| Covid-19 | Oct 13, 2020

HHS Releases Additional Details and Instructions for PRF Phase 3 General Distribution

FDA issued guidance for COVID-19 vaccine sponsors with recommendations regarding the scientific data and information that would support issuance of an emergency use authorization (EUA) for investigational vaccines intended to prevent COVID-19. This guidance also discusses FDA’s current thinking regarding the circumstances under which the issuance of an EUA for a COVID-19 vaccine would be appropriate, providing additional context to the discussion regarding EUAs in the guidance for industry entitled “Development and Licensure of Vaccines to Prevent COVID-19.”