For years, both pharmaceutical companies and attorneys representing people who claim vaccine injuries have argued that the federal compensation program is understaffed and far too slow. They have repeatedly pressed Congress to modernize it. Now, Health Secretary Robert F. Kennedy Jr. is weighing far more sweeping reforms that, according to industry figures and public health officials, could jeopardize vaccine availability in the United States if manufacturers decide to leave the market.
A top adviser to Kennedy has suggested broadening which medical conditions the program considers vaccine-related injuries, including adding certain severe autism cases. Kennedy, who promoted anti-vaccine positions long before taking the role of health secretary, has long asserted a connection between vaccines and rising autism diagnoses despite extensive scientific evidence showing otherwise.
“You are playing with fire. We could lose small vaccine manufacturers entirely,” said Richard Hughes, a vaccine attorney and former Moderna executive. “Even large companies may have to seriously consider whether staying in the market is sustainable if these changes go through.”
Decades ago, when vaccine makers faced waves of lawsuits claiming their products harmed children, many companies exited the U.S. market. That crisis led the federal government to establish the Vaccine Injury Compensation Program in 1986, a no-fault system that protected vaccine access by shielding manufacturers from most lawsuits while compensating families who could demonstrate a likely link between vaccination and injury.
Since then, the program has expanded to cover nearly three times as many vaccines, but its limited staffing and heavy caseload have caused long delays, sometimes forcing families to wait years for a hearing. Still, the program’s biggest test may be coming now.
Kennedy’s senior adviser overseeing the redesign has publicly discussed broadening the federal definition of “encephalopathy,” a general term for brain dysfunction. Such a change could make some autistic children eligible for compensation without explicitly mentioning autism, according to adviser Drew Downing, who has represented vaccine injury clients for years.
The strategy would involve rewriting the “injury table,” the reference document that lists each covered vaccine and the adverse reactions presumed to be linked to it within certain time windows. This table guides decisions on whether a claim qualifies automatically.
That revision process is well underway, but HHS declined to say when it would be finished. The agency must still consult the Advisory Commission on Childhood Vaccines before releasing any proposal.
Industry groups and public health experts warn that expanding eligibility to include autistic children could drain the program’s trust fund — currently more than 4 billion dollars — and once again push vaccine producers out of the market.
Some attorneys representing vaccine injury cases told POLITICO that redefining brain injury might actually improve the process. These claims already reach the program but are considered “off-table,” requiring expensive expert testimony and years of litigation. Treating them as “table injuries,” they say, would reduce the backlog without overwhelming the system, since many autism cases show no evidence of brain injury.
“I do not see courts being overburdened,” said David Carney, head of the Vaccine Injured Petitioners Bar Association.
Other lawyers who work closely with the program argue the opposite, predicting that even a narrow expansion to include only the most severe autism cases could trigger thousands of new claims. With the CDC estimating that 1 in 31 American eight-year-olds has an autism diagnosis, payouts covering lifetime care could reach billions and deplete the fund.
Downing has said he does not want to collapse the compensation program. But some of Kennedy’s strongest anti-vaccine allies — including Children’s Health Defense, the group he founded — openly do. They want the chance to bypass the federal program and sue manufacturers in state courts, hoping to force disclosure of data they believe will show hidden harms.
HHS spokesperson Andrew Nixon did not address questions about the proposal, instead pointing back to Kennedy’s July post on X pledging to “fix” the program.
According to interviews with lawyers, industry officials, and experts, the key question is whether Kennedy will focus on improving the system or approve injury-table revisions that could destabilize it entirely. He has long criticized the program, claiming it discourages companies from making vaccines as safe as possible.
Kennedy “has to choose a side. He cannot do both,” said Sarah Despres, a former Biden HHS official who now advises nonprofits focused on vaccines.
People who believe they or their child were harmed by a vaccine must file claims within three years of symptoms. If the injury table changes, newly eligible individuals would have up to eight years to file.
Awards are funded through a 75-cent tax on each vaccine dose. Claims that match table injuries qualify quickly, while off-table claims require petitioners to prove the vaccine most likely caused the injury.
Encephalopathy is already recognized as a rare post-vaccination risk, but research shows many cases are linked to genetic mutations. Experts agree Kennedy has broad authority to modify the injury table. What remains uncertain is how far he can go in adding conditions with little or no scientific evidence of being vaccine-related.
Kennedy has also speculated that vaccine ingredients, including aluminum salts, could contribute to common conditions like eczema and peanut allergies — ideas lacking scientific support.
Changing the table definition of brain injury also raises questions about how long after vaccination symptoms could be recognized. Most table injuries must appear within hours or weeks, and none are covered if they begin more than a year later. Autism is often diagnosed years after onset, and allergies can appear at any age.
Any proposal expanding these timelines would almost certainly face legal challenges. Historically, revisions have relied on data from clinical trials or post-market studies. Still, the table was always meant as a policy tool designed to provide compensation even when the science was imperfect.
Over time, as the table became more strictly tied to scientific evidence, compensation became harder to obtain, Despres said.
The program is jointly run by HHS’s Health Resources and Services Administration and the Justice Department. Vaccine injury lawyers argue this structure has slowed resolutions, as DOJ attorneys have become more adversarial and less willing to settle.
Kennedy has said he is working on reforms with Attorney General Pam Bondi, who could influence how DOJ attorneys approach settlements.
A DOJ spokesperson declined to comment.
Program defenders argue that compensation decisions do not represent scientific proof that vaccines caused any injury, noting that skeptics often misrepresent payouts as admissions of guilt.
Kennedy has inaccurately claimed that vaccine makers have total liability protection, despite having previously worked on lawsuits attempting to move claims out of the program and into state courts. Individuals cannot sue manufacturers without first going through the federal system, and even then, they must meet strict standards set by the Supreme Court.
Public health experts and industry leaders worry that Kennedy might dismantle the program instead of repairing it.
Changes Kennedy has made elsewhere in HHS could influence the compensation system. The CDC’s Advisory Committee on Immunization Practices, which Kennedy reshaped with members skeptical of vaccines, has begun recommending limits on certain childhood shots. The group is expected to urge delaying the newborn dose of the hepatitis B vaccine next week.
Kennedy allies have also argued that if ACIP shifts vaccines into a category called “shared clinical decision-making,” those vaccines could lose liability protection under the program. Lawyers say this is legally unclear.
Supporters of the program counter that critics misunderstand the U.S. legal system. Outside the federal program, proving a vaccine caused harm is far more difficult, and potential payouts are often too small for attorneys to take the cases.
Industry experts say true reform requires Congress to increase the number of special masters and raise the long-outdated cap on compensation. Lawmakers would also need to extend claim deadlines, another goal Kennedy has mentioned.
A House aide said congressional offices are already working on such legislation and evaluating how Covid vaccines could be incorporated.
Kennedy’s actions have already made investors hesitant to support new vaccines. His statements — as well as those made by President Trump — have contributed to declining public confidence in U.S. vaccine policy. Last week, Kennedy edited a government website to claim that public health agencies have ignored research supporting links between vaccines and autism, prompting strong backlash from medical organizations.
“All these actions begin to chip away at the foundation of the pediatric vaccine schedule,” said Scott Gottlieb, who served as FDA commissioner during Trump’s first term.