- 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 FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) for use in individuals 18 years of age and older.
- 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.
- 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.
- Remove the required number of vial(s) from storage and thaw each vial before use following the instructions below.
|Vial||Thaw in Refrigerator||Thaw at Room Temperature|
|Maximum 11-Dose Vial (range: 10‑11 doses)||Thaw in refrigerated conditions between 2° to 8°C for 2 hours and 30 minutes. Let each vial stand at room temperature for 15 minutes before administering.||Alternatively, thaw at room temperature between 15° to 25°C for 1 hour|
|Maximum 15-Dose Vial (range: 13‑15 doses)||Thaw in refrigerated conditions between 2° to 8°C for 3 hours. Let each vial stand at room temperature for 15 minutes before administering.||Alternatively, thaw at room temperature between 15° to 25°C 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.
- The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain white or translucent product-related particulates. Visually inspect the Moderna COVID-19 Vaccine vials for other particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.
- The Moderna COVID-19 Vaccine is supplied in two multiple-dose vial presentations:
- A multiple-dose vial containing a maximum of 11 doses: range 10-11 doses (0.5 mL each).
- A multiple-dose vial containing a maximum of 15 doses: range 13-15 doses (0.5 mL each).
- Depending on the syringes and needles used for each dose, there may not be sufficient volume to extract more than 10 doses from the maximum of 11 doses vial or more than 13 doses from the maximum of 15 doses vial. Irrespective of the type of syringe and needle:
- Each dose must contain 0.5 mL of vaccine.
- If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
- Pierce the stopper at a different site each time.
- After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° 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.
The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5 mL each) 1 month apart. A third dose of the Moderna COVID‑19 Vaccine (0.5 mL) administered at least 28 days following the first two doses of this vaccine is authorized for administration to individuals at least 18 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Visually inspect each dose of the Moderna COVID‑19 Vaccine in the dosing syringe prior to administration. The white to off-white suspension may contain white or translucent product-related particulates. During the visual inspection,
- verify the final dosing volume of 0.5 mL.
- confirm there are no other particulates and that no discoloration is observed.
- do not administer if vaccine is discolored or contains other particulate matter.
Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Moderna COVID‑19 Vaccine.
Vaccination providers are required to administer the vaccine in accordance with the authorization and must participate and comply with the terms and training required by the CDC's COVID‑19 Vaccination Program.Help vaccine recipients
understand what to expect
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 “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.