The Lyme Disease Vaccine: Regulation in Times of Misinformation

Abstract

As of mid-2026, your dog can get a Lyme disease vaccine, but you cannot. Yet Lyme disease is the most common vector-borne illness in the United States and Europe. What is more, there was once a commercially available Lyme disease vaccine (LYMErix), but it was discontinued due to low sales-a lack of demand that was fueled in no small part by the anti-vaccine movement.    It has now been over two decades since the FDA approved LYMErix. A second human Lyme disease vaccine candidate has been developed, and the agency is expected to begin evaluating it later this year. Other Lyme disease vaccine candidates are close to entering clinical trials.    Against this backdrop, this article looks back at the approval process and commercialization of the first Lyme disease vaccine. It then contrasts it with the current regulatory environment, with a focus on the FDA and ACIP, the vaccine advisory committee at the Centers for Disease Control and Prevention (CDC). The article concludes by identifying potential hurdles for Lyme disease vaccines at a time when misinformation on both vaccines and Lyme disease has begun originating in-and trickling down from-the federal vaccine regulatory system.

Additional Information

This article will appear in a future issue of Saint Louis University Journal of Health Law and Policy

Keywords

vaccine, Lyme, misinformation, health, FDA, ACIP, Advisory Committee on Immunization Practices, public health, pharmaceuticals, pharmaceutical company, anti-vaccine

Disciplines

Health Law and Policy | Law

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