Elsevier has retracted a 2021 study claiming sudden infant death syndrome is linked to vaccines over concerns the paper might influence patient care.
The single-author study, by longtime vaccine critic Neil Z. Miller and published in Toxicology Reports, found 75 percent of SIDS cases reported occurred within seven days of vaccination, suggesting the fatalities are tied to immunizations. In an April 9 notice, Elsevier said it initiated an investigation into the paper after concerns arose from readers about potential research errors and methodological flaws.
According to the removal notice, editor-in-chief Lawrence H. Lash determined the author’s response did not “satisfactorily address” the concerns, particularly, the “serious methodological flaws” in using the Vaccine Adverse Event Reporting System (VAERS) to infer a correlation between vaccination and SIDS.
“In light of these concerns, and given the potential implications for medical practice, the Editor-in-Chief has decided that the article should be removed,” the notice reads.
The study joins several others relying on VAERS data that were subsequently retracted. In 2024, Cureus, now owned by Springer Nature, retracted a paper about the purported harms of vaccines against COVID-19 that used VAERS data. In 2025, we covered an investigation by Taylor & Francis into a paper claiming to find DNA contamination in COVID-19 vaccines that was based on VAERS data.
Miller told Retraction Watch he “strongly opposed” the removal and that the decision was “unjustified.” He said the journal contacted him with eight concerns about the paper, “all from a single woman,” which he addressed “thoroughly.”
“The journal ultimately determined that the concerns affected the article’s integrity and could have implications for medical practice, and therefore warranted removal,” Miller told us. “I strongly disagreed with this assessment and sought clarification regarding the specific methodological flaws cited. Despite repeated requests, no detailed explanation was provided, and the dialogue was eventually terminated.”
Miller refers to himself as a “medical research journalist” who has spent 40 years “educating parents and health practitioners about vaccines,” according to his LinkedIn page. He’s the author of numerous studies and books that suggest vaccines are harmful, including “Miller’s Review of Critical Vaccine Studies” (Volumes 1 and 2).
He spoke recently about the paper on CHD.TV, a program by the Children’s Health Defense, a nonprofit organization founded by now-HHS Secretary Robert F. Kennedy Jr. that opposes vaccines. During the show, Miller said he was “fighting back,” and planned to republish the study so that “people can continue to read it.” Miller told us he’s writing a book that will include the removed paper.
An Elsevier spokesperson told us the journal was alerted to serious concerns regarding the article last year.
“We conducted a thorough assessment which ultimately led to the decision to remove the publication, following careful review and consultation with relevant experts,” the spokesperson told us. “We stand by the decision that the recommendations and conclusions presented in the paper may pose potential risks to public health and could potentially be applied in clinical practice resulting in harm to patients.”
Although the publisher deemed the paper as “removed,” the PDF version of the article initially included the word “removed” across each page with the the text still visible. After we inquired about the discrepancy, the text was removed. A spokesperson said the mistake was “due to human error.” According to the publisher’s policy, in the rare event an article is removed, the metadata are retained and the text of the article replaced with a screen indicating the article has been removed.
The findings are based on data from the VAERS database, a passive surveillance system that accepts reports of vaccine side effects from anyone, including health providers, patients, and family members, according to the U.S. Centers for Disease Control and Prevention. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told us he was surprised the journal took five years to remove the paper, because the system is not intended to establish causality but rather to record suspected vaccine adverse events and to raise hypotheses.
“The title of the paper alone brings the data into question,” Offit, an attending physician in the division of infectious diseases at Children’s Hospital, told us. “I think it speaks to the quality of a journal like Toxicology Reports when, one, they publish a paper like that, and two, they are so slow to retract it when it was obviously, methodologically horribly flawed.”
For the Toxicology Reports study, Miller analyzed 2,605 infant deaths reported to the VAERS database between 1990 and 2019, finding 75 percent occurred within seven days post-vaccination. Miller concluded that while the paper “does not prove an association between infant vaccines and sudden infant deaths, it reveals unusual patterns and safety signals highly suggestive of a causal relationship.”
Miller also wrote because health authorities have eliminated “prophylactic vaccination” as an official cause of death, medical examiners are “compelled to misclassify and conceal vaccine-related fatalities under alternate cause-of-death classifications.”
The paper has been cited 10 times, according to Clarivate Web of Science.
The analysis was met with swift skepticism when it appeared in 2021. Among the criticisms were that Miller misused the VAERS data to suggest causality and misinterpreted how the data should be distributed over time. Magdalen R. Wind-Mozley, a former forensic scientist and vaccine advocate based in Newbury, England, condemned the analysis on X and contacted the journal in 2022 to call for its retraction, she told us.
“I contacted [the journal] on numerous occasions and was mostly ignored,” said Wind-Mozley, chair of the Diversity in Research Group for the National Institute for Health and Care Research Biomedical Research Centre: Oxford. “I am so very glad it’s retracted, but furious that it was ever published and that it took so long to remove it.”
Reliance on VAERS data by researchers to draw conclusions about vaccines has led to other recent retractions. In 2021, Elsevier issued an expression of concern for an entire special issue of Toxicology Reports, including a paper claiming COVID-19 vaccines kill five times as many people over 65 as they save. Elsevier retracted that paper, which relied heavily on VAERS data, in 2022. Miller’s SIDS paper was published in the same volume but wasn’t included in the special issue.
Kennedy has vowed to overhaul VAERS, calling the surveillance system inadequate and in need of greater data collection.
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