CDC Changes Recommendations for Hepatitis B Vaccination in Newborns

On Friday, August 3, advisors to the CDC voted to suggest that mothers without hepatitis B speak to their doctors about vaccination, and if they choose to proceed, to wait two months after birth for the initial dose. This marks a shift from the previous guideline of administering the vaccine shortly after birth, aligning U.S. practices with 24 other high-income nations, where the first vaccine is typically given at 2 or 3 months.

Since 2018, the CDC had recommended vaccination within 24 hours of a child’s birth. Critics have described this new guidance as chaotic, despite the fact that the current U.S. vaccine schedule mirrors that of other Western countries, and the vaccine is widely available to mothers.

As reported in The Washington Post, this decision was seen as major change under the influence of Robert F. Kennedy Jr., as it removes a longstanding recommendation. Some articles have suggested that the new stance incorrectly implies vaccines lack efficacy.

A subheading from the New York Times highlighted that the committee’s vote to delay vaccinations for infants whose mothers test negative for the virus essentially overturns past recommendations. The committee also voted 6-4 in favor of recommending tests for hepatitis B antibodies after the first dose to assess its effectiveness before the second and third doses, urging that such tests be covered by insurance. Universal hepatitis B screening for pregnant women has been a longstanding recommendation from the committee.

Members expressed a range of opinions on whether the health of individual children or the larger public health should dictate vaccination policy. Hepatitis B is most often transmitted through intravenous drug use and sexual intercourse and predominantly affects adults aged 40 to 59.

Following the announcement, Massachusetts Governor Maura Healey remarked on social media that since newborn vaccination against hepatitis B began in 1991, infections in children have seen a significant decline. She criticized attempts to reverse these gains.

All committee members acknowledged a lack of comprehensive data regarding the risks and benefits of these changes. Tracy Beth Hogue from the FDA noted that the original approval of Hepatitis B vaccines in the 1980s relied on studies with short follow-up periods and no control groups. She remarked that this level of evidence would not suffice for vaccine approval today, expressing uncertainty about the safety of the vaccines.

Citing rare side effects like fever, Hogue emphasized that the debate over the changes also included concerns about potential breakthrough infections from only one dose. Some medical professionals raised issues regarding the insufficient publication of safety data.

Commissioner Cody Meisner, who voted against the adjustment, highlighted that while concerns about infant responses to vaccines are valid, they should not distract from broader vaccine assessment.

Secretary of Health Kennedy has reportedly dismissed many committee members, referencing slow turnover and connections to the pharmaceutical industry as reasons for the changes.

The push for universal hepatitis B vaccination began in the U.S. in 1991 following a 25-year increase in hepatitis B transmission among high-risk populations. Vicki Pebsworth, a committee member, mentioned the organization’s mandate to routinely evaluate recommendations.

The committee’s new approach has drawn criticism for being “anti-science” from some members of the medical community, who argue that focusing on individual rather than public health undermines vaccination efforts.

Some pointed out the difficulty of applying policies successfully used in countries with universal healthcare to the U.S. context, where healthcare access issues persist. About 70% of chronic hepatitis B cases in the U.S. occur in immigrants.

As the Department of Health and Human Services revisits its vaccination focus, Vinay Prasad from the FDA emphasized a commitment to prioritize patient safety, ensuring that health risks and benefits are carefully weighted in vaccine policy discussions.