CDC panel votes to remove recommendation for hepatitis B vaccine in newborns

Following a contentious meeting, the vaccine advisory committee of the US Centers for Disease Control and Prevention (CDC) has voted to withdraw its standard recommendation for administering the hepatitis B vaccine to newborns not considered high-risk. The committee now advises that the vaccine be given starting at two months of age. The Advisory Committee on Immunization Practices (ACIP) approved the change with an 8-3 vote favoring individual-based decision-making.

Previously, CDC guidance recommended that all newborns receive the hepatitis B vaccine within 24 hours of birth, regardless of maternal infection status. This decision marks the first major update to the agencys hepatitis B prevention guidance in more than thirty years.

The vote had initially been scheduled for December 4 but was delayed as members debated the exact language of the motion, which had undergone multiple revisions. During the meeting, Professor Cody Meissner, a former FDA vaccine advisory member, emphasized the considerable uncertainty and lack of clarity regarding the votes consequences. He argued that the policy could result in more hepatitis B infections among children, adolescents, and adults.

In contrast, Tracy Beth Hoeg, head of new drug evaluation and research at the FDA, described the policy change as a very positive step, noting that it would align the US with countries such as Denmark, which do not routinely vaccinate at birth.

Meissner also expressed hope that pediatricians would continue to administer the birth dose within the first 24 hours, stating that delaying it may not serve the best interest of infants. Similarly, Flor Munoz, associate professor at Baylor College of Medicine, raised concerns that some ACIP members were making recommendations based on personal opinions rather than existing data.

Currently, two hepatitis B vaccines are approved for infants in the US: MSDs Recombivax and GSKs Engerix-B Pediatric, approved in 1986 and 1989, respectively. No new evidence suggests that these vaccines are unsafe for newborns.

A GSK spokesperson reaffirmed the vaccines safety and effectiveness, noting that Engerix-B has been administered in 1.4 billion doses worldwide. MSD also emphasized that Recombivax HB has a well-established safety profile with ongoing monitoring for adverse events over 35 years.

Research shows that hepatitis B cases among infants have declined by over 99% since vaccines became available. The World Health Organization (WHO) estimates that 95% of infants infected with hepatitis B develop chronic infection, which can lead to severe liver disease, liver cancer, or death. Only 5% of adults who contract the virus develop chronic infection.

The CDCs updated guidance follows broader changes in US vaccine policy, influenced in part by US Health Secretary Robert F. Kennedy Jr.s concerns about childhood vaccine safety. In June, Kennedy replaced ACIP members with individuals skeptical of vaccines or lacking public health expertise, raising alarms among former committee members about potential weakening of the national immunization program.

The policy shift has also sparked criticism from medical experts and lawmakers, including US Senator Bill Cassidy and the Infectious Diseases Society of America. In the New England Journal of Medicine, twelve former FDA commissioners warned that sweeping changes could disrupt vaccine policy, hinder vaccine development, and undermine public trust.

Author: Logan Reeves