Loading ...

The recent federal decision to scale back recommendations for universal hepatitis B vaccination at birth could lead to hundreds of additional infections in US infants each year, particularly if vaccination rates decline among babies born to mothers with unknown infection status, according to a modeling study published in JAMA Pediatrics.

The study comes months after the Advisory Committee on Immunization Practices (ACIP) voted in December 2025 to replace its longstanding universal hepatitis B birth-dose recommendation with “shared clinical decision-making” for infants born to mothers who test negative for hepatitis B surface antigen. Under the new guidance, those infants may delay vaccination until at least 2 months of age.

Additional stated rationales behind the ACIP change in recommendation is that the prenatal screening test are reliable and almost universal, and that rates of perinatal transmission are very low.

Researchers at Boston University School of Public Health, Boston, estimated that the policy shift could result in 69-628 additional neonatal hepatitis B infections annually, depending on how much vaccination coverage falls in infants whose mothers were not screened during pregnancy.

The study modeled outcomes for a US birth cohort of about 3.66 million infants using current maternal screening rates and historical vaccination patterns. Researchers found that preventing the increase in infections under the new recommendation would require screening more than 100,000 additional pregnant women if birth-dose coverage among unscreened mothers remained near current levels. If coverage dropped sharply — as it did after a temporary policy change in 1999 — more than 400,000 additional women would need to be screened to offset the increase in infections.

According to the researchers, universal maternal screening and universal newborn vaccination “operate as complementary safeguards” and warned that replacing one layer of protection with more intensive screening “may be difficult to achieve in practice.”

Effects of Weakening Vaccine Protections

Public health advocates say the concern extends beyond the birth dose itself. Chari A. Cohen, DrPH, president of the Hepatitis B Foundation, warned that changing the recommendation could create confusion for both clinicians and families at a time when vaccination rates are already declining.

“There is strong data to support that the universal birth dose, followed by full completion of the three-dose vaccine, is the best way to prevent infection and save lives,” Cohen said. “There is no data or rationale to support delaying the hepatitis B vaccine or providing fewer than three doses.”

“These changes will have a cascade effect that will cause confusion among parents and providers, and leave the next generation unprotected from this cancer-causing virus,” she added.

Ravi Jhaveri, MD, division head of Pediatric Infectious Diseases at Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, who was not involved in the study, said the findings reinforce longstanding concerns among pediatric infectious disease specialists about weakening universal newborn vaccination policies.

Jhaveri warned that the new recommendation assumes a level of coordination in prenatal care that does not always exist in practice.

“We know that hundreds of thousands of women who present for delivery may never have had prenatal care, and may or may not have ever been tested,” Jhaveri said. “It’s a fallacy to say that our current system truly screens every pregnant woman.”

Jhaveri said the consequences of declining vaccination rates may not become obvious immediately. “We’re not likely to see the consequences for some time because so many of the worst complications of hepatitis B are from chronic infection that we might see a few decades from now,” he said.

Delayed Vaccination Leaves Infants Vulnerable

Su H. Wang, MD, a primary care clinician and medical director for the Chinese Medical Program at Cooperman Barnabas Medical Center in Florham Park, New Jersey, said she was not surprised by the study’s modeling projections. Delaying vaccination, she said, creates more opportunities for infants to miss protection during a critical period.

“This is a really critical window of time where babies can be protected,” said Wang, who is also the senior advisor for global health at the Hepatitis B Foundation. “And if you miss it, that’s it. They become infected for life.”

Nearly 90% of the neonatal hepatitis B infections become chronic, increasing lifetime risks for cirrhosis, liver cancer, and premature death, according to the CDC.

Wang said focusing mostly on maternal transmission risks overlooks how infants can contract hepatitis B from infected family or household members. Wang pointed to her own experience, saying she likely contracted hepatitis B from grandparents who helped care for her as an infant even though her mother did not have the virus.

Additional research published in JAMA Network Open found that children who miss the hepatitis B vaccine at birth are significantly less likely to complete the full vaccine series by 18 months of age. Researchers analyzed records from more than 1.1 million children in the Vaccine Safety Datalink and found that 97.6% of the infants who received a birth dose completed the three-dose series compared with completion rates that fell to 55.3% in children born in 2023 who did not receive the vaccine at birth.

The decline was especially pronounced among White children and English-speaking families, according to the study.

In an accompanying editorial, Grace M. Lee, a pediatric infectious disease specialist at Stanford University School of Medicine, Palo Alto, California, wrote that the new recommendation could undermine decades of progress against hepatitis B.

“Since 1991, the US Advisory Committee on Immunization Practices has endorsed universal hepatitis B vaccination at birth,” Lee wrote. “Since then, cases of HBV [hepatitis B virus] infection in children have declined by 99%.”

Lee wrote that the committee focused heavily on “theoretical safety concerns” despite “the absence of safety signals with more than 1 billion doses given worldwide since 1982.”

She also noted that hepatitis B vaccination rates among newborns had already been declining before the recommendation change, dropping from a peak of 83.5% in early 2023 to 73.2% by August 2025.

Clinicians Urge Clear Vaccine Messaging

Both Wang and Jhaveri said hospitals and clinicians should continue treating hepatitis B vaccination as routine newborn care while strengthening communication with parents about vaccine safety and effectiveness.

“The default is vaccination,” Jhaveri said, describing how clinicians should frame routine immunizations during pediatric visits. “There is real powerful choice and influence in how people make decisions just based on how you present the choice.”

Wang said clinicians should continue giving parents clear recommendations rather than presenting vaccination and delay as equivalent options.

“The benefit far exceeds the risk for vaccinating,” Wang said.

Wang also urged health systems and physicians to invest in patient education and provide families with accessible, evidence-based information about vaccine safety and effectiveness.

“Educated patients are great, and it’s really important, especially now, to make sure we have the resources to provide to patients,” she said. “We should be able to point them to all these great resources that are out there that show them that there are great studies on safety and efficacy and how we’re protecting their babies.”

Lind and her colleagues reported receiving grants from MSD and Regeneron Pharmaceuticals, paid to Yale University, for work unrelated to this project; grants from MSD, paid to the University of Florida, for work unrelated to this project; grants from Pfizer and the National Institutes of Health, paid to their institution, for work unrelated to this project; and grants from the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, and the National Institute on Drug Abuse during the conduct of the study. Jhaveri, Wang, and Cohen reported having no relevant disclosures.

Lara Salahi is a health journalist based in Boston.