CDC ACIP Delays Votes on Hepatitis B Birth Dose Until Tomorrow

Today, the Centers for Disease Control and Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) decided to delay the vote on 3 different hepatitis B virus (HBV) vaccine recommendations about the current immunization schedule for the birth doses.

Committee members voted 7 to 3 in favor of delaying the vote until Friday morning. They did this to clean up language in the votes, which was seen as confusing and repetitive.

An example of the initial vote language was the following:

Vote 1

ACIP recommends a birth dose of hepatitis B virus vaccine and hepatitis B immunoglobulin for infants born to women who test HBsAg [hepatitis B surface antigen]-positive. ACIP recommends individual-based decision-making, in consultation with a health care provider, for parents deciding whether to give the HBV vaccine birth dose to infants born to women who are HBsAg-negative or whose HBsAg status is unknown. Parents should consult with health care providers and decide when or if their child will receive the HBV vaccine series. Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks. For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age.

Specifically, the 2 sentences that are bolded in vote 1 were seen by some committee members as needing better clarification. The committee plans to change the language and share it with members and the public before voting on Friday morning.

The Day’s Proceedings

To understand today’s meeting, it is important to go back to ACIP’s September meeting. At that time, ACIP voted to table their vote on whether to recommend a change to the HBV immunization schedule for neonates and move it back to 30 days after birth. With their decision to table the vote, the ongoing recommendation stayed in place.¹

Today’s meeting began with ACIP Vice Chair Robert Malone, MD, MS, speaking about September's delay in voting on the HBV vaccine and changing its schedule. He said the data “were incomplete” from the ACIP working groups. He spoke about overseeing the meetings this week and the changes in ACIP leadership. (See below for more information on the new leadership.)

The CDC made the current recommendation of universal birth dose vaccination in 1991, and in 2005, universal vaccination guidance was changed to neonates receiving a birth dose within 12 to 24 hours of life.

Although this has a long-established track record with both efficacy and safety, the current administration and US Department of Health and Human Services (HHS) leadership decided to take up hepatitis B vaccination and the timing of the vaccine.

The first presentation of the morning was made by Cynthia Nevison, PhD, who is a CDC contractor and environmental science researcher from the University of Colorado Boulder. She made the claim, without data, that targeted measures are more effective than universal vaccination. “The contribution to the universal birth dose is likely very small,” she said. Targeted measures include sharper declines in posttransfusion hepatitis, needle exchange, etc. To see the list from her presentation, look at Table 1 below.

Nevison said the majority of infections came from immigrants (over 12,000 cases) compared with US-born people (over 8000 cases). Specifically, she focused on data looking at Asian immigrants. She spoke of horizontal transmission of HBV in Asian immigrants (Table 2).

Vaccine Safety

Author and autism advocate Mark Blaxill, who now works for the CDC, presented on HBV vaccine safety. He said “safety evidence is limited” for infants. Blaxill does not have a medical or scientific background.

He attempted to make a veiled connection between sudden infant death syndrome and vaccination, but there is no direct evidence to point to causation.

He then concluded with findings from animal models, specifically mice, that there was immunological activation and neurobehavioral impairment after hepatitis B vaccines (Table 3).

Question and Answer Session

During the morning question and answer segment, there was a spirited discussion about data and the benefit of the ongoing vaccination schedule that has been in place for decades.

“I take strong positions against the 3 presentations,” ACIP panelist H. Cody Meissner, MD, stated after Malone, Nevison, and Blaxill spoke.

He refuted Nevison’s points on antibodies and cellular immunity. He made the point that the evidence is very strong for lifelong immunity to hepatitis B after completing the vaccination series.

“This disease had gone down thanks to the vaccination,” Meissner said.

Malone interrupted Meissner and said it was time for questions.

“When we administer any vaccine, we are weighing the benefit against the risk. What is the risk?” Meissner asked, noting there were no safety data being presented that suggested any adverse effects. 

“We don’t have any reason to claim causality,” Blaxill said.

“There is no evidence of harm,” Meissner said.

Nevison said vaccine harm was established and proven by payouts from the National Vaccine Injury Compensation Program. Malone agreed, and Meissner disagreed. "I can absolutely tell you that these are not confirmed associations." He said Nevison was "incorrect." Meissner has been a member of the National Vaccine Advisory Committee for HHS and a member of the Vaccines and Related Biological Products Advisory Committee for the US Food and Drug Administration.

“This committee fails,” association liaison and meeting attendee Jason Goldman, MD, said. “We need to look at all the evidence and not cherry-pick.” He went on to say the committee needed to be transparent about who is in the ACIP working group. Malone said they could not do that, and Goldman disputed that. Malone corrected himself and said they would share that information. 

Vaccine Manufacturers

Representatives of hepatitis B vaccines, including GSK, Merck, and Sanofi, were all given an opportunity to comment on the proceedings. All stressed the importance of birth dose vaccination, including the long safety record, how 90% of infants who contract HBV develop chronic infection, and how doing another round of clinical trials would likely make the vaccines unavailable to individuals.

Check out our coverage on Friday after the votes have been cast.

Reference
1. Parkinson J. CDC vaccine advisors table hepatitis B vaccine vote, keeps current policy in place. Contagion. September 19, 2025. Accessed December 2, 2025.
https://www.contagionlive.com/view/cdc-vaccine-advisors-table-hepatitis-b-vaccine-vote-keeps-current-policy-in-place