Instead of recommending the hepatitis B vaccine for all newborns, the Centers for Disease Control and Prevention now officially advises women who test negative for the virus to consult health care providers about whether their babies should get their first doses within 24 hours of birth.
The agency’s vaccine advisory committee — whose members Health Secretary Robert F. Kennedy Jr. appointed this year after he fired the previous ones — voted for the recommendation earlier this month, upending more than three decades of agency guidance. Acting CDC Director Jim O’Neill accepted the change on Tuesday — the final step for it to become the agency’s policy.
“We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B,” O’Neill said in a statement.
The CDC had recommended the birth dose of the vaccine since 1991. Many public health experts criticized the advisory committee’s decision: After the meeting, a chorus of doctors, political leaders and health officials called on O’Neill to ignore the suggested change and maintain the CDC’s recommendation, to no avail.
The CDC now suggests waiting until at least 2 months of age for babies’ first hepatitis B shots if they do not receive the birth dose. However, it still recommends that babies born to mothers who test positive for hepatitis B or whose infection statuses are unknown get hepatitis B vaccines within the first day of life.
The agency is still reviewing a secondary recommendation from the panel: that parents consult with health care providers about the possibility of testing children for antibodies to hepatitis B before they decide whether to get second doses of the vaccine. The hepatitis B vaccine is typically given to babies as a three-dose series.
The new policy is one of the most notable examples of the way CDC guidance is diverging from widespread medical consensus. The advisory committee’s discussion of hepatitis B vaccines was rife with misinformation and cherry-picked data, and it ignored decades of evidence that hepatitis B vaccines are safe and effective when they are given shortly after birth.
Many public health experts say delaying the hepatitis B vaccine until babies are older could lead to a resurgence of infections and possibly more deaths from liver disease or cancer. Pediatric cases of acute hepatitis B plummeted after the CDC began recommending a universal birth dose, falling by 99% from 1990 to 2019. Hepatitis B can be passed from mother to child during delivery, and not all pregnant women get tested for it. There is no cure.
“Ending the recommendation for newborns makes it more likely the number of cases will begin to increase again. This makes America sicker,” Sen. Bill Cassidy, R-La., a liver doctor who has treated patients with hepatitis B, said on X earlier this month. Cassidy is one of many medical professionals who publicly asked O’Neill not to adopt the advisory panel’s recommendations.
Pediatricians are expected to keep recommending that parents vaccinate their newborns for hepatitis B. The Department of Health and Human Services has said the new recommendations will not affect insurance coverage of the shots. The vaccine will also continue to be offered to newborns through the Vaccines for Children Program, which provides free shots for uninsured or underinsured kids.
The hepatitis B decision was the latest in a series of CDC policy changes that have not been backed by science, leading some public health experts to suggest that the agency’s guidance should no longer be trusted.
After Kennedy gutted the long-standing membership of the CDC’s vaccine panel — formally known as the Advisory Committee on Immunization Practices — in June, he replaced it with a group that has largely expressed skepticism of vaccines.
O’Neill, a former investment executive who does not have a medical background, previously worked at the Department of Health and Human Services under President George W. Bush. He became acting CDC director in August after Kennedy abruptly fired the previous director, Susan Monarez. Kennedy said Monarez was fired for being untrustworthy, but Monarez said Kennedy dismissed her for refusing to blindly approve the vaccine advisory panel’s recommendations.
Last month, the CDC altered a webpage that had once unequivocally said vaccines do not cause autism, claiming instead that studies have not ruled out a link. (In fact, decades of research have found no association.)
In October, O’Neill called on vaccine manufacturers to develop separate shots for measles, mumps and rubella, without evidence to support breaking up the combined vaccine. And in September, the CDC updated its guidance to tell pregnant women to consider avoiding acetaminophen — the active ingredient in Tylenol — because of a possible connection to autism in children. (The bulk of scientific literature to date has not found a definitive link.)
After decades of leaning on CDC guidance, many states have begun to defer to recommendations from newly formed public health alliances or professional medical societies like the American Academy of Pediatrics. The AAP continues to recommend a first dose of the hepatitis B vaccine within 24 hours of birth, followed by additional doses at 1 to 2 months and 6 to 18 months.