Pfizer and Valneva Report EMA’s MAA Validation for PF-07307405 Against Lyme Disease
Shots:
- The EMA has validated the MAA for PF-07307405, a 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin its assessment of the application developed in collaboration between Pfizer & Valneva
- The application is supported by >70% efficacy in the P-III (VALOR) trial, which evaluated PF-07307405 in individuals aged ≥5 years. The vaccine was well tolerated, with no safety concerns identified
- PF-07307405 was evaluated for its efficacy, safety, tolerability, immunogenicity, & manufacturing consistency. Under an April 2020 collaboration, Pfizer will exclusively manufacture & commercialize the vaccine candidate, subject to regulatory approval
Ref: Globenewswire | Image: Pfizer & Valneva | Press Release
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