CDC Panel Revises Hepatitis B Birth Dose Recommendation

A major shift came out of the December 5, 2025 ACIP meeting. For the first time in over three decades, federal vaccine advisers voted 8–3 ( Dr. Raymond Pollack, Dr. Cody Meissner and Dr. Joseph R. Hibbeln opposed) to end the universal recommendation that all US newborns receive the Hepatitis B (HepB) vaccine within 12 to 24 hours of birth. The CDC director must approve ACIP recommendations before they become official.

What ACIP Actually Changed

Under the new guidance:

• Infants born to mothers who test positive for Hepatitis B, or whose status is unknown
  → Still receive HepB and HBIG at birth.

• Infants born to mothers who test negative
  → The birth dose is no longer automatically recommended.
  → Families and their clinician now make the decision together.
  → If parents decline the birth dose, the first HepB shot should not be given before two months of age.

This change does not remove HepB from the childhood schedule. It simply moves the default first dose to 2 months for infants of HepB negative mothers and places the decision back into parent and clinician hands.

Andrew Johnson from Centers for Medicare & Medicaid Services assured the committee that the language change will not affect Medicaid or insurance coverage of the vaccine.

Why This Update Matters

ACIP members supporting the update emphasized several key points:

• Risk varies. Fewer than 0.5 percent of US mothers are HepB positive, and universal prenatal screening is already standard of care.

• Transmission prevention involves more than the vaccine. For HepB positive mothers, antiviral treatment during pregnancy, HBIG, and vaccination dramatically reduce transmission from about 90 percent down to 0.7 to 1.1 percent.

• Individualized care. Some members raised concerns that birth is not an ideal moment for parents to provide true informed consent.

Members who opposed the change argued that longstanding recommendations should remain unless clear evidence shows harm.

Despite disagreements, the majority concluded that a risk stratified, individualized approach better reflects current data and protects newborns without unnecessary intervention.

Context Behind the Decision

For decades, the HepB birth dose was recommended as a catch all strategy, not because most newborns were at risk, but because adult vaccination rates were low.

Recent discussions at ACIP revisited:

• The lack of long term safety and efficacy data for the neonatal dose.

• The fact that HBV prevalence among US born mothers has remained low for decades.

• The shift in HBV risk toward foreign born populations and specific adult risk groups, not newborns of screened HepB negative mothers.

This vote signals a move toward aligning public health policy with actual risk and current maternal screening practices.

IPA’s Mission

This update echoes values we consistently champion:

• Informed consent must be real, not rushed. Parents deserve the space to review medical decisions, especially in the immediate hours after delivery.

• Medical decisions should match individual risk. A universal intervention for a near zero risk population does not reflect modern evidence based care.

• Transparency strengthens trust. Open debate at ACIP, including disagreement, is healthy. It moves policy toward accountability and clarity.

In short, this change reinforces a principle IPA advocates for in every policy discussion:
Healthcare decisions should be individualized, evidence based, and made collaboratively between families and their clinicians, not driven by one size fits all mandate policy.

As the CDC director reviews the ACIP recommendation, we will continue monitoring developments and keeping our community updated.