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This document outlines the critical activities undertaken by the FDA during the pandemic, focusing on the development, evaluation, and availability of influenza vaccines. It details the FDA's assistance in research and reviews, pre-IND activities including laboratory and animal studies, and the manufacturing processes for pilot lots. The phases of human studies from Phase 1 to Phase 4 are discussed, alongside facility inspections and assessments of safety, efficacy, and immunogenicity. It also covers supplementary considerations, possible Emergency Use Authorizations (EUA), and the identification of candidate vaccines and technologies.
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FDA Role Throughout Pandemic Influenza Vaccine Development, Evaluation and Availability Activities Involving FDA Assistance, Research & Review Pre-Post-IND Pre-IND Laboratory and animal studies Development of manufacturing processes, pilot lots, assays Development and selection of candidate vaccines and technologies Immunogen Identification (e.g. protein, strain) and proof of concept IND Phase 1 Human Studies Phase 3 100s – 1000s Licensing Phase 4 General Investigational Plan Phase 2 • Facility • Inspections • Safety • Efficacy • Lot release • Safety • Immunogenicity • Efficacy • Efficacy • Safety • Safety • Immunogenicity • (surrogate markers) • Dose Ranging Manufacturing & Facility Assessment Supplements (e.g. new facilities, population, strains) Possible EUA Pre EUA
