Health Canada has accepted Valneva’s chikungunya vaccine VLA1553 filing regarding its use in adult individuals for review, with a potential completion by mid-2024.
The news builds on momentum following the French company’s announcement of positive initial Phase III safety results of the vaccine and its use in adolescents a day prior.
The company filed for the vaccine’s authorisation in Canada in May, marking the second regulatory application after previously filing with the US Food and Drug Administration (FDA). The vaccine is the only product of its kind that is in the middle of regulatory reviews, based on the 29 August announcement.
In February, France-based Valneva announced a PDUFA date set for the end of August, but the FDA has since extended the date to the end of November.
Both the FDA and Health Canada applications are based on the final pivotal Phase III trial (NCT04546724) results announced in March 2022, final lot-to-lot consistency, and positive twelve-month persistence data. As per The Lancet, the vaccine showed a seroresponse rate of 98.9% in subjects 28 days after administration.
Chikungunya is a mosquito-borne viral disease that results in fever, severe joint pain and rashes, among other symptoms. The disease has been identified in more than 110 countries, per the World Health Organization (WHO). According to the WHO, chikungunya is easy to misdiagnose as it shares symptoms with dengue and the Zika virus. The number of individuals affected by the disease remains underestimated as a result of problems with diagnosis and reporting. The WHO classifies the condition as one of the 20 neglected tropical diseases.
Outside of Canada and the US, the company is considering regulatory submissions in Brazil and Europe. The regulatory applications in both areas will include data from the vaccine’s Phase III trial in adolescent participants. The data will also be used for a potential label extension in the US.
On 28 August, the company shared positive initial safety data of the trial, with the majority of solicited adverse events after the vaccine’s administration classified as mild or moderate, per the press release. Valneva expects immunogenicity data from the trial to be ready in November.
While Valneva is the closest to a potential approval in the indication, other companies are also trying their luck in developing chikungunya vaccines. Notably, Bavarian Nordic shared positive Phase III data (NCT04650399) of its vaccine candidate in adult and adolescent subjects on 6 August. The trial met all its co-primary endpoints and the vaccine was immunogenic in the majority of subjects 22 days after vaccination, based on the announcement. However, MSD discontinued its chikungunya vaccine programme in February, per a report by Fierce Biotech.
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