Review Article By Misinformation Spreaders Misleads About mRNA COVID-19 Vaccines – FactCheck.org

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The mRNA COVID-19 vaccines have a good safety record and have saved millions of lives. But viral posts claim the contrary, citing a recent peer-reviewed article authored by known COVID-19 misinformation spreaders and published in a controversial journal. The paper repeats previously debunked claims.

How safe are the COVID-19 vaccines?

More thanhalf a billion doses of COVID-19 vaccines have now been administered in the U.S. and only a few, very rare, safety concerns have emerged. The vast majority of people experience only minor, temporary side effects such as pain at the injection site, fatigue, headache, or muscle pain or no side effects at all. As the Centers for Disease Control and Prevention has said, these vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history.

A small number of severe allergic reactions known as anaphylaxis, which are expected with any vaccine, have occurred with the authorized and approved COVID-19 vaccines. Fortunately, these reactions are rare, typically occur within minutes of inoculation and can be treated. Approximately 5 per million people vaccinated have experienced anaphylaxis after a COVID-19 vaccine, accordingto the CDC.

To make sure serious allergic reactions can be identified and treated, all people receiving a vaccine should be observed for 15 minutes after getting a shot, and anyone who has experienced anaphylaxis or had any kind of immediate allergic reaction to any vaccine or injection in the past should be monitored for a half hour. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. Also, those who shouldnt receive one type of COVID-19 vaccine should be monitored for 30 minutes after receiving a different type of vaccine.

There is evidence that the Pfizer/BioNTech and Moderna mRNA vaccines may rarely cause inflammation of the heart muscle (myocarditis) or of the surrounding lining (pericarditis), particularly in male adolescents and young adults.

Based on data collected through August 2021, the reporting rates of either condition in the U.S. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million). The rate for 18- to 24-year-old males was 52.4 cases and 56.3 cases per million doses of Pfizer/BioNTech and Moderna vaccines, respectively.

Health officials have emphasized that vaccine-related myocarditis and pericarditis cases are rare and the benefits of vaccination still outweigh the risks. Early evidence suggests these myocarditis cases are less severe than typical ones. The CDC has also noted that most patients who were treated responded well to medicine and rest and felt better quickly.

The Johnson & Johnson vaccine has been linked to anincreased risk of rare blood clots combined with low levels of blood platelets, especially in women ages 30to 49. Early symptoms of the condition, which is known as thrombosis with thrombocytopenia syndrome, or TTS, can appear as late as three weeks after vaccination andincludesevere or persistent headaches or blurred vision, leg swelling, and easy bruising or tiny blood spots under the skin outside of the injection site.

According to the CDC, TTS has occurred in around 4 people per million doses administered. As of early April,the syndrome has been confirmed in 60 cases, including nine deaths, after more than 18.6 million doses of the J&J vaccine. Although TTS remains rare, because of the availability of mRNA vaccines, which are not associated with this serious side effect, the FDA on May 5 limited authorized use of the J&J vaccine to adults who either couldnt get one of the other authorized or approved COVID-19 vaccines because of medical or access reasons, or only wanted a J&J vaccine for protection against the disease. Several months earlier, on Dec. 16, 2021,the CDC had recommended the Pfizer/BioNTech and Moderna shots over J&Js.

The J&J vaccine has also been linked to an increased risk of Guillain-Barr Syndrome, a rare disorder in which the immune system attacks nerve cells.Most peoplewho develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal.

Safety surveillance data suggest that compared with the mRNA vaccines, which have not been linked to GBS, the J&J vaccine is associated with 15.5 additional GBS cases per million doses of vaccine in the three weeks following vaccination. Most reported cases following J&J vaccination have occurred in men 50 years old and older.

Link to this

Thesafetyof the mRNA COVID-19 vaccines from Pfizer/BioNTech and Moderna is supported by the rigorous clinical trials run prior to their release and numerous studies conducted since. Hundreds of millions of people have been vaccinated in the U.S., many with multiple doses, and serious side effects are rare.

COVID-19 vaccines have also been shown to beeffectivein reducing the risk of severe forms of the disease. Multiple studies have estimated that the COVID-19 vaccines saved millions of lives across the globe.

But anarticle written by misinformation spreaders who oppose COVID-19 vaccination that claims to have reviewed the original trials and other relevant studies largely ignores this body of evidence. Instead, the review, which calls for a global moratorium on the mRNA vaccines, cites multiple flawed or criticized studies manyofwhichwevewritten aboutbefore to falsely claim the mRNA COVID-19 vaccines have caused extensive, well-documented serious adverse events and have killed nearly 14 times as many people as they saved.

The article was peer-reviewed and published in Cureus, an open-access online medical journalthat prioritizes fast publication and has published problematic studies before,as we will explain.

Update, Feb. 19: In a Substack post, one of the papers authors announced that he had been informed by the journal that the editors had decided to retract the article, based on an internal review that found multiple instances of data misrepresentation and incorrect or unsubstantiated claims.

Socialmediapoststhat share the incorrect conclusions of the review have gone viral.

mRNA COVID-19 vaccines caused more deaths than saved: study, reads a Feb. 4Instagram postthat shared a screenshot of a headline by the Epoch Times.

One author of the review as well as other social media users are also using the fact that the paper was published as proof that the mRNA COVID-19 vaccines are unsafe.

People have said Im a misinformation spreader because sinceMay 2021, I have been publicly saying the COVID vaccines are not safe. Now the medical peer-reviewed literature shows I was right.Do you believe me now? Steve Kirsch, a review co-author and a former tech entrepreneur who lacks biomedical training, said in a post on X, formerly known as Twitter, on Jan. 30 (emphasis is his).

!!TRUST THE #SCIENCE!!, the author of aviral postwrote on Instagram on Feb. 7. The post included a screenshot of a news story titled Mainstream science mulls global moratorium on COVID vaccines as cancers rise, boosters flub, and the statement Covid vaccines *may* cause cancer. You dont say.

Just because a paper is published does not make it correct. While peer review is useful in weeding out bad science, its not foolproof, and the rigor and processes vary by journal. This review, which many experts have criticized, is an outlier, not mainstream science. And aswevewritten, theres no evidence mRNA COVID-19 vaccines cause cancer and resulted in millions of deaths.

Many of the reviews authors have a history of spreading COVID-19 or vaccine misinformation.This includes Kirsch, who has repeatedly pushed the incorrect idea that the COVID-19 vaccines have killed millions of people worldwide, as well as Dr. Peter McCullough, Stephanie Seneff and Jessica Rose.

McCullough stillrecommendstreating COVID-19 patients with hydroxychloroquine and ivermectin, even though both have been shown not to work against the disease. He also promotes and sells spike protein detoxification products for people who have been vaccinated, despite no evidence that vaccinated people need any such detox.

Seneff is a computer scientist who has promoted the false notion that vaccines cause autism. She previously co-authored a review paper with McCullough, which the Cureus review cites, that misused data from the Vaccine Adverse Event Reporting System to baselessly claim the mRNA COVID-19 vaccines suppress the innate immune system, as wereported. Rose has also beenaccusedof misusing VAERS data to claim vaccines are not safe a common deception among the anti-vaccination community.

The Cureus review cites and even republishes a figure from one of Roses Substack posts about the supposedly alarming number of VAERS reports for autoimmune disorders following COVID-19 vaccination compared with influenza vaccines. The review claims the increased reporting represents an immense safety signal. But as weve explainedbefore, the higher number of VAERS reports for the COVID-19 vaccines can be explained by multiple factors, such as increased awareness and stricter reporting requirements and does not in and of itself constitute a safety signal. A report can be submitted by anyone and does not mean that a vaccine caused a particular problem.

The review paper, titled COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign, repeats many claims weve already written about, based on studies or analyses that have been widely criticized or debunked.

To claim the vaccines cause serious harms to humans, for example, the review draws on a problematic reanalysis of the adverse events reported in the original trials that was published in the journal Vaccine in 2022. Florida Gov. Ron DeSantis and Dr. Joseph Ladapo, the states surgeon general, have cited the paper to argue that the vaccines are too risky. But aswevewritten and is detailed in a commentary article published in the same journal the paper has multiple methodological flaws, including how it counted the adverse events.

The review also uncritically cites an unpublished analysis by former physics professor Denis Rancourt that alleged that some 17 million people died from the COVID-19 vaccines. We recently explained that the report erroneously ignored deaths from COVID-19 and that such estimates are implausible. And the review recycles unsupported claims about high levels of DNA contamination in the mRNA vaccines and the possibility that such DNA fragments will integrate into the human genome and cause cancer. As weve detailed, trace amounts of residual DNA are expected in vaccines, but there is no evidence the DNA can alter a persons DNA or cause cancer.

Finally, the review highlighted findings from a Cleveland Clinic observational study that it called the best evidence for the failure of the COVID-19 mRNA vaccines ability to confer protection against COVID-19. The study, which identified a correlation between more COVID-19 vaccine doses and a higher rate of testing positive for a coronavirus infection, has frequently been cited by those opposed to vaccination. But asweveexplained, the finding runs counter to that of many other studies, which have generally found increased protection with more doses. And the paper did not demonstrate that more doses actually cause an increased risk of infection. In fact, many experts suspect that the association is likely the result of other differences between people who received a different number of doses. Moreover, the primary purpose of vaccination is to protect against severe disease and there is abundant evidence that the COVID-19 vaccines have been very successful on that front.

Lessons learned? More like conspiracies spun, wrote surgical oncologist Dr.David Gorskiin apostabout the review in his blog Respectful Insolence.

The authors of the review have also been criticized for citing their own studies in the review and for including non-scientific publications as primary sources.

BTW, the McCullough, Kirsch, etc. Cureus paper that is purportedly a scientific review article references trialsitetnews, epoch times, brownstone, the spectator, childrens health defense, and conservative review as primary sources for some of their points, as well as 11 substack articles/blogs, a youtube/twitter video, and 2 explicit anti-vaccine books, plus a large number of self-citations from the review authors,Jeffrey S. Morris, director of the division of biostatistics in the department of biostatistics, epidemiology and informatics at the University of Pennsylvania Perelman School of Medicine,wrote on Xon Feb. 1.

Much of the complimentary coverage of the review paper by some of the usual misinformation spreaders has emphasized that it was published in a peer-reviewed journal.

A review paper published last week in the journal Cureus is the first peer-reviewed paper to call for a global moratorium on the COVID-19 mRNA vaccines, declared a Jan. 29articlepublished on Robert F. Kennedys anti-vaccine website, Childrens Health Defense. The story also received attention onsocial media.

Peer review, or the process of having fellow scientists provide feedback on a manuscript and whether it is good enough to publish, can be immensely helpful in ensuring that a given paper does not contain major flaws or errors. But peer review is only as good as the feedback provided and it does not automatically mean the paper can be trusted. Nor are all peer-reviewed journalsthe same, since each has different standards and reputations.

Cureus is unusual in that it focuses on publishing papers quickly and advertises efficient peer review and a hassle-free publishing experience. The journals metrics for the last six months indicate that the average time from submission to publication is 33 days and that the acceptance rate is 51%. For context, the prestigious journalNature which some posts have misleadingly likened Cureus to, as they share the same parent publisher has a median time of 267 days for submission to acceptance and an 8%acceptance rate. Per thearticle informationfor this review paper, the peer-review process took77days.

In 2015, responding to concerns about the journal and its fast peer-review process, the founder, president and co-editor-in-chief of Cureus, Dr. John R. Adler, said that by design peer rejection is not a big part of our review process, and that the journal also relies on post-publication review to sort out what is quality/important.

A paper by Emory University librarians that was presented at a 2022 conference classified Cureus as potentially untrustworthy or predatory. The journal is available on PubMed Central, the National Institutes of Healths database of biomedical research, but is not indexed on MEDLINE, which requires some vetting for inclusion. (A papers appearance in either database does not imply any kind of endorsement by the NIH.)

Cureus, notably, publishedtwo problematicstudies about ivermectin for COVID-19in 2022. As we reported at the time, the results of the studies were inconsistent with stronger studies that did not find any benefit of using ivermectin for COVID-19. Both studies had methodological flaws and were authored by ivermectin activists a fact that was not disclosedat the time of publication.

Although even the best journals occasionally retract published studies, Cureus has ended upmultipletimesin the pages of Retraction Watch, a blog and online database of retractions most recently on Jan. 26 for56 studiesretracted for faked authorship nearly two years after they were first flagged. In 2022, Retraction Watchreportedthat a study retracted by Frontiers in Medicine was later updated and published in Cureus.

Editors note: SciChecks articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

Safety of COVID-19 Vaccines. CDC. Accessed 15 Feb 2024.

Selected Adverse Events Reported after COVID-19 Vaccination. CDC. Accessed 15 Feb 2024.

COVID-19 Vaccine Effectiveness Update. CDC. Accessed 15 Feb 2024.

Van Beusekom, Mary. Global COVID vaccination saved 2.4 million lives in first 8 months, study estimates. CIDRAP, University of Minnesota. 31 Oct 2023.

Watson, Oliver J., et al. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Infectious Diseases. 23 Jun 2022.

Trang, Brittany. Covid vaccines averted 3 million deaths in U.S., according to new study. Stat. 13 Dec 2022.

COVID-19 vaccinations have saved more than 1.4 million lives in the WHO European Region, a new study finds. WHO. Press release. 16 Jan 2024.

Mead, M. Nathaniel, et al. COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign. Cureus. 24 Jan 2024.

Yandell, Kate. Tucker Carlson Video Spreads Falsehoods on COVID-19 Vaccines, WHO Accord. FactCheck.org. 12 Jan 2024.

Yandell, Kate. Faulty Science Underpins Florida Surgeon Generals Call to Halt mRNA COVID-19 Vaccination. FactCheck.org. 5 Jan 2024.

Jaramillo, Catalina. mRNA Vaccines Protect Against COVID-19 Mortality, Contrary to Misleading Posts. FactCheck.org. 26 May 2023.

Jaramillo, Catalina. COVID-19 Vaccine Benefits Outweigh Small Risks, Contrary to Flawed Claim From U.K. Cardiologist. FactCheck.org. 8 May 2023.

Yandell, Kate. Cleveland Clinic Study Did Not Show Vaccines Increase COVID-19 Risk. FactCheck.org. 16 Jun 2023.

Jaramillo, Catalina. Autopsy Study Doesnt Show COVID-19 Vaccines Are Unsafe. FactCheck.org. 21 Dec 2022.

Swann, Sara. Experts say mRNA COVID-19 vaccines have saved millions of lives, not caused mass deaths. PolitiFact. 9 Feb 2024.

Wong, Adrian. COVID-19 mRNA Vaccines Lessons Learned Fact Check! Techarp. 30 Jan 2024.

Gorski, David. Antivaxxers write about lessons learned but know nothing. Respectful Insolence. 26 Jan 2024.

McDonald, Jessica. Flawed Analysis of New Zealand Data Doesnt Show COVID-19 Vaccines Killed Millions. FactCheck.org. 15 Dec 2024.

Yandell, Kate. COVID-19 Vaccines Save Lives, Are Not More Lethal Than COVID-19. FactCheck.org. 6 Nov 2023.

Yandell, Kate. Posts Push Unproven Spike Protein Detoxification Regimen. FactCheck.org. 21 Sep 2023.

Jaramillo, Catalina. Clinical Trials Show Ivermectin Does Not Benefit COVID-19 Patients, Contrary to Social Media Claims. FactCheck.org. 15 Sep 2022.

Robertson, Lori. No New Revelation on Hydroxychloroquine and COVID-19. FactCheck.org. 2 Jul 2021.

McDonald, Jessica. COVID-19 Vaccination Increases Immunity, Contrary to Immune Suppression Claims. FactCheck.org. 29 Jul 2022.

Gorski, David. 2021: The year the weaponization of VAERS went mainstream. Respectful Insolence. 27 Dec 2021.

McDonald, Jessica. What VAERS Can and Cant Do, and How Anti-Vaccination Groups Habitually Misuse Its Data. FactCheck.org. 6 Jun 2023.

Fraiman, Joseph. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 22 Sep 2022.

McDonald, Jessica, and Catalina Jaramillo. DeSantis Dubious COVID-19 Vaccine Claims. FactCheck.org. 2 May 2023.

Black, Steven, and Stephen Evans. Serious adverse events following mRNA vaccination in randomized trials in adults. Vaccine. 26 May 2023.

Yandell, Kate. Posts Spread False Claim About Moderna Patent Application. FactCheck.org. 22 Nov 2023.

Yandell, Kate. COVID-19 Vaccines Have Not Been Shown to Alter DNA, Cause Cancer. FactCheck.org. 26 Oct 2023.

Yandell, Kate. Faulty Science Underpins Florida Surgeon Generals Call to Halt mRNA COVID-19 Vaccination. FactCheck.org. 5 Jan 2024.

Jaramillo, Catalina, and Kate Yandell. RFK Jr.s COVID-19 Deceptions. FactCheck.org. 11 Aug 2023.

Morris, Jeffrey (@jsm2334) BTW, the McCullough, Kirsch, etc. Cureus paper that is purportedly a scientific review article references trialsitetnews, epoch times, brownstone, the spectator, childrens health defense, and conservative review as primary sources for some of their points, as well as 11 substack articles/blogs, a youtube/twitter video, and 2 explicit anti-vaccine books, plus a large number of self-citations from the review authors. X. 1 Feb 2024.

Scrutinizing science: Peer review. Understanding Science 101. Accessed 15 Feb 2024.

Crossley, Merlin. When to trust (and not to trust) peer reviewed science. The Conversation. 12 Jul 2018.

Reviewer Guide. Cureus. Accessed 15 Feb 2024.

About Cureus. Cureus. Accessed 15 Feb 2024.

Journal Metrics. Nature. Accessed 15 Feb 2024.

Editorial criteria and processes. Nature. Accessed 15 Feb 2024.

Sparks, Katie, and Kimberly R. Powell. Assessing Predatory Journal Publishing Within Health Sciences Authors. SLA conference. 31 Jul 2022.

MEDLINE, PubMed, and PMC (PubMed Central): How are they different? NIH. 28 Dec 2023.

Disclaimer. National Library of Medicine. Accessed 15 Feb 2024.

Some Strange Goings On at Cureus. Emerald City Journal. 20 Aug 2016.

Oransky, Ivan. Journal retracts more than 50 studies from Saudi Arabia for faked authorship. Retraction Watch. 26 Jan 2024.

Kincaid, Ellie. Researcher attacks journal for retracting his paper on COVID-19 drug. Retraction Watch. 26 Jan 2024. 10 Jun 2022.

Jaramillo, Catalina. Evidence Still Lacking to Support Ivermectin as Treatment for COVID-19. FactCheck.org. 6 Jun 2022.

Jaramillo, Catalina. Clinical Trials Show Ivermectin Does Not Benefit COVID-19 Patients, Contrary to Social Media Claims. FactCheck.org. 15 Sep 2022.

Kerr, Lucy, et al. Correction: Ivermectin Prophylaxis Used for COVID-19: A Citywide, Prospective, Observational Study of 223,128 Subjects Using Propensity Score Matching. Cureus. 24 Mar 2022.

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Review Article By Misinformation Spreaders Misleads About mRNA COVID-19 Vaccines - FactCheck.org