Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) – Draft Template - Food and Drug Administration

Pfizer-BioNTech/Comirnaty COVID-19 mRNA Vaccine (nucleoside modified)

Regulatory Information	Date
EUA forTozinameran + Famtozinameran (Comirnaty Original/Omicron BA.4-5) Dispersion for Injection COVID-19 Vaccine (nucleoside modified)	02 December 2022
Sixth EUA Amendment of Pfizer-BioNTech COVID-19 Vaccine	10 October 2022
Seventh EUA Amendment of Comirnaty COVID-19 mRNA Vaccine (nucleoside modified)	03 October 2022
Third EUA Amendment of Comirnaty COVID-19 mRNA Vaccine (nucleoside modified)– Dispersion for Injection (no dilution)	14 June 2022
EUA Amendment of Comirnaty COVID-19 mRNA Vaccine (nucleoside modified)-for children	26 April 2022

Product Information	Product Information (Vaccine for Children)
For Vaccine Recipients	For Vaccine Recipients
For Vaccine Recipients	For Healthcare Providers
For Vaccine Recipients (Bivalent Vaccine)
For Healthcare Providers (Bivalent Vaccine)

For more information on reporting side effects, click here.

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