"Complicating the Decision-Making" for the Universal Birth Dose of the Hepatitis B Vaccine

Last week, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) met for 2 days to discuss the birth dose of the hepatitis B virus (HBV) vaccine. They had 3 new recommendations to vote on, and the one that everyone is talking about is the change to (and confusion about) the universal birth dose.

Prior to the meeting, the previous universal hepatitis B vaccine recommendation was for all neonates to be given their first dose of the hepatitis B vaccine within 12 to 24 hours of their birth. This public health policy, which has been in existence for decades, has led to a significant reduction in disease. Between 1991 and 2019, HBV infection among children and adolescents dropped 99%, preventing tens of thousands of cases of cirrhosis, liver cancer, and death.¹

The voting language for this new recommendation reflected the ongoing confusion and limited knowledge that this completely revamped, new committee is demonstrating. 

For the vote on the universal vaccine language, the new recommendation stated the following:

"For infants born to HBsAg [hepatitis B surface antigen]-negative women: ACIP recommends individual-based decision making, in consultation with a health care provider, for parents deciding when or if to give the HBV vaccine, including the birth dose. Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks. For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age."

The committee approved the recommendation, and the members voted 8 to 3 in favor of it.

In looking at the language, it is vague and confusing, leaving less than clear guidance for clinicians and families, especially the last sentence, which is bolded in the aforementioned recommendation.

“I think the one that concerns us most recommended a change from universal hepatitis B vaccination of newborns to a much more complicated set of decision-making for clinicians,” said Robert Hopkins Jr, MD, medical director of the National Foundation for Infectious Diseases. “They recommended individual-based decision-making, which is the construct of this new committee on what we've known as shared decision-making for many years.”

Hopkins is making the choice to follow the previous recommendation on the birth dose.

“In my practice, I'm going to continue to recommend hepatitis B vaccination for all infants,” he said. “I'm not going to assume that hepatitis B surface antigen testing early in pregnancy remains true and that a woman hasn't seroconverted in that interim. I'm not going to assume that the infant is not going to have contact with somebody who is shedding hepatitis B, which can infect the infant and potentially cause severe and potentially fatal liver disease in that child or as they become a young adult.”

The meetings last week demonstrated the marked differences from previous committees and how they operated in the past. US Department of Health and Human Services Secretary Robert F. Kennedy Jr replaced 17 members of the ACIP earlier this year, and their inexperience in understanding vaccinology and how the proceedings work is showing.

“The current committee continues to struggle with understanding of the purview of the responsibilities and the process, which have been established for many years. And clearly, many of the committee members have limited understanding of a number of important concepts in vaccinology,” Hopkins said.

It is important to note that there are a few voting members, and certainly the liaisons, who understand their roles, but they are outnumbered by those members who create a voting bloc in favor of reducing vaccine access.

ACIP’s work groups are one of its foundations, and these members collaborate to create a framework for new vaccine recommendations when needed and review the vaccine data that are available to help guide the language for these recommendations to be voted on. However, the ACIP committee members and liaisons do not know who has been working in these groups, a departure from past workings of ACIP.

“They have reworked some of the work groups. We know that, at least by what they've said at the meetings, that the COVID-19 vaccine work group has met. We know that the childhood immunization work group has met. We don't know who's on these work groups,” he said. “The GRADE [Grading of Recommendations Assessment, Development, and Evaluation] process of evaluation of vaccines, which is a structured evidence review of the vaccines and the evidence to recommendations, framework for vaccines, which were developed to include input from vaccinology to clinical use of vaccines to public acceptability and equity, have been abandoned, despite the vice chair's and the chair's comments in the committee meeting that we need to develop new ways to assure evidence reviewed and input from all constituencies. They haven't shown evidence of that. Then the failure to understand how vaccines work, that one dose of any given vaccine doesn't necessarily result in long-term protective immunity and how and when serology can be used to assess immunity and/or as a surrogate of protection, was really a huge lapse in my mind.”

Reference
1. APHA joins GW and dozens of public health and policy experts urging the CDC to maintain universal newborn hepatitis B vaccination. Press release. American Public Health Association. December 2, 2025. Accessed December 10, 2025. https://www.apha.org/news-and-media/news-releases/apha-news-releases/public-health-and-policy-experts-urge-the-cdc-to-maintain-universal-newborn-hepatitis-b-vaccination