CDC’s ACIP changes recommendations for hepatitis B vaccination for infants : Shots

In a historic vote, Centers for Disease Control and Prevention vaccine advisers recommended narrowing the agency's recommendations for immunizing newborns against hepatitis B.

The result, if approved by the acting director of the Centers for Disease Control and Prevention (CDC), would be a rollback of the universal recommendation to begin hepatitis B immunization at birth, a standard practice in the United States for more than 30 years that is believed to have significantly reduced liver disease caused by the virus.

The Advisory Committee on Immunization Practices, or ACIP, voted 8 to 3 to recommend hepatitis B at birth only for infants born to women who test positive for the virus, which attacks the liver. Women whose hepatitis B status is negative or unknown should talk to their doctors about vaccination, the recommendation says.

The changes were made over strong opposition from the medical community, which argues that the decades-long universal birth dose policy has significantly reduced the incidence of hepatitis B in U.S. children.

“Our question is: why? Why is there pressure today to change what works because of safety concerns that may be more theoretical than real?” asked Dr. Grant Paulsen during Thursday's meeting. He represented the Society of Pediatric Infectious Diseases.

A second vote was taken regarding the number of vaccinations infants receive. Full immunization for infants includes three shots: usually one shot at birth, a second shot one to three months later, and a third between six and 15 months of age.

The panel voted 6 to 4, with one member abstaining, to recommend testing children's antibody levels after each hepatitis B vaccine to determine whether additional shots are needed. As a result, some children may receive one or two shots instead of the standard three shots.

Dr. Adam Langer, a CDC official in charge of the agency's hepatitis prevention center, said during the discussion that clinical studies of approved hepatitis B vaccines tested a three-dose schedule. Stopping at one or two shots based on antibody testing would make an assumption about effectiveness that is not supported by existing data, he said.

The split vote on lifting the universal vaccine recommendation reflects divisions among members. Several members who were part of the subgroup that considered the topic voted in favor of the change.

This week's committee vote was handpicked by Health Secretary Robert F. Kennedy Jr., who has long questioned many vaccines. Some of the voting members themselves have repeatedly questioned the safety of long-used vaccines.

Retzef Levivoting member and professor at MIT's Sloan School of Management, called the move “a fundamental change in the approach to this vaccine” that will encourage parents to “think carefully about whether they want to take the risk of getting another vaccine for their child.” Levy said parents may want to delay vaccinations for years. “It will be up to them and their doctors,” he said.

Several members expressed concern about the lack of evidence to support the changes and fears it would put children at risk.

“We know the 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. “Recommendations for vaccination against hepatitis B are very well known. We know it is safe and we know it is very effective, and by making these proposed changes we will see more children, adolescents and adults infected with hepatitis B.”

Meissner added that he sees clear evidence that a universal dose of hepatitis B vaccine at birth is beneficial, but not harmful. When he registered his dissenting vote, he declared: “Do no harm is a moral imperative. We are doing harm by changing this language.”

The previous recommendation to vaccinate all healthy newborns against hepatitis B was designed to ensure that no at-risk child was left behind. Hepatitis B can be passed from mother to baby during childbirth, but can also be spread through contact with body fluids of an infected person, including saliva and blood.

Immunization in infancy provides 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 multi-year strategy to eliminate hepatitis B in the United States.