Canada Accepts Valneva's Chikungunya Vaccine License Application For Review

(RTTNews) - Valneva SE (VALN) said that Health Canada has completed screening validation of the company's regulatory application for marketing approval of its single-shot chikungunya vaccine candidate VLA1553 in persons aged 18 years and above, and has determined that the New Drug Submission application is sufficiently complete to permit a substantive review.

The company believes the regulatory review could be completed by mid-2024.

According to Valneva, it is the second regulatory application for VLA1553 filed by the company. The company plans to make additional regulatory submissions in 2023. A Biologic License Application is currently under priority review by the U.S. Food and Drug Administration.

VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need. It would also represent the third vaccine Valneva3 has brought from early R&D to approval.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus, a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite. While mortality with chikungunya virus is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032.

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