EU Validates Pfizer, Valneva's Application for Lyme Vaccine Candidate

02:01 AM EDT, 08/14/2026 (MT Newswires) -- The European Medicines Agency validated Pfizer (PFE.F) and Valneva's (VLA.PA) marketing authorization application for PF-07307405, the companies' Lyme disease vaccine candidate. The regulator will now start its assessment of the application following validation, according to a Friday release. The application was supported by the late-stage Valor clinical trials, in which the vaccine demonstrated efficacy of more than 70% and was well tolerated. The study evaluated whether PF-07307405 prevented the disease in individuals aged five years and older. The companies are collaborating on developing the 6-valent OspA-based Lyme disease vaccine candidate as part of a deal in April 2020, with Pfizer holding the exclusive rights to manufacture and market the product upon receiving regulatory approvals.