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:

                Safety & Availability (Biologics)

Safety & Availability (Biologics)

                        Biologic Product Security
          Blood Safety & Availability
          CBER-Regulated Products: Shortages and Discontinuations
          Pandemics & Emerging Diseases
          Tissue Safety & Availability
          Vaccine Safety & Availability


                        HIV Home Test Kits
          Recalls (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research Home
          Vaccines, Blood & Biologics
          Safety & Availability (Biologics)
          Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of AgeSafety & Availability (Biologics) Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age
  
  	
    Share
    Post
    Linkedin

    Email
    Print**November 1, 2023**

The Food and Drug Administration (FDA) is advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.

The Moderna COVID-19 Vaccine (2023-2024 Formula) is authorized for use in individuals 6 months through 11 years of age.

**Summary of the Issue**

FDA has become aware that some healthcare providers may not recognize that the single dose vial of Moderna COVID-19 Vaccine (2023-2024 Formula) for use in individuals 6 months through 11 years of age contains notably more than 0.25 mL of the vaccine.  Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.  However, the volume of a single dose of Moderna COVID-19 Vaccine (2023-2024 Formula) is only 0.25 mL.

FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine.

**Information for Healthcare Providers**

We are advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.  To provide clarification, the Dosage and Administration section of the Fact Sheet for Healthcare Providers Administering Vaccine has been revised to further clarify that 0.25 mL should be withdrawn from the vial and that the vial and any excess volume should then be discarded.

Healthcare providers, parents and caregivers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at ocod@fda.hhs.gov.

                                                                                  Content current as of:
      11/02/2023Safety & Availability (Biologics)

          
                        Biologic Product Security
          Blood Safety & Availability
          CBER-Regulated Products: Shortages and Discontinuations
          Pandemics & Emerging Diseases
          Tissue Safety & Availability
          Vaccine Safety & Availability


                        HIV Home Test Kits
          Recalls (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research
 
 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