In a historic vote, the Centers for Disease Control and Prevention’s vaccine advisers recommended narrowing the agency’s hepatitis B immunization guidance for newborns.
The result, if approved by the CDC’s acting director, will be a rollback of a universal recommendation to start hepatitis B immunization at birth, a standard practice in the U.S. for more than 30 years that has been credited with dramatically lowering liver diseases caused by the virus.
The Advisory Committee on Immunization Practices, or ACIP, voted 8-3 to recommend hepatitis B at birth only for infants born to women who test positive for the virus that attacks the liver. Women whose hepatitis B status is negative or unknown should talk with their doctors about vaccination, the recommendation says.
The changes were made over the strong objections of liaisons from the medical community, who say the decades-long universal birth dose policy has dramatically reduced cases of hepatitis B in U.S. children.
“Our question is why? Why is there pressure today to change something that has been working, due to safety concerns that may be more theoretical than real?” asked Dr. Grant Paulsen during Thursday’s meeting. He was representing the Pediatric Infectious Diseases Society.
There was a second vote regarding the number of shots babies get. Full immunization of infants involves three shots: usually one given at birth, a second shot one to three months later and a third at six to 15 months of age.
The panel voted 6-4, with one member abstaining, to recommend testing children’s antibody levels after each hepatitis B shot to determine whether additional shots are needed. The result may be that some children get one or two shots instead of the standard three shots.
Dr. Adam Langer, a CDC official in charge of the agency’s center that includes hepatitis prevention, said during the panel’s discussion that clinical studies of approved hepatitis B vaccines tested a three-shot regimen. Stopping at one or two shots based on antibody testing would be making an assumption about efficacy that isn’t supported by existing data, he said.
Sharply diverging views among members
The split vote on removing the recommendation for the universal vaccine reflects disagreement among the members. Several members who served on a subgroup that has been reviewing the topic led the votes in favor of the change.
The committee voting this week was hand selected by Health Secretary Robert F. Kennedy Jr., who has long questioned many vaccines. Several of the voting members themselves have a history of questioning the safety of long-used vaccines.
Retsef Levi, a voting member and professor at the MIT Sloan School of Management, heralded the move as “a fundamental change in the approach to this vaccine,” which would encourage parents to “carefully think about whether they want to take the risk of giving another vaccine to their child.” Levi said parents may want to delay the vaccine for years. “That’s going to be up to them and their physicians,” he said.
A handful of members raised concerns over the lack of evidence supporting the change and concerns it will put children at risk.
“We know vaccines are safe,” said Dr. Cody Meissner, a professor of pediatrics at Dartmouth’s Geisel School of Medicine and the only current member who has served on the committee in previous years. “The hepatitis B vaccine recommendation is very well established. We know it is safe, and we know it is very effective, and to make the changes that are being proposed, we will see more children and adolescents and adults infected with hepatitis B.”
Meissner added that he saw clear evidence of the benefits of the universal hepatitis B birth dose, but not the harms. When he registered his “no” vote, he stated, “Do no harm is a moral imperative. We are doing harm by changing this wording.”
The previous recommendation to vaccinate all healthy newborns against hepatitis B was designed to make sure no at-risk infant falls through the cracks. Hepatitis B can be transmitted from mothers to infants during childbirth, but can also be spread through contact with an infected person’s body fluids including saliva and blood.
Immunization in infancy confers lifelong protection against the hepatitis B virus, which can cause serious, potentially fatal health problems including liver cancer and cirrhosis. It is the cornerstone of a decades-long strategy to eliminate hepatitis B in the U.S.
Questioning vaccines
Friday’s votes came after a previous attempt to change the universal vaccination recommendation failed at an ACIP meeting in September. That meeting descended into chaos, forcing the committee to postpone until this week’s meeting.
During this week’s discussion, Malone framed the debate as a “diversity of opinion regarding the existence of evidence of harm,” and said questions about harms were “largely unresolved” due to a lack of data.
