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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.
{{cquote|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:
{{cquote|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.<ref>https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html myocarditis</ref>}}
==See also==
*[https://www.fda.gov/media/151707/download FDA]
== References ==
{{reflist}}
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.
{{cquote|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:
{{cquote|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.<ref>https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html myocarditis</ref>}}
==See also==
*[https://www.fda.gov/media/151707/download FDA]
== References ==
{{reflist}}