The companies’ marketing authorization application is based on results from a Phase III study showing an efficacy of more than 70 percent in preventing Lyme disease in individuals aged five years and older. More than 9,000 people took part in the study, which was conducted in areas with high Lyme disease prevalence in the United States, Canada and Europe.
EMA opens review of Europe’s first potential Lyme disease vaccine
The European Medicines Agency (EMA) has validated Valneva’s and Pfizer’s application for approval of the companies’ Lyme disease vaccine, meaning it is now ready for formal scientific review.
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