French vaccine developer Valneva said it is voluntarily pulling the paperwork underlying the approval of its chikungunya virus shot in the U.S., ending a short-lived marketing run marred by safety concerns.
In a Monday statement, Valneva said it recently learned that the Food and Drug Administraiton placed a clinical hold on the vaccine, Ixchiq, pending an investigation of a newly reported serious adverse event that occurred outside the U.S. The company has responded by withdrawing its FDA applications altogether.
Ixchiq was awarded an accelerated approval in November 2023. That clearance made Ixchiq the first shot in the U.S. cleared to prevent illness caused by the chikungunya virus, a pathogen typically spread through infected mosquitoes. Infections can cause fever and severe joint pain that, in some cases, may be persistent and debilitating.
Ixchiq, however, has come under heavy scrutiny over the last year amid mounting concerns about its safety. The European Medicines Agency temporarily suspended use of the vaccine for older adults last May following reports of severe adverse events, including multiple hospitalizations and a few deaths, in vaccine recipients. The FDA quickly followed suit, added new warnings to the shot’s labeling and narrowed its use. The agency then suspended Valneva’s U.S. license in August.
Valneva had intended to initiate a new study that might address the FDA’s concerns. And in a note to investors last week, after meeting with management, Jefferies analyst Maury Raycroft speculated that the agency could conceivably lift the suspension “immediately” for reasons such as a disease outbreak.
Still, news that Valneva is abandoning the U.S. had little impact on its stock price Tuesday. Stifel analyst Damien Choplain wrote that his team had removed U.S. sales from its forecasts following the FDA’s decision in August. Choplain speculated that Valneva might “ultimately discontinue the product altogether” given its “unfavorable economics.”
In its statement, Valneva said it plans to move forward with its post-marketing clinical activities “subject to further discussions with relevant regulatory authorities.” The company also said the newly reported severe adverse event occurred with a younger adult who received three vaccines concurrently, including Ixchiq. The incident could be related to Ixchiq, but causality has not been determined, Valneva said.
