Transparency is important so I’d like to provide greater clarity around the timelines for ’s #COVID19 vaccine and the 3 key areas where we must demonstrate success in order to submit for Emergency Use Authorization (EUA) or Approval
Pfizer out with a very clear statement on vaccine timing. If it gets positive data (regardless of when it comes) it will apply for an EUA only when it has enough safety data to meet FDA standard -- which it expects would be the third week of November.
Credit and "So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November."
11/ The scrutiny worked. After Pfizer’s CEO signaled he might aim for an Oct. approval , pushback from scientists & MDs led him to proceed “at the speed of science,” which meant no results before Election Day
Open letter from CEO about #COVID19 vaccine candidate: “So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November.”
“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November.” #COVID19 #COVID19vaccine