A Valneva chikungunya vaccine beneath regulatory scrutiny for a lot of this 12 months amid security issues is now now not permitted on the market within the U.S. market. The FDA has suspended the biologics license of the vaccine, Ixchiq, following new experiences of security issues.
In response to Valneva, the FDA cited 4 new experiences of great opposed occasions that had been in keeping with chikungunya-like sickness. The Saint Herblain, France-based vaccine maker mentioned Monday that suspension of the license requires the corporate to cease delivery and promoting Ixchiq within the U.S. instantly.
Chikungunya is a mosquito-borne virus that circulates in tropical and subtropical areas. The virus can result in An infection that causes fever, headache, and joint and muscle ache. Ixchiq is comprised of a dwell however weakened model of the chikungunya virus administered as a single intramuscular injection. In late 2023, the FDA awarded Ixchiq accelerated approval in adults, making this vaccine the primary for stopping illness attributable to chikungunya. The speedy regulatory nod required Valneva to conduct post-marketing testing to evaluate the danger of extreme chikungunya-like opposed reactions.
This previous spring, experiences of 17 critical opposed occasions had been reported globally in aged individuals who acquired Ixchiq. Two of those experiences had been deaths. A few of these experiences included issues that had been in keeping with extreme chikungunya illness that required hospitalization. In Could, the FDA and Facilities for Illness Management and Prevention advisable a pause on dosing of Ixchiq in these age 60 and older whereas the businesses examine these occasions. The European Medicines Company carried out its personal inquiry.
In early August, the FDA lifted the pause following its risk-benefit evaluation of Ixchiq. An replace added to the product’s label famous post-marketing experiences of issues in individuals age 65 and older. However late Friday, the FDA issued a new security communication stating the suspension of Ixchiq’s license. The choice relies on a Middle for Biologics Analysis and Analysis (CBER) evaluation that discovered Ixchiq seems to be inflicting chikungunya-like sickness in vaccine recipients. Of the extra then 20 reported critical opposed occasions in keeping with chikungunya-like sickness, there have been 21 hospitalizations and three deaths, the company mentioned. The FDA added that medical advantage of Ixchiq has not but been decided in confirmatory research.
“CBER’s benefit-risk evaluation broadly exhibits the vaccine doesn’t have advantages outweighing dangers, beneath most believable eventualities,” the FDA mentioned within the security communication. “For these causes, CBER believes this vaccine isn’t secure and that continued administration to the general public would pose a hazard to well being.”
Valneva mentioned the brand new critical opposed occasions had been 4 circumstances that occurred outdoors of the US. Three of those circumstances had been individuals age 70 to 82; the 82-year-old vaccine recipient was hospitalized and discharged after two days. The fourth case was a 55-year-old particular person. The corporate mentioned it believes all circumstances describe signs in keeping with these beforehand reported throughout medical trials and post-marketing expertise, notably among the many aged. The dangers for this age group is already mirrored within the product label, the corporate mentioned. Valneva is constant to research the circumstances, and if warranted, will pursue additional steps with the FDA.
“We intention to proceed offering Ixchiq to all nations the place the product is licensed and proceed our efforts with our companions to speed up vaccine entry in low-and-middle-income chikungunya-endemic nations — particularly in response to any present or future chikungunya outbreaks, guaranteeing the vaccine reaches these most in want,” Valneva CEO Thomas Lingelback mentioned in a ready assertion.
In addition to its approvals within the U.S. and European Union, Ixchiq has advertising authorizations in Canada, the UK, and Brazil. The April approval in Brazil was the primary for the product in a rustic the place chikungunya is endemic. For the primary half of 2025, Valneva reported Ixchiq accounted for €7.5 million of the corporate’s €91 million in income. The corporate continues to be evaluating the potential monetary impression of the suspension of Ixchiq’s license within the U.S., however isn’t modifying income steering presently.
Individuals in search of a chikungunya vaccine do have an alternate. Earlier this 12 months, the FDA awarded commonplace approval to Vimkunya, a chikungunya vaccine developed by Bavarian Nordic.
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