COVID-19 Vaccine Product Information & Implementation

Single Dose Vial Cap Color: Blue

Dose/Injection Volume: 10 mcg/0.3mL

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For the vial, the vaccine will be clear to slightly opalescent suspension. Do not administer if vaccine is discolored or contains particulate matter.

Storage and Handling:

Refrigeration storage: Refrigerate at 2°C and 8°C (36°F and 46°F) for up to 10 weeks.

Room temperature storage: May be stored at room temperature (8°C to 25°C [46°F to 77°F]) for a total of 12 hours (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: Each vial must be thawed before 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)].

Other administration information: Prior to use, mix by inverting vial gently 10 times. Do not shake. Withdraw a single 0.3 mL dose using a sterile needle and syringe. Discard vial and any excess volume. 

Single Dose Pre-filled Syringe Label Color: Gray

Dose/Injection Volume: 30 mcg/0.3 mL

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For the prefilled syringe, the vaccine will be a white to off-white suspension. Do not administer if vaccine is discolored or contains particulate matter.

Storage and Handling:

Refrigeration storage: Refrigerate at 2°C and 8°C (36°F and 46°F). The expiration date is printed on the carton and syringes.

Room temperature storage: May be stored at room temperature (8°C to 25°C [46°F to 77°F]) for a total of 12 hours prior to use.  

Long-term storage: Do NOT FREEZE . If glass prefilled syringe has been frozen, DISCARD.

Other administration information: Do not shake. Remove tip cap by slowly turning the cap counterclockwise while holding the Luer lock and attach a sterile needle. Use immediately. If not, it must be used within 4 hours. 

• Comirnaty Package Insert (Pfizer-BioNTech ages 5+ years)

Single-dose Pre-filled Syringe Label Color: Red

Dose/Injection Volume: 25 mcg/0.25 mL

Spikevax 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.

Storage and Handling:

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 60 days or up to the expiration date printed on the carton, whichever comes first. (Cannot be re-frozen.) Minimize exposure to light during storage and after thawing.

To thaw: Vaccine may be thawed in the refrigerator or at room temperature. If thawing in the refrigerator (between 2°C and 8°C (36°F and 46°F), 1 hour and 40 minutes for single prefilled syringe or carton to 2 prefilled syringes; and 2 hours and 40 minutes for a carton of 10 syringes. If thawing at room temperature (between 15°C and 25°C [59°F and 77°F]), then 40 minutes for single prefilled syringe or carton of 2 prefilled syringes; and 1 hour and 20 minutes for a carton of 10 syringes. After thawing, SPIKEVAX may be stored between 8°C to 25°C (46°F to 77°F) for up to 12 hours.

Other administration information: Do not shake. For single prefilled syringe: 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. 

Single-dose Pre-filled Syringe Label Color: Blue

Dose/Injection Volume: 50 mcg/0.5mL

Spikevax 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.

Storage and Handling

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 60 days or up to the expiration date printed on the carton, whichever comes first. (Cannot be re-frozen.) Minimize exposure to light during storage and after thawing.

To thaw: Vaccine may be thawed in the refrigerator or at room temperature. If thawing in the refrigerator (between 2°C and 8°C (36°F and 46°F), 1 hour and 40 minutes for single prefilled syringe or carton to 2 prefilled syringes; and 2 hours and 40 minutes for a carton of 10 syringes. If thawing at room temperature (between 15°C and 25°C [59°F and 77°F]), then 40 minutes for single prefilled syringe or carton of 2 prefilled syringes; and 1 hour and 20 minutes for a carton of 10 syringes. After thawing, SPIKEVAX may be stored between 8°C to 25°C (46°F to 77°F) for up to 12 hours.

Other administration information: Do not shake. For single prefilled syringe: 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. 

Single-dose Pre-filled Syringe Label Color: Teal

Dose/Injection Volume: 10 mcg/0.2 ml

MNEXSPIKE 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.

Storage and Handling

Freezer storage: Frozen -40°C to -15°C (-40°F to 5°F)

Refrigeration storage: 2°C to 8°C (36°F to 46°F) for up to 90 days or up to the expiration date printed on the carton, whichever comes first. (Cannot be re-frozen.) Minimize exposure to light during storage and after thawing.

To thaw: Vaccine may be thawed in the refrigerator or at room temperature. If thawing in the refrigerator (between 2°C and 8°C (36°F and 46°F), 1 hour and 40 minutes for single prefilled syringe or carton to 2 prefilled syringes; and 2 hours and 40 minutes for a carton of 10 syringes. If thawing at room temperature (between 15°C and 25°C [59°F and 77°F]), then 40 minutes for single prefilled syringe or carton of 2 prefilled syringes; and 1 hour and 20 minutes for a carton of 10 syringes. After thawing, MNEXSPIKE may be stored between 8°C to 25°C (46°F to 77°F) for up to 24 hours.

Other administration information: Do not shake. For single prefilled syringe: 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. 

• Spikevax Package Insert (ages 6+ months)
• MNEXSPIKE Package Insert (ages 12+ years)

Single Dose Pre-filled Syring Label Color: Dark Cyan

Dose/Injection Volume:  0.5 mL

Nuvaxovid is a colorless to slightly yellow, clear to mildly opalescent suspension. Do not administer if vaccine is discolored or contains other particulate matter.

Storage and Handling

Refrigerated Storage: 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.

Pre-filled syringes are prepared and sealed under sterile conditions by Novavax and do not contain a preservative to help prevent microorganism growth. Once the sterile seal has been broken, the vaccine should be used or discarded by the end of the workday. 
The following information falls outside the approved product labeling and is based on physical stability testing only; the safety and efficacy of product stored outside the recommended conditions cannot be assured. Administration of a product stored outside of conditions stated in the product labeling is at the clinician's discretion

• Time out of Refrigeration (ToR) limits for the storage of the pre-filled syringe support temperature excursions for up to 12 hours at temperatures between 8°C (46°F) and less than 25°C (77°F) (shipment and administration).
• ToR limits for the storage of the pre-filled syringe support temperature excursions for up to 96 hours (cumulative) at temperatures between 0.7°C (33°F) and 2°C (36°F) (shipment and storage prior to administration). Visibly frozen material should be discarded.

• Nuvaxovid Package Insert (ages 12+ years)