FDA suspends Ixchiq chikungunya vaccine license amid safety concerns

The U.S. Food and Drug Administration suspended the license for Ixchiq, the live-attenuated chikungunya vaccine, after new safety concerns emerged, effective immediately. The action comes weeks after the agency had lifted a previous pause for older adults, and it underscores ongoing questions about the vaccine’s risk-benefit profile as regulators and the manufacturer scrutinize reports of serious adverse events linked to the shot. Valneva, the French company that makes Ixchiq, said four additional serious events occurred outside the United States, three of them in people aged 70 to 82, with the fourth involving a 55-year-old. The FDA’s move removes the vaccine from the U.S. market as regulators reassess its place in global vaccination programs.

Ixchiq was the first chikungunya vaccine approved by the FDA, obtained in 2023 under an accelerated approval pathway for adults at increased risk of exposure in tropical and subtropical regions. The company reported that Ixchiq generated about 7.5 million euros (roughly $8.8 million) in sales in the first half of this year. Valneva’s chief executive, Thomas Lingelbach, stressed the company’s commitment to global health, saying Ixchiq...