Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US vac­cine tri­als

It may have come a day late, but the FDA has fi­nal­ly post­ed the dis­cus­sion items that its out­side ex­perts will re­view dur­ing to­mor­row’s ad­comm on the new wave of Covid-19 vac­cines now in the clin­ic.

There are no spe­cif­ic vac­cines or da­ta to dis­cuss. In­stead, the agency wants feed­back on its over­all ap­proach. And they’re will­ing to go late in­to the evening to get it.

Here’s the run­down:

1. Please dis­cuss FDA’s ap­proach to safe­ty and ef­fec­tive­ness da­ta as out­lined in the re­spec­tive guid­ance doc­u­ments.

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