1 week Ago
France's national public health agency has paused dosing of Valneva's vaccine against chikungunya virus in people aged 65 and over while it explores a potential safety issue. The Haute Autorité de Santé (HAS) updated its recommendations for Ixchiq following reports of "serious" adverse events in elderly people with underlying medical conditions during an ongoing vaccination campaign in France's overseas territories La Reunion and Mayotte, both islands in the Indian Ocean. Valneva said it has been supplying Ixchiq to help the French government respond to a major outbreak of chikungunya in La Reunion, which has reported more than 40,000 cases of the disease since the start of the year.
The French biotech is the first company to bring a chikungunya vaccine to market, getting FDA approval for its Ixchiq shot in November 2023 and in Europe and Canada in June 2024, with sales reaching €3.7 million last year. Since then, a rival shot from Bavarian Nordic ( Vimkunya ) has been approved in the US and EU.
Chikungunya is viewed as an emerging global health threat with at least five million cases reported in the past 15 years, with the highest risk seen in Asia, tropical and subtropical regions of Africa, and parts of the Americas. The mosquito-borne disease causes fever and debilitating joint pain, as well as muscle aches, joint swelling, headache, nausea, fatigue, and rash, and in severe cases can result in systemic complications and death. In a statement, Valneva said that the French authorities prioritised vaccination of adults aged 65 and over in its immunisation programme, particularly those with co-morbidities – likely as older people are more prone to severe symptoms and have longer recovery times from the infection.
Dosing of Ixchiq in this age group was suspended on Friday, however, after "three cases of SAEs resulting in hospitalisation, including one death," were seen in La Reunion. "These SAEs were reported through the pharmacovigilance system set up by the French health authorities, and causality has not been definitively established," said the company, which noted that the HAS is still vaccinating people aged 18 to 64 years old in the campaign. "We appreciate the precautionary decision of the authorities while investigations remain ongoing and in the context of the active vaccination campaign," commented Valneva's chief medical officer Juan Carlos Jaramillo.
"We continue to encourage providers to assess the benefit/risk of vaccination based on the individual's medical history, while we are working on a potential update of the product's indication," he added..
