A new review of more than 400 studies spanning 40 years finds no evidence that delaying the universal hepatitis B vaccine birth dose improves safety or effectiveness. The review also finds that birth dose vaccination does not cause any short- or long-term serious adverse events or deaths.
“We did an independent review, prioritizing high-quality studies and systemic reviews and meta-analyses,” says Angela K. Ulrich, PhD, MPH, who helped lead the Vaccine Integrity Project (VIP) analysis. “We wanted to see if there was any new evidence that we weren't aware of that justified delaying the birth dose for newborns. What we found is that there’s not any new evidence to suggest that delaying the birth dose would be safer or more efficacious in the US population.”
The VIP is an initiative of the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP), and the new review comes as the US Centers for Disease Control and Prevention (CDC) vaccine advisory panel—the Advisory Committee on Immunization Practices (ACIP)—prepares to revisit a proposal to delay the birth dose for infants born to mothers who test negative for hepatitis B. In September, the ACIP postponed a vote on delaying the birth dose of the hepatitis B vaccine.
Current schedule has prevented more than 6 million infections
Universal hepatitis B vaccination of newborns has been a cornerstone of the US strategy to prevent hepatitis B infection—and related diseases and deaths—for more than three decades.
These recommendations, which, historically, the ACIP has endorsed, have helped curb viral hepatitis in the United States. Since the universal birth-dose recommendation was adopted in 1991, nationwide pediatric infections have fallen by more than 95%, and infant infections have been almost completely eliminated. A 2024 CDC study showed that the current vaccination schedule has helped prevent more than 6 million hepatitis B infections and nearly 1 million hepatitis B–related hospitalizations.
But at its most recent meeting this September, the current ACIP tabled a vote to delay the birth dose for babies born to women who test negative for hepatitis B. The ACIP, now repopulated with vaccine skeptics and less experienced members, thanks to a reshuffling by Health and Human Services Secretary Robert F. Kennedy Jr., is expected to reconsider the vote again at its December 4 meeting.
Birth dose reduces transmission by roughly 70%
The new review, which spans four decades of randomized trials, surveillance data, long-term follow-up studies and prior ACIP evaluations, strongly supports the existing recommendation that all medically stable newborns receive their first hepatitis vaccine dose within 24 hours of birth.
The birth-dose vaccine reduces perinatal transmission by roughly 70% when used alone. When combined with hepatitis B immune globulin, protection increases to from 83% to 97%. Birth dose vaccine protection against hepatitis B and related complications lasts more than 35 years. Delaying the first dose provides no immune-protection benefit.
There’s not any new evidence to suggest that delaying the birth dose would be safer or more efficacious in the US population.
Short-term reactions, like low-grade fever or local redness, were mild to moderate, and no causal links to serious adverse events or deaths were found. Studies directly comparing infants vaccinated at birth with those vaccinated at one month or later found no differences in safety outcomes.
“Things would be different if there was evidence suggesting a safety challenge or effectiveness challenge, but the data speak for themselves,” says Michael T. Osterholm, PhD, MPH, director of CIDRAP, which publishes CIDRAP News.
Delaying the first dose makes infants vulnerable to missed maternal diagnoses, as well as postnatal exposure. About half of people living with the virus are unaware of their infection, and hepatitis B is highly transmissible and can survive on surfaces for more than a week. What’s more, an estimated 18% of pregnant women do not receive hepatitis B testing, and only 35% of those who test positive receive the recommended follow-up care.
“We've tried risk-based approaches to vaccination before, which is what they're recommending, and we saw persistently high levels of hepatitis B in children, young adults, and adults,” says Ulrich. “By moving to the universal birth dose, we saw this real protection of infants and then of the population as time went on. I think, in some ways, the vaccine is a victim of its own success.”
Will ACIP vote based on the evidence?
Changing the birth-dose recommendation would undermine decades of progress in preventing perinatal and early-childhood hepatitis B infections, the authors of the review say. Without vaccine protection, 90% of infants infected around birth will develop chronic infection and one in four of those children will die prematurely of liver disease or liver cancer.
“The evidence we found overwhelmingly supports keeping the recommendation for universal birth dose,” says Ulrich. “And there's not any new evidence to suggest that what we have should change.”
The real question before ACIP is whether its members will vote based on the evidence.
As the data coalesce into a clear picture, the focus now shifts from the evidence itself to how ACIP will act on it.
“The real question before ACIP is whether its members will vote based on the evidence,” says Osterholm in a CIDRAP press release. “A delay [in the first vaccine dose] will needlessly endanger the health of America’s children.”
