Lyme disease is an infectious disease caused by Borrelia bacteria transmitted to humans by infected ticks. Early symptoms of the disease (erythematous rash or other less specific disease symptoms such as fatigue, fever, headache, neck stiffness, arthralgia or myalgia) are often overlooked or misdiagnosed. If detected late, the infection can cause severe joint, heart or central nervous system complications. Each year, approximately 300,000 Americans and 85,000 Europeans develop Lyme disease.
To fight against this scourge, researchers from the French laboratory Valneva have developed a vaccine, VLA15, which targets the outer surface of protein A (OspA) of Borrelia, one of the proteins most expressed by the bacterium when it is present in a tick. The clinical trial of this vaccine is currently in phase 2: “It is a very important phase, we measure the effectiveness in humans and we adjust the dosage. The whole goal is to move on to phase 3 which will allow this vaccine to be tested on a larger population” has just explained the head of the pre-clinical research group at Valneva in a interview on France 3. And the first trials of this phase 2 are encouraging. “VLA15 has been shown to be immunogenic at all doses tested, including in adults over 50 years old, one of the populations particularly affected by Lyme disease” explains the laboratory in a press release.
But moving from 800 phase 2 patients to a phase 3 test on more than 16,000 people, both in the United States and in Europe (because the bacteria is not the same on both sides of the ‘Atlantic) requires money. This is why the Valneva laboratory has just partnered on this project with the Pfizer laboratory. Together, they hope to commercialize this Lyme disease vaccine in 2025.
A vaccine approved by the US FDA
VLA15, the only vaccine candidate in clinical development against Lyme disease, received “Fast Track” status from the Food and Drug Administration (FDA), the US federal drug agency, in 2017. This status is reserved for products in development targeting serious diseases and having the potential to address an unmet medical need. This generally leads to a faster obtaining of a marketing authorization.
“Lyme disease affects an increasing number of people every year, many of whom must live with long-term sequelae that are not only extremely difficult to treat but also represent a significant economic burden. We are honored to advance the only Lyme disease vaccine currently in clinical development and look forward to working closely with the FDA and other health authorities to facilitate the development of this vaccine towards marketing authorization. market,” declared the CEO of Valneva at the time.
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