Major update on vote that could impact millions and reshape US health policy

A high-stakes decision that could reshape how newborns in the United States receive the hepatitis B vaccine has been pushed back yet again after the CDC’s immunization panel abruptly delayed its vote on Thursday, citing confusion over the very language they were supposed to approve.

The panel—appointed under Health and Human Services Secretary Robert F. Kennedy Jr.—was expected to weigh in on whether the long-standing recommendation for hepatitis B vaccination at birth should be updated or changed. Instead, members said the wording of the proposal had been altered multiple times throughout the week, leaving them unsure of what they were ruling on.

The vote, initially set for 2:30 p.m. ET, was postponed until Friday morning.

Though not legally binding, the committee’s recommendations have historically shaped national vaccination practices. Hospitals, pediatricians, and major medical organizations typically follow ACIP guidance closely, giving the panel’s decisions significant influence over newborn medical protocols.

Confusion stalls the process

Thursday’s meeting marked at least the second delay. A vote slated for September was also put on hold after members said the evidence presented at that time was insufficient to make a “confident evidence-based recommendation.”

During the session, vice chair Dr. Robert Malone noted that the committee’s chair, Dr. Kirk Milhoan, was not present because he was boarding a plane. That absence, combined with shifting language in the proposed statement, added to the uncertainty.

Malone, a former University of Maryland physician known for controversial views on COVID-19 vaccines, raised concerns about members not having clarity on what they were deciding.
Milhoan had only been appointed chair three days earlier, replacing Dr. Martin Kulldorf, who transitioned into a senior HHS post. Kulldorf, a Swedish biostatistician, gained national attention as one of the authors of the Great Barrington Declaration.

The members ultimately agreed to delay the vote until proper language could be finalized.

Why the decision matters

Hepatitis B is a viral infection that targets the liver, often leading to chronic disease, cirrhosis, liver failure, and liver cancer. The virus is highly resilient—capable of surviving on surfaces for up to a week—and spreads through contact with infected blood or bodily fluids.

For infants, the stakes are especially high. Up to 90 percent of newborns who become infected develop chronic hepatitis B, which can lead to lifelong complications.

Since 1991, the U.S. has followed a three-dose schedule for newborns: one shot within 24 hours of birth, followed by doses at one month and six months. Research shows the first dose administered at birth can reduce mother-to-child transmission by up to 90 percent.

The vaccine itself was introduced in 1982. Initial national recommendations in the early 1990s suggested administering the first dose no later than two months of age. That changed in 2005, when health officials urged hospitals to vaccinate newborns before discharge. A 2016 update strengthened the recommendation further: all infants should receive the shot at birth.

Because the majority of infected newborns acquire the virus through childbirth, public health advocates argue the birth-dose policy has been crucial in preventing transmission.

Latest estimates indicate that roughly 20,000 infants are born each year to mothers carrying the hepatitis B virus—many of them unaware of their status. Federal guidelines recommend screening pregnant women, but about 15 percent are never tested.

Due to widespread vaccination, the U.S. now sees only an estimated 10 cases of maternal-to-infant hepatitis B transmission annually.

Members question evidence, timing, and clarity

The hesitation among committee members has centered on the evidence base, with some asserting that the data presented does not adequately justify changing long-standing national guidance. Others have pointed to procedural confusion—particularly around wording changes delivered to members shortly before or even during the meeting.

Several members noted discrepancies between draft versions, including risk-benefit summaries and phrasing of the proposed recommendation. Some said the changes were significant enough that they could not confidently vote.

Observers said the meeting reflected growing tension within the panel since its reorganization. Some members appointed by Kennedy have been outspoken critics of certain vaccine policies. Others on the committee maintain more traditional public health views, creating frequent disagreement during deliberations.

Still, members said the core issue Thursday was clarity—not ideology.

What hepatitis B means for infants and the public

Hepatitis B remains incurable, and symptoms often do not appear until the virus has already caused significant liver damage. In about half of adult infections, there are no symptoms at all, meaning the virus can circulate undetected.

When signs do appear, they can include:

  • jaundice (yellowing of the eyes and skin)

  • fever

  • fatigue or malaise

  • muscle and joint pain

  • dark urine

In adults, the body often clears the infection on its own. But in newborns and young children, the virus almost always becomes chronic.

An estimated 640,000 adults in the U.S. live with chronic hepatitis B. Roughly half are unaware they are infected. Asian and Pacific Islander populations have the highest prevalence rates.

How U.S. policy compares to other countries

While many countries administer the hepatitis B vaccine at birth, several European nations—including the UK, France, and Germany—reserve the birth dose only for infants considered high-risk. Routine infant vaccination typically begins around eight weeks of age in those countries.

Despite that difference, the United States maintains lower hepatitis B transmission rates in newborns than many of those nations, which supporters attribute to universal birth-dose vaccination and maternal screening practices.

Committee leadership and controversy

The panel’s leadership has drawn attention in recent months. Dr. Malone, who presided over the discussion in the absence of Milhoan, has been a central figure in public debates around vaccine safety. Milhoan, a pediatric oncologist and former U.S. Air Force flight surgeon, entered the chairmanship amid ongoing scrutiny of the committee’s direction.

Meanwhile, former chair Dr. Kulldorf’s new HHS role has added another layer of political interest to ACIP’s decisions, particularly those involving childhood vaccines.

Some public health experts warn that internal confusion and delays risk undermining confidence in the process at a time when vaccine guidance is under intense public scrutiny.

What happens next

The committee is expected to reconvene Friday morning to revisit the issue. Members say they will only proceed once the final language of the recommendation is clear and uniform.

Even after a vote, the recommendation would remain non-binding. But historically, ACIP recommendations have shaped hospital and pediatric protocols nationwide, influencing millions of newborns annually.

Public health officials, pediatricians, and advocacy groups are watching closely. Any shift away from universal newborn vaccination could mark the most significant change to hepatitis B policy in more than three decades.

For now, the decision remains in limbo—one more delay in a process already marked by uncertainty, disagreement, and growing national attention.

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