On December 5, 2025, the CDC’s vaccine advisers voted to overturn the universal recommendation that every newborn receive a hepatitis B vaccine at birth. The decision came in an 8 to 3 vote by the agency’s Advisory Committee on Immunization Practices (ACIP) and moves the country toward a model in which parents and providers make individual decisions for babies whose mothers test negative for hepatitis B.
If the CDC’s acting director approves the recommendation, hospitals will no longer automatically administer the hepatitis B vaccine at birth for those infants.
The American Academy of Pediatrics (AAP), the nation’s leading pediatric organization, immediately criticized the decision and urged parents to continue following the long-standing standard of care, including giving newborns a hepatitis B vaccine within 24 hours of birth, for their infants’ safety.
For more than 30 years, the hepatitis B birth dose has been part of routine hospital care and one of the earliest protections newborns receive. It has played a key role in preventing early hepatitis B infections, especially when a parent’s infection status is unknown. Many families heard today’s vote and are now trying to understand how this change affects newborn safety in the first hours of life.
Here is what parents need to know right now.
What changed inside ACIP before this vote
Earlier this year, Health and Human Services Secretary Robert F. Kennedy Jr. removed all 17 sitting ACIP members and later appointed new members, citing transparency and evidence-based guidance. The panel is now chaired by Dr. Kirk Milhoan, a pediatric cardiologist and former Air Force flight surgeon. Since these changes, the restructured committee has revised several long-standing vaccine recommendations.
During this week’s two-day meeting in Atlanta, members said portions of the hepatitis B voting language were unclear, which led to a delay and additional discussion before the final vote. A similar postponement occurred during the September session. Public commenters also included speakers with controversial claims about vaccines, adding to concerns from public-health experts about the direction and clarity of the committee’s deliberations.
Officials at the meeting emphasized that families should not face added costs for vaccination and noted that many insurers have pledged to continue coverage through 2026. Some states are already reconsidering how closely to follow the panel’s guidance in response to concerns about ACIP’s new structure and decision-making approach.
Why ACIP revisited the birth dose now
ACIP’s decision to re-examine the hepatitis B birth dose comes in the context of a newly restructured committee and leadership interest in revisiting long-standing vaccine policies. This review did not stem from new scientific evidence. The move to revisit the hepatitis B birth dose comes despite a long record of evidence showing how effective early vaccination has been for protecting infants.
An independent review from the University of Minnesota’s Center for Infectious Disease Research and Policy analyzed more than 400 studies and found that hepatitis B infections in children have fallen by more than 95% since the birth dose was introduced. According to CDC data, routine childhood hepatitis B immunizations prevented more than 6 million illnesses between 1994 and 2023.
Public-health experts warned that moving away from a universal recommendation could complicate hospital routines and create confusion for families who rely on clear guidance in the first hours after birth.
Despite this strong track record, proposed changes supported by Health Secretary leadership and long promoted by Robert F. Kennedy Jr. have moved this question to the center of national discussion. After confusion over the voting language delayed Thursday’s decision, the committee reconvened and completed the vote on December 5.
1. The birth-dose recommendation has changed for some newborns (Vote 8–3)
ACIP voted to replace the universal hepatitis B birth-dose recommendation with individual decision-making for babies born to mothers who test hepatitis B surface antigen (HBsAg) negative.In practice, parents and their healthcare provider will now decide whether the hepatitis B vaccine is given at birth or delayed until the first routine well-visit.
If the birth dose is skipped, the committee suggested starting the vaccine no earlier than 2 months of age.
Some families may welcome the choice. For others, especially families who prefer clear guidance during the hectic and emotional hours after birth, it may feel like one more decision at a vulnerable moment.
Many experts worry that parents could mistakenly feel the vaccine is less important or safe than before.
What does not change
If a mother tests positive for hepatitis B or her status is unknown, the newborn must still receive the hepatitis B vaccine at birth. That part of the schedule remains the same.
The exact voting language was:
“For infants born to HBsAg-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. (1) 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. Y/N
(1) Parents and health care providers should also consider whether there are risks, for example, such as a household member is HBsAg-positive or when there is frequent contact with persons who have emigrated from areas where hepatitis B is common.”
National coverage described the vote as “scrapping” the universal recommendation (Reuters) and “overturning decades-long policy” (NPR), pending approval by the CDC’s acting director.
2. A new recommendation for post-vaccination antibody testing (Vote 6–4, 1 abstention)
ACIP also recommended a new option for children: post-vaccination blood testing (serology) to check whether a child has developed protective antibodies. If the test shows immunity, additional doses may not be needed. Insurance coverage is expected.
CDC officials noted that hepatitis B vaccines were originally tested as a three-dose series, and using antibody testing to shorten the series goes beyond the available evidence.
This vote drew substantial disagreement within the committee and from pediatric infectious disease experts nationwide.
The recommendations now move to the CDC’s acting director for final approval.
Why many experts opposed the change
Many infectious disease specialists and pediatric groups argued that the universal birth dose remains a foundational safeguard in a health system where screening gaps still exist. Many infectious disease specialists worry that loosening the recommendation will lead to delayed vaccination, missed doses, and preventable childhood infections.
During the meeting, several experts voiced strong concerns. Dr. Cody Meissner said, “[Changing the birth-dose recommendation] will certainly increase the risk of cirrhosis, liver cancer, and premature death in a number of children.” He reminded members that hepatitis B rates are low because of successful vaccination, not because the virus has disappeared. “We will see hepatitis B infections come back,” he said.
Another committee member, Dr. Joseph Hibbeln, said, “This change has a great potential to cause harm.”
Multiple medical and public health organizations issued statements opposing the ACIP decision following the vote.
Related: Calming your concerns: how on-time vaccinations protect your child
How medical organizations responded
The American Academy of Pediatrics
The American Academy of Pediatrics issued a statement, calling the committee’s decision “a dangerous move that will harm children.” AAP President Dr. Susan J. Kressly said, “This irresponsible and purposely misleading guidance will lead to more hepatitis B infections in infants and children. I want to reassure parents and clinicians that there is no new or concerning information about the hepatitis B vaccine prompting this change. Instead, this is the result of a deliberate strategy to sow fear and distrust among families.”
The AAP emphasized that it continues to recommend routine hepatitis B vaccination for all newborns, including a dose within 24 hours of birth, and reinforced that the long-standing schedule has “been rigorously tested and proven to be safe and effective over several decades.”
The American Liver Foundation
The American Liver Foundation called the vote “deeply disappointing” and warned that delaying the birth dose could leave infants vulnerable. ALF noted that without early vaccination, up to 90 percent of babies infected in their first year develop chronic hepatitis B, and nearly one in four may die prematurely from liver disease. The group highlighted that the universal birth dose has reduced infant infections by 95 percent and prevented more than 90,000 deaths since 1991.
The American Public Health Association
The American Public Health Association warned that changing the universal recommendation “increases the risk of infection for babies” and leaves families without clear, evidence-based direction. APHA Executive Director Dr. Georges C. Benjamin said delaying the vaccine offers no proven long-term benefit and instead creates “unnecessary exposure and preventable illness.”
What is Hepatitis B?
Hepatitis B is a viral infection that affects the liver. It spreads through blood or bodily fluids, and while adults who contract it often recover, infants and young children are far more likely to develop chronic, lifelong infection.
Although many people associate hepatitis B primarily with sexual transmission or injection-drug use, infants can be exposed in other ways. Transmission can occur during childbirth, through close household contact in early childhood, or through microscopic blood exposure from infected family members. The virus can survive on surfaces for days.
Chronic hepatitis B can lead to serious complications, including cirrhosis, liver failure, and liver cancer later in life
Before universal vaccination, only about half of cases before 1991 were a result of transmission from an infected mother. Many were caused by unrecognized exposures in the home or community. This is one reason universal newborn vaccination became the global standard.
Adding to the concern, as many as 67% of the roughly two million Americans living with hepatitis B are unaware of their infection, highlighting gaps in screening and the potential risk for newborns.
Related: An age-by-age vaccination guide: From newborn to 21 years old
Where the hepatitis B birth dose fits into the vaccine timeline
According to the CDC’s current immunization schedule:
- Dose 1: Within 24 hours of birth
- Dose 2: 1–2 months
- Dose 3: 6–18 months
Newborns are uniquely vulnerable. If infected, about 90 percent develop chronic hepatitis B, compared with 5–10 percent of adults. Early protection matters.
Modeling presented in November 2025 suggested that delaying the first dose to 2 months could result in:
- 1,437 preventable hepatitis B infections among children
- 304 cases of liver cancer
- 482 hepatitis B–related deaths
- More than $222 million in excess healthcare costs
These estimates are based on models, not observed cases, but they underscore why many public-health experts see the birth dose as a key part of preventing severe disease later in life.
If ACIP ultimately moves away from a universal birth dose, the U.S. would be the first.
The World Health Organization (WHO) continues to recommend a universal newborn birth‑dose of the hepatitis B vaccine, “as soon as possible after birth, ideally within 24 hours. We found no documented case of any country reversing a universal newborn hepatitis B birth‑dose recommendation. If the U.S. proceeds with this change, it would be among the first or possibly the first, to do so.
Parents’ most common questions, answered
If I tested negative during pregnancy, why is hepatitis B still discussed for newborns?
Maternal screening greatly reduces risk, but it is not perfect. Studies reviewed by CDC found that an estimated 12%–16% of pregnant women in the U.S. are not screened during pregnancy, and fewer than half of infants born to mothers with hepatitis B are consistently identified through prenatal screening. Infection can also occur later in pregnancy or through other household members or caregivers. The birth dose is designed as a safety net in these real-world conditions.
If mothers are screened during pregnancy, is the birth dose still necessary?
Some argue that the birth dose isn’t needed because mothers are screened during pregnancy. But roughly 1 in 8 mothers may not be properly screened, leaving thousands of potential infections undetected each year. Screening typically occurs at the first prenatal visit, yet mothers can be exposed anytime before delivery. Risk-factor re-screening at delivery isn’t always done, and only about half of infants born to mothers with positive tests are correctly referred for perinatal care.
Given that infants infected in their first year have a 90% chance of developing chronic hepatitis B, universal birth-dose vaccination remains critical. Before universal screening, 7–11% of children born to hepatitis B–negative mothers still contracted the virus via household or community exposure.
Is the hepatitis B birth dose safe for newborns?
Extensive evidence, including reviews covering more than forty years of data, has found no increased risk of serious side effects for infants who receive the vaccine at birth compared with those vaccinated later in infancy. The Vaccine Integrity Project’s independent review concluded that “no short-term or long-term serious adverse events or deaths were found to be causally associated with hepatitis B vaccination.”
Does delaying the first dose help the immune system mature?
Studies have not shown any immunity advantage from delaying the first dose. However, delays can increase the likelihood of missed doses and early-life exposure, which raises the overall risk of infection.
How effective is the full vaccine series for children?
After completing the three-dose series, about 95 percent of children develop long-lasting protective immunity. Long-term studies have shown that protection can last for decades.
How does the hepatitis B vaccine work?
The vaccine contains a harmless piece of the virus made in yeast cells and combined with a small amount of aluminum salts to boost immune response. When given within 24 hours of birth, it prevents up to 90% of infections passed from parent to baby. Overall, 80–100% of children develop protective immunity after vaccination.
Does changing the timing of the birth dose affect the rest of the vaccine schedule?
No. The timing of the second and third doses remains consistent. The discussion centers on when the first dose should be given.
Could changes to the recommendation lead to missed doses?
Experts have noted that any delay increases the chance that newborns might not receive the first dose on time, especially in systems where follow-up is fragmented or families face access barriers.
If the committee is still reviewing the schedule, should parents change anything now?
The established recommendation remains in place unless and until ACIP issues new guidance and CDC adopts it. Hospitals continue to follow the current schedule: a hepatitis B birth dose within 24 hours for medically stable infants, with additional measures for babies born to parents who have hepatitis B.
How much aluminum is in the hepatitis B vaccine?
Aluminum amounts vary by manufacturer. According to FDA-approved package inserts, Engerix-B contains 0.25 mg of aluminum per 0.5 mL infant dose, and Recombivax HB contains 0.25 mg of aluminum per pediatric dose. These are within the limits established for vaccine adjuvants and are considered safe by regulatory standards.
When did the hepatitis B vaccine start being given at birth?
The United States adopted a universal birth-dose recommendation in 1991, first focusing on infants of mothers with hepatitis B and then expanding to all newborns. In 2005 the CDC strengthened the guidance to recommend administration within 24 hours of birth.
When do children receive the hepatitis B vaccine?
The routine CDC schedule includes three doses: the first within 24 hours of birth for medically stable infants, the second at 1 to 2 months of age, and the third at 6 to 18 months. If the birth dose is delayed, the remaining doses follow the same intervals.
Why is the hepatitis B vaccine given at birth?
Infants who become infected at or soon after birth have about a 90 percent chance of developing chronic hepatitis B, compared with 5 to 10 percent of adults. The birth dose provides early protection during a period when exposure can occur through undetected maternal infection or early household contact.
How is hepatitis B transmitted to babies?
Transmission can occur during childbirth if the birthing parent has hepatitis B, even when this is not known at delivery. Early-life exposure can also happen through infected blood or bodily fluids from household members or caregivers.
What vaccines do babies receive in the first months of life?
In addition to hepatitis B, infants typically receive protection against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, pneumococcal disease, and rotavirus. The exact timing follows the CDC immunization schedule starting at birth and 2 months of age.
Vaccine schedule for babies
The CDC recommends vaccines beginning at birth and continuing at 2, 4, and 6 months. These include hepatitis B, DTaP, IPV, Hib, PCV, and rotavirus. Additional vaccines follow later in infancy and early childhood.
How can someone contract hepatitis B?
Hepatitis B spreads through blood or bodily fluids from an infected person. Common routes include childbirth, sexual contact, sharing needles, or exposure to blood through household items such as razors or toothbrushes used by someone with the virus.
When do babies receive the hepatitis B vaccine?
Most infants receive the first dose within 24 hours of birth, the second at 1 to 2 months, and the third at 6 to 18 months. This schedule provides long-lasting protection against early-life infection.
Why is hepatitis B vaccination offered at birth?
The birth dose offers immediate protection during a period when infants are at the highest risk of developing lifelong infection if exposed. It also protects against missed prenatal screening and unrecognized risks in the home environment.
Why do babies receive the hepatitis B vaccine at all?
Hepatitis B is a serious viral infection that can silently persist for decades and lead to liver cancer and liver failure. Vaccinating in early infancy has been shown to prevent chronic infections and dramatically reduce disease in childhood.
The bottom line
ACIP voted to replace the universal hepatitis B birth-dose recommendation with clinician-guided, individual decision-making for infants born to HBsAg-negative mothers.
Parents can continue to follow the current CDC schedule until the CDC’s acting director issues final approval. Whatever happens next, families deserve recommendations rooted in clear evidence and communicated in ways that reduce fear — not add to it.
Sources:
- CIDRAP. Universal Hepatitis B Vaccination at Birth December 2, 2025
- CDC. Health and Economic Benefits of Routine Childhood Immunizations in the Era of the Vaccines for Children Program — United States, 1994–2023 | MMWR
- AAP. Hepatitis B Immunization is Critical to Protect All Newborns
- AAP. AAP Immunization Schedule | Red Book Online | American Academy of Pediatrics
- American Liver Foundation. 2025. ALF Statement of Hep B Vaccine – American Liver Foundation
- ACIP. 2025. ACIP decision to roll back universal Hepatitis B vaccine schedule recommendations will leave children vulnerable to unnecessary exposure and preventable illness
- Mass.gov. Governor Healey Signs Budget That Prioritizes Affordability, Vaccine and Health Care Access, and Public Safety | Mass.gov
- CDC. Clinical Overview of Hepatitis B
- CDC. Clinical Overview of Perinatal Hepatitis B
- WHO. Hepatitis B
- Missouri Department of Health & Senior Services. Hepatitis B | Health & Senior Services
- CDC. Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations — United States, 2023 | MMWR
- CDC. Child and Adolescent Immunization Schedule by Age (Addendum updated August 7, 2025)
- WHO. Vaccines for Hepatitis A, B, and E