This BLA submission follows the release of the final pivotal Phase 3 data in March 2022 and the final results for lot-to-lot consistency in May 2022
Valneva has started the rolling submission of BLA to the FDA for chikungunya vaccine candidate. (Credit: fernando zhiminaicela from Pixabay)
Valneva has started the rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the chikungunya vaccine candidate.
The speciality vaccine company aims for the approval of the Company’s single-shot vaccine candidate in persons aged 18 years or more.
This BLA submission followed the release of the final pivotal Phase 3 data in March 2022 and the final results for lot-to-lot consistency in May 2022.
In Brazil, a clinical trial of VLA1553 is now being conducted in adolescents, which could help future regulatory filings in this population if VLA1553 is approved for use in adults.
According to the firm, the BLA submission is expected to be finished by Valneva by the end of 2022.
The FDA will decide if the application qualifies for priority review and the deadline by which it will aim to finish its assessment once all required components have been submitted and if the submission is approved.
Valneva chief medical officer Juan Carlos Jaramillo said: “This is an extremely important milestone for our VLA1553 program and we are very proud to be the first company worldwide that has begun submission of a BLA for a chikungunya vaccine candidate.
“Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease.
“We will continue to work assiduously to bring VLA1553 to market as soon as possible.”
The chikungunya virus (CHIKV), a Togaviridae virus, is the cause of the mosquito-transmitted illness chikungunya.
VLA1553 is a live-attenuated and given as a single dose and was created by removing a portion of the genome of the chikungunya virus.
The company also announced that the US Department of Defense (DoD) has agreed not to exercise the second option year of the contract to supply Valneva’s Japanese encephalitis (JE) vaccine IXIARO.
Since 2010, the DoD has depended on IXIARO to assist in defending individuals who are sent to places where JE is endemic and for whom JE immunisation is advised.