FDA Issues Vaccine EUA Guidance Despite Prior White House Opposition

Updated Story Despite prior opposition from the White House, FDA on Tuesday (Oct. 6) published guidance that lays out the criteria for any COVID-19 vaccine maker seeking emergency use authorization. The guidance makes public the agency’s so-called EUA-plus standards that FDA already communicated to industry and to its vaccine advisors, but that President Donald Trump has railed against. When asked on Tuesday whether the White House approved the guidance, FDA said, “yes,” and referred Inside Health Policy...