EMA validates MAA for Pfizer and Valneva's Lyme disease vaccine candidate

On August 14, 2026, Pfizer and Valneva announced that the European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, the companies' 6-valent outer surface protein A-based Lyme disease vaccine candidate, and will begin its assessment of the application.¹

The filing rests on data from the Phase 3 VALOR trial. The application is based on efficacy of more than 70% observed in the trial, formally called "Vaccine Against Lyme for Outdoor Recreationists," which tested whether PF-07307405 prevented Lyme disease cases in people aged five and older.¹ The vaccine was well tolerated in the trial, with no safety concerns identified.¹

The trial itself was large. VALOR was a multicenter, placebo-controlled, randomized, observer-blinded trial run at sites with high Lyme disease incidence across the U.S., Canada, and Europe, enrolling 9,437 participants aged five and older who were randomized 1:1 to receive four doses of either PF-07307405 or a saline placebo, with doses at months 0, 2, and 5 to 9, followed by a fourth dose a year later ahead of the next Lyme season.¹

On the science, the vaccine is an investigational multivalent protein subunit that targets outer surface protein A of Borrelia burgdorferi, and immunization prompts antibodies against six Borrelia OspA serotypes.¹ As a tick feeds on a vaccinated person, it ingests these antibodies, which bind to OspA inside the tick and inhibit the bacterium's ability to leave the tick, blocking transmission to the human host.¹

Pfizer and Valneva have collaborated on the program since 2020. The companies entered into a collaboration and license agreement in April 2020 for co-development of PF-07307405, with Pfizer set to exclusively manufacture and commercialize it if regulatory approval is achieved.¹ PF-07307405 is currently the most clinically advanced Lyme disease vaccine candidate, with two pivotal Phase 3 trials completed.¹ Valneva describes it as the only Lyme disease vaccine candidate in advanced clinical development.¹