EMA validates Pfizer-Valneva Lyme vaccine application
European regulator accepts joint submission for VLA15 Lyme disease vaccine, clearing next regulatory hurdle.
The European Medicines Agency (EMA) has validated the marketing authorization application for the VLA15 Lyme disease vaccine, jointly developed by Pfizer and Valneva.
Validation by the EMA’s Committee for Medicinal Products for Human Use (CHMP) marks the formal start of the review process for the vaccine candidate. The submission, accepted on Wednesday, initiates a centralized procedure under which the EMA will assess the vaccine’s safety, efficacy and quality.
VLA15, currently the only Lyme disease vaccine in advanced clinical development, targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacterium responsible for the disease. Pfizer and Valneva have been collaborating on the vaccine since 2018, with clinical trials ongoing in Europe and North America.
The EMA’s validation does not guarantee eventual approval, but it confirms that the application is sufficiently complete for formal review. If authorized, VLA15 would provide the first vaccine option against Lyme disease in Europe, where the tick-borne illness is a growing public health concern.
Valneva’s shares were not immediately available for comment. Pfizer declined to provide further details on the timeline for potential approval.
Helena covers corporate news for listed and private companies across Europe, from strategy shifts to leadership changes, with an eye for what a story signals about the broader market.
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