Harmful impacts of the recent decision of the US Department of Health and Human Services to remove several vaccines from those routinely recommended for all children, although temporarily blocked by a preliminary court decision, would include reversing 3 decades of progress toward eliminating hepatitis A infection, according to two advisors on the previous, long-standing universal vaccination recommendation.1-2
Noele Nelson, MD, Department of Public and Ecosystem Health, Cornell University, New York, NY, and John Ward, MD, Coalition for Global Hepatitis Elimination, Task Force for Global Health, Emory University, Atlanta, GA, present a rebuttal to that decision in a Viewpoint column in The Lancet.3
"The low incidence of hepatitis A in the USA is a direct result of the success of the hepatitis A vaccination program," Nelson and Ward indicate in their argument against removing hepatitis A from universal childhood vaccination recommendations.
"The loss of protection among unvaccinated children will increase the reservoir of hepatitis A virus in communities, leading to widespread outbreaks and preventable morbidity and mortality among unvaccinated people," they warn.
What You Need to Know
Routine childhood hepatitis A vaccination has been a major public health success, helping reduce US hepatitis A cases by more than 95% since the late 1990s and limiting widespread community transmission.
Experts warn that removing hepatitis A from universal childhood vaccine recommendations could increase outbreaks, hospitalizations, and deaths by expanding the pool of susceptible children and adults, particularly in underserved communities.
The authors argue that hepatitis A vaccines have a strong, well-established safety record backed by pre-licensure trials, FDA review, decades of post-licensure monitoring, and hundreds of millions of doses administered worldwide.
Nelson and Ward recount that hepatitis A vaccines were introduced incrementally in the US after their licensing in 1995, to a population of increasingly wider age range and to regions beyond those with high rates of infection.They attribute the 2006 recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) to provide the vaccine to all children 12-23 months for the decline of more than 95% from 1996, to 0.4 cases per 100,000 population by 2011.
The progress was disrupted, however, by increased homelessness and drug use, and regions with low rates of vaccination, with the national incidence rising to 5.7 cases per 100,000 by 2019. This period was marked by outbreaks across 37 states, with approximately 45,000 confirmed cases, 27,000 hospitalization and 424 deaths. In response, and in recognition that strengthening childhood protection would advance protection among adults, in 2020 the ACIP recommended catch-up vaccination for all children aged 2-18 years.
"Importantly, by protecting children, pediatric hepatitis A vaccination eliminates a reservoir of hepatitis A virus transmission to adults and, as vaccinated children age, this protection extends to adolescents and adults," Nelson and Ward explain.
They note, in addition, that removing the routine recommendation would widen the disparity in vaccine access. In 2021-23, vaccine coverage in children of families with health insurance was 89% by age 24 months, and 75% among uninsured children.
Nelson and Ward also take issue with the argument that evidence of safety is limited without conducting placebo-controlled randomized trials.They note that the pre-licensure studies were appropriately conducted placebo-controlled trials, and that no safety concern or serious adverse events were identified in either those studies or in the regulatory review conducted by the FDA.
They note further, that years of post licensure safety studies have corroborated the safety and effectiveness, quoting a WHO report: "based on the cumulative global experience gained from the use of several hundred million doses, the overall safety profile of all inactivated hepatitis A vaccines administered to children, aged 1 year to <15 years, and adults has been excellent, irrespective of schedule and manufacturer."4
Nelson and Ward conclude that the new policy for ending routine vaccination, "risks increasing reservoirs of hepatitis A virus susceptibility, decreasing population protection, and increasing outbreaks with their associated costs and burden on public health and healthcare professionals."
References
2. American Academy of Pediatrics vs Robert F Kennedy Jr. 25-11916-BEM. United States District Court District of Massachusetts; Boston, MA; March 16, 2026.
3. Nelson NP, Ward JW. Hepatitis A prevention in the USA depends on routine universal childhood vaccination. The Lancet. 2026. Online April 22. https://doi.org/10.1016/S0140-6736(26)00510-6.
