'What else will change?': What ACIP's hepatitis B guidance means for the future of vaccines

Since Robert F. Kennedy Jr., a well-known vaccine skeptic, was appointed secretary of Health and Human Services in February, it was only a matter of time before he took steps to relax vaccine requirements.

In June, he ousted all members of the Advisory Committee on Immunization Practices (ACIP), an expert group that makes vaccine recommendations, and replaced them with several vaccine critics. In September, ACIP changed its recommendations for measles, mumps, rubella, and chickenpox, stopping recommending vaccination of the combination vaccine before age 4 years.

Now, ACIP is proposing to withdraw the hepatitis B guidelines that have been in effect for more than 30 years. Last week, ACIP voted 8-3 to recommend that “parents make decisions on an individual basis about whether to vaccinate infants born to women who test negative for the virus with hepatitis B vaccine, including the birth dose,” according to a press release from the Centers for Disease Control and Prevention (CDC). For those who did not receive the birth dose, ACIP recommends receiving the initial dose “no earlier than” two months.

Hepatitis B is an infectious virus that infects the liver and is the leading cause of liver cancer. It is spread through blood and body fluids. Since 1991, when the CDC recommended that all newborns be vaccinated, infection rates among children and adolescents have dropped by 99%.

The recommendation prompted an outcry from many in the healthcare industry, including organizations such as the American Medical Association, the American Academy of Pediatrics and the National Foundation for Infectious Diseases. The latter told MedCity News that ACIP's guidance could lead to up to 1,400 additional infections and 480 deaths per year, and expressed concerns about the potential impact of other vaccines.

“The U.S. childhood and adolescent immunization program is built on decades of data demonstrating the effectiveness of vaccines that have led to dramatic reductions in diseases such as pneumonia, measles, diphtheria and polio. … These vaccines are not perfect, but they have a good safety record and cause far fewer adverse effects than the lives they save and disabilities they prevent,” Robert H. Hopkins, MD, medical director of the National Foundation for Infectious Diseases, said in an email.

He added that recent reductions in vaccinations have led to outbreaks, including the highest number of measles cases since measles was declared eliminated in 2000, and a six-fold increase in whooping cough in 2024.

Dr. George Benjamin, executive director of the American Public Health Association, is concerned about all other vaccines after ACIP made its recommendation on the hepatitis B vaccine.

“We're going to see more and more people questioning the safety and effectiveness of various vaccines,” he said in an interview. “In addition to hepatitis, we're going to see more measles outbreaks, more whooping cough outbreaks. There's a massive measles outbreak in South Carolina right now, and we've had kids die recently from measles and whooping cough. These are preventable deaths. I believe this is going to happen to all unvaccinated kids.”

According to CDC data, three measles deaths have been confirmed in 2025, Politico reported. Two of the cases were children, both of whom had not been vaccinated. According to the Pan American Health Association, 13 people have died from whooping cough in 2025. It's unclear how many of the deaths were among unvaccinated people, but Louisiana is one example. The two deaths this year were the first since 2018 amid an overall decline in childhood vaccination rates.

Recommendations

Specifically, when ACIP recommends “decision-making based on the individual,” it means that parents and health care providers should consider the benefits of the vaccine, the risks of the vaccine, and the risk of infection, and that parents should consult with their health care provider. For example, parents and providers should consider whether there is a risk of infection in a family member with hepatitis B or if there is regular exposure to people who have immigrated from areas with high hepatitis B prevalence.

Additionally, ACIP recommends that when deciding whether a child needs another dose of hepatitis B vaccine, parents discuss with their health care provider whether to check their child's antibody levels to ensure they are protected.

Despite these recommendations, hepatitis B vaccination will continue to be covered, including by federal programs such as Medicaid and Medicare, as well as programs under the Marketplace. AHIP said back in September that “health plans will continue to cover all ACIP-recommended immunizations recommended as of September 1, 2025, including updated COVID-19 and influenza vaccine formulations, with no cost-sharing for patients through the end of 2026.”

ACIP provides this guidance after hearing presentations on hepatitis B and vaccine safety and briefings from representatives of vaccine manufacturers.

One of the presentations was from climate researcher Dr. Cynthia Nevison, on the burden of hepatitis B disease since 1985. The presentation showed that universal hepatitis B birth doses had little impact on reducing acute cases. Additionally, she explained that 57.9% of the estimated births to women who tested positive for hepatitis B surface antigen were to women born outside the United States.

Another presentation came from Vicky Pebsworth, PhD, RN, chair of the ACIP Child/Adolescent Schedule Working Group, who noted that the United States remains an outlier among low-prevalence developed countries in recommending universal hepatitis B vaccination at birth.

The UK, a developed country by all definitions, has had a universal hepatitis B vaccine since 2017, but only high-risk babies are vaccinated at birth. Others get the first dose at 8 weeks, then again at 12 and 16 weeks.

One of the comparisons made during the meeting was to Denmark, which does not recommend a universal hepatitis B birth dose – although some say this is not an apples-to-apples comparison because Denmark is a much smaller country with universal health care. Canada is probably a closer comparison, allowing provinces and territories to set their own schedules, usually from birth to grade 7.

A September CDC report noted that “116 of the 194 WHO (World Health Organization) member countries recommend universal hepatitis B birth-dose vaccination for all newborns.”

Both Nevison and Pebsworth, who testified at the ACIP conference, are known to have anti-vaccine ties.

ACIP recommendations do not become part of the CDC immunization program until adopted by the CDC Director. Currently, the CDC has no director, only acting CDC Director Jim O'Neill, who has no medical background. However, the American Public Health Association's Benjamin said the acting CDC director does not have the authority to make that decision, so the decision will likely fall to Robert F. Kennedy Jr., although he may delegate the task.

reaction

Many industry experts and professional medical institutions have condemned ACIP’s guidance on hepatitis B.

For example, Benjamin said meetings discussing vaccines were “poorly done” and seemed to blame immigrants (and immigrants as a broad category) and drug use, with little evidence. He said that while drug use is a risk factor, most often people contract hepatitis B through close household contact, which is why it often occurs in families.

Benjamin said this can create a lot of confusion for parents during childbirth, especially during an already chaotic time.

“There are children who were not vaccinated while in hospital and whose parents intended to be vaccinated but they just couldn't get around to it,” he said. Advertisement

The National Foundation for Infectious Diseases' Hopkins echoed those comments, noting that the biggest risk of such action is that more babies may not be protected. According to the organization, hepatitis B vaccination at birth has prevented more than 500,000 childhood infections and prevented about 90,100 child deaths since it was first recommended in 1991.

“Up to half of adults with chronic hepatitis B do not know they are infected, and infants exposed to hepatitis B at birth face the highest likelihood of lifelong infection and serious complications, including liver cancer and cirrhosis,” he said. “Even a small decrease in birth dose coverage could reverse hard-won public health gains. The hepatitis B vaccine has a safety tradition of more than 40 years; the vaccine has not been associated with the common serious adverse effects.”

Dr. Yolanda VanRiel, chair of the nursing department at North Carolina Central University, agreed and raised the question of what this might mean for other vaccines.

“What else is going to change? … This decision is not going to be isolated. We just don't know what they're going to consider next,” Van Riel said in an interview.

Government vilification of vaccines could also have consequences for vaccine manufacturers.

“Vaccines don't make money for companies. It's very expensive… So if the private sector gets discouraged from trying to make a safe and effective product, [but] Benjamin believes that if their product is undermined by bad science, their investors will start to go in a different direction. “I'm worried about our entire vaccine pipeline in this country.”

However, not everyone in the healthcare industry is unhappy with ACIP's recommendations. Dr. Samantha Mitchell, DNP, APRN, AGPCNP-BC, dean of nursing (Houston campus) and interim dean of nursing (Denver campus) at the Denver School of Nursing, said the decision may not have been taken lightly by ACIP and that the group is “doing what's best for those affected, which are newborns.” She added that she expects this will lead to more research by many health care providers and advisory groups on other vaccines.

“I think, in the future, this is just going to lead to them doing more research and looking more deeply at the different things that they use to make the vaccine. So while it does bring benefits and prevent you from getting the disease, it also doesn't lead to other neurotoxic effects or other effects on the body,” she said.

Meanwhile, Hopkins hopes not to withdraw recommendations for other vaccines in the near future. He said NFID is advocating for “the reestablishment of a broadly representative ACIP expert working group, including CDC experts and outside experts in public health, vaccinology, and clinical care, to help ensure that vaccine policies are always based on the best available evidence. Healthcare professionals can help by educating families, answering their questions, and not missing out on vaccination opportunities.”

Photo: Bao Na, Getty Images