14 August 2023 – Valneva today announced that the US FDA has revised the PDUFA action date for the biologics license application for VLA1553, Valneva’s chikungunya virus vaccine candidate, from the previously communicated end of August to the end of November.

The FDA extended the PDUFA date to allow sufficient time to align and agree on the phase 4 program necessary under the accelerated approval pathway. No additional clinical data have been requested for the approval process.

Read Valneva press release