Un­like 1-day VRB­PAC-to-EUA time­line of peers, No­vavax’s Covid-19 jab awaits FDA re­view of re­cent man­u­fac­tur­ing da­ta

Mod­er­na, Pfiz­er/BioN­Tech and John­son & John­son all re­ceived FDA clear­ance for their Covid-19 vac­cines a day af­ter the agency’s ad­vi­sors rec­om­mend­ed emer­gency au­tho­riza­tion. The same will not hap­pen for No­vavax.

The reg­u­la­tor’s out­side ex­perts rec­om­mend­ed 21 to 0 on Tues­day af­ter­noon to give an emer­gency green light to the Mary­land biotech’s vac­cine, but more than 36 hours lat­er, an of­fi­cial OK hasn’t been hand­ed down yet. The FDA re­ceived man­u­fac­tur­ing up­dates from the com­pa­ny just days be­fore the ad­vi­so­ry com­mit­tee’s hours-long hear­ing.

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