A new U.S. policy recommending that only infants considered to be at risk for neonatal infection be vaccinated with hepatitis B vaccine at birth will lead to higher numbers of infected infants and chronic hepatitis B infections in children, generating millions of dollars in extra health care costs, according to two studies published Monday.
“Averting increases in neonatal infections under targeted recommendations would require historically unattained levels of maternal (hepatitis B) screening and application of birth doses to infants of unscreened mothers,” researchers from Boston University, the University of Florida, and Johns Hopkins University wrote in one of their studies.
Second, researchers from Oregon Health & Science University, Los Angeles County Department of Public Health, Emory University, and Cornell University estimated that delaying the first dose of hepatitis B vaccine to infants born to mothers who tested negative for the virus until 2 months of age could result in 90 additional infections, 76 chronic infections, 29 hepatitis B-related deaths, and more than $16 million in additional health care costs per birth cohort per year.
The first paper estimated that the annual number of additional infections could range from 69 if 80% of infants recommended for birth vaccination actually received one, to 628 if only 10% of those infants were vaccinated.
The study, published in the journal JAMA Pediatrics, uses mathematical modeling to assess the impact of a controversial new policy. The policy 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 warning against the new approach.
Eliminating influenza vaccine requirement puts U.S. military readiness at risk
Hepatitis B is a highly contagious virus that is transmitted through body fluids. There is a vaccine to prevent infection, but there is no cure. Most infected adults’ immune systems are able to eliminate the virus. However, infected infants have a 90% chance of developing chronic hepatitis B infection, and about a quarter of those who develop the disease die early from liver disease caused by the infection.
The ACIP, which Secretary of Health Robert F. Kennedy Jr. consulted with vaccine skeptics last year, voted to replace the decades-old recommendation that all infants receive the hepatitis B vaccine at birth with a recommendation that only infants born to mothers who have tested positive for the virus or have not been tested should receive the vaccine at birth. It also recommends that parents of babies born to mothers who test negative during pregnancy can decide whether to vaccinate them later, suggesting that in such cases the first (of three) vaccinations should not be given before 2 months of age.
Many states have declared that they will not adopt this recommendation, but the status is unclear at this time. In mid-March, a federal judge issued a preliminary ruling in a lawsuit brought by AAP and other groups challenging ACIP’s restructuring and subsequent vaccination policy changes. Judge Brian E. Murphy ruled that the move was likely illegal.
Arthur Rheingold, a professor of infectious disease epidemiology at the University of California, Berkeley School of Public Health, said the study is exactly the kind of study ACIP would have considered before making a decision about changing the hepatitis B birth dose recommendation. But Rheingold said there is no evidence that ACIP, which was appointed by President Kennedy, did anything like that.
He called the study “a very thoughtful analysis.”
Rheingold, who previously served on the ACIP board, wholeheartedly opposes the new policy.
“The fact is that birth doses of hepatitis B have been given to tens of millions of children in the United States and hundreds of millions of children around the world, and there is no evidence that there are any side effects or safety concerns,” he said.
In an editorial accompanying the two studies, Grace Lee, former chair of ACIP, noted that the debate over whether to change recommendations has not taken into account the harms that would result from policy changes, and instead focused on unspecified risks from vaccination.
Lee noted that the study’s estimates of the impact of policy changes are conservative. Among other things, they did not take into account the fact that changing policy because of the implication of potential harm could reduce the willingness of parents to vaccinate their babies with hepatitis B vaccine and could make the program more difficult for maternity hospitals and pediatricians to implement.
“As health systems and health professionals are acutely aware, implementation is about friction, not intent,” said Lee, associate dean of the School of Maternal and Child Health at Stanford University School of Medicine. “If there is enough friction, it becomes easier not to vaccinate than to vaccinate.”
It is unclear how broadly the new recommendations will be implemented. Although professional medical societies such as the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists have worked with ACIP for years, these two organizations and many other medical organizations have not synchronized their vaccination recommendations with those issued by the CDC.
However, the new recommendations are widely believed to be confusing and lead to fewer infants receiving hepatitis B vaccination.
“The lack of a universal birth dose recommendation undermines health care provider and parent trust, disrupts long-standing protocols for universal birth dose administration, and may result in failure for unscreened mothers and their infants,” Noelle Nelson, lead author of the second study, said in an email.
Nelson, a professor of public health at Cornell University, said, “Untested mothers may not have access to prenatal care, lack insurance, or have other health barriers that may prevent them from getting tested, which contributes to the lack of optimal newborn care.”
Rachel Epstein, senior author of the original study, agreed.
“In medicine, especially in infectious diseases, we generally know that interventions are more effective when they are recommended to everyone,” said Epstein, a pediatric and adult infectious disease physician and clinical researcher at Boston University. “This puts us in a situation where we have to look for risks rather than routines, which could lead to lower infant vaccination rates.”
Don’t believe headlines about widespread vaccine skepticism
Epstein and his co-authors cited 1999 data to support their argument.
Universal birth dose recommendations went into effect in 1991 and have dramatically reduced the number of infants who become infected with hepatitis B during infancy. However, in 1999, the AAP recommended a moratorium on giving it at birth to infants born to mothers who tested negative for hepatitis B, citing concerns about the vaccine preservative thimerosal at the time. (Multiple studies have since disputed the claim that thimerosal in vaccines is responsible for increased autism rates, as once claimed.)
During the period when vaccination recommendations at birth were suspended, the proportion of infants born to mothers who were not screened for hepatitis B decreased from 53% to 7%. Even so, the recommendation to vaccinate these infants at birth remained unchanged. It recovered after universal birth dose recommendations were reinstated.
Approximately 86% of pregnant women are currently tested for hepatitis B. The new ACIP policy recommends that infants of mothers who were not tested should also receive the birth dose, but given previous experience, Epstein and his coauthors warn that “even a small decrease in birth dose coverage in this group could result in a substantial increase in neonatal infections.”
Lee’s editorial noted that even before the policy change, the proportion of infants receiving prenatal vaccination against hepatitis B was declining, from 83.5% in February 2023 to 73.2% in August last year.
