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Keyword: nonvaccine

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  • FDA Grants Fast Track Designation for Potential Bird Flu Vaccine

    04/14/2025 7:38:04 AM PDT · by dynachrome · 50 replies
    Drug Topics ^ | 4-11-25 | Ashley Gallagher
    The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial of the vaccine was initiated in November 2024. The FDA granted fast track designation for a self-amplifying mRNA vaccine candidate (ARCT-2304) for active immunization to protect against influenza A H5N1 subtype, also known as bird flu. The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial (NCT06602531) of the vaccine was initiated in November 2024. H5N1, Influenza, Bird flu, Immunization The designation addresses the unmet need for prevention...