Moderna COVID-19 Vaccine
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. There is no FDA-approved vaccine to prevent COVID-19.
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.
- FDA Emergency Use Authorization Letter
- EUA Fact Sheet and Full EUA Prescribing Information for Vaccination Providers
- EUA Fact Sheet for Vaccine Recipients & Caregivers
As the vaccination provider, you must communicate to the recipient or their caregiver information consistent with the "Fact Sheet for Recipients and Caregivers" (and provide a copy or direct the individual to the website https://www.modernatx.com/covid19vaccine-eua/ to obtain the Fact Sheet) prior to the individual receiving the COVID-19 vaccine. Information to be communicated includes:
- FDA has authorized the emergency use of the COVID-19 vaccine, which is not an FDA-approved vaccine.
- The recipient or their caregiver has the option to accept or refuse the COVID-19 vaccine.
- The significant known and potential risks and benefits are unknown.
- Information about available alternative vaccines and the risks and benefits of those alternatives.
For more information on the Moderna COVID-19 Vaccine, visit modernatx.com/covid19vaccine-eua/.
Age Indication: 18 year or older
Dose: 0.5 mL
Route: Intramuscular
Schedule: 0, 28 days
Dose preparation: Multi-dose; 10-15 doses per vial depending on the presentation
Storing Moderna COVID-19 Vaccines
Refrigerator
2°C to 8°C | 36°F to 46°F
- Unopened vial: Up to 30 days in the refrigerator
- Punctured vial: Up to 12 hours | 2°C to 25°C (36°F to 77°F)
Room Temperature
- Unopened vial: 24 hours | 25°C (77°F)
- Punctured vial: Up to 12 hours | 2°C to 25°C (36°F to 77°F)
Thawing Moderna COVID-19 Vaccine Vials
Refrigerator
2°C to 8°C | 36°F to 46°F
- 2.5 hours to thaw from frozen
Room Temperature
15°C to 25°C | 59°F to 77°F
- Thaw for 1 hour
Thawed vaccine cannot be refrozen!
You must look up the expiration date for the Moderna COVID-19 vaccine through their Look Up Vial Expiration Date tool.
- Go to modernatx.com. The expiration date tool will display.
- Enter your lot number, printed on the carton and vial of the vaccine, in the Enter Lot # field.
- Click Submit. The expiration date will display.
- Key in the expiration date in LINKS.
For more information or to view LINKS training videos, visit lalink.org.
In the event of a temperature excursion, contact Moderna:
Interactive Excursion Tool: | tools.modernamedinfo.com/excursion/ |
Email: | excursions@modernatx.com |