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Tag: FDA emergency use authorization
Controversial Changes to the COVID-19 Vaccine Framework: Legal and Policy Analysis
COVID-19 Vaccine Framework: Since January 2025, the U.S. Food and Drug Administration (FDA) has enacted sweeping revisions to its COVID-19 vaccine regulatory framework, reshaping approval pathways, real‐world evidence requirements, and emergency use authorization (EUA) standards. These amendments, announced in a Federal Register notice on January 15, adjust the balance between scientific rigor and public-health exigency. “This represents the most significant recalibration of vaccine oversight since the 2005 amendments to the Public Health Service Act,” observes Professor Linda Rosen of Georgetown University Law Center. At the core lies a tension between expediting variant-specific vaccines and preserving the comprehensive safety data historically demanded under the Federal Food, Drug, and Cosmetic Act (FDCA).