Key committee meets Thursday to consider FDA authorization for Pfizer/BioNTech Covid-19 vaccine

There's not much suspense going into Thursday's meeting of the US Food and Drug Administration's vaccine advisers, who will discuss emergency use authorization for Pfizer and BioNTech's coronavirus vaccine. The EUA is widely expected and has been telegraphed with unusual frankness from the top of the FDA on down. "Our team has done their initial analysis, and we do feel that preliminarily that the success criteria have been met," FDA Commissioner Dr. Stephen Hahn told CNN Tuesday. But the FDA has promised to listen to the advice of its Vaccines and Related Biological Products Advisory Committee, made up of independent vaccine experts, infectious disease specialists, industry representatives and a consumer representative -- 17 regular members and 13 temporary voting members. The meeting begins at 9 a.m. Thursday, and a committee vote could come in the afternoon.
The only real questions will be about whether the advisers recommend restrictions to the EUA -- perhaps leaving children off the lIst for now, for example. They'll also discuss how to conduct the post-EUA safety surveillance and whether to offer the shot to clinical trial volunteers who got placebo doses.