Hepatitis B vaccine at birth best protects newborns, new studies find
Newborn vaccination provides a vital safety net when a mother’s hepatitis B status is unknown.
- 1 May 2026
- 6 min read
- by Linda Geddes
At a glance
- Two new studies in JAMA Pediatrics examined the health and financial impact of delaying or limiting hepatitis B vaccination at birth.
- One study estimated that replacing universal birth-dose vaccination with a targeted approach could cause hundreds of additional newborn infections in a single birth cohort, especially if vaccine coverage falls among babies of unscreened mothers.
- A second study found delaying the first dose could add US$ 16 million to US$ 369 million in lifetime healthcare costs for babies born in a single year, while vaccinating within 24 hours of birth prevented the most infections and was cost saving.
Giving babies a hepatitis B vaccine at birth offers the strongest protection against infection, according to two new studies that found delaying the vaccine could lead to more infections, more deaths later in life and higher healthcare costs.
One study projected up to 628 extra infections in newborns among babies born in the US in a single year if universal hepatitis B vaccination at birth were replaced with a more limited approach. The other found that delaying vaccination could add up to US$ 369 million in additional lifetime healthcare costs for babies born in a single year.
[The studies] add to evidence supporting WHO’s recommendation that all countries provide a hepatitis B vaccine dose within 24 hours of birth.
Although the findings are based on US data, they highlight the value of giving the hepatitis B vaccine at birth in any country where missed screening or delayed vaccination could leave newborns unprotected.
How important is a birth dose of hepatitis B vaccine?
Each year, around 250,000 babies are infected with hepatitis B virus at birth, putting them at high risk of cirrhosis, liver cancer and premature death later in life. Most show no symptoms when they are first infected, but about 95% will go on to develop chronic infection, and around one in four will eventually die from liver disease.
To prevent this, the World Health Organization recommends all babies receive a hepatitis B vaccine dose as soon as possible after birth, ideally within 24 hours, followed by two or three more doses. Three doses supply 98–100% protection that can last for decades, and probably for life.
There is currently debate over replacing universal hepatitis B vaccination at birth with a targeted approach, meaning babies born to mothers who test negative during pregnancy no longer routinely receive the vaccine at birth. Instead, their parents decide with their doctor whether and when hepatitis B vaccination should begin.
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Some researchers and health professionals are concerned that this approach could put some newborns at risk because maternal infections may be missed or acquired later in pregnancy. They also warn that although babies of unscreened mothers, who account for 12–16% of pregnancies, are still supposed to receive a birth dose, some may be missed because hospitals must first identify them. Historically, when universal birth-dose recommendations were temporarily withdrawn in the US in 1999, vaccination coverage among these babies fell sharply.
To investigate the potential impact of the change, Prof Margaret Lind at Boston University School of Public Health and colleagues built a mathematical model of a single US birth cohort of 3.6 million babies. They compared universal vaccination at birth with a targeted approach in which only babies of mothers who tested positive or were unscreened were routinely recommended the birth dose, and tested various real-world scenarios, including lower coverage among babies of unscreened mothers, to better understand how screening and vaccination work together to prevent transmission.
What happens when birth-dose coverage falls?
The research, published in JAMA Pediatrics, found that lower vaccination coverage among babies born to unscreened mothers was linked to a substantial rise in infections.
When birth-dose coverage in this group was set at ten percent – similar to levels seen after the temporary policy change in 1999 – the model projected 628 additional neonatal infections compared with universal vaccination. When coverage was 80%, in line with current levels, the projected increase fell to 69 additional infections.
“Our modeling shows how sensitive hepatitis B prevention is to changes in vaccination coverage at birth,” said Lind.
The team stressed the importance of preventing such cases. “Preventing even a single neonatal hepatitis B infection carries significant clinical importance, as nearly 90% of infections become chronic,” they wrote.
One way to offset the rise in infections would be to increase screening during pregnancy. But even if birth-dose coverage remained at 80%, the model estimated that more than 100,000 additional pregnant women would need to be screened for the targeted approach to match universal vaccination at birth, something the researchers said would require “substantial infrastructure”.
What are the financial costs of removing universal birth-dose vaccination?
A second study, also published in JAMA Pediatrics, examined the economic impact of delaying hepatitis B vaccination. Prof Noele Nelson at Cornell University in New York and colleagues used computer models based on existing research to estimate how different hepatitis B vaccination schedules would affect infections and healthcare costs.
They found that delaying the first dose would lead to more infections, chronic liver disease, liver cancer and premature deaths across all scenarios they modeled. The risks were even greater when children did not receive all three recommended doses.
Depending on how long vaccination was delayed and how many children completed the full course, the extra lifetime costs for babies born in a single year ranged from US$ 16 million to US$ 369 million. “Under no scenario would delaying vaccination be cost saving,” the researchers said.
Because safety concerns had been raised during policy discussions, the researchers also reviewed four decades of evidence, including recent comprehensive safety reviews, and found no sign that the hepatitis B vaccine was linked to any serious adverse reactions such as seizures, other neurological disorders, infections or deaths.
“We found that over 35 years of data demonstrate long-term immunogenicity and likely lifetime protection from hepatitis B vaccines,” Nelson said. “We don’t find any advantage in delaying the first dose of this vaccine, and our findings favour maintaining a policy of universal hepatitis B vaccination at birth.”
She added that multiple studies have shown the later children receive their first hepatitis B vaccine, the less likely they are to complete the full course.
How relevant are these findings outside the US?
Although the studies were based on US data, they add to evidence supporting WHO’s recommendation that all countries provide a hepatitis B vaccine dose within 24 hours of birth. This is especially important where screening during pregnancy is incomplete, or newborns may miss follow-up doses.
Nelson and her colleagues said their analysis showed that giving all babies a hepatitis B vaccine within 24 hours of birth, followed by completion of the full vaccine series, prevented the most infections and saved money compared with any approach that delayed vaccination.
