In a decision that has sent shockwaves through the public health world, a federal vaccine advisory panel on Friday voted to end the decades-old recommendation that every newborn in the U.S. receive a hepatitis B vaccine at birth—a move critics warn could unravel one of the nation’s most successful disease-prevention strategies.

The Advisory Committee on Immunization Practices, or ACIP, backed two sweeping measures affecting the hepatitis B shot, despite forceful objections from leading pediatric and medical groups. The vote reshapes long-standing CDC guidance that has been in place since the early 1990s, a period during which hepatitis B infections plunged and infant transmission plummeted.

A Dramatic Reversal in U.S. Vaccine Policy

Hepatitis B remains a highly infectious liver virus spread through even microscopic traces of blood. It can cause life-long infection, cirrhosis, liver cancer and—at worst—death. For more than 30 years, the birth-dose vaccine has been the cornerstone of protection for the youngest and most vulnerable.

But ACIP’s new recommendation takes a drastically different path: parents should decide—using “individual-based decision-making”—if and when their child receives the vaccine.

The changes still require approval from Acting CDC Director Jim O’Neil, who is expected to sign off.

A Narrow Carve-Out, With Major Consequences

Under the revised guideline, only infants born to mothers who test positive or whose status is unknown must receive a vaccine within 24 hours of birth. Everyone else will shift to a “shared decision-making” model.

For parents electing to delay the birth dose, the committee suggested starting the series no earlier than 2 months of age, and floated the idea of using a serology test to evaluate the need for follow-up shots—an approach many experts say has no scientific grounding.

A Committee Reshaped Under Kennedy Draws Intense Scrutiny

These votes mark the most consequential overhaul of the childhood vaccine schedule under Health and Human Services Secretary Robert F. Kennedy Jr., who dismissed the previous committee in June and replaced its members with new appointees—many with publicly stated skepticism toward vaccines.

Public health officials have been bracing for sweeping changes since his appointments, warning that weakening long-standing vaccine standards could open the door to preventable outbreaks.

Experts Warn of Rising Infections and Gaps in Protection

Opponents of the new measure—speaking before and during the two-day ACIP meeting—said real-world gaps in maternal testing will leave infants unnecessarily exposed at the most dangerous stage of life.

Those infected at birth face a significantly higher risk of chronic infection. The universal birth dose has long been credited with driving national hepatitis B rates downward.

Yet some ACIP members argued the vaccine is unnecessary for most newborns. Former President Donald Trump has echoed similar rhetoric, inaccurately characterizing the virus as exclusively “sexually transmitted” and suggesting children wait until age 12 to receive it.

Members Clash Over Evidence—and the Lack of It

Some panelists called the new recommendations unsupported by science.

“We have still not had any information or science presented… on before or after 2 months of age,” said Dr. Joseph R. Hibbeln, who voted against all changes. “This is unconscionable.”

Dr. Cody Meissner, a pediatrician who joined ACIP in September, agreed, criticizing what he described as a leap into “never-never land” by proposing serology tests after just one dose, despite the tests being validated only after the full series.

“To make the changes that are being proposed, we will see more children… infected with hepatitis B,” Meissner warned.

Dr. Raymond Pollak also voted against the measures, while pharmacist Hilary Blackburn opposed the serology-related recommendation. Epidemiologist Catherine Stein abstained.

Confusion, Delays and Rising Concerns Over Transparency

The vote had already been delayed once after several members said they had not been provided final language in advance and raised concerns over redundancy and lack of evidentiary backing. Similar confusion caused the panel to postpone a vote in September.

Critics say the committee’s expansion of “individual-based decision-making” reduces clarity rather than providing it.

“What the public wants… is clarity,” said Lawrence Gostin of Georgetown University’s O’Neill Institute, arguing that ACIP is sidestepping its responsibility to set firm, evidence-based policy.

The panel is expected to resume discussions Friday afternoon on aluminum adjuvants and the broader childhood immunization schedule, signaling more contentious debates ahead.