New Pfiz­er/BioN­Tech Covid vac­cine da­ta in teens show strong pro­tec­tion, lin­ing up sBLA fil­ing

Pfiz­er and BioN­Tech are plan­ning to file for full ap­proval of their Covid-19 vac­cine for all of those over the age of 12 af­ter they said longer-term analy­sis of the vac­cine in teens con­tin­ued to show strong pro­tec­tion against symp­to­matic cas­es of Covid-19 more than four months af­ter the sec­ond dose.

With no se­ri­ous safe­ty con­cerns at least 6 months af­ter the sec­ond dose for those ages 12 through 15, the com­pa­nies said the da­ta will form the ba­sis for a planned up­grade from EUA to sup­ple­men­tal Bi­o­log­ics Li­cense Ap­pli­ca­tion (sBLA).

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