The costs of covering serious autism cases under the National Vaccine Injury Compensation Program (VICP) could undermine childhood vaccine production.
It is widely assumed that Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (HHS), will soon inject his belief that childhood vaccines cause autism into our national vaccine policy. What is not so well appreciated is that if new HHS and Centers for Disease Control and Prevention (CDC) leadership officially declare that childhood vaccines cause autism, the National Vaccine Injury Compensation Program (VICP)—created in 1986 to maintain the flow of childhood vaccines by directly compensating those injured by taking a vaccine rather than forcing them to sue the vaccine manufacturers—will quickly be bankrupted by a tsunami of autism claims. Manufacturers of all childhood vaccines will then likely cease production to escape massive liability risk as victims would return to suing manufacturers directly, just as manufacturers warned 40 years ago.
As I have detailed in a new paper, forthcoming in the Virginia Journal of Social Policy & the Law, the economic burden on the VCIP of just one year of the most serious autism cases would likely total more than $30 billion—more than 100 times the program’s annual revenues. And because such claims could be submitted by those diagnosed within the last three years, the program could be faced with an immediate docket consisting of claims totaling nearly $100 billion. The bankrupt VICP would then cease to be the buffer that the U.S. Congress wanted between vaccine manufacturers and unrestrained state tort liability.
Under the National Childhood Vaccine Injury Act—which Kennedy has long criticized as an impediment to vaccine injury litigation administered by corrupt bureaucrats—individuals injured by a covered vaccine must first submit their claim to the U.S. Court of Federal Claims. The court’s special masters are required to adjudicate a claim within eight months, and the court itself must complete any further review shortly thereafter.
Such tight time frames are feasible because the inquiry under the “no fault” act is limited to whether the injury was caused by the vaccine and, if so, the appropriate amount to compensate the claimant. As to the former, the Act provides that once medical science has convinced HHS that an injury can be caused by a covered vaccine, that condition is added to the VICP Injury Table. Petitioners whose claims satisfy the medical criteria set forth in the Injury Table are generally assured of VICP compensation.
Once petitioners have exhausted these remedies available in the VICP, they have a choice. They may accept the federal compensation award and end their claim. Or they may reject the federal payout and take their chances in a new lawsuit in state court. As a practical matter, however, almost all petitioners accept the federal compensation. But that, of course, assumes the VICP remains solvent.
Given Kennedy’s views on autism causation and his antipathy towards the VICP, it seems prudent to consider the economic burden that the addition of autism claims would impose on the program. A working estimate of that burden begins with the overall incidence of childhood autism. A 2023 CDC study found that one in 54 children ages 4 through 8 were diagnosed with some form of the condition—about 70,000 cases each year. And a general declaration by CDC and Kennedy that “vaccines cause autism” could put all of them before the VICP.
A more conservative approach, however, would focus on only the most severe, “profound” cases. That group, about a quarter of all autism cases, is defined as those with an IQ of 50 or less, or who are nonverbal or minimally verbal. According to the 2023 CDC study, the prevalence of that “profound” form was 4.6 per thousand 8-year-olds, or 0.46 percent.
As set forth in detail in our paper, applying that reported rate of profound autism to the approximately 3.7 million American children born in each recent year—and recognizing that around 93 percent of those children have been vaccinated before they go to school—about 16,000 children who have been vaccinated will be diagnosed with profound autism each year, simply because that is the general prevalence of the condition without considering whether vaccinations increase that rate at all.
One then needs to estimate the likely compensation that would be awarded for each profound autism claim, consistent with VICP precedent involving similar injuries. The leading case is the VICP’s settlement of the claim of Hannah Poling, in which the government agreed that a child had suffered a vaccine-induced encephalopathy—a recognized, but very rare, condition already on the Injury Table. The condition left her with “language, communication, and behavior” problems, one doctor explained—all of which are “features of autism spectrum disorder.”
Although there is debate about labeling Poling’s encephalopathy injury as “autism” per se, the case shows the level of VICP compensation likely to be awarded when a vaccine recipient has significant cognitive deficiencies. Poling’s award totaled more than $1.5 million, and a series of subsequent VICP encephalopathy settlements confirm that awards in the neighborhood of $2 million for significant brain injuries are likely.
If we take the estimated total number of potential claims of profound autism that might be filed if CDC officially links that condition to any VICP vaccine—16,000 claims annually, with an immediate docket of perhaps 48,000—and apply a likely compensation award of $2 million for each, we arrive at a working estimate of as much as $32 billion each year, and almost $100 billion for the backlog of claims that could immediately be filed within the three-year limitations period.
Any addition of autism to the VICP Injury Table would raise additional issues for which the program is simply not designed. Most notably, the entries on the Injury Table for other medical conditions include very brief onset periods that support a diagnosis of the injury within hours, or at most days, of the vaccination. For example, an encephalopathy, such as in Poling’s case, must be evident within as little as 72 hours and at most 15 days, depending on the vaccine at issue. But, except in very rare cases, autism develops much more slowly and subtly. As the American Academy of Pediatrics has explained, although symptoms are “neurologically based, they manifest as behavioral characteristics that present differently depending on age, language level, and cognitive abilities.” Indeed, such symptoms often do not manifest until the child begins to attend school.
Without such medically supportable limits in the Injury Table, the huge number of autism claims would undoubtedly bankrupt the VICP. Unlike some other programs funded by the federal treasury, Congress has provided that any claim filed against the VICP may only be paid out of the VICP Trust Fund, whose sole source of income is a $0.75 excise tax per vaccine dose. The taxes on the approximately 300 million annual vaccinations produce about $250 million each year. The total paid out by the Fund has likewise ranged between $200 and $250 million a year, so the Fund has balanced nicely.
By contrast, the estimated backlog of $100 billion for the initial docket of three years of profound autism claims—or even just the estimated $32 billion of claims each year—would quickly exhaust the $4 billion balance that has been accumulated by the Fund over the past 40 years and obviously outrun the $250 million in annual excise tax revenues.
What would that insolvency of the VICP mean to the relatively few companies currently producing childhood vaccines? As noted, the National Vaccine Injury Act was passed primarily because manufacturers warned Congress that they would promptly exit the unprofitable market for childhood vaccines unless Congress provided relief from unbridled state tort liability.
Those economics have not changed since. Put simply, while a pharmaceutical firm may be willing to run some litigation risk when it can charge $500 a month for a drug that patients will take for years, they are unlikely to continue to provide childhood vaccines, for which they can only charge $20 or $30 for the one or two shots that will protect a recipient for a lifetime. And, if they did, the risk they would confront would not be the one to two per million children affected by the injuries currently on the VICP Injury Table, but rather the general prevalence of one per 200 children who develop profound autism—without any regard to any effect of any vaccine at all.
In short, if Kennedy and his CDC officially declare that vaccines cause autism, it is very likely the VICP will cease to function, and manufacturers will end their production of all childhood vaccines.
