Paper Claiming Hepatitis Vaccine Increases Autism Risk Gets Retracted

The scientific foundation for claims linking early childhood vaccinations to autism has faced a significant setback with the formal retraction of a 2010 study published in the Journal of Toxicology and Environmental Health, Part A. The paper, authored by Carolyn M. Gallagher, PhD, clinical instructor in the department of family, population & preventive medicine at Stony Brook Medicine, and Melody Goodman, PhD, dean for the school of global public health at New York University, originally claimed that infant boys vaccinated with the hepatitis B series as neonates faced a threefold increase in the risk of an autism diagnosis compared with those vaccinated later or not at all.^1,2

However, a post-publication statistical review by an independent expert concluded that the study's findings were fundamentally unsound due to severe methodological flaws, according to MedPage Today. For pharmacists and health care providers, this retraction underscores the importance of rigorous peer review and the dangers of making clinical recommendations based on limited, unadjusted data sets.¹

Why the Paper Was Retracted

The retraction of this specific study is particularly notable because it was included in a safety review presented to the CDC’s Advisory Committee on Immunization Practices (ACIP) in late 2025, just before the committee voted to discontinue the long-standing recommendation that every newborn receive a hepatitis B vaccine at birth. According to MedPage Today, critics of the study, including researchers from the Coalition of Autism Scientists, pointed out that the authors’ conclusions were based on a "critically small" sample of only 31 autism cases, and only 9 of those children had received the vaccine in their first month of life.¹

Furthermore, the study failed to fully adjust for confounders, and the independent reviewer noted that the associations presented were not statistically significant once these biases were addressed. A second paper by the same authors regarding developmental disabilities and the hepatitis B vaccine is also currently under investigation for similar concerns.¹

The Landscape of Vaccine Recommendations

This development arrives amidst a broader, often contentious debate regarding vaccine safety and neurodevelopment. Although some nonCDC authors using data from the Vaccine Adverse Event Reporting System have suggested links between vaccines and neurodevelopmental disorders, these studies have frequently been hampered by methodological limitations, such as an inability to control for confounding factors or a reliance on aggregated data.³

In contrast, a comprehensive CDC report encompassing over 20 studies found no connection between thimerosal—a mercury-containing preservative used in multidose vials—and autism or other neurodevelopmental conditions. Current data indicates that thimerosal use has significantly declined, with approximately 94% of all influenza vaccines in the 2024-2025 season being thimerosal-free and no routinely recommended childhood vaccines for those 6 years and younger containing the preservative.^3,4

"People seem to be foggy on what ‘science’ is.... There is a publication or 3 for every single point of view. It is not enough to say that 1 single study—or even a handful of small studies—makes something correct,” Elizabeth Skoy, PharmD, FAPhA, professor at the Center for Collaboration and Advancement in Pharmacy, North Dakota State University, said.⁴

Pharmacists must also navigate a shifting public health communications landscape, as the CDC recently updated its website to state that the claim "vaccines do not cause autism" is not an "evidence-based claim" because studies have not ruled out every possibility of causation. This nuance has been criticized by some experts as "grossly misleading," as it is scientifically difficult to prove a negative despite decades of data involving millions of children that fail to show an increased risk.^4,5

Experts suggest that raw, unadjusted data often show a correlation between vaccines and autism diagnoses because of health care–seeking bias, such as children who see pediatricians for vaccinations are simply more likely to be evaluated and diagnosed with neurodevelopmental conditions than those who do not see a clinician.⁵

Conclusion

The implications of this debate extend beyond vaccinations to other areas of maternal and pediatric care. For instance, recent administration focus has also turned to acetaminophen, questioning its safety during pregnancy and its potential link to autism. Pharmacy experts warn that shaming pregnant patients away from necessary treatments for pain or fever can be clinically detrimental, leading to risks like maternal tachycardia and hypertension. As front-line providers, pharmacists remain essential in providing context to these retracted studies and evolving CDC guidelines, ensuring that patients receive information rooted in adjusted, statistically significant scientific reality rather than misleading correlations.^4,5

"There’s a lot of commonality...we want to prevent chronic disease in adults and children and lessen that disease burden,” Skoy said.⁴ “But the execution of how some of these things have gone around has caused some mistrust in general in our health care system.”

READ MORE: Immunization Resource Center

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REFERENCES

1. George J. Study Linking Vaccines to Autism Retracted. MedPage Today. June 12, 2026. Accessed June 23, 2026. https://www.medpagetoday.com/neurology/autism/121745

2. Gallagher, C. M., & Goodman, M. S. (2010). Hepatitis B Vaccination of Male Neonates and Autism Diagnosis, NHIS 1997–2002. Journal of Toxicology and Environmental Health, Part A, 73(24), 1665–1677. https://doi.org/10.1080/15287394.2010.519317

3. Gallagher A. CDC report finds no connection between thimerosal and autism. Drug Topics. June 25, 2025. Accessed June 23, 2026. https://www.drugtopics.com/view/cdc-report-finds-no-connection-between-thimerosal-and-autism

4. Gallagher A. What does the make America healthy again movement mean for public health?. Drug Topics. March 20, 2026. Accessed June 23, 2026. https://www.drugtopics.com/view/what-does-the-make-america-healthy-again-movement-mean-for-public-health-

5. Gallagher A. CDC updates web page—no evidence to support “vaccines do not cause autism” claims. Drug Topics. November 20, 2025. Accessed June 23, 2026. https://www.drugtopics.com/view/cdc-updates-webpage-saying-no-evidence-supports-vaccines-do-not-cause-autism-claims