Exciting news for pharmacists and patients — Pfizer and Valneva have announced positive Phase 3 results from the VALOR trial for their investigational Lyme disease vaccine candidate, PF-07307405. The study demonstrated 73.2% efficacy in preventing confirmed Lyme disease cases 28 days after the fourth dose. This is a critical milestone, as there are currently no approved human vaccines for Lyme disease.
The vaccine works by triggering antibodies that, when ingested by a feeding tick, bind to the bacteria in the tick’s midgut and block transmission to the human host. The VALOR trial enrolled participants age 5 and older across high-incidence areas in the US, Canada, and Europe.
With Phase 3 complete, Pfizer is planning to submit a biologics license application to the FDA and a marketing authorization to the EMA in 2026. Pharmacists will play a key role in managing the multidose schedule and educating patients on the importance of annual boosters. The CDC estimates approximately 476,000 people are diagnosed and treated for Lyme disease annually in the United States alone.