As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Set­ting the stage for an ex­tra­or­di­nary one-day meet­ing of the Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee this Thurs­day, the FDA has cleared 2 ex­perts of fi­nan­cial con­flicts to help beef up the com­mit­tee. And reg­u­la­tors went on to spec­i­fy the safe­ty, ef­fi­ca­cy and CMC in­put they’re look­ing for on EUAs, be­fore they move on to the full BLA ap­proval process.

All of this has al­ready been spelled out to the de­vel­op­ers. But the dev­il is in the de­tails, and it’s clear from the first round of post­ed re­spons­es that some of the top play­ers — in­clud­ing J&J and Pfiz­er — would like some ad­just­ments and added feed­back. And on Thurs­day, the ex­perts can of­fer their own thoughts on shap­ing the first OKs.

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