(News Bulletin 247) – The regulatory agency Health Canada has deemed admissible the application for marketing authorization for the group’s candidate vaccine.

Valneva’s chikungunya vaccine reaches another milestone, this time in Canada. The local health authority, Health Canada, has deemed admissible the application file for authorization from the French specialist in vaccines against infectious diseases.

This application relates to the use of this vaccine candidate in persons 18 years of age or older. Health Canada considered that the dossier was sufficiently complete to carry out a substantive review of the data submitted by the company.

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“Based on Health Canada’s usual processing times for authorization applications, the regulatory review is expected to be completed by mid-2024,” Valneva said in a statement.

On the Paris Stock Exchange, in response to this information, the Valneva title won 1.4% on Tuesday around 10:20 a.m. after having already gained 2.4% the day before. The action of the group was then supported by the announcement of positive safety data (ie the absence of harmfulness) of the candidate vaccine in adolescents.

Towards a market of half a billion dollars per year

Valneva’s vaccine candidate, called VLA1553, is already under review by the US health authority, the Food and Drug Administration (FDA). In mid-August, the French company had indicated that this authority had postponed the target date for the end of the treatment review, from the end of August to the end of November, which had weighed on its action.

“The company intends to file further applications for authorization in 2023,” the company said in a statement on Tuesday.

As a reminder, Valneva had published in March 2022 positive data on immunogenicity and safety for the phase III study (the last step before potential marketing) evaluating this vaccine candidate VLA-1553. Then, last December, the company reported conclusive new data on the persistence of the vaccine’s antibodies.

“The VLA1553 is the most advanced product under development in this indication and therefore Valneva has a good chance of being the first and only operator on this market”, explained to News Bulletin 247 Mohamed Kaabouni, analyst at Portzamparc. According to a VacZine analytics study cited by Valneva, the global chikungunya vaccine market could exceed $500 million per year by 2032.