Mer­ck­'s pneu­mo­coc­cal vac­cine suf­fers PDU­FA de­lay in pe­di­atric pop­u­la­tion, with Pfiz­er hot on its tail

Back in Ju­ly, Mer­ck’s pneu­mo­coc­cal vac­cine Vaxneu­vance got the seal of ap­proval from the FDA to treat adults, with an­a­lysts pre­dict­ing it could be a block­buster prod­uct and se­cure more than $1 bil­lion in peak sales. A few months lat­er in De­cem­ber, the FDA grant­ed Pri­or­i­ty Re­view for an sBLA for Vaxneu­vance to be po­ten­tial­ly in­di­cat­ed for mi­nors and in­fants.

And the fed­er­al agency gave the big phar­ma a PDU­FA date of April 1, 2022. But rather than come to a de­ci­sion Fri­day, the FDA in­stead pushed out the PDU­FA date by three months to Ju­ly 1.

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