Chikungunya Vaccine Still Coming in 2023

Valneva SE today announced that the U.S. Food and Drug Administration (FDA) has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA1553, a monovalent chikungunya virus vaccine candidate.

Valneva is committed to working with the FDA in its ongoing BLA review and potentially delivering the world's first chikungunya vaccine.

The previously communicated end of August PDUFA has been adjusted to the end of November 2023.

Valneva stated on August 14, 2023, 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.

Furthermore, no additional clinical data have been requested for the FDA approval process.

Juan Carlos Jaramillo, Chief Medical Officer of Valneva, said in a press release, "We appreciate and take pride in the fact that our BLA for VLA1553 if approved, will represent the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease, and hence the necessary Phase 4 activities will set a future standard."

The Company reconfirms its previous guidance for potential BLA approval, initial launch, and potential award of a priority review voucher in 2023. This PDUFA extension does not impact Valneva's current regulatory submission in Canada or its planned submission with the European Medicines Agency.

VLA1553 is a single-dose, live-attenuated chikungunya vaccine candidate based on an infectious clone (CHIKV LR2006-OPY1) attenuated by deleting a gene encoding the non-structural replicase complex protein nsP3 protection against various Chikungunya virus phylogroups and strains.

Valneva's VLA1553 vaccine candidate is designed for prophylactic, active immunization against Chikungunya in humans over 1-year-old. 

Chikungunya is a viral disease transmitted to humans through the bites of mosquitoes, causing outbreaks in 2023.

The European Centre for Disease Prevention and Control reported that as of July 26, 2023, approximately 300,000 cases and over 300 deaths have been reported worldwide due to Chikungunya virus disease.