Changes to Vaccine Schedule Harm Patients

Millions of Americans rely on vaccines to keep them and their loved ones safe. Unfortunately, policy decisions made by the Department of Health and Human Services (HHS) under the leadership of Secretary Robert F. Kennedy (RFK) Jr. threaten to deprive patients of access to essential vaccines. Recently, the Centers for Disease Control and Prevention (CDC)—which is part of HHS—announced significant changes to its immunization schedule of vaccines recommended for children. Shots for the flu, COVID, rotavirus, meningitis, hepatitis A, and hepatitis B have all been axed from the schedule.

Despite the branding, these changes are more than just altered “recommendations.” The shortened schedule has profound legal consequences, exposing vaccine manufacturers to runaway litigation and threatening access to lifesaving products for millions of Americans. The CDC should reverse course and make clear that patients—not trial lawyers—are in the driver’s seat.

Whether a vaccine is on or off the childhood vaccine schedule directly impacts its exposure to oft-frivolous litigation. Critically, vaccines on the schedule (with the exception of COVID) are covered by the National Vaccine Injury Compensation Program (VICP). As currently constituted, VICP provides payouts for patients injured by vaccines while allowing manufacturers a reprieve from costly lawsuits that could disrupt vaccine supply. Secretary Kennedy has already stated he wants to upend that status quo, proposing to swamp the VICP by adding costly and unfounded autism-related claims to the system.

The question over whether to consider autism as a “table injury”—a health condition found to be caused by vaccines and eligible for a VICP payout—is not a new one. In the early 2000s, VICP addressed more than 5,000 autism-related petitions by consolidating them into a handful of test cases for consideration. Years of study, testimony, and submitted evidence yielded a clear result: vaccines do not cause autism. As United States Court of Federal Claims Special Master Daniel T. Horner noted in more recent proceedings, petitioners in the test cases as well as follow-on individual cases argued separate theories of causation but invariably came up short in the evidence department. That’s not much of a surprise, given that the link between autism and vaccines has been extensively studied and debunked by scientists.

Reversing this carefully thought-out precedent would be exceptionally costly for taxpayers and consumers. As University of Pennsylvania legal scholar Peter Grossi notes, “the economic burden on the VICP 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.” This would almost certainly bankrupt the system, leading to the pre-VICP status quo of disruptive litigation that bankrupted vaccine manufacturers and disrupted supplies.

At least for the time being, VICP’s Advisory Commission on Childhood Vaccines hasn’t given any indication that autism-related claims are about to make their way into the system. But changes to the childhood vaccine schedule could be another tool for cynically chipping away at VICP’s protections by narrowing the number of vaccines eligible for Program protection.

In a perfect world, federal vaccine “recommendations” wouldn’t be decisive in determining which vaccines will be sued out of existence. But if the childhood vaccine schedule is such an important gatekeeper of patient choice, policymakers should do everything in their power to maintain the status quo of patient access. After all, Secretary Kennedy has promised “we’re not taking vaccines away from anybody.” He cannot meaningfully keep his word if legal costs become too high for manufacturers to stay in business. It’s time for a different approach that prioritizes patient lives and choice.