A top-level vaccine panel in the United States government has voted to peel back guidance that newborn babies should receive a vaccine to shield against hepatitis B, a virus that can cause chronic liver problems.

On Friday, the Advisory Committee on Immunization Practices (ACIP) voted eight to three to rescind the medical advice, which has helped make hepatitis B vaccines a routine part of post-natal care.

Recommended Stories

list of 3 itemsend of list

Instead, ACIP approved new guidance that encourages parents who have no history of hepatitis B infection to speak with their healthcare provider about whether to administer the vaccine to their infants.

It also continues to advise administering the vaccine for children of mothers who have hepatitis B.

Medical experts and even pharmaceutical companies quickly denounced the change as dangerous, warning that it could encourage parents to leave their children unvaccinated.

The change is considered the biggest move so far under Secretary of Health and Human Services Robert F Kennedy Jr to change vaccination practices in the US.

“Today is a defining moment for our country. We can no longer trust federal health authorities when it comes to vaccines,” Michael Osterholm, the director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told the news agency Reuters.

“In voting to eliminate the universal birth dose of the hepatitis B vaccine, ACIP ignored decades of evidence confirming its strong safety profile and effectiveness. Its decision will result in more hepatitis B infections and more people with chronic liver disease.”

Advertisement

He added that, if ACIP continues to ignore the evidence about vaccine efficacy and safety, “parents and clinicians must ignore ACIP”.

What is hepatitis B?

Each year, around the world, 1.2 million people become newly infected with hepatitis B. According to the World Health Organization, approximately 1.1 million deaths in 2022 were also linked to the virus.

Hepatitis B is spread through contact with bodily fluids, and children could potentially acquire the virus through activities as simple as sharing a toothbrush.

Infections are known to shorten life spans and can potentially lead to fatal conditions like cirrhosis — a kind of tissue scarring that causes liver failure — and liver cancer.

For most people, the hepatitis B vaccine confers lifelong protection against the virus.

The first shot in the three-dose regimen is usually given shortly after birth. For a healthy baby, the US Centers for Disease Control and Prevention (CDC) had previously advised that doctors administer the first dose within 24 hours of birth.

For a child born to a parent who tests positive for hepatitis B, the first vaccination should be even sooner, 12 hours after birth.

For children born premature and underweight, the advice was formerly to wait a month before administering the first dose.

The third and final dose typically comes before the infant reaches 18 months old.

Prior to Friday’s announcement, health experts in the US government had also recommended vaccination for all infants. Those guidelines had been in place for decades, stretching back to 1991, and the vaccine itself has been available since the 1980s.

Changing health guidelines

But Kennedy has pushed to review vaccination guidelines since taking office as part of President Donald Trump’s second-term cabinet.

The son of former Attorney General Robert F Kennedy, the younger Kennedy is an environmental lawyer and former presidential candidate who gained notoriety as a vaccine sceptic.

While he has repeatedly claimed he is not “anti-vaccine”, he has been accused of spreading vaccine conspiracy theories.

In 2021, for instance, he told an audience of Louisiana politicians that the COVID-19 shot was the “deadliest vaccine ever made”. In 2005, he also published an article linking vaccines to autism and other neurological disorders, promoting a widely discredited theory. That article was later retracted by its publishers.

In February, Kennedy was confirmed as Trump’s health and human services secretary, despite having no professional medical experience. The position oversees a range of health and welfare agencies, including Medicaid, the CDC and the Food and Drug Administration (FDA).

Advertisement

Under his leadership, the US government swiftly changed its approach to certain vaccines.

In August, for example, the FDA limited its guidance for who should take the COVID-19 vaccine. Only people aged 65 and up, or people with health conditions, were recommended for the vaccine.

Critics warned that change could limit the availability of the COVID-19 vaccine and force younger people to get a prescription and pay out of pocket for the preventive care.

Last month, the CDC under his leadership also removed assurances that vaccines do not cause autism from its website.

Meanwhile, he has pulled government funding from research into mRNA vaccines — the technology used for the COVID-19 vaccination — and changed the standards for vaccine development.

Shake-up at ACIP

One of the most prominent changes Kennedy has made, however, has been at the ACIP, a panel focused on vaccines that has been in existence since 1964.

In June, Kennedy fired the 17-member committee and replaced them with figures that critics say are largely sceptical of vaccination or have little research background in the area.

Kennedy defended the mass firing as necessary to maintain the independence of the panel and defend “unbiased science”.

“Today we are prioritizing the restoration of public trust above any specific pro- or anti-vaccine agenda,” he said in a statement.

But public health experts expressed outrage that trusted officials were fired and replaced with those who seemed to reflect Kennedy’s own beliefs.

Despite the shake-up on the panel, its membership was nevertheless split over the issue of changing the recommendation for the hepatitis B vaccine.

A vote on the issue had been delayed twice since September. During Friday’s vote, one ACIP member, paediatrics professor Cody Meissner, cited the medical duty to “do no harm”.

“We are doing harm by changing this wording. And I vote no,” he said in his vote.

But the majority of the ACIP panel ultimately decided to back the change, citing the “flexibility” it offered to new parents. The CDC’s guidelines, however, were not previously binding.

Industry groups responded with grave concerns about the ambiguity the change would create.

“The science is clear: the hepatitis B birth dose saves lives, and there is no new evidence to justify delaying or removing this critical protection,” the American Pharmacists Association said in a statement.

A former CDC director, Thomas Frieden, called on the public to stand against the change.

“Now obstetricians, pediatricians, insurers, state health departments and others should stand up for fact-based care, protect our children, and not mess with success — not accept this misguided and dangerous recommendation,” he wrote.

The ACIP decision is now set to go before the director of the CDC, Jim O’Neill, for final approval.