Feds recommend pausing vaccine for mosquito-borne disease chikungunya in people over 60
Federal drug safety officials have recommended pausing the use of a vaccine for a mosquito-borne disease known as chikungunya for people over 60 following reports of serious adverse events.
The Food and Drug Administration said that 17 serious adverse events, including two that resulted in death, have been reported in worldwide recipients of the vaccine Ixchiq over the age of 60. Six of the events occurred in the United States, the FDA said in a safety communication on Monday, May 12.
Domestic and global cases have been reported to the Vaccine Adverse Event Reporting System, run by the FDA and the Centers for Disease Control and Prevention to flag potential safety problems with vaccines. The reported cases were in individuals with underlying chronic medical conditions and the adverse events "may not be causally related to vaccination," the FDA said.
The vaccine's maker, Valneva, said in a statement that it is "upholding the highest safety standards" and pointed to the potential for underlying conditions and other medications as contributing factors in the adverse events.
"Thorough evaluation of these cases is critical to ensure the safe use of Ixchiq," the company said.
French drug regulators updated their recommendations for Ixchiq in April and the European Medicines Agency announced May 7 that its safety committee had launched a review of the vaccine and prohibited its use in people 65 and older, according to the Center for Infectious Disease Research and Policy at the University of Minnesota.
What is chikungunya?
Chikungunya is a mosquito-borne illness named for the joint pain it causes, according to the Cleveland Clinic.
Most people infected by a mosquito bite recover from the illness in about one week, but some have lasting joint pain – the clinic says. There is no cure for the disease and treatment focuses on managing symptoms inlcuding:
- Headache
- Muscle pain
- Swelling in joints
- Rash
- Fatigue
- Nausea
The FDA approved Ixchiq for the prevention of the disease in adults over 18 in November 2023. It uses a live, though weakened, version of the virus that may cause symptoms similar to the disease, according to the FDA.
The FDA said that some of the reported adverse events were consistent with severe complications of chikungunya disease.
The FDA said it will conduct an updated benefit-risk assessment for the use of Ixchiq in the 60-and-up age bracket and that both the agency and the CDC will continue monitoring safety reports for the vaccine.