The U.S. government’s top vaccine committee has voted to rescind guidance that newborns should be vaccinated to protect against hepatitis B, a virus that can cause chronic liver disease.
On Friday, the Advisory Committee on Immunization Practices (ACIP) voted 8-3 to rescind a medical recommendation that has helped make the hepatitis B vaccine a routine part of postpartum care.
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Instead, ACIP approved new guidance encouraging parents without a history of hepatitis B infection to talk with their health care provider about whether to give the vaccine to their infants.
It also continues to recommend vaccination of children of mothers with hepatitis B.
Medical experts and even drug companies were quick to condemn the change as dangerous, warning that it could encourage parents to leave their children unvaccinated.
The changes are seen as the biggest move yet to change vaccination practices in the United States under Secretary of Health and Human Services Robert F. Kennedy Jr.
“Today is a defining moment for our country. We can no longer trust federal health officials when it comes to vaccines,” Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told Reuters.
“In voting to eliminate the universal birth dose of hepatitis B vaccine, ACIP ignored decades of evidence supporting its strong safety profile and effectiveness. Its decision will result in more hepatitis B infections and more patients with chronic liver disease.”
He added that if ACIP continues to ignore the evidence on vaccine efficacy and safety, “parents and clinicians must ignore ACIP.”
What is hepatitis B?
Each year, 1.2 million people around the world become newly infected with hepatitis B. According to the World Health Organization, there will be approximately 1.1 million deaths related to the virus in 2022.
Hepatitis B is spread through contact with body fluids, and children can contract the virus through simple activities like sharing toothbrushes.
Infections are known to shorten lifespans and can lead to deadly conditions such as cirrhosis (a type of tissue scarring that causes liver failure) and liver cancer.
For most people, the hepatitis B vaccine provides lifelong protection against the virus.
The first injection of a three-dose regimen is usually given immediately after birth. For healthy babies, the U.S. Centers for Disease Control and Prevention (CDC) previously recommended that doctors administer the first vaccine within 24 hours of birth.
For children born to parents who test positive for hepatitis B, the first vaccination should be given even earlier, within 12 hours of birth.
Children born prematurely and with low birth weight were previously advised to wait a month for their first vaccination.
The third and final dose is usually given before the infant reaches 18 months of age.
Prior to Friday’s announcement, U.S. government health experts had also recommended vaccination for all infants. These guidelines have been in place for decades, dating back to 1991, and the vaccines themselves have been available since the 1980s.
Changing health guidelines
However, since taking office in President Donald Trump’s second term Cabinet, Kennedy has been pushing for a review of vaccination guidelines.
His brother Kennedy, the son of former Attorney General Robert F. Kennedy, is an environmental lawyer and former presidential candidate who gained notoriety as a vaccine skeptic.
Although he has repeatedly insisted he is not “anti-vaccine,” he has been accused of promoting vaccine conspiracy theories.
In 2021, for example, he told a group of Louisiana politicians that the COVID-19 vaccine was “the deadliest vaccine ever created.” In 2005, he also published a paper linking vaccines to autism and other neurological disorders, promoting a widely discredited theory. The article was later retracted by the publisher.
Kennedy was confirmed in February to be President Trump’s secretary of Health and Human Services despite having no professional medical experience. This position oversees various Health and Human Services agencies, including Medicaid, CDC, and the Food and Drug Administration (FDA).
Under his leadership, the U.S. government quickly changed its approach to certain vaccines.
For example, in August, the FDA gave limited guidance on who should get the COVID-19 vaccine. The vaccine is recommended only for people 65 years of age and older or those with health conditions.
Critics warned that the changes could limit the availability of coronavirus vaccines and force young people to pick up prescriptions and pay out-of-pocket for preventive care.
Last month, the CDC, which he heads, also removed assurances from its website that vaccines do not cause autism.
But he also changed the standards for vaccine development by pulling government funding from research into mRNA vaccines, the technology used in COVID-19 vaccinations.
ACIP reorganization
But one of the most notable changes Kennedy made was to ACIP, the vaccine-focused committee that has existed since 1964.
President Kennedy fired the 17-member commission in June and replaced it with people who critics said were largely skeptical of vaccinations or had little research background in the field.
Kennedy defended the mass shootings as necessary to maintain the committee’s independence and protect “unbiased science.”
“Today we are prioritizing restoring public trust over any specific pro-or-anti-vaccine agenda,” he said in a statement.
But public health experts expressed outrage that a trusted official was fired and replaced with someone who appeared to reflect President Kennedy’s own beliefs.
Despite the committee’s confusion, the committee was divided on the issue of changing the hepatitis B vaccine recommendation.
A vote on the issue had been postponed twice since September. During Friday’s vote, one ACIP member, pediatrics professor Cody Meisner, cited the medical duty to “do no harm.”
“By changing this language, we are doing harm, and I will vote no,” he said during the vote.
However, the majority of the ACIP committee ultimately decided to support the change, citing the “flexibility” it would provide new parents. However, the CDC guidelines were previously non-binding.
Industry groups expressed significant concerns about the uncertainty created by this change.
“The science is clear: Birth doses of hepatitis B save lives, but there is no new evidence to justify delaying or eliminating this important protection,” the American Pharmacists Association said in a statement.
Former CDC Director Thomas Frieden called on the public to oppose the change.
“Obstetricians, pediatricians, insurance companies, state health departments and others must now stand up for fact-based treatment, protect our children, and not undermine our successes. We must not accept this misguided and dangerous recommendation,” he wrote.
ACIP’s decision will now receive final approval from CDC Director Jim O’Neill.
