Drugmakers Pfizer and Valneva are one step closer to obtaining FDA approval for what would be the first Lyme disease vaccine after publishing positive results from a phase 3 trial, the companies announced July 17.
Lyme disease, caused by tick bites, has been a nationally notifiable condition since 1991, according to the CDC, and it is estimated that each year around 476,000 individuals are diagnosed with the disease.
The vaccine in development would be given as a series of three doses, followed by an extra booster shot one year after the initial vaccination series. The phase 3 study will monitor participants until 2025, but so far, has revealed positive results.
"The completion of the primary series of our VALOR trial is a critical step toward our goal of providing a safe and effective vaccine against Lyme disease," Annaliesa Anderson, PhD, senior vice president and head of vaccine research and development at Pfizer, stated in the release. "VLA15, the Lyme disease vaccine candidate we are co-developing with Valneva, is the one which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress."
Upon completion of the trials, Pfizer plans to submit a Biologics License Application to the FDA in 2026 in addition to a Marketing Authorization Application to the European Medicines Agency, according to the news release.
Pfizer and Valneva initiated phase 3 trials for the vaccine candidate in August 2022 and completed recruitment in December 2023. The two have been working together to develop a Lyme disease vaccine since April 2020.