US in­ves­ti­gates po­ten­tial safe­ty sig­nal with Pfiz­er Covid boost­ers

The FDA and the CDC are in­ves­ti­gat­ing a “pre­lim­i­nary sig­nal” of whether there might be an in­creased risk of stroke for peo­ple who got Pfiz­er and BioN­Tech’s up­dat­ed Covid-19 vac­cine boost­er.

In a state­ment post­ed on the CDC’s web­site, the agency said its mon­i­tor­ing sys­tem for vac­cine side ef­fects had been trig­gered to look for a po­ten­tial is­sue with the shots in peo­ple ages 65 and old­er.

The CDC called the find­ings high­ly pre­lim­i­nary, and said that “no oth­er safe­ty sys­tems have shown a sim­i­lar sig­nal and mul­ti­ple sub­se­quent analy­ses have not val­i­dat­ed this sig­nal.” That in­clud­ed analy­sis of oth­er large vac­cine datasets from Medicare, the Unit­ed States De­part­ment of Vet­er­ans Af­fairs, the com­pa­nies’ own mon­i­tor­ing pro­grams and a vac­cine side-ef­fect re­port­ing col­lec­tion tool known as VAERS.

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