CDC Changes Tack on Hepatitis B Shots in Shakeup of Vaccine Policy

Signage outside the Center for Disease Control headquarters in Atlanta. (Megan Varner/Bloomberg)

Key Points

• The CDC ended its universal hepatitis B vaccination recommendation for newborns, a significant shift.
• The American Medical Association criticized the CDC’s decision, warning it could reverse progress in preventing hepatitis B and lead to preventable illness.
• The CDC now advises parents of newborns whose mothers test negative for hepatitis B to weigh vaccine benefits, risks, and infection risk with their doctor.

The Centers for Disease Control and Prevention dropped its longstanding recommendation that all newborns be vaccinated against hepatitis B, the most significant development yet in Robert F. Kennedy Jr.’s campaign to disrupt how vaccines are used in the U.S.

Rates of acute hepatitis B in the U.S. have dropped sharply since 1991, when the agency recommended universal vaccination at birth. Pediatric hepatitis B has virtually disappeared.

“Rolling back this recommendation creates confusion and doubt about vaccines, reverses hard-won progress in preventing hepatitis B, and will undoubtedly result in completely preventable illness and death,” the American Medical Association said in a statement.

The agency’s decision, announced late Tuesday, comes less than two weeks after a committee of CDC advisers, whom Kennedy appointed earlier this year, voted to change their decades-old guidance.

Infants born to mothers with hepatitis B can easily contract the disease at birth. According to the CDC, up to 90% of children infected with hepatitis B during infancy develop a lifelong infection, and 25% of them will die prematurely of cirrhosis or liver cancer.

“We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B,” the CDC’s acting director, Jim O’Neill, said in a statement.

CDC experts had previously said that up to 16% of women aren’t screened for hepatitis B when pregnant. Unvaccinated newborns can also contract the disease from other adults. Around half of people with chronic hepatitis B infections don’t know they are infected.

The change in approach could have the broadest impact of all the efforts thus far by Kennedy, the secretary for Health and Human Services and a leading vaccine skeptic, to change routine vaccination practices in the U.S.

Insurers will still pay for hepatitis B shots for infants whose parents choose to have them vaccinated. The impact of the decision on rates of hepatitis B vaccination remains to be seen. In 2019, 76% of U.S. newborns received a birth dose of the hepatitis B vaccines, according to the CDC.

Babies who don’t get a dose at birth are advised to receive one after they are two months old under the new guidance. The complete hepatitis B vaccine series consists of three doses for most children.

During contentious Senate confirmation hearings in January, Kennedy played down his interest in vaccines. “News reports have claimed that I am antivaccine or anti-industry,” Kennedy said at the time. “I am neither.”

Later, Sen. Bill Cassidy, a powerful Louisiana Republican who had seemed skeptical of the appointment, said he would vote in favor after Kennedy assured him he wouldn’t make changes to the CDC vaccine advisory committee, among other commitments.

Kennedy removed all members of the committee, the Advisory Committee on Immunization Practices, shortly after his confirmation.

The CDC late Tuesday declined to put in place a separate recommendation made by the committee. It had advised parents to consult doctors about testing the blood of infants who have already received a birth dose of hepatitis B vaccine to see if an additional dose is needed.

The recommendation implied that a single dose of the hepatitis B vaccine may be sufficient, rather than the recommended three doses, if babies have a certain level of anti-hepatitis B antibodies in their blood. One committee member said at the December meeting that the change amounted to “kind of making things up.”

Under the guidance issued on Tuesday, the CDC continues to recommend a birth dose of hepatitis B vaccine for infants whose mothers have tested positive for hepatitis B, or for infants whose mothers haven’t been tested. It now instructs the parents of infants whose mothers test negative for hepatitis B to “consider vaccine benefits, vaccine risks, and infection risk,” and to consult with their doctor about whether to administer a birth dose.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com