FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t de­tect­ed any po­ten­tial safe­ty sig­nals, in­clud­ing for stroke, in peo­ple aged 65 years and old­er who have re­ceived Pfiz­er’s bi­va­lent Covid boost­er, one se­nior of­fi­cial told mem­bers of the agency’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee (VRB­PAC) on Thurs­day.

The up­date comes as the FDA and CDC in­ves­ti­gate a “pre­lim­i­nary sig­nal” that may in­di­cate an in­creased risk of is­chemic stroke in old­er Amer­i­cans who re­ceived Pfiz­er’s up­dat­ed shot.

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