Valneva cleared for the only currently active clinical stage Lyme vaccine candidate

Valneva on Monday said that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its Lyme disease vaccine candidate VLA15.

Fast Track designation is granted by the FDA to products that are under development for serious conditions and have the potential to fulfill an unmet medical need. It is designed to facilitate the clinical development and expedite the review of new drugs and vaccines with the intention to accelerate the availability of promising products on the market, the company said.

Thomas Lingelbach, President and CEO of Valneva noted that Lyme disease affects an increasing number of people each year, many of whom have to live with long-term sequelae that are not only extremely difficult to treat but also represent a heavy health economic burden. He pointed out the feel of privilege to advance the only active clinical stage Lyme vaccine candidate to date. “(We) are looking forward to working closely with the FDA and other authorities to facilitate the development towards approval,” said Lingelbach.