HomeLatest NewsCovid-19FDA clarifies Moderna COVID-19 vaccine dosage for children under 12

FDA clarifies Moderna COVID-19 vaccine dosage for children under 12

Children under age 12 should receive a 0.25 milliliter dose of the 2023-24 Moderna COVID-19 vaccine, not the full vial for that age group, the Food and Drug Administration reminded health care providers recently. FDA said it has not identified any safety risks associated with administering the higher dose but has updated its fact sheet for health care providers administering the vaccine to clarify the correct dosage.
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(2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.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Fact Sheet for Healthcare Providers Administering Vaccine has been revised to further clarify that 0.25 mL should be withdrawn from the vial and that the vial and any excess volume should then be discarded.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.

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