Posted by Michael Wonder on 18 Aug 2022
Valneva initiates rolling submission of FDA biologics license application for its single shot Chikungunya vaccine candidate
18 August 2022 - Valneva today announces that it has initiated rolling submission of the biologics license application to the US FDA seeking approval of the Company’s single-shot chikungunya vaccine candidate in persons aged 18 years and above.
This submission follows final pivotal Phase 3 data reported in March 20221 and final lot-to-lot consistency results reported in May 2022.
