FDA sim­pli­fies Covid-19 bi­va­lent vac­ci­na­tion process ahead of June ad­comm

The FDA is mod­i­fy­ing the emer­gency use au­tho­riza­tion for Mod­er­na and Pfiz­er/BioN­Tech’s Covid-19 vac­cines by re­mov­ing the two-dose pri­ma­ry se­ries (ex­cept for chil­dren) and the orig­i­nal mono­va­lent vac­cines, and al­low­ing for those over 65 to re­ceive one ad­di­tion­al bi­va­lent dose at least four months af­ter a first one.

Fed­er­al reg­u­la­tors put out word Tues­day that the bi­va­lent vac­cines, which can pro­tect against both the orig­i­nal SARS-CoV-2 strain and against Omi­cron BA.4/BA.5, can now be used for all vac­cine dos­es giv­en to those at least 6 months old.

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