Vaccine advisers for the US Centers for Disease Control and Prevention (CDC) voted on Friday morning to limit hepatitis B vaccines in a major move signaling the Trump administration’s regressive approach to vaccines that have been given safely and effectively for decades.
The panel of advisers, hand-picked by the US health secretary, Robert F Kennedy Jr, decided to remove the well-established and far-reaching recommendation that all newborns in the US receive a hepatitis B vaccine.
The committee voted to recommend that parents of infants whose mothers test negative for hepatitis should decide when – or if – their child should receive the vaccine series, in consultation with a healthcare professional. Consulting with doctors was already a standard part of vaccination.
The move on Friday will add confusion to routine vaccinations and create access issues, especially for lower-income families, experts said. While the advisers make non-binding recommendations, they frequently form the basis of official policy, and they directly affect the way private and federal insurance providers cover the vaccines.
Donald Trump welcomed the long-standing recommendation being scrapped and signed a memo to review aligning child immunization recommendations with best practices from “peer, developed countries”.
“This is going to lead to an increase in preventable infections among children,” said Michaela Jackson, program director of prevention policy at the Hepatitis B Foundation. The vote is “removing choice by causing barriers to access” and “parents are not going to know who to trust any longer,” she said.
Hepatitis B vaccines are still recommended to children whose mothers test positive for the virus, the advisers said. The shots for most infants at birth will now be “shared clinical decision-making”, the advisers decided, voting 8-3, although this is a term that is poorly defined and usually reserved for non-routine vaccines.
“We have heard ‘do no harm’ is a moral imperative. We are doing harm by changing this wording,” said Cody Meissner, professor of pediatrics at the Geisel School of Medicine at Dartmouth College, who is widely seen as the most experienced member of the committee and who strongly opposed the change.
Adding language around shared clinical decision-making “creates barriers to care”, said Natasha Bagdasarian, a practicing infectious disease physician and liaison at the meeting for the Association of State and Territorial Health Officials. “Many healthcare providers interpret it as a sign that the vaccine is controversial, that additional steps are required, or that they may be exposed to additional liability.”
If a parent is not able to get their child the vaccine at birth, the advisers now suggest waiting at least two months.
“Some parents may delay the birth dose, but they might come at two weeks or a couple days after delivery,” said Judy Shlay, a liaison at the meeting for the National Association of County and City Health Officials. “We should not restrict that.”
The recommendations will now go to Jim O’Neill, acting director of the CDC, who will weigh changing the US official policy on hepatitis B vaccines.
Independent medical bodies such as the American Academy of Pediatrics strongly recommend that all infants receive the vaccine within 24 hours of birth.
The advisers also recommended giving blood tests to infants after they receive their first shot, in order to determine whether additional shots are needed. It is an approach that has not been studied, and it is unclear if the blood test would reveal the levels of protection offered by the three-shot course.
Recommending that providers perform a blood test, and requiring insurers to cover the test, is outside the scope of the vaccine advisory body.
Delaying the shot from birth to two months would lead to at least 1,400 infections, 300 cases of liver cancer, and 480 deaths every year, according to a recent model. Liver cancer has an 18% five-year survival rate in the United States.
More than half of people who are infected with hepatitis B don’t know where they acquired the virus. Exposures can happen in the home with family and friends, at daycare, while playing sports, and even while sharing nail clippers or jewelry, because the virus can still be infectious on surfaces for up to a week.
The Vaccines for Children program, which covers the vaccinations of 52% of children in the US, must follow the ACIP recommendations. Changing these guidelines makes it more difficult for families in this program to access the shots, experts said.
The second day of the ACIP meeting began 20 minutes early and quickly became heated, with one member arguing it was “unconscionable” to hold a vote on hepatitis B vaccines without more information. The advisers already moved to delay the vote three times, asking for more information and more time to refine the wording of the vote.
“In addition to this not being discussed, there has been no data presented that this plan would actually work,” said Joseph Hibbeln, an adviser and neurologist formerly at the National Institutes of Health.
One of the votes “is kind of making things up”, Meissner said. “I mean, it’s like Never Never Land.”
He pushed back on claims by other advisers that hepatitis B vaccines are given to make up for “adults’ mistakes and flaws in our healthcare system”, as Retsef Levi, an adviser and professor of operations management at the MIT Sloan School of Management, said.
“We’re giving it to protect the infant against a potentially fatal disease,” Meissner said. “We know it’s safe and we know it’s very effective, and to make the changes that are being proposed, we will see more children and adolescents and adults infected with hepatitis B.”
