Federal health officials are examining the feasibility of taking aluminum out of vaccines, a prospect that vaccine experts said would wipe out about half of the nation’s supply of childhood inoculations and affect shots that protect against whooping cough, polio and deadly flu.
The review at the Food and Drug Administration began after President Trump listed aluminum in vaccines as harmful during a press briefing about the unproven link between Tylenol and autism.
Aluminum salts have been in vaccines since the 1920s and are added to enhance the immune-stimulating effect against the virus or bacteria covered by the inoculation. Robert F. Kennedy Jr., the nation’s health secretary, has been a longtime critic of aluminum in vaccines, which he has suggested is linked to autism.
Vaccine experts said the tiny amount of aluminum salts in vaccines — often measured in the one-millionth of a gram — has a long track record of safety and is essential to generating lasting immunity from disease. Developing vaccines without aluminum, they said, would require an entirely new formulation from scratch.
Such efforts take years of careful safety tests, cost hundreds of millions of dollars and could potentially expose thousands of infants to deadly diseases, given Mr. Kennedy’s insistence that new vaccines should be tested in humans against placebos.
Mr. Trump acknowledged that like mercury, which was removed from childhood vaccines more than 20 years ago, the case against aluminum is limited.
“We’ve already taken out and are in the process of taking out mercury and aluminum now,” Mr. Trump said. “And there were rumors about both of them for a long time, but we’re having them taken out.”
Dr. Bruce Gellin, who worked in vaccine safety roles at the Department of Health and Human Services for more than a decade, said that rumors were akin to hearing a smoke detector go off.
“There might be a fire or maybe you need a new battery,” said Dr. Gellin, who is now the president of global immunization at the Sabin Vaccine Institute, a nonprofit health organization. “Following signals is a good idea, but acting on them without investigating and finding the root cause is not a good idea.”
Andrew Nixon, a spokesman for H.H.S,, did not answer questions about removing aluminum, but said an influential vaccine committee at the Centers for Disease Control and Prevention was “reviewing the body of science related to aluminum and other possible contaminants in childhood vaccines.” (Mr. Kennedy fired that committee’s members this summer and replaced them with numerous vaccine skeptics.)
The scientific consensus is that the small amounts of aluminum in vaccines is safe. Aluminum is also one of the most abundant elements on earth; people breathe it in dust and take it in through food and drinks every day.
Before Mr. Trump’s latest remarks, Mr. Kennedy had not announced any formal plans related to aluminum removal. During his career as an anti-vaccine activist, though, he supported researchers who published studies trying to link aluminum in vaccines to autism and that were roundly criticized.
In 2020, Mr. Kennedy described one such researcher, Christopher Exley, as “the world’s leading authority on aluminum toxicity,” saying his research on aluminum and vaccines has “documented grave toxic effects.” Mr. Kennedy wrote on his former nonprofit group’s website that he tried to donate $15,000 to support Dr. Exley’s research, but his university in the United Kingdom returned the check.
Dr. Exley published one study in 2018 that examined the presence of aluminum in the donated brains of five people with autism, suggesting that it could “implicate” aluminum in the development of autism. Asked to elaborate, Dr. Exley said in an email that he did not know the vaccination status of the brain donors because of confidentiality rules.
He said in a Substack post on Oct. 1 that he wrote to Mr. Kennedy before Mr. Trump’s briefing to remind the secretary that aluminum “is the cause of profound autism.”
In an email to the New York Times last week, Dr. Exley wrote, “Secretary Kennedy asks my advice on aluminium in adjuvants as I am the leading authority on human exposure to aluminium.”
In an interview at a National Governors Association meeting in July, Mr. Kennedy said the National Institutes of Health was studying links between aluminum and allergies. A new C.D.C. working group has also stated that it will examine whether there is a link between different aluminum adjuvants and asthma risk.
Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, said the N.I.H. had already invested tens of millions in developing next-generation adjuvants, or immune amplifiers like aluminum. He said there have been questions about aluminum’s role in allergies, given how it stimulates certain immune cells. Further study of vaccine safety is always welcomed, he said.
“Human nature is to keep making things better, and we should keep making things better,” Dr. Levy said.
Companies that make childhood vaccines include Merck, Pfizer, GSK and Sanofi. Representatives from some companies said the aluminum adjuvants, or immune boosters, have a well-understood safety record. Replacements would be novel and need to be evaluated one by one against pathogens for each covered disease, wiping out the use of combination shots that cover several diseases.
Several company representatives said they had not heard from federal health officials on the matter.
If Mr. Kennedy were to act decisively against aluminum in vaccines, he could try to do so through the F.D.A., which approves them. The agency can remove products from the market if there is strong new evidence of harm or a lack of effectiveness. The process, if contested, can take years.
The C.D.C.’s vaccine committee could weaken its recommendation for shots that contain aluminum salts, an effort that would most likely further erode vaccine confidence. It would also very likely lower the use of childhood vaccines, particularly in states that tie their rules or regulations to the committee’s decisions.
Dr. Robert Malone, a member of that committee, the Advisory Committee on Immunization Practices, said he would not expect Mr. Kennedy to take steps to take vaccines away from people who want them.
The scrutiny of aluminum is in some ways similar to criticism of thimerosal, a preservative that was removed from childhood vaccines about 25 years ago. Yet that was a far simpler effort: It only required shifting from F.D.A.-approved vaccine vials that contained the preservatives to pre-filled syringes that do not.
In the intervening decades, a number of large studies refuted any link between thimerosal and autism. And even with it removed from childhood vaccines and phased out for use in pregnant women, autism rates have risen.
Taking out aluminum would be a “waste of resources and will expose U.S. children to unnecessary disease in any transition period,” said Dr. Anders Hviid, a Danish vaccine researcher and epidemiologist.
Dr. Hviid was an author of a major study published in July that reviewed the records of 1.2 million Danish children over 24 years. It found that as their exposure to aluminum in vaccines increased, their risk of a host of conditions, including asthma, allergies and autism, did not rise.
Mr. Kennedy lashed out at the study in a web and social media post, saying it was “deceptive” and downplayed “calamitous evidence of harm.” He urged the Annals of Internal Medicine, which published the study, to retract it.
Mr. Kennedy focused on a subgroup analysis in the Danish study of about 50 children younger than 5 who were diagnosed at higher rates with Asperger’s syndrome, a high-functioning form of autism. He called the findings for that subset “a devastating indictment of aluminum-containing vaccines.”
Dr. Christine Laine, the editor of the medical journal, responded that the set of children was one of about 540 subgroup comparisons.
Dr. Hviid said that Mr. Kennedy was “cherry-picking” in singling out the effects on one small group of children because the broader study and analyses of other age groups did not find an increase in autism.
Apoorva Mandavilli contributed to this report.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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