'A prece­dent you might not want to set.' FDA-in­vit­ed ex­pert blasts Mod­er­na un­blind­ing plan as ad­comm gets un­der­way

At last week’s ad­vi­so­ry com­mit­tee, Pfiz­er ex­ec­u­tives shot down a pro­pos­al from a Stan­ford ex­pert on how to keep a blind­ed study go­ing even af­ter the vac­cine be­comes avail­able. On Thurs­day, the FDA brought the same ex­pert back, who again ar­gued for the blind­ed plan and gave an even more force­ful — al­beit po­lite — de­nun­ci­a­tion of Mod­er­na’s plan.

“This is a prece­dent you might not want to set,” Steven Good­man, as­so­ciate dean of clin­i­cal and trans­la­tion­al re­search at the Stan­ford Uni­ver­si­ty School of Med­i­cine.

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