Today, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) decided to delay the vote on 3 different hepatitis B virus (HBV) vaccine recommendations around 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 the language in the votes as they were seen as confusing and repetitive.
An example of the initial vote language was the following:
Vote1
ACIP recommends a birth dose of Hepatitis B virus vaccine and Hepatitis B immunoglobulin for infant born the women who test HBsAg-positive. ACIP recommends individual-based decision-making, in consultation with a health care provider, for parents deciding whether yo give the HBV vaccine birth dose to infants born to women who HBsAg-negative or whose HBsAg status is unknown. Parents should consult with health care providers and decide when or if their child will the HBV vaccine series. Parent 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 the aforementioned Vote 1 were seen by some committee members as needing better clarification. The committee plans to change the language and share with the 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 its September's delay in voting on the hepatitis B vaccine and changing its schedule. He said the data “was 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.)
ACIP Make Changes in Leadership Again
Earlier this week, Health and Human Services announced a change at the helm for the CDC ACIP. Kirk Milhoan, MD, PhD, a pediatric cardiologist and former U.S. Air Force flight surgeon, will now chair ACIP. He replaces Martin Kulldorff, PhD, who will now serve as chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE). Robert Malone, MD, will serve as vice chair of ACIP. Kulldorff, Milhoan, and Malone have all been critics of vaccines.
During this week’s proceedings, Malone oversaw the meetings at CDC.
The CDC made the current recommendation of universal birth dose vaccination in 1991, and in 2005, universal vaccination guidance was changed to neonates getting a birth dose within 12-24 hours of life.
Although this has a long-established track record with both efficacy and safety, the current administration and Health and Human Services 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 in Boulder. She made the claim without data that targeted measures being more effective over universal vaccination. “The contribution to the universal birth dose is likely very small,” she said. Targeted measures include sharper declines in post transfusion 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 to US born (over 8,000 cases). Specifically, she focused on data looking at Asian immigrants. She spoke of horizontal transmission of HBV in Asian immigrants. (See 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,” on infants. Blaxill does not have a medical or scientific background.
He attempted to make a veiled connection between SIDS and vaccination, but there is no direct evidence to point out there was causation.
He then concluded with findings around animal models, specifically mice, that there was immunological activation and neurobehavioral impairment after hepatitis B vaccines. (See Table 3.)
Question and Answer Session
During the morning Question and Answer segment, a spirited discussion around data and the value of the benefit of the ongoing vaccination schedule that has been in place for decades.
“I take strong positions against the three presentations,” said ACIP panelist Cody Meissner, MD stated after Malone’s, Nevison, and Blaxill spoke.
He refuted Nevison’s points on antibodies and cellular immunity. He made the point that the evidence is very strong to 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 this 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 was 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 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 and Advisory Committee for HHS and a member of the Vaccines and Related Biological Products Advisory Committee for FDA.
“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 for 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 become chronically infected, and doing another round of clinical trials would likely make the vaccines unavailable to individuals.
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
