BLA, EUA Most Likely COVID-19 Vaccine Paths; Narrow EUAs Possible

Top FDA officials say the traditional biologics license application process and emergency use authorization, including possible subpopulation EUAs, are the most likely avenues for COVID-19 vaccine approvals, and they suggest vaccine makers veer away from the agency’s Accelerated Approval program. FDA would be reluctant to review COVID-19 vaccines under the agency’s Accelerated Approval pathway unless there’s sufficient evidence the vaccine will have clinical benefit, FDA chief Stephan Hahn and biologics center director Peter Marks wrote in a Friday (Aug. 7)...