EMA accepts Lyme vaccine application
Analysis based on 6 articles · First reported Aug 14, 2026 · Last updated Aug 14, 2026
The EMA acceptance boosts the commercial prospects for Pfizer and Valneva SE, with Valneva SE's stock surging nearly 16%. The vaccine addresses a significant unmet medical need, potentially creating a new market in the pharmaceutical industry.
The European Union — European Medicines Agency (EMA) accepted the marketing authorization application for PF-07307405, an experimental Lyme disease vaccine developed by Pfizer and Valneva SE. Clinical trials showed 70% efficacy in people aged five and older. Despite earlier disappointing trial results, the EMA's acceptance marks a major regulatory milestone. Lyme disease is the most common tick-borne illness, with no approved vaccine currently. More than 200 million people in Europe live in risk areas, and climate change may increase transmission. Valneva SE's shares surged nearly 16% on the news.
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