(CercleFinance.com) – Valneva announces that it has completed the submission of its marketing authorization application (MA) to the US FDA, for its single-injection vaccine candidate against chikungunya, VLA1553, in people aged 18 and over.
This marketing authorization request follows the final phase 3 data announced in March 2022 and the final results of the clinical batch homogeneity trial announced in May. A study in adolescents is underway in Brazil.
The FDA will review the submission for acceptance, decide whether the vaccine candidate is eligible for priority review, and indicate the target date for completing its review. Valneva also plans to file an MA application in Europe in the second half of 2023.