US approves world’s first Chikungunya vaccine for adults
Nov 10 (Reuters) – French drugmaker Valneva said on Friday the U.S. Food and Drug Administration (FDA) has approved its Chikungunya single-dose vaccine in individuals aged 18 and above.
The company said it plans to start selling the IXCHIQ vaccine in the U.S. early next year.
“Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies”, Valneva said.
Valneva’s vaccine, is the first preventive shot to be approved in the United States for the mosquito-borne disease.
Chikungunya virus spreads to people through the bite of an infected mosquito. The most common symptoms of infection are fever and joint pain. Other symptoms may include headache, muscle pain, joint swelling or a rash.
The FDA’s decision is based on late-stage trials, which showed the vaccine was able to induce antibody levels that could neutralize the chikungunya virus in 98.9% of participants for 28 days post-vaccination.
The health regulator, however, asked the company to conduct a post-marketing study to assess the risk of severe chikungunya-like adverse reactions following administration of Ixchiq.
