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COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine for use in people 12 years of age and older to protect against coronavirus disease 2019 (COVID-19).
Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)†
†EMERGENCY USE AUTHORIZATION
Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months through 11 years of age. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
The U.S. Food & Drug Administration (FDA) has issued an emergency use authorization and approval for COVID-19 vaccines by Pfizer and BioNTech.
The FDA has issued full approval for COMIRNATY® (COVID-19 Vaccine, mRNA), designed for the XBB variant, for individuals 12 years of age and older and has updated the emergency use for Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) for all doses administered to people 6 months through 11 years of age.
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