COVID-19 Vaccine Product Information

Recipient age:

6 months – 4 years 

Cap Color:

Yellow

Diluent:

Sterile 0.9% Sodium Chloride Injection, USP
ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent.

Use 1.1 mL of diluent per vial.

Dose/Injection Volume:

3 mcg/0.3 mL

Doses per vial:

3 doses per vial
Do not pool excess vaccine from multiple vials.

Recipient Age:

5 – 11 years 

Cap Color:

Blue

Dose/Injection Volume:

10 mcg/0.3mL

Diluent:

Do Not Dilute

Dose per vial:

Single dose vial
Do not pool excess vaccine from multiple vials.

Recipient Age:  

12+ Years

Cap Color: 

Gray

Dose/Injection Volume:

30 mcg/0.3 mL

Diluent:    

Do Not Dilute

Dose per vial:    

Single dose vial OR
Single-dose pre-filled syringe

Do not pool excess vaccine from multiple vials 

Refrigeration storage:

Refrigerated  at 2°C and 8°C (36°F and 46°F) for up to 10 weeks.

Room temp:

May be stored at room temperature (8°C to 25°C [46°F to 77°F]) for a total of 12 hours prior to dilution (including thaw time). Thawed vaccine cannot be refrozen. 

Long-term storage:

Ultra Cold -90°C to -60°C (-130°F to -76°F)*
Do NOT store at -25°C to -15°C (-13°F to 5°F).

*Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials may also arrive at refrigerator temperature 2°C to 8°C. If received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. 

To thaw:

For all vials: Each vial must be thawed before dilution or administration. Allow vial(s) to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes. A carton of 10 vials may take up to 2 hours to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)].

For prefilled syringes (12+ years): A full carton of prefilled syringes may also be thawed at room temperature [up to 25ºC (77ºF)] for 60 minutes. If individual frozen prefilled syringes are thawed at room temperature outside of the carton, they can be kept at room temperature and must be used within 4 hours of thawing.

Reconstituted/Punctured:

After dilution (if needed), the vial should be held between 2ºC to 25°C (35°F to 77°F).
Vials should be discarded 12 hours after puncture.

• CDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines
• Cominarty Package Insert (Pfizer-BioNTech ages 12+ years)
• FDA EUA for updated (2023-2024 formula)  COVID-19 Vaccine (Pfizer-BioNTech, ages 6 months – 11 years)
• FDA Fact Sheet for Healthcare Professionals (Pfizer-BioNTech, ages 6 months – 11 years)

Recipient Age:

6 months – 11 years

Cap Color:

Blue Cap/Green Label

Dose/Injection Volume:

25 mcg/0.25 mL

Diluent:

No Diluent

Doses per vial:

Single dose vial*

*There may be more than 0.25mL in each vial. Do not inject more than the 0.25mL dose. Discard vial and excess volume after extracting a single dose.

Recipient Age:

12 years and older

Cap Color:

Blue Cap/Blue Label

Dose/Injection Volume:

50 mcg/0.5mL 

Diluent:

NO DILUTION

Doses per vial:

Single-dose vial
Multi-dose vial (5 doses)
Single dose pre-filled syringe

Do not pool excess vaccine from multiple vials.

Freezer storage:

Frozen -50°C to -15°C (-58°F to 5°F)

Refrigeration storage:

2°C to 8°C (36°F to 46°F) for up to 30 days
Cannot be re-frozen

To thaw:

Vaccine may be thawed in the refrigerator or at room temperature.

• Refrigerator: Between 2°C and 8°C (36°F and 46°F):
  • 45 minutes  for single dose vials
  • 1 hour for single dose pre-filled syringes
  • 2 hours for multiple-dose vials
    
    Let vial stand at room temperature for 15 minutes before administering.
    Unpunctured vials may be stored in the refrigerator for up to 30 days.
• Room temperature: Between 15°C and 25°C (59°F and 77°F).
  • 15 minutes (single dose vials)
  • 45 minutes (single dose pre-filled syringes/multiple-dose vials).

Room Temperature/Post-Puncture Storage:    

Unpunctured vials may be stored between 8°C to 25°C (46°F to 77°F) for a maximum of 24 hours.

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 label. Vials should be discarded after 12 hours.

Notes:

Do NOT refreeze thawed vaccine.
Do NOT shake but swirl the vial gently after thawing and between each withdrawal.

For single dose pre-filled syringes: use a sterile needle of the appropriate size for intramuscular injection. With tip cap upright, remove tip cap by twisting counterclockwise until tip cap releases. Remove tip cap; attach the needle by twisting clockwise until the needle is secured on the syringe. 

• Storage and Handling of Moderna COVID-19 Vaccines
• Moderna Expiration Date Lookup Feature
• FDA Fact Sheet for Health Care Providers Administering Vaccine
• Moderna Dear HCP Letter” 
  Provides a thorough explanation of the dosing and administration guidance for pediatric vials
• Moderna Training Video 
  Provides a step-by-step guide for accurately drawing and administering the pediatric COVID-19 vaccine from our vials, ensuring each child receives the proper dose. 

Recipient Age:

12-17 years 

Cap Color:

Dark Blue

Dose/Injection Volume:

5 mcg/0.5 mL

Diluent:

Do Not Dilute

Doses per vial:

5-doses per vial

Do not pool excess vaccine from multiple vials.  

Expiry:

The expiration date is NOT printed on the vaccine vial or carton. To determine the expiration date, enter the lot number printed on the carton or vial into the “Expiry Date Checker” tool.  

Refrigeration storage:

2°C to 8°C (36°F to 46°F)
Do not freeze.

Punctured vials:

Refrigerated 2°C to 8°C (36°F to 46°F) for up to 6 hours
Discard 6 hours after puncturing vial.

• Storage and Handling of Novavax COVID-19 Vaccine
• Fact Sheet for Healthcare Providers Administering Vaccine - Novavax