FDA tightens label of Valneva's chikungunya vaccine, lifts pause in older adults https://t.co/0DgyPCpQ9F
JCVI did cost benefit analysis and figured out the ~£25 cost was only offset by care savings (based on pharma data) for healthy over.... 90 year olds. Offer was restricted to over 75s in spring 2024. Now same restriction for autumn 2025. https://t.co/aon7uLbfzY
FDA lifts pause on Valneva’s chikungunya shot, but adds new limits https://t.co/EBIABpybQK $VALN by @Lilah_Alvarado
The U.S. Food and Drug Administration has ended a nearly three-month pause on Valneva’s chikungunya vaccine, Ixchiq, for people aged 60 and over. The suspension was imposed in May while regulators probed reports of serious adverse events, including two deaths, among older recipients. Regulators concluded the vaccine can resume in the United States but narrowed its indication. Ixchiq is now recommended only for adults 18 and older who face a high risk of exposure to the mosquito-borne virus, and its label carries expanded warnings that the risk of severe reactions appears greatest in adults 65 and above with chronic illnesses. The agency said the shot is ‘not advisable for most U.S. travellers’. Valneva welcomed the decision, noting that a similar restriction imposed by the European Medicines Agency was lifted in July. Investors reacted positively: the company’s shares rose about 6.7% in Paris on Thursday. Ixchiq, cleared by the FDA in 2023 as the first vaccine against chikungunya, generated €3.7 million in revenue last year, and Valneva is still seeking an extension of its approval to adolescents.