Federal health recommendations for hepatitis B vaccination have come under pressure after a federal vaccine advisory committee voted to change when newborns should receive the shot, a decision criticized by prominent pediatric and public health figures.
The Advisory Committee on Immunization Practices (ACIP) voted to do away with the longstanding recommendation that all babies receive a hepatitis B vaccine dose right after birth. Under the new guidance, ACIP recommends a birth dose only for newborns whose mothers test positive for the virus or whose infection status is unknown, the Associated Press reported.
For other babies, the committee suggested that parents and their doctors decide and that vaccination should begin when the child is 2 months old, rather than in the first day of life. The AP report said the committee’s vote was taken at a meeting where its current members were appointed by Health Secretary Robert F. Kennedy Jr.
Critics said the change would harm children. Dr. Paul Offit of Children’s Hospital of Philadelphia, described by the AP as a vaccine researcher and former government adviser, said the committee “has just condemned hundreds of children to a shorter life.” Offit also argued that those in a position to make decisions on public health lacked the expertise and described what he said was an ACIP shaped in Kennedy’s image.
Other pediatric advocates denounced the process and the potential impact. Dr. James Campbell, vice chair of the American Academy of Pediatrics’ infectious diseases committee, called the meetings a “brazen attempt to sow fear and distrust in vaccinations that have saved countless lives.” Campbell told of treating a 15-year-old in Baltimore in 1999 who, he said, was not vaccinated as a newborn and later died from hepatitis B after suffering liver failure and undergoing two failed liver transplants.
In the AP account, ACIP’s members raised concerns about giving a vaccine to a baby so early in life and about whether doctors and nurses fully discuss the pros and cons of newborn vaccination with parents. The report also said Kennedy fired all 17 ACIP members earlier in the year and replaced them with a group that includes several anti-vaccine voices.
Hepatitis B is a serious liver infection that lasts less than six months for most people but can become long-lasting in infants and children, leading to outcomes including liver failure, liver cancer and cirrhosis, according to the AP report. The article said up to 90% of infants who contract hepatitis B develop chronic infections. It also said that about 2.4 million people in the U.S. are estimated to have hepatitis B, and as many as half are unaware they are infected.
The AP described the birth-dose recommendation as the product of decades of guidance, including ACIP’s 1991 recommendation for an initial hepatitis B vaccine dose at birth. It said the current approach has called for a dose within 24 hours for medically stable infants weighing at least 4.4 pounds (2 kilograms), followed by doses at about 1 month and 6 months. The report also said newborn hepatitis B vaccinations have been widely considered a success, with cases among children falling over roughly 30 years from about 18,000 per year to about 2,200.
A separate analysis cited in the AP report—a release from the Vaccine Integrity Project—said it analyzed more than 400 studies and reports spanning 40 years and concluded that the newborn dose is safe and helped drive declines in pediatric infections. The AP also cited an estimate from a recent report that delaying the vaccine to 2 months could lead to at least 1,400 hepatitis B infections in children and 480 deaths, while noting the estimate has not yet been peer reviewed or published in a medical journal.
The AP report said ACIP’s most direct influence may come through what’s covered by the federal Vaccines for Children program, which helps pay for shots for uninsured children from low-income families. It reported that Dr. Sean O’Leary said the change likely would not be a major economic obstacle for hospital practice because hepatitis B shots are often bundled into childbirth bills, but that the shift could confuse and frighten parents.
After the vote, the AP said some state and local officials indicated they do not plan to follow the committee’s advice to delay vaccination, including the governor of Massachusetts and health officials in Maryland, New York City and Santa Clara County, California. It also said Milwaukee’s health department told parents to keep talking to doctors and “follow trusted sources like the American Academy of Pediatrics.”
The AP reported that the American Academy of Pediatrics said it will continue recommending routine hepatitis B vaccination for all newborns—first dose within 24 hours of birth, a second dose at one to two months, and a third dose at six months. It said 45 organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association and the American Public Health Association, sent a statement describing themselves as “deeply alarmed” by ACIP’s actions, saying the committee’s decision “will harm children, their families and the medical professionals who care for them.”
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