ACIP Votes to End Universal Hepatitis B Vaccination Recommendation for Infants

The Advisory Committee on Immunization Practices (ACIP) has voted 8 to 3 to remove the universal recommendation for a hepatitis B virus (HBV) vaccine, including the birth dose, for infants born to hepatitis B surface antigen–negative (HBsAg-negative) mothers. The vote was announced following a multiday meeting at CDC headquarters in Atlanta, Georgia.¹

The committee now 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. For patients not receiving the HBV birth dose, ACIP now recommends that the initial dose be administered no earlier than 2 months of age.¹

The committee also voted 6 to 4, with 1 abstainer, to recommend that parents consult with health care providers to determine whether postvaccination anti-HBs serology testing should be offered when evaluating the need for a subsequent HBV vaccine dose in children. According to the voting language, the serology results should determine whether the established protective anti-HBs titer threshold of 10 mIU/mL has been achieved, with the cost of the testing being covered by insurance.¹

No changes were made to the vaccination recommendation for infants born to women who test positive for HBsAg or who have an unknown HBsAg status. For these individuals, HBV vaccination remains universally recommended.^1,2

ACIP also voted to approve language allowing the federal Vaccines for Children (VFC) program to provide HBV vaccines, adhering to these new recommendations, to children whose parents or guardians may not be able to afford them. Some members expressed confusion surrounding the voting language, leading to 7 affirmative votes and 4 abstentions.¹

Reactions From ACIP Members

Previously, ACIP recommended HBV vaccination for all infants within 24 hours of birth, regardless of a mother’s hepatitis B status. Infants were recommended to receive 3 doses of the vaccine over a period of 6 months. The effectiveness of the HBV vaccine has been proven in numerous clinical trials, with studies indicating that immunity persists for at least 30 years in healthy patients who initiate HBV vaccination at less than 6 months of age.²

Joseph R. Hibbeln, MD, ABPN, CAPT, USPHS (Ret), a psychiatrist and ACIP member, characterized the confusion that emerged during the committee’s discussions throughout the 2-day meeting.^1,3

“Once again, we have great uncertainty and a lack of clarity on what these votes mean,” Hibbeln said before voting to abstain on the VFC resolution. Other members, including H. Cody Meissner, MD, a former member of the FDA’s Vaccine and Related Biological Products Advisory Committee, spoke out strongly against the need for changes to the childhood immunization schedule.^1,3

“Thoughtful inquiry is always acceptable,” Meissner said. “However, that inquiry should not be confused with mindless skepticism.”¹

Meissner also questioned the logic behind removing a universal vaccine recommendation at birth while recommending that, if such vaccination occurs, it should be done after 2 months of age. Meanwhile, he decried the argument that serology testing alone could confirm whether a child has adequate protection against hepatitis B, claiming the voting language seemed “made up” and from “never-ever land.”¹

“There are absolutely no data to support [that 1 dose is as good as multiple doses],” Meissner claimed. “The risk of harm is great if we do not complete the [HBV] immunization schedule. Again, there is no evidence of harm.”¹

Safety of the HBV Vaccine

In presentations to the committee, individuals cited differences in the US vaccine schedule compared with those of other countries and shifting opinions and supposed dissatisfaction among parents of the HBV birth dose as reasons to alter ACIP’s recommendations. A safety presentation by Mark F. Blaxill, MBA, claimed that the safety of the universal birth dose had not been confirmed in randomized, placebo-controlled trials, leading to questions regarding the potential for adverse effects.^4,5

These claims are contrary to extensive CDC-gathered safety data. A Vaccine Safety Datalink study conducted by the CDC in 2004 found no relationship between HBV and neonatal death and no differences between vaccinated and unvaccinated newborns. Reviews of Vaccine Adverse Event Reporting System reports over a decade did not find any new or unexpected safety concerns. Furthermore, a 4-year case series review of HBV reports among newborns found no serious problems linked to vaccination, constituting the largest review of HBV reports among newborn babies and infants ever conducted.^6-8

REFERENCES

1. CDC YouTube page. Accessed December 5, 2025. https://www.youtube.com/live/kUgXRUpKal4

2. Hepatitis B vaccine administration. CDC. September 18, 2025. Accessed December 5, 2025. https://www.cdc.gov/hepatitis-b/hcp/vaccine-administration/index.html

3. ACIP membership roster. CDC. December 3, 2025. Accessed December 5, 2025. https://www.cdc.gov/acip/membership/roster.html#cdc_generic_section_2-h-cody-meissner-md

4. Pebsworth V. Hepatitis B virus vaccine birth dose. Presented at: Advisory Committee on Immunization Practice Childhood/Adolescent Schedule Workgroup; December 4, 2025. Accessed December 5, 2025. https://www.cdc.gov/acip/downloads/slides-2025-12-04-05/01-Pebsworth-hepatitis-b-508.pdf

5. Blaxill MF. Safety review of hepatitis B birth dose vaccination. Presented at: CDC Advisory Committee on Immunization Practices; December 4, 2025. Accessed December 5, 2025. https://www.cdc.gov/acip/downloads/slides-2025-12-04-05/03-blaxill-Hepatitis-B-508.pdf

6. Eriksen EM, Perlman JA, Miller A, et al. Lack of association between hepatitis B birth immunization and neonatal death: a population-based study from the Vaccine Safety Datalink project. Pediatr Infect Dis J. 2004;23(7):656-662. doi:10.1097/01.inf.0000130953.08946.d0

7. Haber P, Moro PL, Ng C, et al. Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015. Vaccine. 2018;36(4):559-564. doi:10.1016/j.vaccine.2017.11.079

8. Lewis E, Shinefield HR, Woodruff BA, et al; Vaccine Safety Datalink Workgroup. Safety of neonatal hepatitis B vaccine administration. Pediatr Infect Dis J. 2001;20(11):1049-1054. doi:10.1097/00006454-200111000-00009