New Hepatitis B Vaccine Recommendation Serves as a Blueprint for Federal Vaccine Policy Going Forward

Unlike ever before, the current Health and Human Services (HHS) leadership has muddied the waters as it relates to the agency's longstanding intentions regarding access to vaccines for Americans.

A microcosm of this new federal public health policy can be seen with the recent events around the hepatitis B virus vaccine (HBV) during the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meetings earlier this month.

During these meetings, the committee voted on 3 recommendations around the birth dose of the hepatitis B virus (HBV) vaccine. The biggest and most newsworthy vote was the one that changed the previous CDC recommendation to move the first HBV immunization from a universal birth dose at 12-24 hours of life back to 2 months of age for neonates whose mothers tested negative for hepatitis B. Also, the committee emphasized individual-based decision-making after consultation between the mothers and clinicians on vaccination.

The prior guidance of the HBV birth dose immunization was widely viewed as a successful public health policy. It had been in existence for decades and 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

Looking at this new individual-based decision-making recommendation, Robert Hopkins Jr, MD, medical director of the National Foundation for Infectious Diseases (NFID) believes this unnecessarily complicates the process.

“I think the one [vote] 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,” Hopkins said. “They recommended individual-based decision-making, which is the construct of this new [ACIP] committee on what we've known as shared decision-making for many years.”

During the ACIP meetings, no safety data was presented to warrant the changes they made.

The Human and Healthcare Costs

Prior to this new CDC HBV birth dose recommendation, a modeling analysis was conducted on the potential health and economic consequences of delaying the infant HBV birth dose vaccine. The findings—based on a model of 2024 US births—show that even short delays in vaccination lead to substantially more infections, severe long-term health complications, and sharply increased health care spending.2

The analysis came from a partnership with HepVu, the Hepatitis B Foundation, and the National Viral Hepatitis Roundtable, and the findings show: By delaying the birth dose to 2 months among infants whose mothers are not known to be living with hepatitis B, there could be at least 1400 preventable hepatitis B infections among children, 300 excess cases of liver cancer, 480 preventable deaths, and over $222 million in excess health care costs for each year the revised recommendation is in place.2For each year, this delayed birth dose policy is in place, it could result in at least 62 preventable deaths and 39 cases of liver cancer annually, and cost at least $21.6 million in health care.2

“I think the change in timing of the hepatitis B vaccine to infants is going to result in many more children getting infected with hepatitis B at birth,” said Sharon Nachman, MD, chief of pediatric infectious diseases, Stony Brook Children's Hospital. She also mentions another consideration is if parents do decide to delay the HBV vaccine to 2 months, they will be taking other vaccines during that wellness visit, which is often scheduled at 2 months.

Typically, during this 2-month check-up, babies are given the following: RSV immunization, (if eligible and in season), as well as their first dose of Rotavirus vaccine, Diphtheria, tetanus, and acellular pertussis vaccine, Haemophilus influenzae type b vaccine, Pneumococcal conjugate vaccine and inactivated poliovirus vaccine. In the past, for babies who missed their second dose of the HBV vaccine at 1month, they could be given this dose at 2 months.3

Although the aims of the current HHS and ACIP is to give less vaccines, under the new recommendation, babies would be given all those immunizations plus the first dose of the HBV vaccine during the 2-month well-visit.

Additionally, Nachman says the message from CDC’s ACIP is deferment of HBV vaccines. “That message of deferment tells families you don't need it now; I don't know that you need it later; and I don't know when you need it,” she said.

A Study That Comes With Controversy

After the ACIP meetings, the CDC awarded an unsolicited, single-source grant to the University of Southern Denmark to support a large randomized clinical trial evaluating the health effects of neonatal monovalent hepatitis B vaccination. Unsolicited grants are problematic as they can be seen as bias.4

The study will be conducted in Guinea-Bissau, a low-income country where the World Health Organization recommends administration of 3 vaccines at birth: Bacille Calmette-Guérin (BCG), oral polio vaccine (OPV), and hepatitis B vaccine. BCG and OPV have been studied for broader effects on child health, the CDC noted that evidence regarding non–hepatitis-specific health effects of HBV remain limited.5

The University of Southern Denmark collaborates with the Bandim Health Project which has been criticized for focusing on non-specific effects (NSEs) of vaccines, defined as health effects beyond protection against their target pathogens. 5A subsequent analysis by outside researchers found problems associated with their studies, including methodological concerns, unpublished primary outcomes, outcome switching, reliance on statistically fragile subgroup analyses, selective emphasis on secondary findings when primary outcomes were null, and underpowered sample-size calculations based on optimistic assumptions.5

Ideology Over Science

The concerns are the current ACIP is adapting ideology over what the science data is showing. And this is not just going to affect hepatitis B infections and the potential increases. We are now witnessing the results of long-time, ongoing anti-vaccine campaigns that have led to more measles and pertussis (whooping cough) cases, including severe disease and some deaths.

These changes to the childhood vaccine schedule will affects a greater number of Americans. And for those who feel they don’t have a stake, the cost of health care will certainly affect taxpayers through Medicare and Medicaid as there will be a greater burden of disease.

In the end, everyone wears a seatbelt for protection against potential accidents. You hope to never get in one, but you wear it to be sure. Vaccines are prevention that have been some of the greatest public health interventions ever put forth.

Despite the science demonstrating efficacy and safety for the birth dose hepatitis B vaccine, the ACIP’s ideology won out and a 2-month delay or beyond for the first HBV vaccine is now the recommendation from the CDC.The new recommendation and its long-term consequences may not be realized for a generation with delayed infections happening when this current generation of newborns become infected with hepatitis B. Nachman points to this youngest generation growing up potentially unvaccinated then participating in risky behaviors, and getting infected as teens or young adults.

“We are going to see children who do not get the birth dose, whose mothers are truly not infected with hepatitis B, so their risk at birth of acquiring it is zero, or close to zero. But, if they don't get the vaccine at 2 months, or at 2 years or some other time, they're going to grow up to be adolescents and adults with no memory that they've never gotten this vaccine. They're going on to have behaviors that may include some risk, and they're going to acquire this infection—which is silent at an age when they're quite vulnerable—and get chronic active Hepatitis B, a disease that we could have easily prevented,” Nachman said.

“We will not see a change in children's health over the next 5 to 10 years, and that means 20 plus years from now, when that cohort of children starts getting sick, we're never going to remember who caused this damage, because it's going to be lost into the annals of history."

References

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

2. New analysis shows delaying the hepatitis B birth dose may lead to thousands of preventable infections and hundreds of millions in avoidable healthcare costs. HepVu. December 1, 2025. Accessed December 2, 2025.
   https://hepvu.org/news-updates/new-analysis-shows-delaying-the-hepatitis-b-birth-dose-may-lead-to-thousands-of-preventable-infections-and-hundreds-of-millions-in-avoidable-healthcare-costs/

3. Start strong with routine checkups and vaccines. Pfizer. Accessed December 23, 2025.
   https://www.babycheckupscount.com/0-2-months

4. Notice of Award of a Single Source Unsolicited Grant to Fund University of Southern Denmark (SDU). CDC. December 18, 2025. Accessed December 23, 2025. https://public-inspection.federalregister.gov/2025-23245.pdf

5. Abene S. CDC Awards Grant to Study Neonatal Hepatitis B Vaccination Outcomes in Guinea-Bissau. Contagion. December 21, 2025. Accessed December 23, 2025.
   https://www.contagionlive.com/view/cdc-awards-grant-to-study-neonatal-hepatitis-b-vaccination-outcomes-in-guinea-bissau