(News Bulletin 247) – The American health authority has approved the world’s first anti-chikungunya vaccine developed by Valneva. The laboratory plans to launch the marketing of this vaccine in the United States at the beginning of next year.

This is an important step for Valneva, which will be able to market the first vaccine against chikungunya in the United States from the beginning of 2024. The laboratory announced before the markets opened that the Food and Drug Administration, that is to say the American health authority, has approved its vaccine candidate against chikungunya, called “VLA1553”. The vaccine will be marketed under the name Ixchiq.

It is approved for a population aged over 18 years at increased risk of exposure to this virus transmitted by mosquitoes and resulting in particular in acute fevers and joint pain.

“With this U.S. authorization, Ixchiq becomes the world’s first authorized chikungunya vaccine to address this unmet medical need and the third vaccine that Valneva has advanced from early stages of research and development to market.” , welcomes Valneva.

“As the holder of the first marketing authorization in the United States for a chikungunya vaccine, Valneva has received a Priority Review Voucher (PRV) from the FDA which it intends to monetize to help to finance its research and development (R&D) programs,” adds the laboratory. It also plans to begin marketing Ixchiq in the United States early next year.

Towards a market of half a billion dollars per year

In Europe, Valneva announced that it had filed a marketing authorization application (MA) with the European Medicines Agency (EMA) at the end of October for its single-injection vaccine candidate against chikungunya. At the end of August, a similar request was submitted to Health Canada for people aged 18 and over.

“VLA1553 is the most advanced product under development in this indication and therefore Valneva has a good chance of being the first and only operator on this market,” Mohamed Kaabouni, analyst at Portzamparc, explained to News Bulletin 247. According to a VacZine analytics study cited by Valneva, the global chikungunya vaccine market could exceed $500 million per year by 2032.

On the Paris Stock Exchange, the market appreciates the news. The laboratory’s stock increased by 8.1% to 6.82 euros after being reserved for a few minutes on the rise at the opening of the markets.

The enthusiasm of the markets should be put into perspective with the disappointment on this issue this summer. In mid-August, the French company indicated that this authority had postponed the target date for the end of examination of the treatment, moving from the end of August to the end of November, which had weighed heavily on its action. This Friday, the horizon is brightening for the laboratory which has just won the precious key, opening the doors to invest in the American market.

Chikungunya and beyond

But Valneva has a portfolio of vaccines and vaccine candidates that goes well beyond chikungunya, including a vaccine candidate against Lyme disease, or against the Zika virus as well as a vaccine already marketed against Japanese encephalitis and cholera. .

At the end of September, the Valneva laboratory won a new contract for Ixiaro, its vaccine against Japanese encephalitis for a minimum amount of $32 million. It has been used by the American army since 2010 to protect its soldiers stationed in Southeast Asia.

It is the only vaccine approved by the Food and Drug Administration (FDA) to protect people traveling to or living in areas with Japanese encephalitis, a disease that is caused by Culex mosquito bites.

For Lyme disease, Pfizer and the French laboratory communicated positive data in children and adolescents at the beginning of September with the use of a booster dose of their vaccine candidate against this systemic infection caused by bacteria transmitted to the man by ticks.

Concerning its vaccine candidate against Covid-19, Valneva recently requested the withdrawal of the marketing authorization for VLA2001 in Europe, obtained in June 2022. This withdrawal was accepted by the European Medicines Agency and will take effect on December 1, 2023. After having suffered numerous setbacks, the laboratory prefers to limit the damage and “save additional costs linked to the vaccine, including licensing fees”.