FDA Plans EUA-Plus Standard For COVID-19 Vaccine, Drafting Guidance

FDA will apply a so-called emergency use authorization-plus standard to COVID-19 vaccine review that leans closer to requirements for a full biologics license application, agency biologics center chief Peter Marks said Thursday (Sept. 10). He added that the EUA-plus standard won’t have the same level of safety information that’s included in a typical BLA. The biologics center director also signaled that more guidance is coming on the agency’s EUA process, though he didn’t specify what will be in the upcoming...