For certain indications, the Moderna COVID‑19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by the FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older. There are two presentations/formulations of the Moderna COVID‑19 Vaccine authorized for use.
The EUA for the Moderna COVID‑19 Vaccine 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.
See below for Moderna COVID‑19 Vaccine authorized uses.
Moderna COVID-19 Vaccine Presentations
5.5 mL vial or 7.5 mL vial for primary series doses or booster doses
2.5 mL vial for booster dose only
- 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.
- When extracting only primary series doses, 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 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:
- Each primary series dose 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 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
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 Moderna COVID‑19 Vaccine is authorized for use in individuals 18 years of age and older.
- The vaccination provider must communicate to the individual receiving the Moderna COVID‑19 Vaccine information consistent with the “Vaccine Information Fact Sheet for Recipients and Caregivers” prior to the individual receiving the Moderna COVID‑19 Vaccine.
- The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.
- The vaccination provider is responsible for mandatory reporting of the following 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), and
- cases of COVID-19 that result in hospitalization or death.
- The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and cases of COVID‑19 that result in hospitalization or death following administration of the Moderna COVID‑19 Vaccine to recipients.
- 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.
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.