Skip to Main Content
Skip Nav Destination
Vaccine vials and syringe

FDA: Do not use entire single-dose vial of Moderna’s COVID-19 vaccine when vaccinating children

November 2, 2023

Editor’s note: For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19.

Vaccine providers should not use the entire contents of single-dose vials of Moderna’s COVID-19 vaccine for children.

The Food and Drug Administration (FDA) is clarifying that the proper dose is 0.25mL for children ages 6 months through 11 years.  The single-dose vials contain more than that amount and the excess should be discarded.

The FDA said it has not identified safety risks or serious adverse events related to a higher dose.

Updated COVID-19 vaccines for the 2023-’24 season are available for everyone 6 months and older and better match circulating virus strains. However, just 7% of adults and 2% of children and adolescents have received them.

The Centers for Disease Control and Prevention (CDC) recently announced flexibilities in the Vaccines for Children program this season for COVID-19 vaccines. They include not being required to keep a private stock until March 31, 2024 if privately insured patients will not be vaccinated, allowing limited bidirectional borrowing of VFC and private stock with rules around repayment within 30 days and allowing certain types of providers like temporary vaccination clinics and pharmacies to offer a limited formulary of vaccines such as just COVID and influenza vaccines.

In addition, the CDC recently provided more clarity on when young children can get COVID-19 vaccines from two different brands and how to handle age transitions.

Health care providers, parents and caregivers can ask the FDA questions about the vaccines at ocod@fda.hhs.gov.

 

Resources

Close Modal

or Create an Account

Close Modal
Close Modal