A new U.S. policy that recommends offering hepatitis B vaccine at birth only to babies perceived to be at risk of neonatal infection will lead to increased numbers of infected infants and more cases of chronic hepatitis B infection in children that will generate millions of extra dollars in health care costs, two studies published Monday project.
“Avoiding an increase in neonatal infections under the targeted recommendation would require historically unattained levels of maternal [hepatitis B] screening or birth-dose coverage among infants of unscreened mothers,” said one of the studies, from researchers at Boston University, the University of Florida, and Johns Hopkins University.
The second, from researchers at Oregon Health and Science University, the Los Angeles County Department of Public Health, Emory University, and Cornell University, estimated that delaying the first dose of hepatitis B vaccine to two months of age for babies born to mothers who tested negative for the virus could result in an additional 90 infections, 76 chronic infections, and 29 hepatitis B-related deaths annually, with more than $16 million dollars in additional health care costs for each year’s birth cohort.
The first paper estimated the additional infections annually could range from 69 if 80% of the babies recommended to have a birth dose actually got one to 628 if only 10% of those infants were vaccinated.
The studies, published in the journal JAMA Pediatrics, use mathematical modeling to assess the impact of the controversial new policy, which was approved by the Advisory Committee on Immunization Practices in early December and adopted by the Centers for Disease Control and Prevention shortly thereafter, despite public health experts’ warnings against the new approach.
Hepatitis B is a highly infectious virus that is transmitted via bodily fluids. While there is a vaccine to prevent infection, there is no cure. The immune systems of most adults who become infected are able to clear the virus. But babies who are infected have a 90% chance of developing chronic hepatitis B infection, and about a quarter of those who do will die prematurely from liver disease triggered by the infection.
The ACIP, which health secretary Robert F. Kennedy Jr. stacked with vaccine skeptics last year, voted to replace a decades-old recommendation that all babies be vaccinated at birth against hepatitis B with one that suggests only babies born to mothers who have either tested positive for the virus or who haven’t been screened should be offered the vaccine at birth. It goes on to recommend that parents of babies born to a mother who tested negative during pregnancy could decide whether to vaccinate later, suggesting the first (of three) doses not be given before 2 months of age in these cases.
Many states have declared they will not adopt the recommendation, the status of which is currently uncertain. In mid-March, a federal court judge issued a preliminary ruling in a case challenging the restructuring of the ACIP and subsequent changes to vaccination policy, brought by the AAP and other organizations. Judge Brian E. Murphy ruled that the moves were likely illegal.
The studies are precisely the type of research that previous iterations of the ACIP would have pored over before making any decision about changing the hepatitis B birth dose recommendation, said Arthur Reingold, a professor of infectious disease epidemiology at the UC Berkeley School of Public Health. But Reingold said there is no indication that the Kennedy-appointed ACIP did anything of the sort.
He called the studies “very thoughtful analyses.”
Reingold, who previously served on the ACIP, heartily disagrees with the new policy.
“The fact of the matter is … the hepatitis B birth dose has been given to tens of millions of children in the United States and hundreds of millions around the world. And there’s simply not a shred of evidence that there are any adverse effects or safety concerns,” he said.
In an editorial that accompanied the two studies, Grace Lee, a former chair of the ACIP, noted that the debate about whether to change the recommendation did not consider the harms that would flow from changing the policy, focusing instead on unspecified risks of getting the vaccine.
Lee noted the estimates of the impacts of the policy change generated in the studies were conservative. Among other things, they did not take into consideration the fact that changing the policy because of implied potential harms could drive down parents’ willingness to vaccinate their babies against hepatitis B, and would make administering the program more challenging for birthing hospitals and pediatricians.
“As health systems and health care professionals are keenly aware, implementation is not about intent, it is about friction,” wrote Lee, an associate dean for maternal and child health at Stanford University School of Medicine. “With enough friction, it becomes easier to not vaccinate than to vaccinate.”
It is unclear how broadly the new recommendation will be put into practice. Whereas professional medical associations such as the American Academy of Pediatrics and the American College of Obstetrics and Gynecologists for years worked hand in glove with the ACIP, many organizations— including these two — no longer synchronize their vaccination recommendations with the ones issued by the CDC.
It’s widely believed, however, that the new recommendation will lead to confusion and a lowering of the number of babies who get vaccinated against hepatitis B.
“Lack of a universal birth dose recommendation weakens provider and parent confidence and disrupts long-standing protocols for universal birth dose administration which could cause unscreened mothers and their infants to fall through the cracks,” Noele Nelson, senior author of the second study said in an email.
“Unscreened mothers may lack prenatal care, lack insurance, and have other health barriers causing them to be unscreened which contribute to lack of optimal neonatal care,” said Nelson, a professor of public health at Cornell University.
Rachel Epstein, senior author of the first study, agreed.
“We know in general in medicine — infectious diseases in particular — that an intervention is more effective if it’s recommended for everyone,” said Epstein, a pediatric and adult infectious disease physician and clinician investigator at Boston Medical Center. “This could be a situation where having to look for the risk and not it being a routine thing might make the vaccination rate lower in those babies.”
Epstein and her co-authors pointed to data from 1999 to bolster their argument.
The universal birth dose recommendation went into effect in 1991, leading to a dramatic reduction in the number of babies who contracted hepatitis B during infancy. But in 1999 the AAP recommended pausing the birth dose in babies born to mothers who tested negative for hepatitis B, because of concerns at the time about the vaccine preservative thimerosal. (Multiple studies have since disputed the claim that thimerosal in vaccines was responsible, as once alleged, for an increase in autism rates.)
During the period when the universal birth dose recommendation was paused, the percentage of vaccinated babies born to mothers who had not been screened for hepatitis B fell from 53% to 7% — even though the recommendation to offer the vaccine at birth to those babies had not changed. It rebounded after the universal birth dose recommendation was reinstated.
Currently about 86% of pregnant people are tested for hepatitis B. The new ACIP policy recommends that the babies of those mothers who were not tested should still be given a birth dose, but given the earlier experience, Epstein and her co-authors warn that “even modest declines in birth-dose coverage among this group may meaningfully increase neonatal infections.”
Lee’s editorial noted that even prior to the change in policy, the percentage of babies who receive hepatitis B birth doses has been declining, dropping to 73.2% last August from 83.5% in February 2023.