On June 20th, Pfizer and Valneva unveiled the terms of their collaboration and licensing agreement for VLA15, a vaccine candidate against Lyme disease. Valneva is a French company specialized in the development of vaccines against infectious diseases. Its expertise has enabled the company to develop several vaccines against Covid-19 and the Chikungunya virus.
The phase 3 of the clinical trial involving VLA15 will be initiated by Pfizer in the third quarter of this year. To date, VLA15 is the only vaccine in clinical trials against this disease that affects many people in Europe and the United States. Caused by Borrelia bacteria transmitted to humans by infected ticks, symptoms of Lyme disease include skin disorders, joint and muscle pain, but also vision, heart and neurological disorders with long-term consequences.
Due to the excellent data demonstrated by VLA15 during pre-clinical and early clinical studies, the US regulatory agency (FDA) granted it “Fast Track” status in 2017. This approach, introduced in the FDA Modernization Act in 1977, aims to reduce review times to make new drugs available to patients quickly.
The American laboratory therefore plans to invest €90.5 million in Valneva’s capital. At the end of the study, a marketing authorization application will be filed and submitted to the FDA.
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