Emergency uses of the vaccine have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019
(COVID-19). The Moderna
COVID-19 Vaccine is authorized in individuals
6 months of age and older as a primary series. The Moderna COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals
6 months through 5 years of age at least 2 months after the Moderna COVID-19 Vaccine primary series and is authorized in individuals 6 years of age and older at least 2 months after any authorized or approved vaccine.
The EUA for these products is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.
For more information on the EUA authorized uses of the vaccine, refer to the Fact Sheets for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information.
- The multiple‑dose vials contain a frozen suspension that does not contain a preservative and must be thawed prior to administration
- Thaw each vial before use following the instructions below
|Multiple-Dose Vial Containing||Thaw in Refrigerator||Thaw at Room Temperature|
|2.5 mL||Thaw between 2°C to 8°C (36°F to 46°F) for 2 hours. Let each vial stand at room temperature for 15 minutes before administering.||Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 45 minutes.|
|5.5 mL||Thaw between 2°C to 8°C (36°F to 46°F) for 2 hours and 30 minutes. Let each vial stand at room temperature for 15 minutes before administering.||Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 1 hour.|
Moderna COVID-19 Vaccines do not require dilution. Swirl vial gently after thawing and between each withdrawal. Do not shake or dilute. After thawing, do not refreeze.
Prior to injection, inspect each dose:
- Confirm liquid is white to off-white in color in both vial and syringe
- The vaccine may contain white or translucent product-related particulates. Do not administer the vaccine if it is discolored or contains other particulate matter. The vaccine does not contain a preservative. For detailed information regarding storage and handling, see the Fact Sheet
- For patients 12 years of age and older, verify syringe volume of 0.5 mL (50 mcg) for Bivalent Booster Dose from dark blue cap vial with gray border
- For patients 6 years through 11 years of age, verify syringe volume of 0.25 mL (25 mcg) for Bivalent booster dose from dark blue cap vial with gray border
- For patients 12 years of age and older, verify syringe volume of 0.5 mL (100 mcg) for Primary Series Dose from red cap vial with a light blue border
- For patients 6 through 11 years of age, verify syringe volume of 0.5 mL (50 mcg) for Primary Series Dose from dark blue cap vial with a purple border
- For patients 6 months through 5 years of age, verify syringe volume of 0.25 mL (25 mcg) for Primary Series Dose from dark blue cap and magenta border
- If the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and contents. Do not pool excess vaccine from multiple vials. Discard vial 12 hours after first puncture, even if vaccine remains in the vial. Record date and time of the first use on the vial label
- Administer Moderna COVID-19 vaccines intramuscularly
- For more information refer to the Fact Sheet for Healthcare Providers
How to Swirl Vials of the Moderna COVID-19 Vaccine Prior to Administration
Monitoring and Reporting Requirements
In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Moderna COVID‑19 Vaccine, the following items are required. Use of unapproved Moderna COVID‑19 Vaccine for active immunization to prevent COVID‑19 under this EUA is limited to the following (all requirements must be met):
The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for the MANDATORY reporting of the listed events following Moderna COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS)
- Vaccine administration errors whether or not associated with an adverse event
- Serious adverse events* (irrespective of attribution to vaccination)
- Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children
- Cases of COVID-19 that result in hospitalization or death
- A life-threatening adverse event;
- Inpatient hospitalization or prolongation of existing hospitalization;
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
- A congenital anomaly/birth defect;
- An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.
Instructions for Reporting to VAERS
The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods:
- Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
- If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report, you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to email@example.com.
IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible.
Other Reporting Instructions
Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.
To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information below or by providing a copy of the VAERS form to ModernaTX, Inc.