‘What Else Is Going to Change?’: What ACIP’s Hep B Guidance Means for the Future of Vaccines

Since Robert F. Kennedy Jr. — a known vaccine skeptic — was appointed as Secretary of Health and Human Services in February, it was only a matter of time before he took steps to loosen requirements around vaccines.

In June, he removed all members of the Advisory Committee on Immunization Practices (ACIP), an expert panel that makes vaccine recommendations, and replaced them with several vaccine critics. In September, ACIP changed its recommendations for measles, mumps, rubella and varicella to stop recommending the combined vaccine before the age of 4 years.

Now, ACIP is proposing to roll-back guidance for hepatitis B that has been in effect for more than 30 years. Last week, ACIP voted 8-3 to recommend “individual-based decision-making for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus,” according to a news release from the CDC. For those not receiving the birth dose, ACIP suggested receiving the initial dose “no earlier” than two months.

Hepatitis B is a contagious virus that infects the liver and is a leading cause of liver cancer. It is transmitted through blood and bodily fluids. Since 1991, when the CDC recommended the vaccination for all newborns, infections in children and teens have fallen by 99%. 

This recommendation has led to an outcry from many in the medical industry, including organizations like the American Medical Association, the American Academy of Pediatrics and the National Foundation for Infectious Diseases. The latter organization told MedCity News that ACIP’s guidance could lead to as many as 1,400 additional infections and 480 deaths every year, and expressed concern about the potential implications for other vaccines.

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

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

Dr. Georges Benjamin, executive director of the American Public Health Association, worries about all other vaccines after ACIP’s recommendations on hepatitis B vaccines. 

“We’re going to see more and more people questioning safety and efficacy for a whole range of vaccines,” he said in an interview. “We’re going to see more measles outbreaks, more pertussis outbreaks, in addition to hepatitis. We’ve got an enormous outbreak occurring in South Carolina right now with measles, and then we’ve had kids that have died from both measles and pertussis recently. These are preventable deaths. They were, I believe, in all unvaccinated kids.”

According to the CDC, there have been three confirmed deaths from measles in 2025. Two of these cases were children, and neither were vaccinated, Politico reported. There have been 13 deaths from pertussis in 2025, according to the Pan American Health Association. Data is not available on how many of those deaths were in people who were unvaccinated but take Louisiana for instance. The two deaths it experienced this year were its first since 2018 amid an overall fall in childhood vaccinations.

The recommendation

Specifically, when ACIP recommends “individual-based decision-making,” it means that parents and healthcare providers should consider vaccine benefits, vaccine risks and infection risks, and parents should consult with their healthcare provider, according to the announcement. For example, parents and providers should consider whether there are infection risks from a household member with hepatitis B, or if there is frequent contact with someone who emigrated from areas with high hepatitis B rates.

In addition, ACIP advised that when deciding if a child needs another hepatitis B vaccine dose, parents should talk with their healthcare provider about whether to check the child’s antibody levels to make sure they’re protected.  

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

ACIP provided this guidance after hearing presentations on hepatitis B and vaccine safety and briefings from vaccine manufacturer representatives. 

One of the presentations was from Cynthia Nevison, Ph.D., a climate researcher, on hepatitis B disease burden since 1985. The presentation suggested that the universal hepatitis B birth dose has had only a small effect on reducing acute cases. In addition, she explained that 57.9% of estimated births to women who test positive for the hepatitis B surface antigen are attributable to non-U.S.-born women. 

Another presentation was from ACIP Childhood/Adolescent Schedule Workgroup Chair Vicky Pebsworth, Ph.D., RN, who noted that the U.S. remains an outlier among low-prevalence developed countries in recommending a universal hepatitis B vaccine dose at birth.

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

One of the comparisons during the meetings was Denmark, which does not recommend a universal hepatitis B birth dose — though some say this is not an apples-to-apples comparison as Denmark is a significantly smaller country with universal healthcare. Canada may be a closer comparison, which allows provinces and territories to set their own schedules, generally from birth to grade 7. 

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

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

The recommendation from ACIP does not become a part of the CDC immunization schedule until it is adopted by the CDC director. Currently, there isn’t a CDC director, only Acting CDC Director Jim O’Neill, who does not have a medical background. However, the acting CDC director does not have the authority to make this decision, so it will likely fall on RFK Jr., though he may delegate the task, according to Benjamin of the American Public Health Association. 

The reaction

Several experts in the industry and professional medical organizations have condemned ACIP’s guidance on hepatitis B.

For example, Benjamin said the meetings to discuss the vaccine were “poorly done” and seemed to place blame on immigrants (and used immigrants as a broad category) and drug use with very little evidence. While drug use is a risk factor, most of the time people get hepatitis B from close family contact, which is why it’s often seen in households, he said.

This will create a lot of confusion for parents when giving birth, particularly at a time that is already chaotic, Benjamin said.

“There’ll be kids who don’t get vaccinated while they’re in hospital, whose parents intend to do it, but they just don’t get around to it,” he stated. “And we know that happens. It’s not neglect, it’s just life, the way things work. … There may be some confusion of who pays for it. Even though the insurance companies have said they’re going to pay for it, patients may not be sure who’s paying for it. There will be states who will not follow the ACIP recommendation, so you have a lack of coordination at the federal, state and local level.”

Hopkins of the National Foundation for Infectious Diseases echoed these comments, noting that the greatest risk of this action is that more infants could be left unprotected. The hepatitis B birth dose has prevented more than 500,000 childhood infections and prevented an estimated 90,100 childhood deaths since the original recommendation was put in place in 1991, according to the organization.

“Up to half of adults with chronic hepatitis B don’t know they’re infected, and babies exposed around the time of birth face the highest likelihood of lifelong infection and severe complications, including liver cancer and cirrhosis,” he said. “Even small declines in birth-dose coverage could reverse hard-won public health gains. The hepatitis B vaccine has a 40+ year legacy of safety; there have been no common severe adverse effects linked to this vaccine.”

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

“What else is going to change? … This decision won’t be in isolation. We just don’t know what’s going to be the next ones that they are looking at,” VanRiel said in an interview. 

The administration’s vilification of vaccines will likely have an impact on vaccine manufacturers as well.

“Vaccines don’t make money for the companies. It’s very expensive. … So if the private sector is discouraged because they’re going to produce a product that’s going to be safe and effective, [but] have poor science used to undermine their product, their investors are going to start going in different directions,” Benjamin argued. “I fear for the whole pipeline of vaccines in our country.”

Not everyone in the medical industry is upset with ACIP’s recommendation, however. Dr. Samantha Mitchell, DNP, APRN, AGPCNP-BC, dean of nursing (Houston Campus) and interim dean of nursing (Denver Campus) at Denver College of Nursing, said this decision likely wasn’t made lightly by ACIP and that the panel is “doing what’s best for those that are affected, which are the neonates.” She added that she anticipates this to cause a lot of medical providers and advisory panels to look more into other vaccines.

“I think that in the future, it’s just going to lead to them doing more research studies and looking more in depth on the different things that they’re using to create the vaccines. So while it does cause benefits, which keeps you from having disease, it’ll also not cause other neurotoxic effects or other effects to the body,” she said.

Hopkins, meanwhile, hopes that there isn’t a rollback on recommendations for other vaccines in the near future. He said that NFID is advocating “for the re-establishment of broadly representative ACIP expert workgroups, including CDC experts and external experts in public health, vaccinology, and clinical care, to help ensure that vaccine policy remains anchored in the best available evidence. Healthcare professionals can help by educating families, answering their questions, and not missing opportunities to vaccinate.”

Photo: baona, Getty Images