Rfk Jr. Is Overhauling The Program That Helps Preserve Americans' Access To Vaccines

Drug companies and lawyers for patients have thought for years that the federal program for people injured by vaccines is understaffed and too slow to offer compensation. They’ve been urging Congress to overhaul it.

Now, Health Secretary Robert F. Kennedy Jr. is considering much more dramatic changes that industry insiders and public health experts worry could threaten the availability of vaccines for the public by prompting drug companies to flee the U.S. market.

A senior Kennedy adviser has proposed expanding the conditions that the program considers vaccine injuries to include some cases of severe autism. Kennedy, an anti-vaccine activist before he became health secretary, has long believed there’s a link between rising autism rates and vaccines despite ample science to the contrary.

“You’re playing with fire, because I think that we could seriously lose small vaccine manufacturers,” said Richard Hughes, a vaccine lawyer and former executive at vaccine maker Moderna. “For large manufacturers, they ultimately have to ask serious questions about whether it’s viable for them to remain in the market” and provide vaccines to Americans.

Decades ago, amid an influx of lawsuits against vaccine makers alleging their products caused serious adverse reactions in children, many companies did leave the U.S. market, prompting the federal government to create the Vaccine Injury Compensation Program in 1986. The no-fault alternative to state courts aimed to ensure vaccines remained available by largely shielding drugmakers from liability while offering quick, fair compensation to families who could show their children’s conditions were more likely caused by the shots than not.

Over the years, the program — which now covers nearly triple the number of vaccines it did at its inception — has been rattled by problems that have strained its limited resources and forced many families to wait years for their arguments to be heard. Even so, its biggest challenge may be yet to come.

The senior adviser Kennedy charged with restructuring the program has publicly floated the possibility of the Department of Health and Human Services redefining “encephalopathy” — a broad term for brain dysfunction. As a result, some autistic children would become eligible for compensation without necessarily using “the ‘A word,’” according to the adviser, Drew Downing, a longtime vaccine injury lawyer.

This would be done by revamping a cheat sheet known as the “injury table” that lists vaccines and associated injuries that manifest during a specific time period after a shot is administered. The document guides the vaccine program in presuming whether a shot caused a reaction.

That proposal is well underway, although HHS declined comment on when it would be finished. The department also must seek input from the Advisory Commission on Childhood Vaccines, an outside panel of experts, before unveiling the plan.

Industry insiders and public health experts have warned that expanded eligibility to include children with autism would bankrupt the compensation program’s trust fund — currently sitting at more than $4 billion — and once again drive vaccine makers from the market.  

Some vaccine injury lawyers told POLITICO that a broader reading of what constitutes an eligible brain injury could help the program. Those cases are already filed but are considered “off-table” injuries requiring expert witness testimony and years of litigation.

Compensating them as so-called table injuries, they argue, would cut through the backlog that is stymying the program without crushing it with an influx of cases, since many people with autism have no evidence of brain injury.

“I don't foresee any undue hardship or strain on the courts,” said David Carney, president of the Vaccine Injured Petitioners Bar Association.

But other lawyers close to the program project that — even if Kennedy were to limit an injury table change to cover only the severest cases of autism — thousands of claims could flood into the program now that the CDC estimates 1 in 31 8-year-olds in the U.S. have an autism diagnosis. That could prompt billions in payouts covering lifetime care costs, bankrupting the fund.

While Downing has said he doesn’t want to see the vaccine program fail, Kennedy’s most ardent anti-vaccine boosters — including the leadership of Children’s Health Defense, which he cofounded — do. They want the ability to circumvent the compensation program and go straight to state court to compel vaccine makers to disclose data they believe will prove that companies have hidden an array of ills caused by their products.

HHS spokesperson Andrew Nixon didn’t respond to questions about the forthcoming proposal, pointing to Kennedy’s July X post vowing to “fix” the program.

The question, according to interviews with lawyers, industry experts, drug company officials and others, is whether Kennedy will hew to his promise to reform the program so it functions better, or approve changes to the vaccine injury table that break it altogether. The secretary is a longtime critic of the compensation program, which he claims discourages drugmakers from ensuring shots are safe.

Kennedy “has to take one side or the other. He can’t do both,” said Sarah Despres, a Biden HHS official who now consults for nonprofits focused on vaccine policy.

Science vs. policy

People who believe they or their child suffered a vaccine injury can submit claims to the program within three years of symptom onset. If the injury table is revised, the newly eligible can file as long as the alleged injury occurred within eight years of the change.

The program issues awards — funded by a 75-cent per dose excise tax on vaccines — to individuals if they allege a table injury that’s presumed to be caused by the product in question or, if they claim an off-table injury, show the vaccine most likely caused it.

Encephalopathy — the brain injury category that could be broadened to include autism-like symptoms — is recognized as a rare adverse event post-vaccination. Decades of research shows many cases are likely linked to genetic mutations.

Experts on the compensation program agree that Kennedy has wide latitude to amend the injury table. What’s less clear is how far he can push the envelope by adding conditions for which the scientific evidence of links to vaccination are tenuous, if not nonexistent.

For example, Kennedy has suggested that vaccine ingredients — including aluminum salts used to boost immune response — could be one of the factors driving common ailments like eczema and peanut allergies, a claim for which there’s scant evidence.

A potential change to the table definition of brain injury also raises the question of just how long HHS could propose giving petitioners to demonstrate symptom onset post-vaccination.

Most table injuries are limited to those occurring within hours to weeks of a shot; none with onset beyond a year are covered. Autism can take years to diagnose and manifests differently across people, while allergies can emerge at any age.

Any such proposal is all but guaranteed to draw a legal challenge — past changes to the list, program experts say, were grounded in data generated during clinical trials or post-marketing studies. Still, the table — while not divorced from science — serves as a policy document that was originally intended to sweep in people who may not have actually suffered a vaccine injury.

“The more it became a scientific document, the harder it was for people to get compensated, and there are downsides to that that are policy-related,” Despres said, referring to the table amendments HHS has made with input from the National Academy of Medicine and the broader scientific literature.

The program is jointly administered by HHS’s Health Resources and Services Administration and the Justice Department, a setup that vaccine injury lawyers say has also hampered speedy resolutions for claims.

They say that, over the last 10 to 15 years, DOJ attorneys who represent HHS against petitioners have consulted less with HHS reviewers to determine cases that could be settled rather than taken to trial — and that they’ve become more adversarial than those who created the program intended.

“They don’t seem to be on the same page,” said Michael Milmoe, a former DOJ lawyer who worked on the compensation program’s cases for 30 years.

Kennedy has said he’s pursuing changes alongside Attorney General Pam Bondi, who could influence whether DOJ attorneys lean more heavily toward compensating families in vaccine court cases.

A DOJ spokesperson declined to comment.

Program proponents lament the way that vaccine skeptics in Kennedy’s orbit — and some public health experts — suggest that settlements or compensation made by the court equate to admissions of causality between a vaccine and an adverse event. That has never been the standard for compensation in the program, they said.

“We're trying to get people compensated, not trying to make any grand scientific proclamations that a certain vaccine increases your risk of getting a certain injury,” Carney said.

Kennedy has erroneously suggested drugmakers’ liability shield is absolute, despite working on cases for people trying to exit the compensation program to argue their claims in traditional courts. Individuals must first exhaust their claims through the federal program before attempting to take vaccine makers to court for damages. He has also claimed without evidence that those protections discourage manufacturers from developing the safest vaccines possible.

A fragile balance

Still, the drug industry and public health professionals worry that Kennedy would rather blow up the system than improve it.

Policy changes that Kennedy has driven in other corners of HHS could eventually influence how the compensation program works.

The CDC crafts the childhood immunization schedule with input from its Advisory Committee on Immunization Practices, the membership of which Kennedy overhauled last summer to be dominated by vaccine skeptics. The group has so far recommended eliminating or restricting use of certain vaccines — advice Kennedy’s CDC has adopted — and is poised next week to push back the currently recommended birth dose of the hepatitis B shot.

Kennedy acolytes have suggested that, should the committee embrace downgrading routine recommendations for childhood shots to a classification known as “shared clinical decision-making” — where vaccination is not the provider’s default position — that could remove the products from the compensation program.

“If vaccines start moving to shared decision-making, they're removed from that liability protection,” Del Bigtree, an anti-vaccine activist who advised Kennedy during his presidential campaign, said earlier this month at a conference.

Lawyers and industry experts acknowledge it's a legal gray area. 

Proponents of the compensation program say detractors’ focus on liability protections ignores the reality of the U.S. tort system where the standard of proof is much higher than in the no-fault vaccine court.

The potential award amounts at stake in individual suits outside class action litigation likely wouldn’t be high enough to convince an injury attorney to take on a case, program lawyers say. Plus, a 2011 Supreme Court decision made plaintiffs’ odds of victory steep because they must prove causation and either fraud or negligence — and cannot allege a vaccine was defectively designed.

“It’s not any better in terms of the outcomes,” said Robert Krakow, a lawyer who represents claimants for the compensation program who’s worked with Kennedy on past litigation.

Industry and public health advocates say administrative changes alone won’t help the program because congressional action is necessary for basic updates — namely, increases to the number of special masters who can judge cases and the original $250,000 cap on awards for pain and suffering or death. They also say lawmakers would have to extend the statute of limitations for people to file claims, another Kennedy priority.

A House aide said member offices are working on legislation to make some of those changes and to consider how Covid vaccines could be added to the program.

Kennedy’s moves have already chilled investment in new vaccines. His public statements, as well as President Donald Trump's, have also contributed to the erosion of trust in U.S. vaccine policy, public health advocates say. Last week, Kennedy revised a government website to say public health experts have ignored studies supporting a link between vaccines and autism, prompting outcry from medical and public health groups.

“All of these pieces start to pull out planks under the pediatric vaccine schedule,” said Scott Gottlieb, who served as FDA commissioner during Trump’s first term.