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

Oakland County, Michigan sent this bulletin at 11/08/2023 09:09 AM EST

This email is being sent to VFC, Non-VFC and Covid-19 Providers in Oakland County, Michigan by the Oakland County Health Division (OCHD) Immunization Action Plan (IAP)

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Hello Immunization Partners,

Please share the following information with staff and colleagues.

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Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the single dose vial, so that the correct dose is administered to the vaccine recipient.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.

Information for Healthcare Providers

  • 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(2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.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Fact Sheet for Healthcare Providers Administering Vaccine has been revised to further clarify that 0.25 mL should be withdrawn from the vial and that the vial and any excess volume should then be discarded.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.

On November 3, 2023, this guidance was added to the COVID-19 vaccination schedule for correct dosage and administration within the Centers for Disease Control and Prevention’s (CDC)  Interim Clinical Considerations for Use of COVID-19 Vaccines in the U.S.

Please contact checcimms@michigan.gov for further questions. 

Thank you for all you do!

Oakland County Health Division, Immunization Action Plan