On the heels of similar moves in France and the European Union, U.S. health authorities are calling for a pause in the use of Valneva’s chikungunya vaccine in older adults.
The FDA and the Centers for Disease Control and Prevention (CDC) are recommending a pause in the use of the single-dose shot, dubbed Ixchiq, in U.S. individuals age 60 and older as investigations into serious adverse event reports play out on both sides of the Atlantic.
The recommendation from the FDA and CDC comes after the latter agency’s Advisory Committee on Immunization Practices recommended in April that the vaccine carry a precaution when used in adults ages 65 and older, Valneva noted in a Monday press release.
Additionally, the European Medicines Agency (EMA) last week rolled out its own Ixchiq restriction in older adults, as well as in people with compromised immune systems.
The EMA—which unveiled its vaccine pause roughly one week after a similar move by French health authorities—has kicked off a safety review of Ixchiq following reports of 17 serious adverse events, including two deaths, in vaccine recipients between the ages of 62 and 89.
“As highlighted by FDA/CDC, adverse events may not be causally related to vaccination, yet thorough evaluation of these cases is critical to ensure the safe use of Ixchiq, of which over 40,000 doses are estimated to have been utilized to date, worldwide,” Valneva said in its latest release on the U.S. pause recommendation.
The company added that it’s working closely with global health authorities and expects formal reviews of post-marketing safety reports in all regions where Ixchiq is approved.
Just last month, Ixchiq scored marketing authorization in Brazil, marking the shot’s first approval in a country where chikungunya is endemic. Besides the U.S., Brazil and Europe, Ixchiq is also approved in Canada.
Valneva stressed that it’s committed to safety and working closely with regulatory bodies to provide “timely information about all known SAEs.” Most of the safety flags have cropped up in elderly people with underlying medical conditions, the company explained.
Despite potential safety concerns, Valneva is sticking by its vaccine, which became the first ever approved for the chikungunya virus when it won an FDA nod in November 2023. Ixchiq was specifically approved for adults who are at increased risk of exposure to the virus, which is carried by mosquitoes in tropical regions around the world.