Pfizer-Valneva Lyme Vaccine Advances to EMA Review

August 17, 2026 at 14:23

Pfizer and Valneva announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for PF-07307405. The companies described PF-07307405 as an investigational 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate; EMA will now begin assessing the application.

The application is supported by efficacy and safety results from Phase 3 VALOR. Pfizer reported efficacy of more than 70% against Lyme disease cases among participants aged 5 years and older. The vaccine candidate was well tolerated in the trial, with no safety concerns identified, according to the release.

VALOR was a multicenter, placebo-controlled, randomized, observer-blinded trial conducted in high-incidence areas of the US, Canada, and Europe. The study enrolled 9,437 participants aged 5 years and older and randomized them 1:1 to PF-07307405 or saline placebo. Participants received doses at months 0, 2, and 5-9, followed by a fourth dose 1 year later.

PF-07307405 is a multivalent protein subunit vaccine designed to target OspA on Borrelia burgdorferi sensu lato. Pfizer said vaccination generates antibodies against 6 OspA serotypes; during a tick’s blood meal, those antibodies are intended to inhibit the bacteria from leaving the tick and reaching the human host. The candidate covers the 6 most prevalent OspA serotypes in North America and Europe. The companies said no human Lyme disease vaccine is currently approved.

MAA validation starts EMA’s assessment but does not constitute marketing authorization. Pfizer’s disclosure states that whether and when the application is approved remains uncertain and will depend in part on the regulator’s assessment of benefit-risk and efficacy. PF-07307405 remains investigational while the review proceeds.