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 18 years of age and older.
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.
Currently Available Dose Presentations
5.5 mL vial for booster dose (age 18 and older) or primary series doses (age 12 and older)
2.5 mL vial for booster doses (age 18 and older) or primary series doses (age 6-11 years)
2.5 mL vial for primary series doses (age 6 months-5 years of age)
- The Moderna COVID‑19 Vaccine 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.|
|7.5 mL||Thaw between 2°C to 8°C (36°F to 46°F) for 3 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 1 hour and 30 minutes.|
- After thawing, do not refreeze.
- Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not dilute the vaccine.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
- The Moderna COVID‑19 Vaccine is a white to off-white suspension. It may contain white or translucent product-related particulates. Do not administer if vaccine is discolored or contains other particulate matter.
- Primary series doses of 0.5 mL and booster doses of 0.25 mL may be extracted from vial presentations with a red cap and a label with a light blue border, preferentially using low dead-volume syringes and/or needles.
- Vial presentations with a dark blue cap and label with a purple border may only be used for booster doses. Booster doses from dark blue cap vials are 0.5 mL.
- Vial presentations with a dark blue cap and label with a magenta border may only be used for pediatric primary series doses. Primary series doses from dark blue cap vials are 0.25 mL.
- When extracting only primary series doses from the red cap vial and label with a light blue border, depending on the syringes and needles used, a maximum of 11 doses (range: 10-11 doses) may be extracted from the vial containing 5.5 mL or a maximum of 15 doses (range: 13-15 doses) may be extracted from the vial containing 7.5 mL.
- When extracting only primary series doses from the dark blue cap vial and label with a magenta border, a maximum of 10 doses may be extracted from the vial containing 2.5 mL.
- When extracting only booster doses or a combination of primary series and booster doses, the maximum number of doses that may be extracted from either vial presentation should not exceed 20 doses. Do not puncture the vial stopper more than 20 times.
- Irrespective of the type of syringe and needle:
- Primary series doses from the dark blue cap vial must contain 0.25 mL of vaccine.
- Primary series doses from the red cap vial must contain 0.5 mL of vaccine.
- Booster doses from the red cap vial must contain 0.25 mL of vaccine.
- Booster doses from the dark blue cap vial must contain 0.5 mL of vaccine.
- If the vial stopper has been punctured 20 times, discard the vial and contents.
- If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL or 0.25 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
- After the first dose has been withdrawn, the vial should be held between 2°C to 25°C (36°F to 77°F). Record the date and time of first use on the Moderna COVID‑19 Vaccine vial label. Discard vial after 12 hours. Do not refreeze.
How to Swirl Vials of the Moderna COVID-19 Vaccine Prior to Administration
Moderna COVID-19 Vaccine Primary vs Booster Dose
Blue Cap - 0.25mL Dose
Blue Cap - 0.50mL Dose
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 results 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.