(AOF) – Valneva is starting a Phase 3 trial in adolescents for its single-shot chikungunya vaccine candidate, VLA1553. Funded by the Coalition for Innovations in Epidemic Preparedness (CEPI), the trial is being carried out with a view to requesting an extension of the product’s indication to this age group after obtaining an initial marketing authorization. in adults with the US Health Agency (FDA).
It could also make it possible to obtain the approval of the vaccine in Brazil, which then potentially constitutes the first authorization for use in endemic populations.
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: assessment of tolerance and efficacy on several hundred patients to identify side effects. Phase III: assessment of the overall benefit/risk ratio with several thousand patients.
FDA (Food and Drug Administration)
Among the attributions of the Food and Drug Administration (the health authorities in the United States) there is in particular the issuance of marketing authorizations for all drugs intended for this country, which represents the world’s largest market for ‘pharmaceutical industry.
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