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Home » FDA Outlines Data Required for Modifying COVID-19 Vaccines Against Viral Variants
FDA Outlines Data Required for Modifying COVID-19 Vaccines Against Viral Variants
The FDA has published draft guidance letting COVID-19 vaccine developers that modify authorized vaccines against new viral variants know what they need to present to the agency for amending Emergency Use Authorizations (EUAs), noting that it doesn’t expect large-scale trials will be needed for the altered versions.