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Authorization status of the COVID-19 mRNA Vaccine (BNT162b2)
In the EU and Switzerland, BNT162b2 received Conditional Marketing Authorizations under the name COMIRNATY®.
Following recommendation of the European Medicine Agency (EMA), COMIRNATY® (COVID-19 mRNA Vaccine) has been granted conditional marketing authorization by the European Commission for active immunization to prevent COVID-19 caused by SARS-COV-2 virus, in individuals 16 years of age and older.
For the EMA SmPC, please visit the download section on the EMA website.
In the U.S., BNT162b2 is authorized under an Emergency Use Authorization (EUA) as "Pfizer-BioNTech COVID-19 Vaccine".
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. 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.
Please see EUA Fact Sheet at www.cvdvaccine.com.
In the UK, BNT162b2 is authorized under a temporary authorization for emergency supply under the name "COVID-19 mRNA Vaccine BNT162b2".
Additional rolling submissions have been initiated across the globe including Australia and Japan. Applications to other regulatory agencies around the world are planned to be submitted. Please check the approval status in your respective country.
For further country specific prescribing information, please visit www.cvdvaccine.com.
Indication and Usage
The COVID-19 mRNA Vaccine (BNT162b2) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) in individuals 16 years of age and older.
The use of the COVID-19 mRNA Vaccine (BNT162b2) should be in accordance with official guidance.
Additional Safety Monitoring
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse reactions:
Phone: +49 6131 9084-0
Information on how to report adverse events can be found at Medical Information Center.