In a recent press release, the FDA issued an advisory to inform healthcare providers who administer the Moderna COVID-19 Vaccine (2023–2024 Formula) to patients aged 6 months through 11 years to be aware and ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial so that the correct dose is administered to the vaccine recipient.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 currently authorized for emergency use in individuals aged 6 months through 11 years as a two-dose series (0.25 mL per dose) administered 1 month apart. The vaccine is also authorized for use in this patient population as a single booster dose (0.25 mL per dose) at least 2 months after completing the primary series.

In the publication, the FDA noted, “The 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.”

The FDA also indicated that their agency has not identified any safety risks linked with administration of the higher dose in individuals aged 6 months through 11 years, and no serious adverse events were detected with regard to a dosing error for the vaccine.

The FDA also provided information for healthcare providers stating “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(2023–2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.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Fact Sheet for Healthcare Providers Administering Vaccine has been revised to further clarify that 0.25 mL should be withdrawn from the vial and that the vial and any excess volume should then be discarded.”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 the FDA’s Center for Biologics Evaluation and Research at ocod@fda.hhs.gov.

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