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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age

The Food and Drug Administration (FDA) released a bulletin today through their MedWatch listserv to provide information about the correct dosage and administration of Moderna COVID-19 vaccine (2023-2024 Formula) for individuals 6 months through 11 years of age.

  • The Moderna COVID-19 Vaccine (2023-2024 Formula) is authorized for use in patients 6 months through 11 years of age.
  • Each dose is 0.25mL.
  • Each single dose vial contains more than 0.25mL.
  • The FDA has been made aware that some healthcare providers are withdrawing the entire contents of the vial which is more than the recommended 0.25mL dose.

Recommendations for Healthcare Providers

Healthcare providers should be aware that there is more than the recommended 0.25mL in the single dose vials of the Moderna COVID-19 Vaccine (2023-2024 Formula). Ensure that the correct volume of the vaccine is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.

Vaccination

Vaccine administration errors make up 13% of all IHS reports submitted to the Vaccine Adverse Event Reporting System (VAERS).

  • Report serious or unexpected adverse vaccine events and vaccine administration errors related to the Vaccine and Adverse Event Reporting System (VAERS) and ensure that you document “IHS” in field #26 of the form.
  • Report serious or unexpected adverse drug events to the FDA MedWatch program and ensure that you document “IHS” in the Reporter section (section G) of the form.

Instructions for submitting an adverse vaccine event or adverse drug event can be found on the IHS Pharmacovigilance website and guidance on reporting can be found in the Indian Health Manual.

You can view this bulletin on the FDA website.

Information related to usage and dosing of the Moderna COVID-19 Vaccine (2023-2024 Formula) can be viewed in the Fact Sheet for Moderna COVID-19 Vaccine (2023-2024 Formula).