A sweeping shift in national vaccine guidance for infants set off intense debate on Friday, as the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to push back the first hepatitis B shot for babies whose mothers test negative for the virus. For more than three decades, federal guidance has emphasized administering the vaccine within the first 24 hours of life. Now, with an 8–2 vote, the committee endorsed delaying that dose until two months of age for infants born to mothers confirmed negative.
The vote also endorsed a second change: Instead of automatically giving a newborn the hepatitis B shot, the new language advises “individual decision-making in consultation with a health care provider” for babies whose mothers have tested negative. The shift has stunned a wide range of medical organizations, including the American Academy of Pediatrics, which argue that easing the universal birth recommendation erodes vital protections for infants and undermines decades of solid data demonstrating safety and effectiveness.
These decisions landed on the second day of ACIP’s December convening — a meeting marked by confusion, procedural hiccups, and unusually sharp disagreements. Thursday’s scheduled vote had to be postponed after committee members said they couldn’t clearly see the latest draft of the ballot language and were unsure how many questions they were supposed to address. Technical failures added to the disorder, prompting concerns about transparency and accuracy.
When the panel reconvened Friday, the deliberations grew more charged. Members — all appointed by Health and Human Services Secretary Robert F. Kennedy Jr. — opened with a reading of the proposed text. One of the strongest objections came from Restef Levi, a mathematician with no medical background, who declared that experts had “never tested (the vaccines) appropriately” and insisted that the committee should refrain from recommending any timeline at all. His remarks quickly prompted pushback from longtime vaccine specialists.
Among the most vocal critics was Dr. Cody Meissner, a respected pediatrics expert who previously served on the FDA’s vaccine advisory panel. He and ACIP member Dr. Joseph Hibbeln repeatedly warned colleagues that the committee had been handed four versions of the proposal in less than a week. Hibbeln argued that “no rational science has been presented” to justify altering a schedule that has protected millions of infants for more than three decades. As Meissner cast his vote against revising the guidance, he offered a pointed reminder: “We’ve heard ‘do no harm’ as a moral imperative. We are doing harm by changing this wording.”
Hepatitis B poses life-altering risk to young children, leading to liver disease, cancer, and early death. Universal newborn vaccination has been recommended since 1991, leading to a 99% drop in pediatric infections. Experts warn that weakening the first-dose recommendations removes a crucial safety net in cases where prenatal testing is missed — a problem the CDC estimates affects roughly 16% of pregnant women each year.
Soon after the main vote, ACIP took up another contentious proposal: whether parents should test their children after the first dose to see if it provided a sufficient antibody response. The panel narrowly endorsed encouraging such discussions between families and physicians, though even supporters acknowledged the data remain thin and some wording was unclear.
If approved by the CDC director, these measures could influence not only clinical advice but also insurance coverage. ACIP recommendations often set the benchmark for what private insurers must cover. A shift in timing or structure could therefore have financial implications for families.
Friday’s debate followed a tumultuous Thursday session in which several members criticized the limited or contradictory data presented on vaccine safety. Meissner took particular issue with one presentation that suggested safety information on the birth dose was sparse — a claim contradicted by decades of published research documenting no increase in infant death, fever, sepsis, autoimmune disease, multiple sclerosis, or other serious reactions.
Frustration spilled into the public comments as well. Dr. Jason Goldman, representing the American College of Physicians, condemned the approach taken during the proceedings, calling the meeting “completely inappropriate” and accusing ACIP of “wasting taxpayer dollars by not having scientific, rigorous discussion on issues that truly matter.” He reminded the panel that the hepatitis B birth dose has never been mandated nationwide and that families already retain the right to make individualized decisions with their doctors.
This is not the first time ACIP has confronted procedural turmoil. At its September meeting, confusion over ballot wording led members to vote down funding for a combined measles-mumps-rubella-chickenpox vaccine for toddlers, reverse themselves minutes later, and then shift course again the following day.
The public health stakes remain stark. Newborns who contract hepatitis B at or around birth face a 90% chance of developing chronic infection, often culminating in cirrhosis, liver cancer, or premature death. Past research has shown that limiting early vaccination only to babies whose mothers test positive results in missed cases — with devastating consequences.
For years, critics of vaccination have targeted the hepatitis B birth dose, including Kennedy, who inaccurately alleged in a June podcast that the shot was a “likely culprit” in autism. Extensive research has disproven such claims, consistently showing that the vaccine has one of the strongest safety records in modern medicine. Numerous studies confirm that delaying the dose offers no measurable safety benefit.
The American Academy of Pediatrics reiterated this point in strong terms. Dr. Sean O’Leary emphasized that the vaccine administered at birth is “one of the most well established safety records of any vaccine,” adding that early protection is essential to preventing chronic illness and liver cancer. “We’ve been using it for a long time. It’s one of our best tools to protect babies from chronic illness and liver cancer.” He warned that even a single missed infection can have lifelong consequences: “This is a situation where one missed case is too many.”
{Matzav.com}
