(RTTNews) - Valneva SE (VALN) Friday said its chikungunya vaccine, IXCHIQ for people aged 18 and above, has been approved by the Food and Drug Administration (FDA).
This makes IXCHIQ the world's first vaccine approved for chikungunya.
In March last year, the company had reported pivotal Phase 3 data for the vaccine showing 98.9% seroresponse rate at 28 days with a single vaccination.
Valneva plans to commercialize the vaccine in the U.S early next year. It also expects vote from the Advisory Committee on Immunization Practices (ACIP) at the end of February next year.
The company added that it intends to use the Priority Review Voucher (PRV) received from the FDA along with this approval, to finance its research and development (R&D) programs.
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