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.

“The Ad­vi­so­ry Com­mit­tee’s pos­i­tive rec­om­men­da­tion ac­knowl­edges the strength of our da­ta and the im­por­tance of a pro­tein-based COVID-19 vac­cine de­vel­oped us­ing an in­no­v­a­tive ap­proach to tra­di­tion­al vac­cine tech­nol­o­gy,” CEO Stan­ley Er­ck said in a state­ment. “We have heard in to­day’s VRB­PAC meet­ing the sig­nif­i­cant sup­port for our vac­cine from physi­cians, health­care or­ga­ni­za­tions, and con­sumers who are ea­ger­ly an­tic­i­pat­ing a pro­tein-based vac­cine op­tion. We look for­ward to the FDA de­ci­sion.”

Read the full article at: endpts.com