Agency revokes approval for chikungunya vaccine due to rising safety concerns based on accumulating reports
FDA Suspends License for Valneva's Chikungunya Vaccine Ixchiq
The Food and Drug Administration (FDA) has suspended the license for Valneva's chikungunya vaccine, Ixchiq, following reports of serious adverse events. The decision was made on Friday after Valneva received four reports of chikungunya-like illness in vaccine recipients outside the U.S.
The approval of Ixchiq, which was granted in November 2023, was not for people 60 and older, as previously paused. Instead, it was for adults who are at an increased risk of exposure to the mosquito-borne virus.
The suspension of the license was due to safety concerns, but it's important to note that the approval of Ixchiq was not due to safety concerns. The FDA had previously recommended a pause in May for the vaccine's administration to people 60 and older, but the pause was lifted on Aug. 6 after requiring an updated label from the company.
At the time of the license suspension, Thomas Lingelbach was the president (Chief Executive Officer) of Valneva. Outbreaks of the chikungunya virus have become more widespread globally over the last 20 years, making a vaccine like Ixchiq crucial for those at risk.
The FDA's decision was made after the reports of serious adverse events. Three of the reported cases occurred in people aged 70 to 82, one of whom was hospitalized. The fourth case was in a 55-year-old.
Valneva made this announcement on Monday, stating that the approval of Ixchiq was for adults, not for people 60 and older. The approval was accelerated, allowing for quicker access to the vaccine for those at increased risk of exposure.
The chikungunya virus is a mosquito-borne virus, and Ixchiq was approved for use in individuals at risk of exposure to the virus. The company will work closely with the FDA to address the safety concerns and hopefully reinstate the vaccine's license in the future.
As the situation develops, updates will be provided to ensure the public is informed about the status of Ixchiq and the chikungunya vaccine.
