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If Comirnaty Is Available?
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[quote:Anu, father of Enki:MV81MDAzODQ0XzVFM0RGMEFF] Why are Moderna and J&J still available? From the FDA’s website: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained [b][i]What is an Emergency Use Authorization (EUA)?[/i][/b] [i]Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, [b][i]including that there are no adequate, approved, and available alternatives.[/i][/b] [/i] From Pfizer’s Comirnaty website: https://www.comirnaty.com/ [b][i]Is the Pfizer-BioNTech COVID-19 Vaccine the same as COMIRNATY®? [/i][/b] [i]When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (purple cap and gray cap) can be used interchangeably without presenting any safety or effectiveness concerns.[/i] [b]Notice:[/b] This does not actually answer the simple “[b]Yes[/b]” or “[b]No[/b]” question posed. [/quote]
Original Message
Why are Moderna and J&J still available?
From the FDA’s website:
[
link to www.fda.gov (secure)
]
What is an Emergency Use Authorization (EUA)?
Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met,
including that there are no adequate, approved, and available alternatives.
From Pfizer’s Comirnaty website:
[
link to www.comirnaty.com (secure)
]
Is the Pfizer-BioNTech COVID-19 Vaccine the same as COMIRNATY®?
When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (purple cap and gray cap) can be used interchangeably without presenting any safety or effectiveness concerns.
Notice:
This does not actually answer the simple “
Yes
” or “
No
” question posed.
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