(RTTNews) - Pfizer Inc. (PFE) and Valneva SE's (VALN) Lyme disease vaccine candidate has reached a key regulatory milestone, with the European Medicines Agency (EMA) validating the companies' Marketing Authorization Application (MAA) for PF-07307405, a 6-valent OspA-based vaccine. The application will now move forward into formal review. The submission is supported by results from the Phase 3 VALOR trial, which showed the vaccine reduced Lyme disease cases by more than 70% in individuals aged five years and older. The candidate was well tolerated, with no safety concerns identified. Lyme disease is the most common vector-borne illness in Europe, affecting over 100,000 people annually. Left untreated, it can cause long-term complications involving the skin, joints, nervous system, and heart. Pfizer's Chief Vaccines Officer Annaliesa Anderson emphasized the potential of vaccination to provide a new layer of protection, while Valneva CEO Thomas Lingelbach highlighted that more than 200 million people in Europe live in areas at risk. Pfizer and Valneva entered into a collaboration in 2020, with Pfizer holding exclusive rights to manufacture and commercialize the vaccine upon regulatory approval. The candidate has been evaluated for efficacy, safety, tolerability, immunogenicity, and manufacturing consistency. This validation marks a significant step toward potentially introducing the first Lyme disease vaccine in Europe, offering hope for improved prevention in regions where the disease remains a persistent public health challenge. PFE has traded between $23.58 and $28.75 over the past year. The stock closed Thursday's trading at $26.80, up 1.86%. In pre-market trading the stock is at $26.79, down 0.03%. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.