Experts who advise the Centers for Disease Control and Prevention are going to vote on Dec. 4 on whether to alter recommendations for hepatitis B vaccination.
The Advisory Committee on Immunization Practices (ACIP) is going to curtail the recommendation for hepatitis B vaccination, according to voting language published on Dec. 3.
If the vote is approved, ACIP would recommend hepatitis B vaccination for infants born to women who test positive for the virus, but it would advise parents of other children to consult with doctors and consider the risks and benefits of the vaccine.
For children who do not receive a dose near the time of birth, the committee would recommend vaccination no earlier than 2 months of age.
Hepatitis B vaccination is currently recommended for most children on the first day of their life, with two additional doses within 18 months.
The CDC does not have to accept recommendations from ACIP, but often does.
Jim O’Neill, acting CDC director and deputy health secretary, approved all of ACIP’s most recent recommendations in October, including changing near-universal COVID-19 vaccine recommendations to advising people to consult with doctors and other health care professionals before receiving one of the shots.
Hepatitis B is a virus and a liver disease. As many as 2.4 million people have hepatitis B in the United States, according to the CDC. Transmission can happen through exposure to bodily fluids from people who have acute or chronic infection. Infected mothers can also transmit hepatitis B to their babies.
The CDC recommends that all pregnant women be screened for hepatitis B before birth.
Safety and Effectiveness
The hepatitis B vaccine is safe even for infants, a group of outside scientists, including former CDC Director Dr. Rochelle Walensky, said in a review released on Dec. 2. The vaccine is also effective and confers long-lasting immunity, the group, which is named the Vaccine Integrity Project at the University of Minnesota and funded by the Alumbra Innovations Foundation, said.
They cited safety studies including a 2001 paper from the CDC and Kaiser Permanente that found children who received a hepatitis B vaccine within 21 days of birth were no more likely to receive care for fever, allergic reactions, seizures, or other neurologic events in their first 21 days of life.
Cited studies on effectiveness included a CDC paper that said that among healthy infants, 25 percent achieved high anti-hepatitis B antibody levels after the first dose and 63 percent achieved it after a second dose, and a 2022 paper from the CDC that found about half of people immunized as babies had high levels of the antibodies 35 years later.
Studies they did not cite include a 2022 paper from researchers in Thailand that found anti-hepatitis B antibodies declined over time after early vaccination and were not detectable in some people 16 to 28 years after vaccination.
Multiple members of ACIP supportive of altering recommendations have pointed to a 2012 report from the Institute of Medicine that determined that available evidence supported hepatitis B vaccination causing allergic shock. It also said there was insufficient evidence to figure out whether hepatitis B vaccines cause or do not cause 26 conditions.
“I personally believe we should be erring on the side of caution and adopt a more prudent vaccination policy similar to what is used in most of Europe,” Vicky Pebsworth, one of those members, said during a September meeting before the panel tabled a planned vote on delaying the first hepatitis B dose.
Multiple other countries, such as Denmark and Finland, only recommend hepatitis B vaccination at birth or in general to children born to mothers infected with hepatitis B.
Brian Hooker, chief scientific officer of the organization Children’s Health Defense, which was formerly headed by Health Secretary Robert F. Kennedy Jr., said that he supports removing the hepatitis B vaccine from the U.S. schedule, in part because of concerns over the aluminum salts adjuvant it contains.
“My recommendation would be the hepatitis B shot just be taken off the schedule for infants and children,” Hooker told The Epoch Times.
The American Public Health Association and some other groups said in a public comment filed with ACIP that the current schedule should be kept in place based on what they described as extensive evidence of safety and effectiveness.
Current Recommendation
Hepatitis B vaccination for newborns has been in place in the United States for decades as part of a campaign to eliminate the virus among children. The recommendation at present is for all babies with a birth weight of at least 2,000 grams and deemed medically stable to receive their first dose within 24 hours, regardless of whether their mother tests positive or negative for the infection, followed by two additional doses, one at 1 to 2 months of age and the other at 6 to 18 months of age.
The latter doses are sometimes in vials with other vaccines.
“Hepatitis B vaccination is the cornerstone of hepatitis B prevention and control,” the CDC said in a briefing document to ACIP.
Federal scientists said in a 2023 review that the vaccination campaign has resulted in a 99 percent drop in hepatitis cases among children and young adults.
The CDC says on its website that hepatitis B vaccines are “safe and effective.” It says that vaccinating a newborn baby “prevents the spread of the virus from mother to child” and that children who receive the full hepatitis B vaccination schedule are protected for life.
In its regularly updated book about vaccines, though, the agency acknowledges that some individuals do not develop protective antibodies following hepatitis B vaccination, that up to 30 percent of infants who are vaccinated could still contract hepatitis B from their mothers, and that “there is an age-specific decline in immunogenicity,” with vaccines less likely to generate antibodies in older people. It also says that antibody levels decline with time but that immunity remains in place “for more than 30 years following immunization.”
Adverse reactions following vaccination have included fever, vomiting, and insomnia, according to regulatory labels for the shots.
Manufacturers of hepatitis B vaccines did not respond to requests for comment.
Sanofi and Merck, two of the manufacturers, have expressed opposition to changing the current schedule for hepatitis B vaccination.
Discussing Schedule
The childhood vaccine schedule has expanded over time. If a child follows the schedule, including annual influenza vaccination, he or she will receive dozens of doses by the time they are 18. They will also receive multiple shots during certain doctor visits, such as a visit at 6 months of age.
Advisers will on Friday hear about the history of the schedule, according to a draft agenda. They will then discuss vaccines recommended for children.
No votes are listed for the vaccine schedule.
The panel recently established a workgroup to review the schedule and said in a document released in the fall that the workgroup would focus on the safety and effectiveness of the schedule, in part by analyzing the timing of vaccines and data on concurrent administration of multiple shots.
Advisers also planned to look at vaccine schedules utilized in other countries, including Denmark, and adjuvants that are part of certain vaccines.