Pfizer, Valneva Lyme Disease Vaccine Shows Over 70% Efficacy in Late-Stage Trial

Pfizer said it had planned to seek U.S. regulatory approval for the vaccine called PF-07307405.

There is currently no ‌approved vaccine ⁠to ⁠prevent Lyme disease - spread by bites from infected blacklegged ticks - after ​GSK discontinued its Lymerix shot in 2002, citing insufficient consumer demand.

While ​the Pfizer-Valneva vaccine showed 73.2% efficacy from 28 days after the fourth dose, it missed the primary goal ​in the first analysis due to ⁠fewer-than-anticipated Lyme ‌cases being accrued in the trial leaving ​a ​small number of data points.

However, a ⁠second planned analysis met the bar, with 74.8% efficacy, ​adding to Pfizer's confidence "in the vaccine's potential," ​as it plans "submissions to regulatory authorities."

According to the U.S. Centers for Disease Control and Prevention, symptoms of Lyme disease include fever, headache, fatigue, and a skin rash called erythema migrans. If left untreated, infection ‌can spread to joints, the heart, and the nervous system.

Most cases of Lyme disease can ​be ​treated successfully with a ⁠few weeks of antibiotics.

The CDC estimates about 476,000 people are diagnosed and treated for Lyme annually in the U.S., ​while roughly 132,000 cases are reported each year in Europe, the companies said.

Last year, Valneva said it expects Pfizer to launch the vaccine in the second half of 2027 following approval.