Fate of hepatitis B vaccine for US babies hangs in the balance

Members of a top US vaccine advisory panel are scheduled to vote Friday on whether to roll back a decades-old recommendation that all newborns receive a hepatitis B vaccine shortly after birth — a measure that has been associated with a sharp decline in mother-to-child transmission of the hepatitis B virus, which causes liver disease.

In discussions on Thursday, some members of the US Advisory Committee on Immunization Practices (ACIP) raised questions about the ‘birth dose’ of the vaccine. Several members of the panel have expressed criticism of vaccines.

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“What we are doing here is trying to undo some really, really bad decision processes we had in the past,” said ACIP member Retsef Levi, a professor of operations management at the Massachusetts Institute of Technology in Cambridge.

“We have to look at what is happening now that this programme has been in place for decades,” said ACIP member Evelyn Griffin, an obstetrician and gynecologist at Baton Rouge General Hospital in Louisiana. “Sometimes autoimmune conditions take decades to develop.”

But the US vaccine-safety monitoring system can detect “very, very rare” safety events, Rochelle Walensky, who directed the US Centers for Disease Control and Protection (CDC) from 2021 to 2023 and is now a professor of medicine at Harvard Medical School in Boston, Massachusetts, responded at a media briefing. “And over 35 years, with a huge amount of experience and millions of doses given, we have not detected those events.”

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Chronic infection with the hepatitis B virus can cause liver cancer and even death. Since 1991, US public-health officials have recommended vaccinating all healthy babies at birth, a policy that helped to drive down infections¹ in people younger than 19 by 99%. But, in September, members of the ACIP, which provides advice to the CDC, started discussing the possibility of delaying the first vaccine dose.

“ACIP will review the evidence at its meeting this week and issue recommendations based on gold-standard, evidence-based science and common sense”, said Emily Hilliard, the press secretary for the US Department of Health and Human Services, which includes the CDC.

Here, Nature examines some of the questions that have been raised about the hepatitis B birth dose.

What is the rationale for revisiting this vaccine recommendation?

The ACIP routinely revisits its recommendations in light of new evidence. This re-evaluation was prompted by concerns about public dissatisfaction with US vaccination policy, according to ACIP member Vicky Pebsworth, a nurse and health-policy analyst at the National Vaccine Information Center in Sterling, Virginia. During the meeting Thursday, Pebsworth cited two surveys, including one in which 16% of parents reported skipping or delaying childhood vaccines in part because of concerns about side effects and safety. “This level of dissatisfaction is of societal significance and poses challenges for vaccination policy making,” she said.

The same survey also found that 90% of parents said it is important for children to receive the vaccine for measles, mumps and rubella, and 88% said the same for the polio vaccine.

Pebsworth also noted that the US policy is “misaligned relative to existing recommendations in most other developed countries” where universal birth-dose vaccination is not the standard practice. Walensky responded at the briefing that “the United States has access issues and insurance issues that don’t mirror access and insurance issues of other countries”.

Hepatitis B is a sexually transmitted disease, so why should newborns be vaccinated?

It’s true that hepatitis B spreads through contact with infected body fluids such as blood, semen and vaginal fluids. In countries where the virus is less prevalent, such as the United States, most infections are acquired during adulthood, according to the World Health Organization. But even in the United States, more than 600 mothers transmit the virus to their babies annually, according to a study² published 3 December by Walensky and others.

“People are talking about hepatitis B as if we’re back in the 1970s, when we were very concerned about sexual transmission,” says John Ward, a medical epidemiologist specializing in hepatitis at the Task Force for Global Health, a non-profit programme in Decatur, Georgia. At the time, “the studies had not yet been done showing how frequently the virus spread from mother to child”.

Why not vaccinate only babies whose parents test positive for hepatitis B?

If screening worked perfectly well, targeting only these babies might be enough. But “there will be a number of infants who sneak through the cracks, who are missed by gaps in prenatal detection”, says Angela Ulrich, an infectious-disease epidemiologist at the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

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For example, pregnant people can receive false-negative test results; one study³ estimated that tests detect 95-100% of infections, meaning that that some of the tests are highly sensitive but not perfect. And some people are never screened at all: an analysis of more than 500,000 US pregnancies from 2015 to 2019 found that almost 15% of the pregnant people studied were not tested⁴.