FDA safe­ty re­view to hold up Mod­er­na’s Covid-19 vac­cine for teens un­til 2022

Mod­er­na has run in­to a de­lay in its push to ex­tend the reach of its Covid-19 vac­cine.

The FDA needs ad­di­tion­al time to com­plete its as­sess­ment of Mod­er­na’s emer­gency use au­tho­riza­tion fil­ing for the use of mR­NA-1273 among ado­les­cents 12 to 17 years old be­cause the agency wants to “eval­u­ate re­cent in­ter­na­tion­al analy­ses of the risk of my­ocardi­tis af­ter vac­ci­na­tion,” Mod­er­na said. The re­view could take un­til Jan­u­ary 2022.

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