Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Vaccines, Blood & Biologics

Vaccines, Blood & Biologics

                        Infectious Disease Tests


                        Fecal Microbiota Products
          Allergenics
          Blood & Blood Products
          Blood Donor Screening
          Cellular & Gene Therapy Products
          Development & Approval Process (CBER)
          Guidance, Compliance & Regulatory Information (Biologics)
          International Activities
          News & Events (Biologics)
          Resources for You (Biologics)
          Safety & Availability (Biologics)
          Science & Research (Biologics)
          Tissue & Tissue Products
          Vaccines
          Xenotransplantation Home
          Vaccines, Blood & Biologics
          SPIKEVAXVaccines, Blood & Biologics SPIKEVAX
  
  	
    Share
    Post
    Linkedin

    Email
    Print**STN:**125752**Proper Name:**COVID-19 Vaccine, mRNA**Tradename:**SPIKEVAX**Manufacturer:** Moderna Tx Inc.**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 olderProduct Information

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

September 11, 2023 Clinical Review - SPIKEVAX
	September 11, 2023 Statistical Review - SPIKEVAX
	September 11, 2023 Approval Letter - SPIKEVAX
	May 9, 2023 Approval Letter - SPIKEVAX
	January 31, 2022 Approval Letter - SPIKEVAX
	January 30, 2022 Summary Basis for Regulatory Action - SPIKEVAX
	Approval History, Letters, Reviews, and Related Documents - SPIKEVAXSpikevax Safety and Effectiveness FAQ

Spikevax (COVID-19 Vaccine, mRNA)

                                                                                  Content current as of:
      09/21/2023
              
              
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  VaccinesVaccines, Blood & Biologics

          
                        Infectious Disease Tests


                        Fecal Microbiota Products
          Allergenics
          Blood & Blood Products
          Blood Donor Screening
          Cellular & Gene Therapy Products
          Development & Approval Process (CBER)
          Guidance, Compliance & Regulatory Information (Biologics)
          International Activities
          News & Events (Biologics)
          Resources for You (Biologics)
          Safety & Availability (Biologics)
          Science & Research (Biologics)
          Tissue & Tissue Products
          Vaccines
          Xenotransplantation
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop