FDA grants pri­or­i­ty re­views for Pfiz­er's Pre­vnar 20 for kids and Roche lym­phoma can­di­date

The FDA grant­ed two pri­or­i­ty re­views: one for a po­ten­tial Pfiz­er vac­cine for kids and the oth­er for Roche’s bis­pe­cif­ic an­ti­body glofi­ta­m­ab, the com­pa­nies an­nounced Fri­day.

The FDA will re­view Pfiz­er’s sup­ple­men­tal bi­o­log­ics li­cense ap­pli­ca­tion (sBLA) for the 20-va­lent vac­cine can­di­date, 20vP­nC, which is al­ready ap­proved for adults as Pre­vnar 20, the com­pa­ny said in a press re­lease. The vac­cine is meant to pre­vent in­va­sive pneu­mo­coc­cal dis­ease caused by Strep­to­coc­cus pneu­mo­ni­ae bac­te­ria, as well as pre­vent oti­tis me­dia ear in­fec­tions. In­fants and chil­dren 6 weeks old through 17 years old would be el­i­gi­ble.

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