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FDA fast tracks Valneva’s Lyme disease vaccine

pharmafile | August 7, 2017 | News story | Research and Development, Sales and Marketing Valneva, biotech, life sciences, lyme disease, medicines, pharma, pharmaceutcial 

French firm Valneva has announced that its Lyme disease vaccine, known at this stage only by VLA15, has been fast-tracked for approval by the FDA. There is no vaccine available to prevent Lyme disease infection in humans, though one is available for dogs.

According to health officials, Lyme disease is the most rapidly growing vector-borne disease in the US. Incidence of the tick-borne disease has been on the rise, and the development of a vaccine has proven difficult, as any prospective treatment must account for variations of Borrelia burgdorferi, the bacteria which causes it. In New York alone, there were 3,252 confirmed cases of Lyme disease in 2015, and national Centers for Disease Control and Prevention is now claiming that actual diagnosis numbers could be ten times higher than reported, estimating around 300,000 cases across the US.

According to Valneva, the vaccine is effective against the six most common forms of the disease across the US and Europe. The vaccine has to date been administered to just 180 patients across the US and Europe in a preliminary clinical trial. The drug maker has plans to commence a Phase 2 trial at the beginning of 2018.  

“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,” commented Thomas Lingelbach, President and CEO of Valneva. “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.”

However, despite this good news, medical professionals have warned that, despite Lyme’s media prevalence, the same tick which causes the disease can also cause anaplasmosis and babesiosis with the same bite. “A Lyme disease vaccine is important, but it is also important to recognize other tick-borne diseases,” warned Dr Luis Marcos, Associate Professor of Clinical Medicine in Stony Brook’s Division of Infectious Diseases.

Matt Fellows

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