The publisher Taylor & Francis is investigating concerns raised on PubPeer about a paper claiming to find DNA contamination in COVID-19 vaccines beyond regulators’ recommended amounts.
The move comes as the U.S. body tasked with making recommendations for vaccine use is scheduled to consider the safety of COVID-19 shots, and two of the study’s authors say their findings will be discussed.
The paper at issue was published September 6 in the journal Autoimmunity, a Taylor & Francis title. Scientific sleuth Kevin Patrick soon posted concerns on PubPeer, which he forwarded to the ethics department of the publisher.
On September 8, Laura Wilson, Taylor & Francis’ Head of Research Integrity & Ethics, thanked Patrick for raising the concerns and said the company would “investigate in accordance with the COPE guidelines and our Editorial policies.”
The publisher added a pop-up notification to the article to alert readers to the ongoing investigation after we asked if they would do so. Taylor & Francis began using such notices last year.
Jennifer McMillan, a spokesperson for Taylor & Francis, confirmed the publisher’s Ethics and Integrity team “are aware of the comments made on PubPeer and are investigating the article in question.”
“As the investigation is in its very early stages we cannot make any further comment,” she said.
Paolo Casali, editor-in-chief of Autoimmunity, did not respond to our request for comment.
On September 19, a meeting of the Advisory Committee on Immunization Practices of the U.S. Centers for Disease Control and Prevention will include presentations on “COVID-19 vaccine safety.”
Retsef Levi, a professor of operations management at the Massachusetts Institute of Technology’s Sloan School of Management in Cambridge and chair of the ACIP work group on COVID-19 vaccines, will introduce the session. The work group’s activities include reviewing and summarizing “gaps in the existing knowledge regarding potential impurities (e.g., DNA contamination and endotoxins) in existing immunization products and their health impacts to inform immunization recommendations.”
Study coauthor Kevin McKernan of the Beverly, Mass.-based company Medicinal Genomics said in a Sept. 14 post on Substack he had been “contacted by the ACIP committee to go over our paper.” A post on X by another coauthor, independent researcher Jessica Rose, stated the committee will be considering their paper.
In her own Substack post, Rose wrote Senator Ron Johnson (R – Wisconsin) had submitted the study as evidence in a hearing of the Permanent Subcommittee on Investigations September 9.
She also included a prediction: “they will try to retract our work.”
The authors of the paper — Rose, McKernan, and David J. Speicher of the University of Guelph in Ontario, Canada — describe using two different methods to measure the amount of DNA remaining in mRNA COVID-19 vaccines from Pfizer-BioNTech and Moderna due to their manufacturing processes. Speicher, the corresponding author, did not respond to our request for comment.
McKernan was also an author on a July preprint about “Synthetic mRNA Vaccines and Transcriptomic Dysregulation” that was withdrawn on Sept. 11 after sleuths Elisabeth Bik and Reese Richardson documented problems with the manuscript.
Using one method, fluorometry, the authors of the Autoimmunity paper said they found amounts of DNA in all their samples of various vaccine lots that were higher than guidelines from the U.S. Food and Drug Administration and World Health Organization recommend. Using the other method, qPCR, they said three samples were over the limit.
On PubPeer, Patrick, who uses the pseudonym “Actinopolyspora biskrensis,” pointed out that the regulators’ recommendations were set for qPCR tests, not fluorometry. “Applying that regulatory threshold to fluorometry values is misleading, since regulators do not recognize fluorometry as the standard,” he wrote. Fluorometry also picks up mRNA, according to Australia’s Therapeutic Goods Administration, so it does not correctly measure DNA amounts in the mRNA COVID-19 vaccines.
In subsequent comments, Patrick also questioned the authors’ use of data from the FDA’s Vaccine Adverse Event Reporting System, or VAERS, and the appropriateness of several of the documents the authors cited. One reference consisted of the attachments to a meeting agenda for the town council of Port Hedland, Australia, which included a report referencing a 2023 preprint from the paper’s coauthors.
In addition to the questionable references Patrick identified, Retraction Watch found the FDA guidance the researchers cited was issued for gene therapies, and explicitly stated it “does not apply to vaccines for infectious disease indications.”
Other commenters on PubPeer added technical critiques of the paper as well.
“I have no idea how this paper could have made it through peer review,” Patrick told us. “Sadly, we almost never find out what happens behind the scenes.”
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