Blake Ferguson, 12, receives his first dose of the Pfizer vaccine (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

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.

Right now, Pfiz­er and BioN­Tech have the on­ly shot that’s au­tho­rized for ado­les­cents above the age of 12 — but noth­ing is sanc­tioned yet for those younger. (Cana­da and the EU, though, have green­light­ed Mod­er­na’s jab for the same pop­u­la­tion.)

Reg­u­la­tors set the stage by not­ing that al­though pe­di­atric pop­u­la­tions seem less like­ly to be in­fect­ed by the coro­n­avirus (and when they do, tend not to get as sick), many have still been hos­pi­tal­ized or died from Covid-19:

As of May 25, 2021, ap­prox­i­mate­ly 553,000 and 2.7 mil­lion COVID-19 cas­es, re­spec­tive­ly, were re­port­ed in chil­dren 0-4 and 5-17 years of age in the US, among which 121 (0.02%) and 278 (0.01%), re­spec­tive­ly, were fa­tal, and more than 38,000 of which re­sult­ed in hos­pi­tal­iza­tions re­port­ed since Au­gust 1, 2020, in pa­tients 0-17 years of age

The FDA em­pha­sized that any au­tho­riza­tion for pe­di­atric use should fol­low “sub­stan­tial ev­i­dence of ef­fec­tive­ness from ad­e­quate and well-con­trolled tri­als” plus am­ple safe­ty da­ta. Yet with three vac­cines from Pfiz­er/BioN­Tech, Mod­er­na and J&J al­ready show­ing ef­fi­ca­cy in adults, they won­der if the ev­i­dence could take a dif­fer­ent shape.

Giv­en the low­er in­fec­tion, hos­pi­tal­iza­tion and death rates in chil­dren, af­ter all, the dy­nam­ics are quite dif­fer­ent.

FDA ac­knowl­edges that di­rect demon­stra­tion of ef­fec­tive­ness in field ef­fi­ca­cy tri­als may not be fea­si­ble in pe­di­atric pop­u­la­tions and thus, fol­low­ing di­rect demon­stra­tion of pro­tec­tion in adults, ef­fec­tive­ness of the same vac­cine could be in­ferred in pe­di­atric pop­u­la­tions by im­muno­bridg­ing. … In this ap­proach, an im­mune re­sponse bio­mark­er(s) elicit­ed by the vac­cine in a pe­di­atric age group is com­pared to the same im­mune re­sponse bio­mark­er(s) elicit­ed by the same vac­cine in a rel­e­vant adult age group, with for­mal sta­tis­ti­cal hy­poth­e­sis test­ing to demon­strate that the mea­sured im­mune re­sponse in the pe­di­atric age group is non-in­fe­ri­or to that in adults.

There are al­so ques­tions about whether there should be a longer safe­ty fol­lowup than the two months man­dat­ed for the adult and ado­les­cent OKs.

One oth­er spe­cif­ic con­sid­er­a­tion for chil­dren, the FDA added, would be how the Covid-19 vac­cine might in­ter­fere with oth­er rou­tine­ly rec­om­mend­ed im­mu­niza­tions. Vac­cine mak­ers are en­cour­aged to in­clude in­for­ma­tion but will not be re­quired to as­sess con­comi­tant ad­min­is­tra­tion to sup­port li­cen­sure.

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