Carl Zimmer -- April 24, 2026
The 8-4 vote backs a three-dose shot from Pfizer and Valneva targeting six bacterial strains, ending a two-decade gap since the last licensed Lyme vaccine.
An advisory panel to the Food and Drug Administration voted 8 to 4 on Thursday to recommend approval of a Lyme disease vaccine developed by Pfizer and Valneva, marking the first positive recommendation for a licensed Lyme vaccine in the United States in more than two decades.
The panel reviewed phase 3 trial data drawn from more than 6,000 participants across North America and Europe, covering an 18-month follow-up period. The vaccine demonstrated 89 percent efficacy against confirmed Lyme disease, a figure that panel members voting in favor described as sufficient to support a positive benefit-risk determination.
The four dissenting members did not contest the efficacy findings. Their objections centered on the 18-month follow-up period, which they considered insufficient to assess long-term safety. That concern was informed in part by the history of LYMErix, the only previously licensed Lyme vaccine in the United States, which was withdrawn from the market in 2002 following post-approval reports of arthritis-like symptoms. Later studies found those reports to be unsubstantiated.
Panel members who voted in favor cited the scale of the Lyme disease burden in their assessment. Approximately 476,000 Americans are diagnosed with Lyme disease each year, and a significant proportion experience debilitating or persistent symptoms even after treatment.
The FDA is not bound by its advisory committees but follows their recommendations in the majority of cases. A final agency decision on the application is expected within six months.