The vote by the US Centers for Disease Control and Prevention (CDC) vaccine panel to scrap broad hepatitis B vaccine recommendations for newborns will reverse decades of progress in fighting the virus, medical experts have said.
Vaccines to prevent hepatitis B first won US Food and Drug Administration (FDA) approval in 1986. The US has recommended universal vaccination for infants against hepatitis B since 1991, with the first of three shots administered very soon after birth.
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That guidance may change after a recent vote by the CDC’s Advisory Committee on Immunization Practices (ACIP) to withdraw universal recommendations for hepatitis B immunisation at birth.
The American Association of Immunologists (AAI) said that it is “extremely disappointed” following the vote.
AAI president Dr Ulrich von Andrian commented: “AAI strongly urges the CDC to reject the recommendation and reaffirm the long-standing, evidence-based guidance to administer the first dose within 24 hours of birth for all infants.”
According to the latest vaccine panel’s recommendation, a birth dose should only be given to newborns whose mother tests positive for hepatitis B or whose status is unknown. In cases where the mother tests negative, an “individual-based decision-making” process should be adopted to see if the baby receives a jab.
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By GlobalDataThe guidance, which still needs to be approved by CDC director Jim O’Neil, marks the agency’s first change in recommendation related to hepatitis B prevention in more than three decades.
Data shows that since the implementation of vaccination at birth, chronic hepatitis B cases in children and adolescents have fallen by 99%.
“Delaying the vaccine would mark a dangerous departure from decades of achievement in preventing hepatitis B infection and its complications. Now is not the time to undermine confidence in one of the most successful vaccine-based public health interventions in modern history,” von Andrian added.
The makeup and expertise of the current ACIP committee has drawn criticism. Health secretary Robert F Kennedy (RFK) Jr fired the previous panel in June, replacing them with vaccine sceptics and individuals who have been critical of both the Covid-19 vaccines and related countermeasures such as lockdowns. During the vote on hepatitis B guidelines, several members questioned the vaccine’s safety.
The American Academy of Pediatrics, Infectious Diseases Society of America and the Society for Maternal-Fetal Medicine, among others, said in a joint statement: “Previously, we could expect science to drive decisions, experts to debate evidence, and consensus to lead to shared, clear recommendations. That is not the case with the current committee, and this change puts Americans’ health at risk. We urge the CDC leaders to reject ACIP’s new recommendation and instead retain the current, evidence-based approach.”
The American Medical Association (AMA) states that the ACIP’s new stance is “reckless and undermines decades of public confidence in a proven, lifesaving vaccine”.
As the US shifts its hepatitis B vaccine goalposts, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) clarified its endorsement of current guidelines. In the UK, all babies born to mothers infected with hepatitis B are vaccinated within 24 hours of birth. All other babies are routinely vaccinated from eight weeks of age.
The MHRA’s chief safety officer Dr Alison Cave said: “Extensive safety monitoring in the UK and internationally continues to show that the benefits of these vaccinations outweigh any risks.”
Last week, a leaked memo by the Center for Biologics Evaluation and Research (CBER) director Vinay Prasad revealed that the FDA is mulling significant changes to vaccine regulation. A group of 12 former commissioners from the agency attacked the proposals, highlighting an undermining of public interest. In 2025, there has been a wider strategic shift from the Trump administration to reduce reliance on vaccines protecting against respiratory viruses.
