(BFM Stock Exchange) – The company announced that the European Medicines Agency had decided to remove these temporary restrictions on the use of this vaccine, called IXCHIQ, in people over the age of 65. Which takes away an uncertainty about the title.

The horizon emerges somewhat for the Valneva action. The specialist in infectious disease vaccines announced on Friday evening, after the closing of the market, that the European Medicines Agency (AME), the European Health Authority, had raised its temporary restrictions on its vaccine against chikungunya.

On May 7, the AME had suspended the use of this vaccine in people over the age of 65 after serious desirable effects occurred in several patients belonging to this age group.

The European health authority had then made this decision temporarily, the time to conduct a review of this vaccine called “IXCHIQ”. Vaccination was maintained in people aged 12 to 65.

Previously, at the end of April, the French authorities had, following an opinion from the High Health Authority (HAS), suspended the vaccination campaign against chikungunya among those over 65 on Reunion Island, which faces an epidemic. Three vaccinated people had previously presented unwanted events and one of them had died. However, these three people were aged 80 and presented comorbidities.

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Soon a lifting of FDA restrictions?

The Valneva action had found itself under pressure. “In the immediate future, there is no matter to be alarmed, even if it will be necessary to see what the investigation will say about the causality between vaccination and undesirable effects. So you have to wait and see,” Mohamed Kaabouni, analyst at Portzamparc.

In mid-May, the Food and Drug Administration (FDA), the American health authority had in turn recommended that the American medical community suspend the use of IXCHIQ in people over 65.

The lifting of the AME restrictions announced on Friday can however lead the market to hope that the FDA will also remove its own restrictions in the coming months. And that vaccinations in the elderly will resume.

The Valneva action takes 9% this Monday, July 14, around 11:30 am after this announcement. According to the information communicated by the company, the AME made its decision after its complete review of the vaccine by its risk assessment committee in terms of pharmacovigilance.

“The AME underlines that the vaccine is already contraindicated for people whose immune system is weakened and concludes that, for people of all ages, Ixchiq must be administered when there is a significant risk of infection by chikungunya and after an in-depth examination of profits and risks,” wrote Valneva in its press release.

Potential sales of several hundred million euros

“The AME has also indicated that if the most serious side effects occurred in the elderly, IXCHIQ makes it possible to generate a production of antibodies against the chikungunya virus, which can be particularly beneficial for the elderly who have an increased risk of serious infection in chikungunya,” adds the company.

IXCHIQ was approved by European health authorities in July 2024 for people over the age of 18, before its indication was extended to over the age of twelve in March 2025. The vaccine had previously been approved in 2023 in the United States for patients over the age of 18. IXCHIQ is also authorized in Canada, the United Kingdom and Brazil.

Last year, Valneva had generated its first sales on IXCHIQ for a total of 3.7 million euros. “In the medium term (4-5 years), and according to our estimates, Ixchiq could generate a peak of annual sales around 200 million euros,” said Mohamed Kaabouni in April.