Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA re­leased brief­ing doc­u­ments this week from the agency and Pfiz­er each out­lin­ing their ar­gu­ments for to­day’s Covid-19 boost­er shot ad­comm, but one thing con­spic­u­ous­ly miss­ing was the ques­tion on which pan­el mem­bers would be vot­ing. But late Thurs­day night, reg­u­la­tors pub­lished that ques­tion.

Ad­comm mem­bers will be asked whether or not the safe­ty and ef­fi­ca­cy da­ta from Pfiz­er/BioN­Tech’s orig­i­nal Phase III study “sup­port ap­proval” of a boost­er shot at least six months af­ter the sec­ond dose in in­di­vid­u­als old­er than 16. The ques­tion no­tably ex­cludes the re­al-world da­ta from Is­rael and oth­er analy­ses that Pfiz­er and the Biden ad­min­is­tra­tion had said would be a cen­ter­piece of their ar­gu­ments for boost­ers.

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