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Moderna COVID-19 Vaccine Dosing Errors in Pediatric Population Prompt FDA Response

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Article

The FDA is advising health care professionals who administer the vaccine to make sure the correct volume of the vaccine is withdrawn from the vial and the correct dose is administered to the patient.

The FDA is highlighting dosing information for Moderna’s COVID-19 Vaccine (2023-2024 Formulation) in children aged 6 months to 11 years, after the federal agency learned that some health care professionals did not recognize entire vials were sometimes being administered to children.1

The correct volume of the vaccine to be administered to children under the FDA authorization is 0.25 mL. Some health care providers have administered the entire contents of the single dose vial to children, not recognizing this vial contains “notably more” than 0.25 mL of the vaccine.1

No associated safety risks have been identified with the administration of the higher dose in children aged 6 months to 11 years. Further, no serious adverse events were reported as related to a dosing error for the vaccine.1

The FDA is advising health care professionals who administer the vaccine to make sure the correct volume of the vaccine is withdrawn from the vial and the correct dose is administered to the patient.1

The Dosage and Administration section of the Fact Sheet for Healthcare Providers Administering Vaccine has been updated to provider further clarification regarding the correct volume of 0.25 mL for this patient population.1 In part, this section of the Fact Sheet states:

  • Withdraw a single 0.25 mL dose using a sterile needle and syringe.2
  • Discard the vial and excess volume after extracting a single dose.2

Click here to view the full Fact Sheet, provided by the FDA.

The Emergency Use Authorization (EUA) for the Moderna COVID-19 Vaccine was amended to include the 2023-2024 formulation on September 11, 2023. The vaccine includes a monovalent component which corresponds to the Omicron variant XBB.1.5 of SARS-CoV-2.3

The updated formulation is authorized for all doses administered to the age group referenced throughout the article. Following the amendment to the EUA, the Moderna COVID-19 Vaccine, Bivalent is no longer authorized for use in the United States.3

This article originally appeared on Contemporary Pediatrics.

References
1. Important information about the correct dosage and administration of Moderna COVID-19 Vaccine (2023-2024 Formulation) for individuals 6 months through 11 years of age. FDA. Press release. November 1, 2023. Accessed November 6, 2023. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-information-about-correct-dosage-and-administration-moderna-covid-19-vaccine-2023-2024?utm_medium=email&utm_source=govdelivery
2. Fact sheet for healthcare providers administering vaccine: emergency use authorization of Moderna COVID-19 Vaccine (2023-2024 Formula), for individuals 6 months through 11 years of age. FDA. Accessed November 6, 2023. https://www.fda.gov/media/167208/download?attachment
3. Moderna COVID-19 Vaccine. FDA. Updated November 1, 2023. Accessed November 6, 2023. https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/moderna-covid-19-vaccine#additional
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