A growing problem

Lyme disease is transmitted to humans via infected ticks and can lead to long-term neurological symptoms, chronic joint inflammation, and fatal heart rhythm irregularities if not treated adequately in its early stages.

Because initial symptoms such as fatigue, headaches and fevers are non-specific, treatment is often delayed. Up to 20% of patients diagnosed with early Lyme disease go on to develop the more serious chronic form, which is often debilitating and associated with serious long-term complications.

Warmer winters have driven the spread of the disease outside of its usual territories, especially in Europe. In the UK, annual cases are up ten-fold from 2001.

Lymerix: a false start

In 1998, the US Food and Drug Administration (FDA) approved the vaccine Lymerix as a safe and effective preventive measure against Lyme disease.

However, following now-discredited reports of patients developing arthritis after receiving the vaccine, an anti-vaccination campaign received widespread media coverage and the manufacturer, GlaxoSmithKline, faced a number of lawsuits.

It withdrew the vaccine from the market in 2002, a mere four years after its approval.

Ticking all the boxes

Following a number of abortive attempts by various companies to develop a novel vaccine, often held back by commercial factors, Valneva’s VLA15 is now the closest to the market.

The fast-track status of the drug entitles it to more frequent communications from the FDA during the clinical trial design and implementation process. It is also eligible for accelerated approval.

If its clinical trials are a success, the drug could be on the market before 2023, which was its previous estimated launch date.

For Valneva, this would mean tapping into a global market worth an estimated $900m, while for the public it would mean that those in the newly emerging at-risk areas could be adequately protected, and a potential public health crisis stemming from the effects of chronic Lyme disease could be averted.