FDA is­sues new rec­om­men­da­tions to take on Covid-19 vari­ants

The FDA on Mon­day un­veiled rec­om­men­da­tions for vac­cine, drug and di­ag­nos­tic test de­vel­op­ers to ad­dress the im­pact of Covid-19 vari­ants on the ef­fi­ca­cy and per­for­mance of their prod­ucts.

The rec­om­men­da­tions are made across four new and up­dat­ed guid­ances tar­get­ing vac­cines, drugs and bi­o­log­ics, mon­o­clon­al an­ti­bod­ies and di­ag­nos­tic tests.

“The pur­pose of these guid­ances is to ad­dress the emer­gence and po­ten­tial fu­ture emer­gence of vari­ants of SARS-CoV-2, the virus that caus­es COVID-19. The rea­son for these guid­ances is any of these prod­ucts might be im­pact­ed by changes to the virus, par­tic­u­lar­ly their ef­fi­ca­cy or per­for­mance. There­fore, we need to iden­ti­fy ef­fi­cient ways to mod­i­fy the prod­ucts that are ei­ther in the pipeline or are [emer­gency use au­tho­riza­tion] EUA prod­ucts to ad­dress these vari­ants,” Act­ing FDA com­mis­sion­er Janet Wood­cock said dur­ing a press con­fer­ence.

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