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US FDA Frustrates Valneva With Chikungunya Vaccine Decision Delay

PDUFA Date For VLA1553 Pushed Out To November

 
• By Kevin Grogan

Valneva is sticking by its forecast of getting US approval, and getting hold of a lucrative priority review voucher before the end of the year, despite the Food and Drug Administration needing more time to evaluate the French vaccine specialist’s single shot for chikungunya.

Valneva Vienna
• Source: Valneva

Valneva SE is going to have to wait a bit longer to get approval for what could be the world's first vaccine for chikungunya virus after the US Food and Drug Administration pushed back a decision on the jab.

The French group had been given a Prescription Drug User Fee Act (PDUFA) action date for VLA1553 for the end of August but has been informed by the FDA that a decision on a possible accelerated approval for its single-shot chikungunya vaccine has been delayed to the end of November

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