The Big Plan Behind Kennedy’s Overhaul Of Childhood Vaccines

Anti-vaccine activists see a big opportunity behind Health Secretary Robert F. Kennedy Jr.’s dramatic overhaul of the childhood vaccine schedule.

In dropping government recommendations Monday that children routinely receive shots for four diseases, Kennedy’s allies believe they are closer to realizing a top priority: a country in which people who claim vaccine injuries can more easily sue vaccinemakers for millions in civil court.

Manufacturers of those vaccines would no longer be shielded from liability, the plan’s proponents assert, and could be driven from the market amid an influx of lawsuits alleging injuries from their products. In that scenario, the anti-vaccine movement would have a high-profile opportunity to shape the public narrative about childhood shots in courts nationwide.

Kennedy and Health and Human Services Department officials announced that longstanding recommendations that children receive flu, meningitis, hepatitis A and rotavirus vaccines were downgraded to a category known as “shared clinical decisionmaking,” meaning patients are encouraged to confer with health care providers before getting the shots.

In all, the number of “routine” vaccine recommendations — which assume vaccination as the default — have now been cut by a third, from 18 to 11, since 2024.

A senior HHS official said Monday that department attorneys “have assured us there will be no changes in liability protection” for the vaccines moved to shared clinical decisionmaking. But that position won’t stop interested attorneys from testing their theory in court, as proponents and detractors alike expect.

“Look, it’s still, I think, hypothetical, theoretical,” Del Bigtree, a member of the anti-vaccine movement who served as Kennedy’s presidential campaign spokesperson, told POLITICO in an interview.

But he added, “the legal authorities that I talk to, they believe that this is solid ground.”

Bigtree and Aaron Siri, a vaccine injury lawyer who’s worked with and advised Kennedy, have publicly suggested in recent weeks that people who claim injury from vaccines recommended under shared clinical decisionmaking would no longer be required to go first to the Vaccine Injury Compensation Program, the no-fault government alternative to civil courts. Congress established the program in 1986 as the U.S. vaccine industry neared collapse from lawsuits. It provides a liability shield for vaccinemakers while ensuring quick compensation for families who can prove that an injury was more likely caused by a vaccine than not.

The law that established the program specifies that the injuries it covers must stem from vaccines recommended for “routine” administration in children and pregnant women.

This means, Bigtree, Siri and others say, that claimants could take manufacturers of the shots no longer recommended as routine directly to civil court for damages — a long-standing goal for Kennedy, who was a vaccine injury attorney for many years and also founded the influential anti-vaccine group, Children’s Health Defense.

Moving vaccines to shared clinical decisionmaking “is a way to get rid of the [manufacturers’] immunity without Congress,” Siri said during a Dec. 18 podcast interview.

“And you know who can do that?” Siri said. “The CDC director with the stroke of a pen.”

Acting Centers for Disease Control and Prevention Director Jim O’Neill ordered the changes Monday, effective immediately.

The prospect of losing liability protections is perhaps most fraught for the flu shot, for which the vast majority of compensation claims are filed under the federal program.

Some vaccine policy experts had expected any adjustments to the schedule to take longer to account for the role of CDC’s external Advisory Committee on Immunization Practices, which meets three times a year to review and make recommendations. But then HHS made the changes directly, circumventing the panel’s authority.

Siri signaled where likeminded advocates will look next.

“Next stop should be to make non-routine the vaccines which do not stop transmission,” he said in an X post after Monday’s announcement. He referred to two combination shots that target diphtheria, tetanus and whooping cough and the polio vaccine.

In an email to POLITICO, Siri questioned why pharma companies need liability protections for vaccines that have existed for decades.

“Do we not yet know they are safe enough to lift the immunity?” he said.

Program supporters worry that those arguments obscure the reality of the American tort system, which vaccine injury claimants can opt into if they first go through the compensation program and reject their outcome.

The standard of proof in traditional court is considerably higher, they say, and few petitioners succeed in that system, where potential damages outside of class-action suits likely wouldn’t be high enough for injury attorneys to take on.

“It’ll either be all sound and fury and nothing happens, or it will be completely devastating to those people injured by vaccines” because of the potential lack of compensation, Renée Gentry, director of George Washington University’s Vaccine Injury Litigation Clinic, said of the schedule changes’ effects on liability.

Lawyers who work in or closely observe the compensation program acknowledged it’s a legal gray area as to whether vaccines without routine recommendations must be covered under the program. Courts have never addressed the issue.

Dorit Reiss, a professor at University of California’s law school in San Francisco, said she interprets HHS’ statement that the schedule change doesn’t affect existing liability protections to mean the status quo “won’t change without an additional step, including rulemaking.”

The law is clear, she said, in requiring the agency to change the vaccine injury table through rulemaking in order to remove vaccines from the government compensation program. The injury table is a legal document that serves as a cheat sheet that shows how individual vaccines are presumed to be linked to specific injuries that make families eligible for speedy compensation without a trial.

Such a change “requires a pretty elaborate process,” Reiss added, with HHS first needing to present its proposal to an obscure advisory panel for input before publishing it for public comment. “It is not automatic.”

Reiss and David Mansdoerfer, an HHS official during the first Trump administration, said the administration appeared to shield the announcement from legal challenges by asserting that all childhood vaccines would continue to be covered by insurance and the compensation program.

“Who would have standing to come against that?” Mansdoerfer said.

Richard Hughes, an attorney representing the American Academy of Pediatrics in a lawsuit challenging earlier vaccine policy moves by Kennedy, said Tuesday that he and his colleagues are “evaluating all available legal options in response” to the schedule changes

Meanwhile, Bigtree said he expects litigation testing the liability shield for the downgraded vaccines as soon as this year.

If it happens, the end of liability protections for certain vaccines is “going to be a gold rush for personal injury attorneys.”

“It’ll be a case in the millions and millions of dollars, and there’s not one of them — there’s many,” he said.