Comirnaty

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Comirnaty is an unavailable COVID vaccine which was approved by the FDA on August 23 to give cover to its lack of approval of the Pfizer vaccine.

Comirnaty is still experimental -- the approval is contingent on studies on myocarditis with a 5-year follow-up that will not end until 2-27.

8.4 Pediatric Use Safety and effectiveness of COMIRNATY in individuals 16 through 17 years of age is based on safety and effectiveness data in this age group and in adults [see Adverse Reactions (6) and Clinical Studies (14.1)]. The safety and effectiveness of COMIRNATY in individuals younger than 16 years of age have not been established.

Myocarditis is "predominantly" in males 16 years of age and older. Safety and effectiveness So is not established for those 15 and younger:

Reported cases have occurred predominantly in male adolescents and young adults 16 years of age and older. Onset was typically within several days after mRNA COVID-19 vaccination, and cases have occurred more often after the second dose than the first dose.[1]

See also

References