Covid-19 vac­cines for kids: FDA spells out ques­tions on im­muno­bridg­ing, safe­ty fol­lowup ahead of ad­comm

NI­AID chief An­tho­ny Fau­ci pre­dict­ed days ago that Covid-19 vac­cines for younger chil­dren will be avail­able by the end of the year or ear­ly next year. But what re­quire­ments should they sat­is­fy be­fore get­ting the clear­ance from the FDA? The agency laid out some of its thoughts on brief­ing doc­u­ments for an ad­vi­so­ry com­mit­tee set for Thurs­day.

As with the first ex­pert pan­els con­vened to dis­cuss Covid-19 vac­cine reg­u­la­tions, the ad­comm won’t be talk­ing about spe­cif­ic prod­ucts. Rather, the goal is to gauge their opin­ion on frame­work, such as da­ta need­ed and ap­pro­pri­ate end­points.

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