A panel of US vaccine advisers has voted to rescind its long-standing recommendation that hepatitis B virus (HBV) vaccination be given immediately after birth.
The Advisory Committee on Immunization Practices (Acip) voted 8 to 3 to support “individualized decision making” about whether to vaccinate children born to mothers who test negative for liver infection.
In June, Health Secretary Robert Kennedy Jr., a vaccine skeptic, fired all Acip members and replaced them with others critical of vaccines.
The United States has recommended that newborns be vaccinated against hepatitis B since 1991. data suggests that vaccines have prevented about 90,000 deaths since then.
Hours after the decision, President Donald Trump ordered his top health officials to review all childhood vaccination recommendations in the United States.
In a White House memo, he asked them to “reconsider the best practices of peer developed countries regarding key childhood vaccination recommendations.” If they find that other countries' practices are better, then Trump will order them to change the US schedule.
In the memo, he noted that some other countries are recommending fewer vaccinations for children.
Trump also praised the advisory committee for their Friday decision, calling it “very good” in a social media post.
Acip is responsible for providing recommendations to the US Centers for Disease Control and Prevention (CDC) on when and who should be vaccinated. The Acting Director of the CDC has final approval of the recommendation.
The new guidance also suggests that infants who do not receive a vaccine dose at birth should receive an initial dose of the vaccine “no earlier than two months of age,” a recommendation that several panel members opposed.
Public health experts worry the vote could raise unfounded concerns about the vaccine's safety and prompt some people to refuse it, leading to more cases.
This concern was shared by some Acip panel members.
“The recommendations for hepatitis B vaccination are very well established,” Dr. Cody Meissner said before voting no.
“We know it's safe and we know it's very effective. And to make the proposed changes, we will see more children, adolescents and adults infected with hepatitis B.”
The group still recommends that a dose of the vaccine be given to children born to mothers who test positive for hepatitis B. The move is not expected to affect insurance coverage of the shot.
Hepatitis B is a liver infection that is spread by direct contact with body fluids and can lead to dangerous liver diseases, including cancer, liver failure, and cirrhosis.
Pregnant women with hepatitis B can also pass the virus to their newborns during childbirth, which can lead to chronic infections that can damage the liver.
People infected with HBV do not always have symptoms, meaning they may not even know they have the virus and may spread it while caring for children and infants.
Friday's decision came after a tense two-day meeting on the issue, after Acip twice decided to delay a vote on hepatitis B vaccinations.
On Friday, several members of the commission expressed their objections to the new rules, in particular against the fact that vaccinations are recommended no earlier than two months of age.
The ballot measures are “incredibly problematic”, said Dr Joseph Hibbeln, while Dr Meissner said members were acting on the basis of “unfounded skepticism”.
One of the committee members advocating the change, Retzef Levy, said U.S. hepatitis B vaccination policy is “out of sync” with other countries around the world.
The World Health Organization recommends that children be vaccinated against HBV at 0, one and six months of age.
In the UK, vaccination is recommended at eight, 12 and 16 weeks, unless the mother tests positive for the virus.
During hours-long meetings on Thursday and Friday, the committee heard from several doctors, including many who criticized the panel for considering lifting recommendations for universal vaccination.
Committee members who voted for the new recommendations argued that the risk of contracting the virus is low and that vaccines should be individualized for each patient.
Critics of the birth dose argue that babies should only be vaccinated as newborns if their mother tests positive for the virus.
But doctors say this puts some children at risk because not all pregnant women have reliable access to testing, while others may receive a false negative test for hepatitis B.
Kennedy and his allies have questioned the safety of the hepatitis B vaccine and argue that it is primarily spread through sexual contact and the sharing of needles.
However, research has shown that it can also be spread through indirect contact, such as shared toothbrushes and razors.
Since taking office, Kennedy has made a number of changes to U.S. vaccine policy.
Acip's decision to revise vaccine recommendations angered Republican Sen. Bill Cassidy, a physician who cast the tie-breaking vote in confirming Kennedy as health secretary despite concerns about his previous stance on vaccines.
“As a liver specialist who has treated patients with hepatitis B for decades, this change in the vaccination schedule is a mistake,” Cassidy said in a statement.
“The hepatitis B vaccine is safe and effective. Birth dose is a recommendation, NOT a requirement.”
In response to the committee's vote, the Maryland Department of Health on Friday issued an advisory, citing a recommendation from the American Academy of Pediatrics, urging health care providers and hospitals to continue offering hepatitis B vaccines at birth and said it was working to ensure access to the vaccine for all infants and children in the state.
