Experts Examine Transfusion Safety Implications of ACIP Hepatitis B Birth-Dose Recommendation Change

In a recent editorial, a group of experts raised concerns that eliminating the recommendation for universal hepatitis B (HBV) vaccination at birth could increase pediatric HBV risk, particularly for infants and children who require blood transfusions. The editorial was published in JAMA Pediatrics.

In December, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted to rescind guidance that all newborns receive hepatitis B vaccination within 24 hours of birth. Instead, the committee recommended “individual decision-making” for infants born to parents who test negative for hepatitis B surface antigen, allowing vaccination to be deferred until at least two months of age. A federal judge issued a preliminary injunction on Monday that temporarily blocks the committee’s recommendations.

In the editorial, Brian D. Adkins, MD; Garrett S. Booth, MD, MS; and Jeremy W. Jacobs, MD, MHS, noted that the universal birth-dose recommendation provided an additional safety layer in transfusion medicine. While modern nucleic acid testing and the Blood Donor History Questionnaire have significantly reduced the risk of transfusion-transmitted infections, the authors emphasized that HBV transmission through blood products has not been eliminated. Estimated HBV risk ranges from approximately 1 in 600,000 to 1 in 2 million donations, depending on background prevalence and testing strategy. The authors cautioned that although the risk of transfusion-transmitted HBV is low, it is not zero and could have an outsized impact in pediatric patients.

“For a vaccinated, immunocompetent recipient population, those odds are undesirable but small,” the experts wrote. “For vaccine-naïve children who may receive transfusions in early life, the consequences of even a single infected unit are magnified.”

Adkins, Booth and Jacobs further cautioned that ACIP’s guidance could create a cohort of vaccine-naïve infants during a period when transfusion exposure may occur, noting that transplacentally transferred anti–hepatitis B surface antigen antibodies may provide only transient, partial protection. The risk, they emphasized, is concentrated among infants with prematurity, congenital heart disease, or hematologic or oncologic conditions that increase the likelihood of transfusion.

The authors also outlined several steps to mitigate potential risks. First, they urged clinicians to counsel families that while transfusion-transmitted HBV is rare, it is not purely theoretical and that deferring the hepatitis B birth dose may increase vulnerability if a testing failure occurs in the blood supply. They also suggested regulators and accrediting organizations evaluate whether additional testing or monitoring may be warranted if baseline immunity declines. In addition, they called on professional societies to issue clear guidance emphasizing the importance of the birth dose, particularly for infants likely to require transfusion, and to monitor the policy change’s potential impact on HBV vaccination rates.

AABB Committee Perspective

A subset of members of AABB’s Transfusion-Transmitted Diseases Committee reviewed the editorial and offered the following observations:

“The transfusion medicine implications of ACIP’s new HBV vaccination recommendations appear minimal in the short term, although the authors do point out nominal short-term and more substantial longer-term risks. Currently low residual risk among donors from a heretofore growing HBV-immune U.S. population is unlikely to meaningfully impact neonatal and pediatric transfusion-transmitted (TT) infection risk for quite some time. The falling risk for TT-HBV from wider donor immunity may, however, be slowly reversed as cohorts of unvaccinated children become blood donors.”

Additional information on hepatitis and blood safety is available on AABB’s hepatitis resource page.