Biotech, aca­d­e­m­ic lead­ers en­cour­age FDA to con­sid­er T-cell as­sess­ment in Covid-19 vac­cine tri­als

More than 60 sig­na­to­ries sent a let­ter to the FDA’s Robert Califf and Pe­ter Marks on Thurs­day urg­ing the agency to in­clude a rec­om­men­da­tion for T-cell as­sess­ment in Covid-19 vac­cine clin­i­cal tri­als in its guid­ance to vac­cine de­vel­op­ers to com­pre­hen­sive­ly mea­sure im­mune re­sponse more ef­fec­tive­ly.

Mea­sur­ing T-cell re­spons­es in ad­di­tion to an­ti­bod­ies is crit­i­cal to help bet­ter eval­u­ate vac­cine ef­fi­ca­cy and in­formed de­ci­sions re­gard­ing pro­tec­tion against cur­rent and fu­ture vari­ants of the dis­ease, ac­cord­ing to the let­ter.

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