$PFE #Comirnaty's FDA approval comes with 6 myocarditis post-marketing study requirements, as well as expected further pediatric study. Approval letter: fda.gov/media/151710/d…
4 additional vax post-marketing study requirements: pregnancy registry,
immunogenicity and safety of lower dose in 12 through <30 yrs of age,
post-EUA safety surveillance study in the Veteran’s Affairs Health System, and
effectiveness study - Kaiser Permanente Southern California
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