Harv's Corner 12/08/2025

Harv's Corner

Panel nixes a vaccine for newborns
Hepatitis B shots have been routine for decades; new proposal recommends only if moms are infected or status is unknown.
By APOORVA MANDAVILLI The New York Times

A federal vaccine committee on Friday took a major step toward Health Secretary Robert F. Kennedy Jr.'s goal of remaking the childhood vaccine schedule, voting to end a decades-long recommendation that all newborns be immunized at birth against hepatitis B, a highly infectious virus that can cause severe liver damage.

The divisiveness and dysfunction of the committee in making the decision, however, raised questions about the reliability of the advisory process and left at least one critic "very concerned about the future" of the Centers for Disease Control and Prevention.

The panel, called the Advisory Committee on Immunization Practices, voted 8-3 that women who test negative for hepatitis B should consult with their health care provider and decide "when or if" their child will be vaccinated against the virus at birth. The committee did not change the recommendation that newborns of mothers known to be infected or whose status is unknown be immunized. The shift is not expected to affect insurance coverage of the shots.

The new recommendations will become official CDC guidance once Jim O'Neill, the agency's acting director, accepts them. More changes to vaccine policy are likely to follow in the coming months, as the committee goes on to review all childhood immunizations. The meeting's presenters and at least some of the panelists are known for their antivaccine views and are close associates of Kennedy.

Aaron Siri, a lawyer who for years joined with Kennedy in court battles over vaccines, talked at length later in the day about the evolution of the childhood schedule. Siri has petitioned the government to stop distribution of 13 vaccines, including polio vaccines.

The meeting dealt another blow to the CDC's standing as an authority that the nation and the world could look to for advice on issues of public health.
"Today is a defining moment for our country," said Michael Osterholm, a public health expert at the University of Minnesota.

"We can no longer trust federal health authorities when it comes to vaccines."

Dr. Debra Houry, who served as the CDC's chief medical officer before resigning in protest in August, said she found it "heartbreaking to see this science-driven agency turn into an ideological machine."

Political appointees, many of them vaccine skeptics, are now in high agency positions, she noted.

"I am very concerned about the future of CDC at this point," Houry said.
The votes on the hepatitis B shot were originally scheduled for the September meeting but were deferred twice because some members said there was insufficient data to make a decision.

The committee attempted the vote again Thursday but postponed it after some panelists questioned whether a change to the recommendation was warranted.

Some panelists noted that universal hepatitis B vaccination at birth had helped to nearly eliminate cases among newborns in the United States and that there was no evidence of harm from the shots at any age.

"We know it's safe, and we know it's very effective," Dr. Cody Meissner, a professor of pediatrics at the Dartmouth Geisel School of Medicine, said during Friday's meeting.

He warned that if the proposal passed, "we will see more children and adolescents and adults infected with hepatitis B."

Kennedy and his associates have argued that hepatitis B is primarily a sexually transmitted disease and that babies do not need the protection unless their mothers are infected.

The risk of "infection throughout your early stage of life, and probably throughout most of your childhood, is extremely low," said Retsef Levi, a panelist and a professor of operations management at the Massachusetts Institute of Technology.

"To quantify how low it is, it's probably 1 in several millions," he said.
But supporters of the vaccine note that the virus can be spread by people who do not know they have it, as well as by household objects like toothbrushes, razors or combs that are used by an infected person. Only about half of cases before 1991 were a result of transmission from an infected mother.

The CDC has recommended for almost 35 years th
at doctors administer the first dose of the hepatitis B vaccine within 12 hours of birth to infants whose mother is known to be infected, and within 24 hours for all other newborns.

The first dose is given on its own, but two later doses are often administered as combination products containing vaccines for other diseases, like diphtheria, tetanus and polio.

The panelists recommended that for infants born to mothers who test negative for the virus, parents should decide whether and when to immunize their babies in consultation with their health care providers.
Parents and their providers should "consider vaccine benefits, vaccine risks, and infection risks" and administer the shot "no earlier than 2 months of age," the committee's new recommendation says.

The panel also voted 6-4 to recommend that parents seek out antibody tests to evaluate the effectiveness of the vaccine, although there was disagreement about whether such tests were meaningful in determining how much protection the shots afforded. One panelist abstained from the vote. The vaccine panel does not typically make recommendations about testing.

In a third vote, the panel agreed to include the hepatitis B vaccine in the Vaccines for Children program, which provides shots free to about half of American children. But Dr. Robert Malone, the panel's vice chair, who ran the meeting, seemed unaware that a separate vote was required to ensure coverage of the vaccine.

Kennedy fired all 17 previous members of the vaccine panel in June, replacing them with people who largely share his skepticism about vaccines. Meetings of the new members, most of whom have no experience in vaccine research or clinical practice, have been marred by disorganization and intense disagreements, sometimes devolving into shouting matches.

Siri began his presentation with a long list of his conflicts of interest, which include dozens of lawsuits involving vaccines against federal agencies. He did not disclose that his law firm receives millions of dollars from ICAN, the Informed Consent Action Network, an anti-vaccine organization. The group's most recent financial filings report that it paid Siri $6 million.

Over more than 95 minutes, he said that the clinical trials that tested childhood vaccines were too small and that the study populations were not diverse enough, opinions shared by some vaccine experts.

But he also repeated his frequent and incorrect claim that "not one" of the shots administered to children had been compared against a placebo or an inert substance. He cited discredited studies as evidence of vaccine harm, and questioned studies that detailed the benefits of vaccination.

Malone said that the committee had invited Dr. Paul Offit and Dr. Peter Hotez, two prominent vaccine experts, to present at the meeting, and lamented the fact that both had declined.

Offit, a pediatrician at the University of Pennsylvania, said the panel was offering misleading information to parents
.
"This is a political group, not a scientific group," he said in a message. "I don't want any part of that."

Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, echoed that sentiment. "I declined because ACIP seems to have shifted its mission away from science and evidence based medicine,"

​he said in a message, referring to the vaccine committee. "I'm always happy to discuss the science of vaccines with individuals or groups who are committed to truth and genuine intellectual inquiry."