CDC vaccine committee overturns decades-old hepatitis B recommendation for newborns

Members of a key CDC advisory committee, known as the Advisory Committee on Immunization Practices, met in Atlanta on Dec. 4. Maya Homan/Georgia Recorder

ATLANTA — A Centers for Disease Control and Prevention committee voted to eliminate a recommendation that all newborn babies receive a vaccine against hepatitis B, ending a policy that has been in place since 1991 to protect Americans against an incurable liver disease that can lead to cirrhosis, cancer and liver failure. 

The current three-dose series for hepatitis B includes one vaccine administered to infants within 24 hours of birth, and subsequent booster shots given one month and six months after the initial dose. The universal vaccination policy is credited with a 99% drop in serious infections among American children between 1990 and 2019.

In its updated guidelines, the agency will continue to recommend that babies born to mothers who test positive for hepatitis B receive a vaccine at birth. However, in all other cases, the decision will be left to “individual-based decision-making,” a change that experts say will lead to an increase in chronic hepatitis B infections. The new recommendation also suggests that parents delay the first dose of the vaccine until at least two months after birth.

Friday’s decision comes after an 8-3 vote from a key CDC advisory committee, known as the Advisory Committee on Immunization Practices, which is charged with setting national guidelines around which people should be vaccinated against a wide range of preventable diseases and when those vaccines should be administered. The recommendations play a key role in determining which vaccines insurance companies are willing to cover and how accessible those immunizations are to the public.

The two-day meeting included several presentations from prominent anti-vaccine activists, including Aaron Siri, a vaccine injury lawyer who has previously represented U.S. Health Secretary Robert F. Kennedy Jr. and reportedly helped him vet health officials for President Donald Trump’s administration. At least two of them — Cynthia Nevison, a climate researcher who has ties to anti-vaccine groups, and Mark Blaxill, a former consultant and author — were recently hired by the CDC.

Retsef Levi, an ACIP member and professor of operations management at the Massachusetts Institute of Technology, called the updated recommendation a “very positive change in policy,” arguing that blanket vaccine recommendations force newborns to serve as “a safety net for adults’ mistakes.”

Advisory Committee on Immunization Practices member Robert Malone, a doctor and biochemist who once said he views the label of anti-vaxxer as ‘high praise,’ was recently appointed to vice chair of the committee. Photo by Maya Homan/Georgia Recorder

But Dr. Cody Meissner, another member of the committee who also serves as a professor of pediatrics and medicine at Dartmouth College, argued that the vaccines play a crucial role in protecting infants from the disease, and said there was no valid scientific evidence to support the changes implemented by the panel.

“Thoughtful inquiry is always commendable,” he told the committee. “But that inquiry should not be confused with baseless skepticism, which is what I think we’re encountering here.”

Sandra Fryhofer, a doctor and liaison for the American Medical Association, also criticized the move, arguing that implementing guidelines based on the mother’s hepatitis status will leave babies vulnerable to developing the disease from other sources, such as infected relatives. According to CDC data, roughly half of people with hepatitis B do not know they are infected.

“Are we going to test every patient that has access to or touches that baby?” she asked the committee Thursday. “I mean, that’s not something that’s really doable.”

The updated recommendation for the hepatitis B vaccine mirrors COVID-19 vaccine guidelines passed by the same panel in September, which place new emphasis on the risks of immunizations, though the CDC’s own data shows that the vaccines are safe and effective for most people. 

A second vote, which passed 6-4, encourages parents to discuss using serology testing, a type of blood test that measures antibodies to gauge how well a patient’s immune system has responded to a disease, before allowing their children to receive additional doses of the hepatitis B vaccine.

The changed recommendations will not prevent doctors from administering hepatitis B vaccines to newborns, but critics say they could create additional hurdles for families and healthcare providers.

“Adding excessive or ambiguous language around shared decision-making for routine vaccines muddies the waters, creates a false sense of scientific uncertainty and places unnecessary burden on clinicians and families,” said Dr. Natasha Bagdasarian, who was representing the Association of State and Territorial Health Officials.

Children enrolled in Medicaid or the Vaccines for Children program, which provides free immunizations to children who are uninsured or underinsured, will continue to be eligible for hepatitis B vaccines at birth under the new recommendations, according to program liaisons.

Federal fallout

As with the new COVID-19 vaccine recommendations, the updated hepatitis B guidelines will not take effect until being officially signed off by the acting CDC Director, Jim O’Neill.

But amid shifting federal guidance on public health policies, a growing number of state and federal officials are developing their own policies rather than relying on the agency’s guidelines. In a Dec. 3 letter sent ahead of ACIP’s meeting, more than 30 members of Congress urged O’Neill to maintain the existing recommendations, regardless of what the advisory committee decided.

“There is no data to support delaying the first immunization to one-month, four years, or 12 years of age,” the letter states.

U.S. Sen. Bill Cassidy, a Louisiana Republican who heads the Senate Health, Education, Labor and Pensions Committee, also called for O’Neill to forgo signing the updated recommendations.

“As a liver doctor who has treated patients with hepatitis B for decades, this change to the vaccine schedule is a mistake,” he wrote in a social media post after the vote. “The hepatitis B vaccine is safe and effective. The birth dose is a recommendation, NOT a mandate.”

Cassidy, a doctor, cast the deciding vote to confirm Kennedy as health secretary on the condition that Kennedy “maintain the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices without changes.” Kennedy later backtracked on that promise, firing all 17 previous members of the committee and replacing them with a slate of hand-picked appointees, many of whom are seen as vaccine skeptics.

In a Thursday social media post, Cassidy criticized the committee for its plans to hear testimony from Siri, the vaccine injury lawyer.

“The ACIP is totally discredited,” he added. “They are not protecting children.”