Federal vaccine advisers selected by Health Secretary Robert F. Kennedy Jr. are planning to vote on ending the practice of vaccinating all newborns for hepatitis B and to examine whether shots on the childhood immunization schedule are behind the rise of allergies and autoimmune disorders, the newly appointed chair of the group told the Washington Post.
Kirk Milhoan, a pediatric cardiologist and critic of coronavirus vaccination who recently took over as chair of the influential vaccine panel, said members meeting Thursday and Friday are broadly scrutinizing vaccines recommended for children. The wide-ranging discussions on the timing of vaccines and ingredients could signal major changes to how children in the United States are vaccinated, marking the latest flash point in an accelerating reshaping of immunization policy under Kennedy.
For decades, the childhood and adolescent immunization schedule has called for administering vaccines at set milestones. But Kennedy, the founder of an anti-vaccine group, has long linked the rise of chronic disease, autism, and food allergies in the U.S. to what he calls the “exploding vaccine schedule” — claims that have been rebutted by medical associations and extensive research into the safety of shots.
The members of the Advisory Committee on Immunization Practices are preparing to make their most significant change to the childhood vaccine schedule yet since Kennedy purged the panel and replaced members with experts who have largely been critical of public health vaccination practices.
The new members plan to vote Thursday on scrapping the recommendation to give babies a dose of hepatitis B vaccine within 24 hours of birth if their mothers test negative for the virus. Instead, the panel is weighing a delay in that first dose byan interval that is “still being finalized,” Milhoan said. Vaccine advisers pushed back a vote on hepatitis B vaccine recommendations at their September meeting following disagreement.
The birth dose has been credited for a 99% drop in infections in children and teens since the 1991 recommendation from the Centers for Disease Control and Prevention and the American Academy of Pediatrics, according to a 2023 study in the official journal of the U.S. Surgeon General.
Critics of the birth dose, including Kennedy, say that it is unnecessary to vaccinate all children for the virus when the vast majority are not at risk for infection.
Clinicians say the birth dose acts as a safety net to give infants immediate protection if they acquire the infection from mothers whose infection status is unknown, incorrectly documented or whose test results are delayed.
ACIP makes recommendations to the CDC director on how approved vaccines should be used. CDC directors have almost always adopted the committee’s recommendations, which compel insurers to pay for vaccines and have traditionally guided pediatricians and medical organizations.
The committee also plans to begin public discussions on its effort to review the childhood immunization schedule and the cumulative health effects of the dozens of shots children receive.
“We’re looking at what may be causing some of the long-term changes we’re seeing in population data in children, specifically things such as asthma and eczema and other autoimmune diseases,” Milhoan said in an interview Monday.
“What we’re trying to do is figure out if there are factors within vaccines,” he said, such as their ingredients or unintended substances contaminating them during manufacturing.
Milhoan said the panel is focusing on the use of aluminum as an adjuvant, an ingredient added to vaccines to help the body produce an immune response strong enough to protect the person from the disease.
Aluminum salts are in more than a dozen routinely recommended vaccines such as hepatitis A, hepatitis B, diphtheria-tetanus-containing vaccines, Haemophilus influenzae type B, HPV, and meningococcal B and pneumococcal vaccines. Adjuvants are essential because without them, the vaccine might not be able to trigger adequate immune responses.
Aluminum salts have been used safely in vaccines for more than 70 years, according to the CDC. Aluminum-adjuvant-containing vaccines have only uncommonly been associated with severe local reactions, according to the Food and Drug Administration, which tests vaccines containing adjuvants extensively in clinical trials before they are licensed. The agency notes that the most common source of exposure to aluminum is food and drinking water.
Public health and medical experts have raised alarms that the panel is moving toward recommending that only vaccines without aluminum adjuvants be used, a move that health and industry experts have said would be expensive and difficult on a practical level and could lead to shots being pulled from the market. Milhoan said the panel is not calling for the removal of aluminum from vaccines.
“We’re not saying that at all,” he said. “We’re just starting to have the discussion.”
The FDA generally has the responsibility to direct manufacturers to remove ingredients from vaccines. Some high-level FDA officials think that it would be infeasible to take aluminum adjuvants out of vaccines and that it cannot be done on any practical timeline, according to a senior federal health official who spoke on the condition of anonymity to be candid.
Vaccine industry officials said that removing aluminum adjuvants from vaccines would cost billions of dollars and that finding a replacement would take years, according to people involved in the drug industry who spoke on the condition of anonymity to avoid publicly antagonizing the administration. The costs and technical complexities of doing so are enormous, one of the people said.
The two-day ACIP meeting this week follows intense upheaval in the federal vaccination system.
The committee has come under intense criticism from public health groups who accused the new members of botching and misstating science to further an agenda to undermine vaccines.
Sean O’Leary, who chairs the infectious-diseases committee of the American Academy of Pediatrics, said revisions to the childhood immunization schedule by the newly reformulated ACIP “should not be trusted.”
“Any changes they do make could be devastating to children’s health and public health as a whole,” O’Leary said in a briefing with reporters.
Andrew Nixon, a spokesman for the Department of Health and Human Services, said in a statement that the vaccine panel “remains committed to evidence based decision making, and will carefully consider all data before any recommendation is made.”
HHS announced Monday that Milhoan would be chair because his predecessor Martin Kulldorff, a Swedish biostatistician and prominent critic of the public health response to COVID, is joining the health agency in a staff role.
Milhoan is affiliated with an organization that promoted ivermectin as a coronavirus treatment despite trials finding it is not effective, and in March, he called for mRNA vaccines to be halted.
Former CDC director Susan Monarez said she was fired in August after refusing to rubber-stamp recommendations from the reformulated committee, and several top CDC officials resigned in protest.
Last week, the CDC revised its website to contradict its longtime guidance that vaccines don’t cause autism. Kennedy told the New York Times he personally directed the change.
On Friday, the nation’s top vaccine regulator, Vinay Prasad, announced plans to impose a more stringent approach to approving vaccines, including the annual flu shot, citing his team’s conclusion — without detailing the underlying evidence — that coronavirus vaccines had contributed to the deaths of at least 10 children.
With the exception of the vote on hepatitis B vaccine, the federal vaccine advisers have not scheduled any other votes on the childhood vaccine schedule this week. According to the draft agenda, there are no presentations about vaccine effectiveness, access, equity or practical consequences of disrupting well-established schedules, which were always included before panel membership changed.
Milhoan said vaccine benefits are well known and have been extensively discussed.
“Not enough attention is being paid to risk,” he said.
