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Pfizer and French partner to seek approval for Lyme disease vaccine after late-stage trial

Steve Goldstein
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Pfizer and French biotech firm Valneva announced plans to seek regulatory approval for their Lyme disease vaccine after completing a Phase 3 trial. The vaccine demonstrated over 70% efficacy in preventing Lyme disease in participants aged 5 and older, though it narrowly missed its predefined statistical threshold for the primary endpoint. The late-stage trial results, released in March 2026, mark a key step toward potential commercialization of the first Lyme vaccine in over two decades. If approved, the vaccine could address rising Lyme disease cases, which have expanded geographically due to climate change and increased outdoor activity. The companies aim to submit approval applications to global regulators, targeting a market with no currently available human Lyme vaccine.
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Pfizer and French partner to seek approval for Lyme disease vaccine after late-stage trialListen(1 min)Listen(1 min)Pharmaceutical giant Pfizer and French partner Valneva on Monday said they planned to seek regulatory approval for a Lyme disease vaccine after a late-stage trial.The companies said a Phase 3 study of its Lyme disease vaccine candidate demonstrated more than 70% efficacy in preventing Lyme disease in those 5 and older. However, the predetermined statistical criterion was not met in the primary endpoint.About the AuthorSteven Goldstein is based in London and responsible for MarketWatch's coverage of financial markets in Europe, with a particular focus on global macro and commodities. Previously, he was Washington bureau chief, directing MarketWatch's economic, political and regulatory coverage. Follow Steve on Twitter: @MKTWgoldstein.A Dow Jones CompanyCopyright © 2026 MarketWatch, Inc. All rights reserved.

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