Health Canada Accepts Application for Valneva’s Chikungunya Vaccine

Yesterday, Valneva announced 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 older and has determined that the New Drug Submission (NDS) application is sufficiently complete to permit a substantive review.

As previously reported by Contagion, VLA1553 met its preliminary endpoint, with 98.9% of participants reaching protective levels of chikungunya virus (CHIKV) neutralizing antibodies 1 months after vaccination. The positive results included a 6-month follow-up period, after which 96.3% of participants maintained CHIKV neutralizing antibodies.

Based on Health Canada’s performance standard to process an NDS application, Valneva believes the regulatory review could be completed by mid-2024.

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.

In the United States, it was just recently announced the FDA moved the company’s PDUFA date for VLA1553, from the end of August to the end of November. The federal agency extended the PDUFA date to allow sufficient time to align and agree on the phase 4 program necessary under the accelerated approval pathway, and no additional clinical data have been requested for the approval process.

VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries. It has been designed by deleting a part of the chikungunya virus genome.Valneva reported final data from the pivotal phase 3 trial of VLA1553 in March 2022.

If approved, VLA1553 would be a consideration for people traveling to countries where Chikungunya is endemic.

“Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for US and Canadian travelers,” Valneva Chief Medical Officer Juan Carlos Jaramillo, MD, said in a statement.

A major concern in contracting the virus as there is no treatment at this time.

Read a first-hand account about what it is like to have Chikungunya.

“This threat continues to grow as shown by the recent epidemiological alert issued by the Pan American Health Organization (PAHO). “No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to make VLA1553 available in different territories as quickly as possible.”

Although Chikungunya is not a domestic threat to people in the United States, the emergence of vector-borne illnesses in this country has become a concern in public health. A small number of locally acquired malaria cases have been reported in the US this summer.

Ultimately, as vector-borne illnesses become an emerging health consideration, treatments and vaccines will need to be developed and approved.