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                Vaccines, Blood & Biologics

Vaccines, Blood & Biologics

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          COMIRNATYVaccines, Blood & Biologics COMIRNATY
  
  	
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    Print**STN:**125742**Proper Name:**COVID-19 Vaccine, mRNA**Tradename:**COMIRNATY******Manufacturer:**BioNTech Manufacturing GmbH**Indication:**

For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.Product Information

Package Insert - COMIRNATY
	Demographic Subgroup Information – COVID-19 Vaccine, mRNA (COMIRNATY)
	Refer to Section 1.1 of the Clinical Review Memofor information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.Supporting Documents

December 6, 2023 Approval Letter - COMIRNATY
	October 17, 2023 Approval Letter - COMIRNATY
	September 22, 2023 Approval Letter - COMIRNATY
	September 11, 2023 Approval Letter COMIRNATY
	September 11, 2023 Clinical Review Memo - COMIRNATY
	Statistical Review - COMIRNATY
	April 20, 2023 Approval Letter COMIRNATY
	August 25, 2022 Approval Letter - COMIRNATY
	July 8, 2022 Approval Letter - COMIRNATY
	July 8, 2022 Clinical Review Memo - COMIRNATY
	Statistical Review - COMIRNATY
	December 16, 2021 Approval Letter - COMIRNATY
	November 8, 2021 Summary Basis for Regulatory Action - COMIRNATY
	August 23, 2021 Approval Letter - COMIRNATY
	Approval History, Letters, Reviews, and Related Documents - COMIRNATYComirnaty Safety and Effectiveness FAQ

Comirnaty (COVID-19 Vaccine, mRNA)

                                                                                  Content current as of:
      12/07/2023
              
              
Regulated Product(s)
		 BiologicsVaccines, Blood & Biologics

          
                        Infectious Disease Tests


                        Fecal Microbiota Products
          Allergenics
          Blood & Blood Products
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          Cellular & Gene Therapy Products
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          Resources for You (Biologics)
          Safety & Availability (Biologics)
          Science & Research (Biologics)
          Tissue & Tissue Products
          Vaccines
          Xenotransplantation
 
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