coronavirus vaccine works before granting an emergency waiver -- something he called “EUA plus."FDA Commissioner Stephen Hahn tweeted later Thursday that the agency planned to release guidelines for drugmakers that aim to submit an EUA request for a Covid-19 vaccine.Hahn also tweeted that the guidelines for an EUA would lay out the type of data the FDA expects.
This builds on guidance the agency put out in June that said any Covid-19 vaccine should be at least 50% effective.Marks said the data requirement will more closely mimic the standards that apply for an application for a regular approval.