Borreliosis vaccine receives FDA Fast Track Status

According to the Centers for Disease Control and Prevention (CDC), Lyme disease is the fastest growing vector-borne infectious disease in the United States. At the end of June, Valneva has received Fast Track designation by the U.S. Food and Drug Administration (FDA) for its borreliosis vaccine candidate VLA15. Currently, there is no vaccine available which protects humans against this disease. The France-based company recently completed subject enrolment for the ongoing Phase I study, which is conducted in the U.S. and in Belgium, combining approximately 180 subjects aged between 18 and 40 years. First results are expected in the first quarter of 2018. Furthermore, Valneva plans to initiate a Phase II trial at the beginning of 2018. „We feel privileged to advance the only active clinical stage Lyme vaccine candidate to date and are looking forward to working closely with the FDA and other authorities to facilitate the development towards approval“, states Valneva CEO Thomas Lingelbach. VLA15 is a hexavalent, protein subunit-based vaccine candidate targeting the Outer Surface Protein A (OspA) of Borrelia. Pre-clinical data have proven the potential to provide protection against a majority of Borrelia species that are pathogenic for humans.

Lyme borreliosis is an infectious disease caused by Borrelia bacteria that are transmitted to humans by infected ticks. It can lead to serious complications involving the heart and central nervous system. Each year around 85,000 Europeans develop Lyme disease. The global vaccine market against it is estimated at €700m to €800m annually.