MODERNA COVID-19 VACCINE CX-024414 Suspension for injection Ref.[10624] Active ingredients: mRNA-1273

For intramuscular injection only.

2.1 Preparation for Administration

• The Moderna COVID-19 Vaccine multiple-dose vial contains 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.
• Thaw in refrigerated conditions between 2° to 8°C (36° to 46°F) for 2 hours and 30 minutes. After thawing, let vial stand at room temperature for 15 minutes before administering.
• Alternatively, thaw at room temperature between 15° to 25°C (59° to 77°F) for 1 hour.
• 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.
• Each dose is 0.5mL.
• After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F).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 6 hours. Do not refreeze.

2.2 Administration

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.

Administer the Moderna COVID-19 Vaccine intramuscularly.

2.3 Dosing and Schedule

The Moderna COVID-19 Vaccine is administered as a series of two doses (0.5 mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.

Store frozen between -25° to -15°C (-13° to 5°F). Store in the original carton to protect from light. Do not store on dry ice or below -40°C (-40°F).

Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. Do not refreeze.

Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours. Do not refreeze.

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Discard vial after 6 hours. Do not refreeze.