After a fiery panel meeting, the US Centres for Disease Control’s (CDC) vaccine committee has voted to revoke its routine hepatitis B vaccine recommendation in non-high-risk newborn infants, instead issuing guidance that children two months and older receive the jab.
This follows an eight-to-three vote in favour of “individual-based decision-making” from the Advisory Committee on Immunization Practices (ACIP). Current CDC guidance recommends that newborn infants receive the hepatitis B vaccine within 24 hours of birth, regardless of the mother’s infection status.
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This marks the agency’s first change in recommendation related to hepatitis B prevention in more than three decades.
The vaccine advisory panel originally intended to vote on the vaccine’s place in the routine schedule on 4 December. However, the decision was once again delayed as members of the department questioned the wording of the terms they would vote on, which had changed several times previously.
This theme continued into today’s session, as paediatrics professor and ex-FDA vaccine panel member Cody Meissner highlighted the “great uncertainty and lack of clarity” around voting implications.
Alongside his qualms towards the voting language, Meissner strongly opposed the new policy throughout the discussions, noting that the proposed changes would “see more children, adolescents and adults infected with hepatitis B”.
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By GlobalDataThis differed significantly from the stance taken by the US Food and Drug Administration’s (FDA) new drug evaluation and research head, Tracy Beth Hoeg, who described the recommendation update as a “very positive move of vote”. In the meeting, she stated that this change in recommendation would bring the US in line with peer nations such as Denmark, which do not currently recommend routine administration at birth.
When asked how this move would impact the prescribing activity of physicians, Meissner said he hoped paediatricians will continue to administer the birth dose with the first 24 hours of delivery, as “any other course is not in the interest of the infant”.
Speaking on behalf of the Infectious Disease Society of America at the ACIP meeting, Flor Munoz, associate professor paediatrics and infectious diseases at Baylor College of Medicine, also expressed her concerns. She claimed certain ACIP members were “pushing assumptions made on personal opinion,” leading to the “incorrect or inadequate interpretation of actual information that is already available”.
There are currently two US-approved hepatitis B-only vaccines: MSD’s Recombivax and GSK’s Engerix B Paediatric, which have been on the market since their FDA approval in 1986 and 1989, respectively.
No new evidence has emerged to suggest that the routine use of either approved paediatric hepatitis B vaccine is unsafe in newborn infants.
In a statement to Pharmaceutical Technology, a GSK spokesperson said: “GSK stands behind the science of all our vaccines. Engerix-B has been approved since 1989, with 1.4 billion doses administered worldwide, with data from dozens of studies establishing that it is effective with an acceptable safety profile.”
An MSD spokesperson commented: “The safety profile of RECOMBIVAX HB has been well established over decades and is closely monitored on a continuing basis.
“Participants in the clinical trials of RECOMBIVAX HB were monitored for adverse events and the company has been collecting post marketing safety data for over 35 years. The totality of the data continues to support a favourable benefit-risk profile for RECOMBIVAX HB.”
Research indicates that cases of hepatitis B reported in infants have dropped by more than 99% since vaccines have been available.
The World Health Organization (WHO) currently estimates that 95% of infants infected with hepatitis B go on to develop a chronic form of the virus, which can cause severe liver damage, hepatic cancer and – in some cases – death. In contrast, only 5% of adults that develop the disease go on to contract hepatitis.
US vaccine shifts spark concern from experts
The CDC’s call to change the vaccine policy around hepatitis B administration follows a slew of changes – partially driven by US Health Secretary Robert F Kennedy (RFK) Jr’s concerns around childhood vaccination safety.
In June, RFK Jr fired all members of the ACIP committee, replacing them with vaccine sceptics and individuals who lacked public health expertise. This has led former members to warn of a weakened immunisation programme in the US.
In addition, the CDC publicly stated that vaccine use is correlated with autism, which was met with ire from experts, including US Senator Bill Cassidy and The Infectious Diseases Society of America (IDSA).
In a recent opinion piece published in the New England Journal of Medicine, 12 former FDA commissioners condemned the current sweeping vaccination changes, noting that they could upend core policies governing vaccine development and updates” and “undermine public interest”.
