CDC vaccine advisors again postponed their vote on changes to the hepatitis B vaccine schedule for infants, this time delaying it by 1 day after raising concerns about the precise wording of the measure they are considering.
Members of the Advisory Committee on Immunization Practices (ACIP) voted 7-3 Thursday to table the issue until Friday, citing confusion over voting language that one member said had been revised three times in 72 hours.
Several members opposed the delay. Newly appointed chair Kirk Milhoan, MD, PhD, did not record a vote; attending remotely, he appeared to lose connection during the vote.
The proposal under consideration would recommend shared clinical decision-making between clinicians and parents of infants born to mothers who test negative for hepatitis B surface antigen (HBsAg). Members said it was unclear whether that language referred narrowly to the birth dose or to the initiation of the full three-dose series, both of which appeared in the draft wording.
Under the same proposal, ACIP would continue recommending the birth dose for infants of HBsAg-positive mothers while stating that infants whose parents defer the birth dose not receive their first shot until 2 months of age.
The latest vote delay came nearly 3 months after members postponed a vote on changing their recommendations. It marked the seminal moment of a contentious meeting that unfolded 3 days after former chair Martin Kulldorff, PhD -- who used his first ACIP meeting to challenge the universal hepatitis B birth-dose recommendation -- left for a role at HHS. With Milhoan participating online, vice chair Robert Malone, MD, presided over the session.
Current U.S. recommendations call for a three-dose hepatitis B vaccine series administered at birth, 1-2 months, and 6 months or later. Pediatricians and infectious disease experts warn that delaying the start of that series would increase transmission risk. Chronic hepatitis B virus infection sharply increases the risk of cirrhosis and liver cancer.
"Let me be very clear about this: Delaying the birth dose would leave newborns unprotected during a critical window of their lives," said José R. Romero, MD, of the American Academy of Pediatrics. "Despite what HHS Secretary Robert F. Kennedy Jr. and some ACIP members suggested today, the science is unequivocal. Hepatitis B remains a real and serious risk to infants."
Vicky Pebsworth, PhD, RN -- an executive for the National Vaccine Information Center (formerly Dissatisfied Parents Together), a group widely considered to be a spreader of vaccine misinformation -- said the childhood immunization schedule workgroup had endorsed a shared clinical decision-making approach for infants of HBsAg-negative mothers.
She cited uncertainty around incidence, prevalence, and horizontal transmission; questions about whether all three doses are necessary; and what she described as poor-quality evidence on safety. She said the "overwhelming majority" of infants born to HBsAg-negative mothers do not face high infection risk in the first months of life, and presented a slide stating that the 1991 universal birth-dose recommendation "was made in error."
However, a comprehensive review by the Vaccine Integrity Project released this week found no evidence of any safety or efficacy benefits in delaying the birth dose and concluded that delaying vaccination would "needlessly endanger" infants. Since the adoption of the birth-dose recommendation, infant hepatitis B virus infections have been nearly eliminated and pediatric infections in the U.S. have dropped by more than 95%.
Some ACIP members "spoke without evidence," Romero said, "and in most cases, they were just downright wrong."
A previous recommendation change -- in 1999, when the American Academy of Pediatrics and the U.S. Public Health Service recommended delaying hepatitis B vaccination for infants of HBsAg-negative mothers -- was linked to at least one documented death, according to a Morbidity and Mortality Weekly Report that detailed the case of a 3-month-old Michigan girl who died of fulminant hepatitis B after her mother's infection status was incorrectly recorded during prenatal care.
Two of the meeting's first three presenters -- author Mark Blaxill, MBA, and climate researcher Cynthia Nevison, PhD -- co-authored a 2021 study on autism retracted by the Journal of Autism and Developmental Disorders for methodological flaws and undisclosed conflicts of interest.
Nevison -- a CDC contractor who assisted the panel's hepatitis B workgroup -- argued that the universal birth dose should not receive credit for declines in infection rates seen over three decades, asserting that those reductions did not appear until 2012. Her position contradicted CDC scientists who said in September that apparent plateaus reflect generational shifts in exposure. Nevison instead attributed declines to blood-safety screening improvements, safer sex practices, needle-exchange programs, and case management for HBsAg-positive mothers.
"The answer to the question of which has had more effect -- the universal birth dose or other, more targeted measures -- logically, when you look at the age range in which the biggest declines have occurred, it had to be other measures," Nevison said.
Panelist H. Cody Meissner, MD, of the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, rejected that interpretation. "This disease has gone down in the United States thanks to the effectiveness of our current immunization program," he said.
"In your opinion," Malone interjected.
Meissner replied, "These are facts, Robert."
Blaxill -- who chairs an anti-vaccine group but was listed on the agenda as representing the CDC -- described himself as a "critic of the CDC" and questioned vaccine safety, calling evidence "limited" and "often concerning." He cited Vaccine Injury Compensation Program (VICP) claim numbers and rodent-model injury mechanisms. Meissner -- a former VICP chair -- pushed back, noting that "there is no evidence of harm" and that VICP settlements are not confirmations of causality. "These are not confirmed associations," he said.
However, Jason Goldman, MD, president of the American College of Physicians, delivered the sharpest rebuke.
He blasted the panel for having "no understanding of the process or the gravity of the moment," questioned why the hepatitis B vaccine workgroup roster had not been disclosed, and called the proceedings "completely inappropriate" with presenters advancing an "anti-vaccine agenda" without necessary evidence.
"The best thing you can do is adjourn the meeting and discuss vaccine issues that actually need to be taken up," Goldman said.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.