- Based in Nantes, the Valneva company has been working for ten years on the development of a vaccine candidate against Lyme disease.
- Before marketing in 2025, the team is currently working on determining the best dosage and the best administration schedule for the vaccine.
For several years, Lyme disease has been talked about regularly, especially in summer, the season adored by ticks. In Nantes and Vienna (Austria), around fifty researchers from the company Valneva are working on the development of a vaccine candidate against this disease, which is still difficult to diagnose. After an agreement just concluded with Pfizer, the general manager of Valneva Franck Grimaud hopes to market this highly anticipated vaccine in 2025. He answers questions from 20 Minutes.
How are you doing with the Lyme VLA15 vaccine candidate?
We started almost ten years ago now, a bet at the time when there was still little talk of the disease in France. Today we are the only company to have reached this stage of development. This vaccine has the distinction of asking us to include six serotypes (subtypes) of the bacteria, which account for 95% of infections. Last year, we completed phase 1 which allowed us to demonstrate that this vaccine was safe and did not cause any side effects, while generating a good level of antibodies.
We are now in phase 2 which includes 800 people. In addition to continuing to monitor the safety of the vaccine, the objective is to determine the best dosage and the best administration schedule for phase 3. We have already established that to be protected, it will take three doses at one or more months apart, then follow up with reminders.
When do you expect to place it on the market?
We plan to start phase 3 in 2022, and include approximately 16,000 people in order to achieve statistically significant efficacy and protection. Then will come the hoped-for market launch in 2025. We have just established a partnership with the Pfizer laboratory which is extremely important, in particular for the worldwide marketing of the vaccine, in particular in Europe and the United States where the disease is most present. . As part of this agreement, we are expected to receive payments totaling $ 308 million as well as increasing royalties on sales starting at 19%.
How is the disease progressing?
Each year, there are 250,000 new cases in Europe and between 300 and 400,000 cases in the United States, where the figure has increased tenfold in twenty years. In France, we talk more and more but this disease is still underdiagnosed. We do not always realize that we have been bitten by a tick, the symptoms can take time to appear. However antibiotic treatment must be taken early enough and for a certain period of time for it to be effective ... Finally, many people are not diagnosed and one day find themselves with severe fatigue, joint or even cardiac, or neurological problems in the worst case. A preventive vaccine is therefore of great interest.
How do you think countries will seize this vaccine?
It will depend on their policies, depending on the presence of the disease. For example, there is a vaccine against tick-borne encephalitis, another disease that is very common in some countries such as Austria, where vaccination against this disease is now compulsory. It may well be that in other countries the obligation or the recommendation to vaccinate the population against Lyme disease, where there is a high incidence of the disease such as for example in rural areas or around cities.
Your company is also working on a Covid-19 vaccine candidate ...
The medical authorities are ready to go quickly but there must be a safety requirement for the vaccine. We plan to enter clinical trials by the end of the year and our goal is to make doses available by 2021. There are different vaccine strategies and some have never been approved to date. As far as we are concerned, we decided to use a classic and well-known technology, that of inactivated vaccines: you take the virus, you inactivate it, and you mix it up. This technology has the advantage of being able to be used on the whole population, including in immunocompromised groups or in the elderly.
We must also think now of the production challenges, because it is not all about developing a vaccine. If the virus is still present, there will be a significant demand for the number of doses, perhaps three or four billion worldwide. For us, this vaccine is a "Plug & Play", that is to say that we rely on the platform of one of our already marketed vaccines to develop it and that we can produce it in our factory in Livingston in Scotland already approved by the US Health Authority FDA.
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- Lyme disease
- Vaccine
- Coronavirus
- Nantes
- Health