Vaccine injury scheme review raises fears over US supply safeguards

A reported review of the US vaccine compensation system has prompted warnings that wider manufacturer liability and changes to coverage could threaten routine immunisation supplies.

The Trump administration’s reported review of the federal Vaccine Injury Compensation Programme has raised fresh fears that the United States could weaken one of the main legal safeguards behind the country’s vaccine supply. According to STAT, the concern is not only that fewer vaccines could be covered by the programme, but that broader changes might expose manufacturers to greater liability and make it harder for parents and carers to get routine immunisations when they need them.

The Vaccine Injury Compensation Programme was created in 1986 to provide a no-fault route for people harmed by covered vaccines while protecting supply by limiting unpredictable court costs, according to the Health Resources and Services Administration. Between 2006 and 2024, more than 5 billion doses of covered vaccines were distributed in the United States, and around 10,500 claims were compensated under the scheme, a rate of roughly one successful claim for every million doses. That long record, public-health experts say, has helped keep manufacturers in the market and vaccines broadly available.

STAT reported that the administration is considering ideas pushed by Health Secretary Robert F. Kennedy Jr. and one of his advisers that could strip some vaccines from the programme, including childhood shots the federal government is trying to make optional under its recommendations. The article also said officials may attempt to make autism-related claims compensable through the programme, a move critics say would be far outside the scheme’s original purpose and could overwhelm its finances. The federal compensation fund currently holds about $4 billion, far short of the sums that would be needed if such claims were paid on a large scale.

One response, the STAT article argued, would be for states to step in and make vaccines themselves if private suppliers pull back. That idea is not without precedent. MassBiologics, founded by Massachusetts in 1894, remains the nation’s only non-profit, FDA-licensed vaccine manufacturer, according to the University of Massachusetts Chan Medical School. It has produced vaccines and related biologics for more than a century, and the university says it still makes a tetanus and diphtheria vaccine distributed nationwide. The existence of that state-run operation is central to the argument that public manufacturing could be revived if federal policy destabilises the market.

The policy case for such a back-up system is strengthened by the fact that vaccine compensation remains a live political issue. The Kaiser Family Foundation says both the Vaccine Injury Compensation Programme and the separate Countermeasures Injury Compensation Programme were designed to preserve access while providing a path for compensation, but both have come under renewed scrutiny in recent years. Taken together, the reporting suggests that the legal framework supporting vaccination in the United States is under pressure at the very moment public-health specialists say supply chains and confidence need the most stability.