FDA ad­vi­sors vote 21-0, with one ab­sten­tion, to au­tho­rize No­vavax’s Covid-19 vac­cine to be the fourth US op­tion

A pan­el of FDA’s out­side ex­perts rec­om­mend­ed 21 to 0, with one mem­ber ab­stain­ing, that the agency give emer­gency use au­tho­riza­tion for No­vavax’s two-dose Covid-19 vac­cine for peo­ple aged 18 years and old­er.

The ad­vi­sors’ vote of con­fi­dence was de­liv­ered days af­ter the FDA’s sci­en­tists de­ter­mined the vac­cine to be ef­fec­tive but with the caveat of po­ten­tial rare heart in­flam­ma­tion. Last au­tumn, pre-Omi­cron, the vac­cine was found to have a 90.4% ef­fi­ca­cy in a tri­al com­pris­ing 17,272 peo­ple giv­en a vac­cine and 8,385 peo­ple giv­en a place­bo.

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