criticism. Three sources of ACM data were considered in our paper, and we accurately synopsized all three: the Benn et al. (2022), Aarstad and Kvitastein (2022), and Rancourt et al. (2023) analyses. The paper’s eight reviewers’ agreed with the way we presented these ACM data. All agreed that the Benn et al. analysis showed the mRNA vaccinations did not lead to a reduction in overall mortality. All agreed that the Aarstad and Kvitastein analysis of 31 European countries showed “(a) increases in ACM during the initial nine-month period of 2022 were positively correlated with increases in 2021 vaccination distribution; and (b) each percentage point increase in 2021 vaccination coverage was associated with a 0.105% increase (95%CI 0.075-0.134) in monthly mortality during 2022.” Reviewer Alpha (evidently chosen by Cureus) asked us to emphasize the Rancourt et al. 180-page analysis extensively showed booster rollouts synchronously followed by peaks in all-cause mortality, so we inserted that important statement as well.
    Citations
    #52. Benn CS, Schaltz-Buchholzer F, Nielsen S, et al.: Randomised clinical trials of COVID-19 vaccines: do adenovirus-vector vaccines have beneficial non-specific effects?. Lancet preprint. April. 5:2022. 10.2139/ssrn.4072489
    #254. Aarstad J, Kvitastein OA: Is there a link between the 2021 COVID-19 vaccination uptake in Europe and 2022 excess all-cause mortality?. Asian Pac J Health Sci. 2022, 2023:25-31. 10.21276/apjhs.2023.10.1.6
    #255. Rancourt DG, Baudin M, Hickey J, Mercier J: COVID-19 Vaccine-Associated Mortality in the Southern Hemisphere. Correlation Research in the Public Interest, Ontario, Canada; 2023.
    Our reanalysis of the postmarketing data provided to the FDA for the Pfizer trial data yielded a 31% higher ACM risk in the BNT162b2 group compared to the placebo group. The detailed explanation for this calculation can be found in the second to last paragraph in the section, “Revisiting the registrational trials”. This was thoroughly analyzed by all eight reviewers, with no objections. We clearly noted that the 31% increase was not a statistically significant finding, but still a trend in the wrong direction. The 31% increase and theoretical estimate of the timeframe that would be required to reach statistical significance (2.8 years) was independently confirmed by Masterjohn (citation #64).
    2) Kerjses claim: We find that the article appears to be misrepresenting VAERs data
    Response: Kerjses is making an oblique, unsubstantiated comment, again borrowing directly from Laxton’s comment above. Our two charts were based on documented queries to the Vaccine Adverse Events Reporting System (VAERS). There is no misrepresentation because the charts were generated directly from data supplied by these VAERS queries. In the last paragraph in the section “Quality control issues and process-related impurities”, our paper states the following: “Based on a query of the MedDRA code ‘Autoimmune disorder’ in the Vaccine Adverse Events Reporting System (VAERS), there was an 803% increase in autoimmune disorders per million doses administered when comparing the administration of Influenza vaccines from 2018 to 2020 with COVID-19 vaccinations from 2021 to 2023 (Figure 5) [173]. This represents an immense safety signal.” All eight reviewers agreed with this wording and interpretation.
    In the second paragraph of the Discussion, we offer this clear caveat about the use of VAERS: “Although invaluable as tools for detecting safety signals, national health surveillance databases such as VAERS and Yellow Card do not meet the rigorous standards set by controlled trials, further underscoring the necessity of this approach for the assessment of medical and public health interventions.” This is why we only cite VAES as indicative of safety signals and concerning trends.
    Referring to Figure 7 in the Discussion, we offered the following interpretation and substantiation: “Figure 7 shows a graph based on myocarditis reports in VAERS Domestic Data as of September 29, 2023, which offers an indication of the gravity of this situation. All myocarditis reports are plotted according to age and dose (dose 1 (pink), dose 2 (green), and dose 3 (blue)). After dose two, there was a five-fold increase in myocarditis cases among 15-year-old males. Regardless of age, myocarditis cases were more frequent following dose two, which is suggestive of a causal link between myocarditis and the COVID-19 mRNA inoculations. The data depicted in the chart are further reinforced by a recent disproportionality analysis of VAERS data showing a statistically significant association between cardiovascular events and COVID-19 vaccinations [263].”
    All eight reviewers agreed with this concise, cogent presentation of the VAERS data. Note that we use the phrase “suggestive of a causal link”. We are not declaring a cause-and-effect relationship, only suggesting the possibility on a precautionary basis. The most compelling study of VAERS is the large disproportionality analysis by Yan et al.(2022), which is citation #48 in our paper. This study found very strong signals for myocardial infarction, pulmonary embolism, cardio-respiratory arrest, cerebral infarction, ischemic stroke, and cerebral hemorrhage associated with both mRNA vaccines.
    Citations
    #48. Yan MM, Zhao H, Li ZR, et al.: Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: gaining insight through the VAERS. Front Pharmacol. 2022, 13:921760. 10.3389/fphar.2022.921760
    #173. VAERS Reports Contradict Claim of No AEs in Frameshifting Context. (2023). Accessed: December 16, 2023: https://jessicar.substack.com/p/vaers-reports-contradict-claim-of.
    #263. Amir M, Latha S, Sharma R, Kumar A: Association of cardiovascular events with COVID-19 vaccines using vaccine adverse event reporting system (VAERS): a retrospective study. Curr Drug Saf. 2023, 10.2174/0115748863276904231108095255
    3) Kerjses claim: The article states that the Pfizer COVID-19 vaccine saved two lives and caused 27 deaths per 100,000 vaccinations, and the Moderna vaccine saved 3.9 lives and caused 10.8 deaths per 100,000 vaccinations, though there does not appear to be convincing evidence for this claim.
    Response: Kerjses is referring to Appendix 2, but he fails to understand that this is not a matter of evidence but biostatistical reasoning and calculation. The calculations were derived and presented as estimates based on conservative assumptions that are clearly explained and delineated in Appendix 2. The fact that Kerjses points to not enough “convincing evidence” to support this estimate suggests a fundamental lack of understanding of epidemiological principles, methods and procedures, much less how to place quantitative analyses in context. The calculation of number of lives saved per 100K vaccinations was in fact based on generous assumptions of benefit, utilizing data from the relatively healthy population recruited for the Pfizer trial. It was also based on conservative assumptions of risk based on the Fenton analysis of UK Yellow Card data.
    The epidemiological and biostatistical rationale for Appendix 2 is that any risk-benefit analysis must consider how much the presumed benefit in terms of reducing COVID-19-related mortality is offset by the potential increase in vaccine-induced mortality. Assessments of the safety profile of the Covid-19 modified mRNA injections warrant an objective, precautionary perspective. Any substantial upward trend in all-cause mortality within the intervention arm of the study population reflects poorly on the intervention and indicates an unacceptable safety risk to the general public. All eight reviewers agreed with this rationale and several applauded us for using it because they understood that, from a precautionary standpoint, our analytical approach was balanced and appropriate.
    4) Kerjses claim: Incorrect claim: Vaccines are gene therapy products.
    Response: Here Kerjses is making a simplistic and distorted interpretation of what we stated in our paper. The focus of the paragraph in question (see below) was on the terminology that has been in use for the 30 years preceding the pandemic. During that time, as we state in the paper, the terms gene therapy and mRNA vaccination were often used interchangeably [23]. The third to last paragraph in the Introduction reads as follows:
    Concerns about inadequate safety testing extend beyond the usual regulatory approval standards and practices. Although we employ the terms “vaccine” and “vaccination” throughout this paper, the COVID-19 mRNA products are also accurately termed gene therapy products (GTPs) because, in essence, this was a case of GTP technology being applied to vaccination [21]. European regulations mandate the inclusion of an antigen in vaccines, but these immunogenic proteins are not intrinsic to the mRNA vaccines [22]. The GTP vaccine platform has been studied for over 30 years as an experimental cancer treatment, with the terms gene therapy and mRNA vaccination often used interchangeably [23]. This is due to the mRNA products’ specific mode of action: synthetic mRNA strands, encapsulated within a protective lipid nanoparticle (LNP) vehicle, are translated within the cells into a specific protein that subsequently stimulates the immune system against a specific disease. Another accurate label would be prodrugs because these products stimulate the recipient’s body to manufacture the target protein [24]. As there were no specific regulations at the time of the rapid approval process, regulatory agencies quickly “adapted” the products, generalized the definition of “vaccine” to accommodate them, and then authorized them for EUA for the first time ever against a viral disease. However, the rationale for regulating these products as vaccines and excluding them from regulatory oversight as GTPs lacks both scientific and ethical justification [21]. (Note: Throughout this review, the terms vaccines and vaccinations will be used interchangeably with injections, inoculations, biologicals, or simply, products.)
    All eight reviewers agreed with the content of the above paragraph, as did the Cureus editors.
    Citations:
    #21. Banoun H: mRNA: vaccine or gene therapy? he safety regulatory issues. Int J Mol Sci. 2023, 24:10514. 10.3390/ijms241310514
    #22. Guerriaud M, Kohli E: RNA-based drugs and regulation: toward a necessary evolution of the definitions issued from the European Union legislation. Front Med (Lausanne). 2022, 9:1012497. 10.3389/fmed.2022.1012497
    #23. Van Lint S, Renmans D, Broos K, et al.: The ReNAissanCe of mRNA-based cancer therapy. Expert Rev Vaccines. 2015, 14:235-51. 10.1586/14760584.2015.957685
    #24. Cosentino M, Marino F: Understanding the pharmacology of COVID-19 mRNA vaccines: playing dice with the spike?. Int J Mol Sci. 2022, 23:10881. 10.3390/ijms231810881
    5) Kerjses claim: The article states that vaccines are contaminated with high levels of DNA. Upon review we found that the cited references are not sufficient to support these claims.
    Response: This is a mere hand-waving argument. The references were sufficient as we will now show. Yu et al. were the first to report the issue of batch variability [150]. Speicher et al. then reported DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada [151]. In an analysis of multiple vials of the bivalent Pfizer and Moderna mRNA products, McKernan et al. found “high levels of DNA contamination in both the monovalent and bivalent vaccines” that were “orders of magnitude higher than the EMA’s limit” of 330 nanograms of DNA per milligram of RNA [152]. The DNA process-related impurities also exceeded the safety limits of the FDA (10ng/dose). These data were then independently confirmed by Buckhaults and his genomics research team. They examined two batches of Pfizer mRNA vials and confirmed contamination with the plasmid DNA vector that had been used as the template for mRNA vaccine production [8,153]. At a South Carolina Senate hearing, Buckhaults reported having consistently sequenced substantial quantities of plasmid DNA, 200 billion DNA fragments per vial [153].
    We acknowledge that the research on process-related impurities (bacterial DNA fragments) is quite new and therefore controversial. Our discussion of process-related impurities was the very last section included in this narrative review, and it was inserted at the behest of reviewer alpha (again, ostensibly chosen by Cureus) in order to better address the manufacturing and quality control issues. All eight reviewers agreed that this was a serious issue and that, contrary to your assertion, the citations provided were sufficient. We understand that this is not an issue the vaccine enterprise wants to be made public, and it is alarming to see Springer Nature, the largest medical publisher in the world, evidently attempting to censor such information. DNA contamination has emerged as perhaps the most dangerous aspect of these experimental products because of the potential threat of integration into the human genome. Again, the precautionary principle should be honored if protection of public health is to be considered paramount.
    Citations:
    #150. Yu B, Taraban MB, Briggs KT: All vials are not the same: potential role of vaccine quality in vaccine adverse reactions. Vaccine. 2021, 39:6565-9. 10.1016/j.vaccine.2021.09.065
    #151. Speicher DJ, Rose J, Gutschi, Wiseman DM, McKernan K: DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: exploratory dose response relationship with serious adverse events [PREPRINT]. OSFPreprints. 2023, 10.31219/osf.io/mjc97
    #152. McKernan K, Helbert Y, Kane LT, McLaughlin S: Sequencing of bivalent Moderna and Pfizer mRNA vaccines reveals nanogram to microgram quantities of expression vector dsDNA per dose [PREPRINT]. OSFPreprints. 2023, 10.31219/osf.io/b9t7m
    #153. Senate H∂earing On Dangerous and Potentially Fatal Errors Within The Methods of Vaccine Distribution.. ( September 20, 2023.). Accessed: January 17, 2023: https://arvozylo.medium.com/senate-hearing-on-dangerous-and-potentially-fatal-errors-within-the-methods-of-vaccine-di….
    6) Kerjses claim: The article states that SV40 promoter can cause cancer because SV40 virus can cause cancer in some organisms and inconclusively in humans. However, we find that this is misrepresenting the cited study (Li, S., MacLaughlin, F., Fewell, J. et al. Muscle-specific enhancement of gene expression by incorporation of SV40 enhancer in the expression plasmid. Gene Ther 8, 494–497 (2001). https://doi.org/10.1038/sj.gt.3301419
    Response: Ironically, this statement from Kersjes is, in fact, misrepresenting our content. For citation 159, we stated the following: “In a 2001 study on somatic gene delivery to skeletal muscle cells, it was shown that incorporation of the SV40 enhancer into DNA plasmids could increase the level of exogenous gene expression by a factor of 20 [159].” The statement is perfectly accurate, and the Cureus editors and reviewers agreed with this interpretation. We are sorry if Kersjes has once again humiliated himself and his corporate superiors by exploiting or consulting with Dopler and/or Laxton to make this erroneous claim.
    Additionally, we cite several studies to support the potential causal connection between SV40 and cancer [155-158], again entirely relevant when considering the precautionary principle. Moreover, concerns around the SV40 sequence being present in the bacterial DNA were also cited in a 2023 Cureus article by Angues and Bustos, a paper focusing on the multi-hit hypothesis of oncogenesis.
    Citations
    #155.Vilchez RA, Butel JS: Emergent human pathogen simian virus 40 and its role in cancer. Clin Microbiol Rev. 2004, 17:495-508. 10.1128/CMR.17.3.495-508.2004
    #156. Rotondo JC, Mazzoni E, Bononi I, Tognon M, Martini F: Association between simian virus 40 and human tumors. Front Oncol. 2019, 9:670. 10.3389/fonc.2019.00670
    #157. Vilchez RA, Kozinetz CA, Arrington AS, et al.: Simian virus 40 in human cancers. Am J Med. 2003, 114:675-84. 10.1016/s0002-9343(03)00087-1
    #158. Qi F, Carbone M, Yang H, Gaudino G: Simian virus 40 transformation, malignant mesothelioma and brain tumors. Expert Rev Respir Med. 2011, 5:683-97. 10.1586/ers.11.51
    #159. Li S, MacLaughlin FC, Fewell JG, et al.: Muscle-specific enhancement of gene expression by incorporation of SV40 enhancer in the expression plasmid. Gene Ther. 2001, 8:494-7. 10.1038/sj.gt.3301419
    #160. Orient JM: Beyond negative evidence: Lessons from the disputes on DNA contamination of COVID-19 vaccines. J Am Phys Surg. 2023, 28:106-12.
    #219. Angues VR, Bustos PY: SARS-CoV-2 vaccination and the multi-hit hypothesis of oncogenesis. Cureus. 2023, 15:e50703. 10.7759/cureus.50703
    7) Kerjses claim: The article states that mRNA COVID-19 vaccines did not undergo adequate safety and efficacy testing, which the journal considers to be incorrect.
    Response: Once again, Kerjses provides no evidence to support this claim. This statement sounds like a broad-sweeping position statement being issued by the publisher and by the vaccine industry stakeholders, certainly not from the journal itself. We worked closely with the journal’s editors and they never once made such a comment, because they could see that the evidence and arguments we presented were sound.
    First, the serious adverse events, or SAEs, are all well-documented in our paper. Second, the registrational trials were far too short to able to assess safety (2-3 months, in contrast with the previous industry standard of 10-15 years). Third, the trials underreported and underestimated the SAEs, and these underestimations were only demonstrated later on (see Fraiman et al. and Michels et al. re-analyses). In order to help Kersjes see the error of his thinking, we recommend that he sift through and study all our paper’s 294 scientific citations in order to more clearly understand the serious nature of the situation. Only by studying these reports and analyses can you honestly come to recognize and comprehend the profoundly unsafe nature of these mRNA products. As the Dutch saying goes, “van fouten kun je leren”—you can learn from your mistakes.
    Examples can be found throughout our paper. Based on re-analyses of the data from Pfizer’s founding trial, Michels and colleagues found a nearly four-fold increase (OR 3.7, 95%CI 1.02-13.2, p = 0.03) in serious cardiac events (e.g., heart attack, acute coronary syndrome) in the vaccine group. Neither the original trial report nor Pfizer’s Summary Clinical Safety report acknowledged or commented on this crucial safety signal. Moreover, the Fraiman et al. re-analysis of the Pfizer trial found a significant 36% higher risk of serious adverse events (SAEs), which included deaths and many life-threatening conditions in the vaccinated participants [50]. Fraiman’s group also found a four-fold higher risk of serious adverse events of special interest (AESIs) compared to the risk of COVID-19 hospitalizations, while the Moderna trial demonstrated a more than 2-fold higher risk. For perspective, the official SAE rate for other vaccines is only 1-2 per million. The Fraiman team’s estimate based on the Pfizer trial data (1,250 SAEs per million) exceeds this benchmark by at least 600-fold. An independent risk-benefit analysis by Mörl et al. 2022 [51] showed that the Pfizer mRNA vaccine produced 25 times more SAEs than the number of severe COVID-19 cases prevented. As reported by Montano in 2021 [47], two large drug safety reporting systems in the US and Europe found 7.8 million vaccine-related adverse events among approximately 1.6 million individuals, with older age groups showing a higher frequency of death, hospitalizations, and life-threatening reactions. Signals were identified for heart attack, pulmonary embolism, cardio-respiratory arrest, cerebral infarction, and cerebral hemorrhage, with relative risk estimates ranging from approximately 1.5 to 8.5.
    In summary, this idea that the “mRNA COVID-19 vaccines did not undergo adequate safety and efficacy testing” is the central premise of our entire paper. It was the basis for our paper being considered by Cureus in the first place, and then eventually accepted following an exhaustive, lengthy review process. The fact that Kerjses is making this statement suggests that he and his Springer superiors are overriding the Cureus editors in this matter (and scapegoating the editors in the process). After extensive back-and-forth communications, revisions, and follow-up confirmation, the Cureus reviewers and editors concurred with our conclusions, which resulted in acceptance of the paper for publication.
    The following citations from our paper provide a sampling of studies, analyses, and evidence-based reviews that help drive home the seriously unsafe nature of these COVID-19 mRNA products:
    #47. Montano D: Frequency and associations of adverse reactions of COVID-19 vaccines reported to pharmacovigilance systems in the European Union and the United States. Front Public Health. 2021, 9:756633. 10.3389/fpubh.2021.756633
    #48. Yan MM, Zhao H, Li ZR, et al.: Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: gaining insight through the VAERS. Front Pharmacol. 2022, 13:921760. 10.3389/fphar.2022.921760
    #49. Classen B: US COVID-19 vaccines proven to cause more harm than good based on pivotal clinical trial data analyzed using the proper scientific endpoint, “all cause severe morbidity”. Trends Int Med. 2021, 1:1-6.
    #50. Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P: Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022, 40:5798-805. 10.1016/j.vaccine.2022.08.036
    #51. Mörl F, Günther M, Rockenfeller R: Is the harm-to-benefit ratio a key criterion in vaccine approval?. Front Med (Lausanne). 2022, 9:879120. 10.3389/fmed.2022.879120
    #54. Michels CA, Perrier D, Kunadhasan J, et al.: Forensic analysis of the 38 subject deaths in the 6- month interim report of the Pfizer/BioNTech BNT162b2 mRNA vaccine clinical trial. IJVTPR. 2023, 3:973-1009. 10.56098/ijvtpr.v3i1.85
    #57. Oster ME, Shay DK, Su JR, et al.: Myocarditis cases reported after mRNA-based COVID-19 vaccination in the US from December 2020 to August 2021. JAMA. 2022, 327:331-40. 10.1001/jama.2021.24110
    #58. Rees AR: Viruses, vaccines and cardiovascular effects. Br J Cardiol. 2022, 29:16. 10.5837/bjc.2022.016
    #59. Almas T, Rehman S, Mansour E, et al.: Epidemiology, clinical ramifications, and cellular pathogenesis of COVID-19 mRNA-vaccination-induced adverse cardiovascular outcomes: a state-of-the-heart review. Biomed Pharmacother. 2022, 149:112843. 10.1016/j.biopha.2022.112843
    #60. Gao J, Feng L, Li Y, et al.: A systematic review and meta-analysis of the association between SARS-CoV-2 vaccination and myocarditis or pericarditis. Am J Prev Med. 2023, 64:275-84. 10.1016/j.amepre.2022.09.002
    #61. Yasmin F, Najeeb H, Naeem U, et al.: Adverse events following COVID-19 mRNA vaccines: a systematic review of cardiovascular complication, thrombosis, and thrombocytopenia. Immun Inflamm Dis. 2023, 11:e807. 10.1002/iid3.807
    #62. Shiravi AA, Ardekani A, Sheikhbahaei E, Heshmat-Ghahdarijani K: Cardiovascular complications of SARS-CoV-2 vaccines: an overview. Cardiol Ther. 2022, 11:13-21. 10.1007/s40119-021-00248-0
    #63. Jeet Kaur R, Dutta S, Charan J, et al.: Cardiovascular adverse events reported from COVID-19 vaccines: a study based on WHO database. Int J Gen Med. 2021, 14:3909-27. 10.2147/IJGM.S324349
    #71. Gøtzsche PC, Demasi M: Serious harms of the COVID-19 vaccines: a systematic review [PREPRINT]. medRxiv. 2022, 10.1101/2022.12.06.22283145
    #139. Hulscher N, Alexander PE, Amerling R, et al.: A systematic review of autopsy findings in deaths after COVID-19 vaccinations. Zenodo. 2023, 10.5281/zenodo.8120770
    #140. Hulscher N, Hodkinson R, Makis W, McCullough PA: Autopsy findings in cases of fatal COVID-19 vaccine-induced myocarditis. ESC Heart Failure. 2024, 1-14. 10.1002/ehf2.14680
    #141. Schwab C, Domke LM, Hartmann L, et al.: Autopsy-based histopathological characterization of myocarditis after anti-SARS-CoV-2-vaccination. Clin Res Cardiol. 2023, 112:431-440. 10.1007/s00392-022-02129-5
    #142. Pathology Conference: Vaccine-induced spike protein production in the brain, organs etc., now proven [Webpage in German]. (2022). Accessed: October 16, 2023: https://report24.news/pathologie-konferenz-impfinduzierte-spike-produktion-in-gehirn-u-a-organen-nun-erwiesen/.
    #143. Reutlingen Autopsy/Histology Study: Side-effects from corona vaccinations [Webpage in German]. (2020). Accessed: October 16, 2023: https://corona-blog.net/2022/03/10/reutlinger-autopsie-histologie-studie-nebenwirkungen-und-todesfaelle-durch-die-cor….
    #144. Seneff S, Kyriakopoulos AM, Nigh G, McCullough PA: A potential role of the spike protein in neurodegenerative diseases: a narrative review. Cureus. 2023, 15:e34872. 10.7759/cureus.34872
    #207. Liu J, Wang J, Xu J, et al.: Comprehensive investigations revealed consistent pathophysiological alterations after vaccination with COVID-19 vaccines. Cell Discov. 2021, 7:99. 10.1038/s41421-021-00329-3
    #208. Collier JL, Weiss SA, Pauken KE, Sen DR, Sharpe AH: Not-so-opposite ends of the spectrum: CD8(+) T cell dysfunction across chronic infection, cancer and autoimmunity. Nat Immunol. 2021, 22:809-19. 10.1038/s41590-021-00949-7
    #209. Irrgang P, Gerling J, Kocher K, et al.: Class switch toward noninflammatory, spike-specific IgG4 antibodies after repeated SARS-CoV-2 mRNA vaccination. Sci Immunol. 2023, 8:eade2798. 10.1126/sciimmunol.ade2798
    #210. Uversky VN, Redwan EM, Makis W, Rubio-Casillas A: IgG4 antibodies induced by repeated vaccination may generate immune tolerance to the SARS-CoV-2 spike protein. Vaccines (Basel). 2023, 11:99. 10.3390/vaccines11050991
    8) Kerjses claim: The article incorrectly states that spike proteins produced by COVID-19 vaccination linger in the body and cause adverse effects.
    Response: Kersjes makes this false claim without citing any evidence. In our review, we cite numerous studies that contradict his claim regarding spike protein-induced adverse effects. For example, upon biopsy in young individuals hospitalized with COVID-19 vaccine myocarditis, Baumeier et al. found spike protein (s-protein) in the heart associated with the active inflammation of myocarditis. Several studies cited below found spike protein causing inflammation and damage in the heart, brain and other organs. Yonker et al. [202] observed that the S-protein persists in circulation in young adults who developed myocarditis post mRNA vaccination, but not in vaccinated individuals who did not develop myocarditis.
    As Parry et al. [180] document in great detail, the modified nature of the synthetic mRNA (pseudouridine mRNA) accounts for the prolonged mRNA persistence and spike protein production throughout the body. Röltgen et al. [236] found persistence of both vaccine mRNA and spike protein for the full 60 days duration of their study; the mRNA and free spike proteins were found in the cytoplasm and nuclei of germinal cells in axillary lymph nodes ipsilateral to deltoid muscle injection site. The persistence of these mRNA vaccine components is due to the fact that the synthetic mRNA is excessively stable over the course of months, while “natural” mRNA degrades rapidly. Trougakos et al. [25] surmise that “vaccination-mediated adverse effects (AEs) can be attributed to the unique characteristics of the S-protein itself (antigen) either due to molecular mimicry with human proteins or as an ACE2 ligand.”
    Again, Kerjses provides no evidence to support his claim and instead resorts to arbitrary hand-waving statements. We encourage him and his handlers at Springer to stop denying what the scientific evidence is showing to be the foundational basis for the SAEs that have been clearly demonstrated to be either caused or strongly associated with these experimental genetic injections.
    Citations
    24. Cosentino M, Marino F: Understanding the pharmacology of COVID-19 mRNA vaccines: playing dice with the spike?. Int J Mol Sci. 2022, 23:10881. 10.3390/ijms231810881
    25. Trougakos IP, Terpos E, Alexopoulos H, et al.: Adverse effects of COVID-19 mRNA vaccines: the spike hypothesis. Trends Mol Med. 2022, 28:542-54. 10.1016/j.molmed.2022.04.007
    142. Pathology Conference: Vaccine-induced spike protein production in the brain, organs etc., now proven [Webpage in German]. (2022). Accessed: October 16, 2023: https://report24.news/pathologie-konferenz-impfinduzierte-spike-produktion-in-gehirn-u-a-organen-nun-erwiesen/.
    175. Bellavite P, Ferraresi A, Isidoro C: Immune response and molecular mechanisms of cardiovascular adverse effects of spike proteins from SARS-CoV-2 and mRNA vaccines. Biomed. 2023, 11:451. 10.3390/biomedicines11020451
    180. Parry PI, Lefringhausen A, Turni C, Neil CJ, Cosford R, Hudson NJ, Gillespie J: ’Spikeopathy’: COVID-19 spike protein is pathogenic, from both virus and vaccine mRNA. Biomed. 2023, 11:2287. 10.3390/biomedicines11082287
    202. Yonker LM, Swank Z, Bartsch YC, et al.: Circulating spike protein detected in post- COVID-19 mRNA vaccine myocarditis. Circulation. 2023, 147:867-76. 10.1161/CIRCULATIONAHA.122.061025
    203. Baumeier C, Aleshcheva G, Harms D, et al.: Intramyocardial inflammation after COVID-19 vaccination: an endomyocardial biopsy-proven case series. Int J Mol Sci. 2022, 23:6940. 10.3390/ijms23136940
    Mr. Kerjses alludes to the journal’s Editors-in-Chief as the source of these publication concerns. This appears to be a duplicitous act of scapegoating. The assertion is wholly implausible, as we worked closely with the Cureus editors for several months, and they ultimately approved the paper for publication, following an intensive review process that lasted several months and included multiple editors and reviewers. Indeed, all of the above issues were previously raised and successfully addressed by the Cureus editors and reviewers, resulting in the final acceptance and publication of the paper after completing the peer review process.
    Careful inspection of the nature and manner of presenting these eight points for retraction makes it quite clear that Kersjes overrode the Cureus editors in criticizing the validity of our paper. Instead, he and his Springer superiors rely mainly on the unsubstantiated, misleading comments of the vaccine industry trolls, Laxton and Dopler. This is somewhat understandable, since Kersjes has no first-authored, peer-reviewed publications and no high-level scientific training, thus no capacity to judge or opine on the validity of the paper. He therefore cannot be considered a content expert on COVID-19 vaccine safety, and his questions indicate that he never once consulted with experts on COVID-19 vaccination. In short, Kersjes is unqualified to make an ex post facto decision on publication validity. The eight point list appears to be his personal attempt to scrub the permanent record on vaccine safety. Nevertheless, in offering the eight statements, Kerjses has violated the COPE guidelines. Any final decision regarding the retraction of the paper will have to be taken out of his hands since he is on the COPE committee, presenting a clear conflict of interest.
    We vigorously reject this opinionated, ex post facto, arbitrary, and capricious decision on the part of Kerjses and his Springer superiors. If this article is retracted, we will report Springer Nature and the Cureus editors (whose integrity we believe is being unfairly impugned in this matter) to be in violation of the COPE guidelines. We will then bring this matter to the attention of the Committee on Publication Ethics. Furthermore, we will contact the editorial board of Cureus to express our concerns, as we do not believe they had predatory intentions (i.e., deliberately accepting the paper in order to then retract it in a devious attempt to undermine its validity and credibility). Finally, we may also appeal to the U.S. Office of Research Integrity (ORI), which is part of the U.S. Department of Health and Human Services.
    In closing, we note that the average Cureus-promoted paper receives 2700 views in a year. Our “Lessons Learned” paper has received more than 320,000 views in a single month. Our Scholarly Impact Quotient (SIQ) rating is just under 9.3, therefore outstanding and indeed unprecedented, given that no previous Cureus paper has elicited this much attention, interest and enthusiasm in such a short period of time. We challenge the publisher to show us evidence to the contrary. If this paper is retracted, it will be in violation of the COPE Guidelines resulting in both the Journal, Kerjses, and Springer being reported to multiple organizations for violation of publication ethics, integrity, and breach of contract.
    ALL OF THE AUTHORS OF THIS PAPER REJECT THIS THREATENED RETRACTION.
    Sincerely,
    M. Nathaniel Mead MSc, lead author
    Peter A. McCullough MD, MPH, senior author (694 listings in PUBMED)
    Stephanie Seneff PhD
    Russ Wolfinger PhD
    Jessica Rose PhD
    Steve Kirsch MSc
    Kris Denhaerynck PhD
    Citation:
    Mead MN, Seneff S, Wolfinger R, Rose J, Denhaerynck K, Kirsch S, McCullough PA. COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign. Cureus. 2024 Jan 24;16(1):e52876. doi: 10.7759/cureus.52876. PMID: 38

    Reply

    1. Boy, this sure leans heavily on the reliability of the Cureus peer reviewers and editors. Lesson learned, indeed.

      Reply

    3. You out of all people shouldn’t be making ad hominem attacks.

      Reply

    4. Hi Peter, it’s Dr Laxton. It is laughable to think I had anything to do with the retraction. I find it interesting you comment on “libel” and then go on to declare that I have a “cognitive disability” – I have of course made copies od this reply. Anyways, ypu shouldn’t let me live rent-free in your head like this. God bless! 🥰

      Reply

        1. McCullough never said he was unfamiliar with the table 2 fallacy, just that there was no instance of it in his paper.

          Reply

          1. To say more, I had looked at that Cleveland paper when it came out, and I hought that the main table everyone was citing was very misleading. I can’t remember exactly now what it was, but the basic idea was that it showed getting more shots made you more likely to get covid, but sort of hid the fact that you were still better off with having shots than not having shots, although it did say this, the table was misleading (this is in addition to the fact that there could have been unrecorded confounds in who it was that was getting multiple shots ). I was so annoyed by this I wrote the authors but they refused to do anything about the fact that this table was being reported in a miseading way all over the place in social media.

            I will look at it again and report back here, because I think this might indeed be an example of the so called “table 2 fallacy”. I have never heard about this before, but from what I read briefly it sounds like this might be the case. I would trust Laxton over McCulloch on this and perhaps Laxton will comment again.

  11. “Peer review” by “fact-checking organizations (e.g., Factcheck.org, and the USA Today and Politico factcheck teams).” Are you joking? If not, then RetractionWatch ceases to be a useful resource, at least in politicized areas of science, which is a great disappointment.

    Reply

  12. https://www.medscape.com/viewarticle/958916
    “The largest nonprofit health system in Texas has secured a temporary restraining order against cardiologist Peter A. McCullough, MD, MPH, a COVID-19 vaccine skeptic who allegedly continued to claim an affiliation with Baylor Scott & White Health months after he entered into a confidential separation agreement in which he agreed to stop mentioning his prior leadership and academic appointments.”

    Reply

    1. What does this info have to do with the actual CONTENT (arguments, data, stats, etc) of the paper and its retraction?

      Reply

      1. Well, McCullough is a leading author of the paper and this provides useful context on how he works. Baylor Scott & White Health obtaining a restraining order (no doubt after having to present examples of his not complying with the agreement he signed) shows that he is someone who does not play by the rules.

        Reply

      2. You are correct that the comment is not directed at the paper.

        However, Dr. Peter’s lengthy replies in the comments here can legitimately be viewed through the lens of his history of *possible* exaggerations or *possible* mis-statements. The credibility of his complaints about Tim Kersjes, for example, may be compromised if readers were aware of *possible* ethical concerns about Dr. Peter’s own past behavior.

        Reply

      3. What does his classification of myself as “intellectually disabled” or “cognitively impaired” have to do with the content of my criticisms of his paper?

        Reply

  13. Retraction published: https://www.cureus.com/articles/203052-covid-19-mrna-vaccines-lessons-learned-from-the-registrational-trials-and-global-vaccination-campaign/retraction#!/

    “ The Editors-in-Chief have retracted this article. Following publication, concerns were raised regarding a number of claims made in this article. Upon further review, the Editors-in-Chief found that the conclusions of this narrative review are considered to be unreliable due to the concerns with the validity of some of the cited references that support the conclusions and a misrepresentation of the cited references and available data.

    The authors disagree with this retraction.”

    Reply

  14. It is impossible for such an extensive paper to not have problems. Yet I won’t even bother assessing that in detail for one simple reason: There are tons of pro-vaccine studies that are horrible and should be retracted. We shouldn’t be supporting retractions that entrench a double-standard. It’s not if you are right or wrong. It’s if you are in a majority large enough to get away with whatever you want. For example, the CDC’s own journal MMWR has been a horrific offender consistently for years. In any case, the paper in question does at least make readers aware of a host of research which most have never even heard about. That alone makes it significant, even if a magic wand had already instantly and infallibly highlighted and annotated all issues for all to see.

    Reply

    1. There are tons of pro-vaccine studies that are horrible and should be retracted. We shouldn’t be supporting retractions that entrench a double-standard.

      The way to avoid a double standard is to ensure that any flawed pro-vaccine studies are the subject of Letters to the Editor and PubPeer comments that lay bare their shortcomings.

      Reply

    2. I will cheerfully support retraction of bad papers on any side of any argument. If you have specific examples, please do put them on PubPeer.

      But “this bad paper should not be retracted because other papers are also bad” is a terrible argument from the point of view of having accurate scientific literature. And that’s really the point, isn’t it? Not winning for “my side” against “their side,” but actually having good research that finds out the truth. As soon as we lose sight of that, we’re sunk.

      Reply

  15. Sad but typical that many of the comments here degenerate into slander and use of hate speech by those who have no articulatable criticisms of the paper. Astonishingly included is the immature reference to undefined “misinformation” which is apparently any evidence presented that happens to be contrary to the groupthink (frequently a position of ignorance). Many of these comments/aggressions expressed here represent classic mass formation behavior and delusional psychopathology which are completely incongruous with scientific discourse.

    Reply

    1. I suspect that there is a high degree of frustration with perceived purveyors of nonsense. For example, VAERS cannot be used to estimate negative effects of vaccination. And please tell me; as a clinical psychologist, I’m unfamiliar with the term ‘mass formation behaviour’. What is this? What peer reviewed source does it come from?

      Reply

        1. Thank you. So not from the literature. I cannot find any such term in Google Scholar, and have no need to investigate this crankiness further.

          Reply

        3. “What peer reviewed source does it come from?”

          “Here is a Fox News broadcast from a notorious propagandist who was later sacked by Fox News for being such garbage.”

          Reply

      2. There are 523 peer-reviewed manuscripts that appropriately use VAERS to report on safety events after vaccination. As a clinician, I make VAERS entries when I have determined the vaccine is the cause of the adverse event. Reporting is serious and falsification is punishable by federal fines or imprisonment. This safety database among many demonstrate unacceptable rates of injuries, disabilities, and death after COVID-19 vaccination. The US FDA guidance on genetic technology such as mRNA indicates the regulatory window of concern after the last injection is 5-15 years. https://pubmed.ncbi.nlm.nih.gov/?term=vaers&sort=date

        Reply

          1. He’s employed by Foster Coulson (Vigilant Fox/Vigilant News – fringe right wing conspiracy blog) as the “Chief Scientific Officer” of his Wellness Company that flogs expensive snake oil packs of unapproved, repurposed prescription meds, while misrepresenting their efficacy against Covid. He posts conspiracy charged advertorial in such leading outlets as Breitbart.

            Although the American Board of Internal Medicine won’t have a bar of his quackery, this Foster Coulson shyster is making a packet out his racket.

        2. This is the notice on VAERS;, from the CDC page.
          “VAERS data alone cannot determine if the vaccine caused the reported adverse event.
          This specific limitation has caused confusion about the publicly available data, specifically regarding the number of reported deaths. In the past there have been instances where people misinterpreted reports of death following vaccination as death caused by the vaccines; that is a mistake.

          VAERS accepts all reports of adverse events following vaccination without judging whether the vaccine caused the adverse health event. Some reports to VAERS might represent true vaccine reactions, and others might be coincidental adverse health events not related to vaccination at all.

          Generally, a causal relationship cannot be established using information from VAERS reports alone.

          The number of reports submitted to VAERS may increase in response to media attention and increased public awareness.
          It is not possible to use VAERS data to calculate how often an adverse event occurs in a population.”
          This may be worth reviewing. What is the base rate of adverse events:
          a) in the general population, and particularly populations of interest such as older adults?
          b) after Covid infection?
          Balancing risks AND benefits is the concern, not only focusing on risks (I have patients who had life-altering injuries after falling out of bed in their sleep – I do not recommend that people only sleep on the floor).

          Reply

          1. This identifies one of the fallacies inherent in the claim “As a clinician, I make VAERS entries when I have determined the vaccine is the cause of the adverse event”.

            Firstly, if Dr McCullough claims to know how to determine which adverse events are caused by a vaccine, then he is prejudging the results of the research by which he claims to identify precisely those causal links.

            Secondly, by claiming that some VAERS entries are restricted to recording only those adverse events caused by vaccines, it is suggested that most or all such entries are also causal: which as the material from VAERS makes clear, is not the case. Again, this prejudges the results of the research.

    2. Many of these comments/aggressions expressed here represent classic mass formation behavior and delusional psychopathology

      The COVID-19 pandemic somehow turned everyone into a social psychologist.

      Reply

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