Experts fear for US childhood vaccine schedule after hepatitis B guideline change

The entire US childhood vaccine schedule is now open for scrutiny, experts say, after government vaccine advisers took up discussions of the safety and efficacy of the vaccines and their components and changed its recommendations on one crucial prevention.

Several of the vaccine advisers are longtime anti-vaccine activists, and they were all chosen by Donald Trump’s controversial health secretary Robert F. Kennedy after he fired the previous advisers in an unprecedented move to enact dramatic changes to US vaccination policy. Kennedy has been a frequent critic of vaccines.

The Advisory Committee on Immunization Practices (ACIP) makes recommendations to the director of the US Centers for Disease Control and Prevention, who decides whether to change official policy. The recommendations also have sweeping effects on state-level policies and insurance coverage. Some states have laws based on recommendations made by the ACIP.

The panel’s landmark vote to change the hepatitis B recommendation will create confusion and access issues for families, and questions about routine vaccines more widely indicate a worrying trend, experts said.

“It’s really very devastating to have seen what unfolded today,” said Susan Wang, a pediatrician and the former lead for prevention of perinatal hepatitis B at the CDC. “It’s also laying the groundwork for destroying the rest of the childhood immunization schedule.”

Robert Malone, vice-chair of the ACIP and an outspoken critic of vaccines, raised doubts about the vaccination schedule, calling it the “elephant in the room” on Friday.

“The specific elephant, in this case, has to do with cumulative risk across the entire childhood vaccine schedule – and that is a risk for which we do not have adequate data,” he said. Vaccines have been given safely in combination to children for decades, and no risks have been observed, according to the CDC.

Malone and other advisers also took aim at aluminum adjuvants, which help vaccines work effectively and multiple studies have shown are safe.

Aaron Siri, a lawyer who is currently engaged in several lawsuits against the US government over vaccines, presented for 90 minutes a selective history of vaccine trials and called into question the long-term effects of vaccination – arguing, without evidence, that some effects may not appear for years.

“What you have said is a terrible, terrible distortion of all the facts,” said Cody Meissner, an adviser and professor of pediatrics at the Geisel School of Medicine at Dartmouth College, sharply criticizing Siri’s presentation.

Siri also claimed that Paul Offit and Peter Hotez, both well-known vaccine experts, were invited but chose not to attend the meeting alongside him.

Offit, reached by phone, said he was “never contacted” about speaking before ACIP. But, he said, he would have declined.

“It’s not an ACIP any more. It’s an anti-vaccine organization,” he said. He pointed to previous decisions to limit flu vaccines containing thimerosal and Covid vaccines for vulnerable populations as unscientific decisions.

The hepatitis B decision is a major misstep, he said. The virus lives on surfaces for a week, making it a concern for anyone who comes into contact with it – but young children are especially vulnerable to long-term illness and death.

“There is no doubt in my mind that this shortens children’s lives. Why would I be part of that?” Offit said. “It’s a parody of public health. It’s a clown show.”

Recommending new restrictions on established vaccines with no evidence of harm means any vaccine is now up for debate, he said.

For Raksha Raheja, the committee’s decisions are professional and personal. She is a pediatrician whose child is living with cancer.

Eroding access to and confidence in vaccines puts her immune-compromised son at greater risk, she said.

“When enough people in a community are vaccinated, it protects those that cannot get immunized, like my son with cancer,” Raheja said. “With vaccination rates dropping, we are putting vulnerable populations at risk, and we see the resurgence of preventable illnesses, like measles.”

The US is currently experiencing the worst measles outbreak in three decades; two unvaccinated children and one adult died of measles in the US this year. If the outbreak is not contained by mid-January, the US will lose its measles-elimination status.

At the meeting, several presenters and advisers repeated myths and misinformation about vaccines, including inaccurate claims that they weren’t studied adequately or that they cause allergies and autism, links that have been roundly debunked in decades of research.

Yet debates about established vaccines that have long been proven as safe and effective has caused public trust in vaccines to begin dropping.

Vicky Pebsworth, an adviser and a nurse said to have been “anti-vax longer than RFK”, seemed to argue on Thursday that the hepatitis shot should not be given because the US has low prevalence of the virus – but that dip in prevalence is due in large part because of “efforts to vaccinate newborns”, said Kevin Ault, an obstetrician and gynecologist and previous ACIP member.

Even so, 2 million people in the US have hepatitis B, indicating the need to continue the vaccination program, Ault said. Ending or impeding widespread vaccination will result in more disease, he added.

Insurers are required to cover vaccines recommended on the childhood immunization schedule, though they may opt to cover optional shots as well. Vaccines for Children, a federal program, covers the vaccination of more than half of children (52%) in the US, and it must follow ACIP recommendations.

Changing the vaccine recommendations will “generate lots of confusion for parents”, said Wang.

In recent weeks, she has cared for several children who came in sick and were completely unvaccinated.

“The mothers say that they’re not against vaccines, but they’re concerned about safety, they’re not sure which ones to give their children, and they need to do their own research,” Wang said.

Dropping vaccination rates aren’t just a danger to children who aren’t protected by vaccination – they make preventable disease a greater threat to everyone, she said. “You have to worry about things we, in the past, did not have to worry about.”