Valneva (VALN) said Monday the Brazilian Health Regulatory Agency has granted marketing authorization for its single-dose vaccine, IXCHIQ, for individuals 18 years and above to prevent disease caused by the chikungunya virus.
The decision marks the world's first approval of a chikungunya vaccine in an endemic country, the company said.
The approval allows for starting of large-scale clinical trials of the vaccine in Brazil, including phase 4 studies that support approval by the US Food and Drug Administration and the European Commission to generate additional data, it said.
Shares of Valneva were up over 7% in recent trading.
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