COVID-19 mRNA (Moderna) vaccine FDA Alerts
The FDA Alerts below may be specifically about COVID-19 mRNA (Moderna) vaccine or relate to a group or class of drugs which include COVID-19 mRNA (Moderna) vaccine.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for COVID-19 mRNA (Moderna) vaccine
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
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
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(2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.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Fact Sheet for Healthcare Providers Administering Vaccine has been revised to further clarify that 0.25 mL should be withdrawn from the vial and that the vial and any excess volume should then be discarded.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.
Content current as of: November 1, 2023
Source: FDA
More COVID-19 mRNA (Moderna) vaccine resources
- COVID-19 (12y+) vaccine Spikevax 2024-2025 Consumer Information
- COVID-19 (6m-11y) vaccine, Moderna 2024-2025 Consumer Information
- Moderna COVID-19 (2024-2025) PF Vaccine (cvx 311) 2024-2025 Consumer Information
- Spikevax (2024-2025) PF (cvx 312) 2024-2025 Consumer Information
- Sars-cov-2 (covid-19) vaccine, mrna (moderna) Advanced Consumer Information
- Spikevax (Sars-cov-2 (covid-19) vaccine, mrna (moderna) Intramuscular) Advanced Consumer Information
- Spikevax (Sars-cov-2 (covid-19) vaccine, mrna-lnp, spike protein (moderna) Intramuscular) Advanced Consumer Information
- OVID-19 Vaccine, mRNA (Moderna) (2024-2025 Formula) AHFS DI Monograph
- Moderna COVID-19 Vaccine, Bivalent Prescribing Information