ARTICLE | Product Development
FDA’s Marks says time is now to start trials for vaccines against new COVID-19 variants as agency issues guidance
FDA issues guidance for vaccines, therapeutics and diagnostics
February 23, 2021 2:25 AM UTC
Updated on Oct 14, 2022 at 4:58 PM UTC
FDA is outlining a streamlined clinical development path for COVID-19 vaccines against emerging variants based on clinical immunogenicity studies, and it’s time for manufacturers to start those trials, according to FDA’s Peter Marks.
An update to the Oct. 20 EUA guidance on preventive COVID-19 vaccines allows manufacturers to seek amendments to existing emergency use authorizations for modified versions of COVID-19 vaccines that are made by the same process and manufacturer but designed to enhance efficacy against a variant. ...