COVID-19: Vaccines

Ages 12 and Older (Purple Cap Vials)
 

• The Pfizer-BioNTech COVID-19 vaccine multiple dose vial contains a frozen suspension and must be thawed and diluted prior to administration.
• Vials may be thawed in the refrigerator (2°C to 8°C), or at room temperature (up to 25°C).
• Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles. DO NOT SHAKE. Before dilution, the vial should be gently inverted ten times to mix.
• Sterile 0.9% Sodium Chloride Injection, USP is not packaged with the vaccine and must be sourced separately. DO NOT USE BACTERIOSTATIC STERILE 0.9% SODIUM CHLORIDE INJECTION OR ANY OTHER DILUENT.
• The contents of the vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form the Pfizer-BioNTech COVID-19 Vaccine. The vial should be gently inverted ten times to mix.
• After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that a vial contains 5 doses of 0.3 mL. Health Canada has approved a label change rendering the 5 dose statement outdated.
  • Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial.
• After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm there are no particulates and no discolouration is observed.
• Visually inspect each dose in the dosing syringe prior to administration. If the visual inspection fails, do not administer the vaccine.
• Time and date of dilution must be recorded on the vial label. Any unused vaccine must be discarded 6 hours after dilution.
• Vaccine must be stored between 20°C and 25°C.
• Strict adherence to aseptic techniques must be followed.

Ages 12 and Older (Purple Cap Vials)

Frozen vials prior to use

• Vials must be kept frozen between -80°C to -60°C (-112°F to -76°F) or between -25°C to -15°C (for up to 2 weeks).
• Vials stored at -25°C to -15°C for up to 2 weeks may be returned one time to the recommended storage condition of -80°C to -60°C. Total cumulative time the vials are stored at -25°C to -15°C should be tracked and should not exceed 2 weeks.
• If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently refilled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature range of -90°C to -60°C (-130°F to -76°F). Storage within this temperature range is not considered an excursion from the recommended storage condition.

Thawed vials prior to dilution

• Prior to dilution, vials may be thawed and stored in the refrigerator [2°C to 8°C (35°F to 46°F)]. A carton of 25 vials or 195 vials may take up to 2 or 3 hours to thaw in the refrigerator, respectively, whereas a fewer number of vials will thaw faster. Vials may be stored in the refrigerator for up to one month if thawed in refrigerator.
• Frozen vials may also be thawed at room temperature [up to 25°C (77°F)]. Prior to dilution, vials may be stored at room temperature for no more than 2 hours.
• During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
• Thawed vials can be handled in room light conditions. Do not refreeze thawed vials.

Vials after dilution

• After dilution, vials must be stored between 2°C to 25°C (35°F to 77°F) and used within 6 hours from the time of dilution.
• Any vaccine remaining in vials must be discarded after 6 hours.
• After dilution, the vaccine vials can be handled in room light conditions.
• Do not freeze. If the vaccine is frozen, it must be discarded.
• Use the product before the expiration date on the vial label.

Ages 5-11 (Orange Cap Vials)

• The Pfizer-BioNTech COVID-19 vaccine multiple dose vial contains a frozen suspension and must be thawed and diluted prior to administration.
• Vials may be thawed in the refrigerator (2°C to 8°C), or at room temperature (up to 25°C).
• Prior to dilution, the thawed suspension may contain opaque amorphous particles. DO NOT SHAKE. Before dilution, the vial should be gently inverted ten times to mix.
• Sterile 0.9% Sodium Chloride Injection, USP is not packaged with the vaccine and must be sourced separately. DO NOT USE BACTERIOSTATIC STERILE 0.9% SODIUM CHLORIDE INJECTION OR ANY OTHER DILUENT.
• The contents of the vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form the Pfizer-BioNTech COVID-19 Vaccine. The vial should be gently inverted ten times to mix.
• After dilution, one vial contains 10 doses of 0.2 mL.
  • Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.
• After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm there are no particulates and no discolouration is observed.
• Visually inspect each dose in the dosing syringe prior to administration. If the visual inspection fails, do not administer the vaccine.
• Time and date of dilution must be recorded on the vial label. Any unused vaccine must be discarded 12 hours after dilution.
• Vaccine must be stored between 2°C and 25°C.
• Strict adherence to aseptic techniques must be followed.

Ages 5-11 (Orange Cap Vials)

Vial storage prior to use

• Vials may be kept frozen between -90°C to -60°C (-130°F to -76°F) or may be transferred to the refrigerator between 2°C to 8°C, thawed and stored for up to 10 weeks.
• Do not store vials at -25°C to -15°C.
• If vials are 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.
• Vaccines should be used after 12 months from the date of manufacture.
• Once vials are thawed, do not refreeze.

Vial storage during use

• If the vial is not already thawed at 2°C to 8°C, thaw at room temperature [up to 25°C (77°F)] for 30 minutes.
• Prior to dilution, vials may be stored at temperatures up to 25°C (77°F) for a total of 12 hours.
• After dilution the vials should be stored at 2°C to 25°C (35°F to 77°F).
• Vials should be discarded 12 hours after dilution
• If the vial labels and cartons state that a vial should be discarded 6 hours after dilution, information in the Product Monograph supersedes the number of hours printed on vial labels and cartons.

Ages 6 months- 5 (Maroon Cap Vials)

• The Pfizer-BioNTech COVID-19 vaccine multiple dose vial contains a frozen suspension and must be thawed and diluted prior to administration.
  
• Vials may be thawed in the refrigerator ​​(2°C to 8°C), or at room temperature (up to 25°C).
  
• Prior to dilution, the thawed suspension may contain opaque amorphous particles. DO NOT SHAKE. Before dilution, the vial should be gently inverted ten times to mix.
• Sterile 0.9% Sodium Chloride Injection, USP is not packaged with the vaccine and must be sourced separately. DO NOT USE BACTERIOSTATIC 0.9% SODIUM CHLORIDE INJECTION OR ANY OTHER DILUENT.  
• The contents of the vial must be diluted with 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form the Pfizer-BioNTech COVID-19 Vaccine. The vial should be gently inverted ten times to mix. 
• After dilution, one vial contains 10 doses of 0.2 mL.
  
• Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume. 
• After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm there are no particulates and no discolouration is observed.  
• Visually inspect each dose in the dosing syringe prior to administration. If the visual inspection fails, do not administer the vaccine. 
• Time and date of dilution must be recorded on the vial label. Any unused vaccine must be discarded 12 hours after dilution. 
• Vaccine must be stored between 2°C and 25°C. 
• Strict adherence to aseptic techniques must be followed.
  

Ages 6 months- 5 (Maroon Cap Vials) 

Vial storage prior to use

• Vials may be kept frozen between -90°C to -60°C (-130°F to -76°F) or may be transferred to the refrigerator between 2°C to 8°C, thawed and stored for up to 10 weeks. 
• Do not store vials at -25°C to -15°C. 
• If vials are 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. 
• Vaccines should not be used after 12 months from the date of manufacture. 
• Once vials are thawed, do not refreeze. 

Vial storage during use 

• If the vial is not already thawed at 2°C to 8°C, thaw at room temperature [up to 25°C (77°F)] for 30 minutes. 
• Prior to dilution, vials may be stored at temperatures up to 25°C (77°F) for a total of 12 hours. 
• After dilution the vials should be stored at 2°C to 25°C (35°F to 77°F). 
• Vials should be discarded 12 hours after dilution.
• If the vial labels and cartons state that a vial should be discarded 6 hours after dilution, information in the Product Monograph supersedes the number of hours printed on vial labels and cartons. 

Ages 12 Years and Older (Vials with Gray Cap and Gray Label Border)

• The Pfizer BA.4/BA.5 Bivalent COVID-19 vaccine multiple dose vial contains a volume of 2.25mlL, and is supplied as a frozen suspension that does not contain preservative. Each vial must be thawed prior to administration. DO NOT DILUTE prior to use. 
• Vials may be thawed in the refrigerator (2°C to 8°C) or at room temperature (up to 25°C).
  
• Before use, mix by inverting vaccine vial gently 10 times. DO NOT SHAKE. 
• Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. 
• After mixing, the vaccine should appear as a white to off-white suspension with no visible particles.  Do not use if liquid is discoloured or if particles are observed after mixing. 
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of Pfizer COVID-19 vaccine (for 12 years of age and older) preferentially using a low dead-volume syringe and/or needle. 
• Each dose must contain 0.3 mL of vaccine. 
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. 
• Administer immediately and no later than 12 hours after first puncture. 
• Record the date and time of first vial puncture on the vial label. 
• Store between 2°C to 25°C. 
• Discard any unused vaccine 12 hours after first puncture 

Ages 12 Years and Older (Vials with Gray Cap and Gray Label Border) 

Vial storage prior to use 

• Vials may arrive frozen at ultra-cold conditions in thermal containers with dry ice.  
• Frozen vials may be immediately transferred to the refrigerator (2°C to 8°C). Thawed and stored for a single period of up to 10 weeks.  
• The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer.  
• A carton of 10 vials may take up to 6 hours to thaw at this temperature.  
• Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C for up to 12 months from the date of manufacture.  
• Do not store vials at -25°C to -15°C.  
• Once vials are thawed, do not refreeze. 
• Vials may also arrive at 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. 
• Vaccines should not be used after 12 months from the date of manufacture.  

Vials storage during use 

• If the vial is not already thawed at 2°C to 8°C, thaw at room temperature (up to 25°C) for 30 minutes.  
• Vials may be stored at room temperature up to 25°C for a total of 12 hours prior to the first puncture.  
• DO NOT DILUTE PRIOR TO USE. 
• After first puncture, the vial should be stored at 2°C to 25°C. Vials should be discarded 12 hours after first puncture. 
• Thawed vials can be handled in room light conditions.  

To learn more, please visit the following product monograph, including patient medication information: Pfizer BA.4/BA.5 Bivalent COVID Vaccine (Pfizer, October 7th, 2022) 

Ages 12 Years and Older (Vials with Gray Cap and Gray Label Border)

• The Pfizer BA.1 Bivalent COVID-19 vaccine multiple dose vial contains a volume of 2.25mlL, and is supplied as a frozen suspension that does not contain preservative. Each vial must be thawed prior to administration. DO NOT DILUTE prior to use.
• Vials may be thawed in the refrigerator (2°C to 8°C) or at room temperature (up to 25°C).
• Before use, mix by inverting vaccine vial gently 10 times. DO NOT SHAKE.
• Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles.
• After mixing, the vaccine should appear as a white to off-white suspension with no visible particles. Do not use if liquid is discoloured or if particles are observed after mixing.
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of Pfizer COVID-19 vaccine (for 12 years of age and older) preferentially using a low dead-volume syringe and/or needle.
• Each dose must contain 0.3 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
• Administer immediately and no later than 12 hours after first puncture.
• Record the date and time of first vial puncture on the vial label.
• Store between 2°C to 25°C.
• Discard any unused vaccine 12 hours after first puncture

Ages 12 Years and Older (Vials with Gray Cap and Gray Label Border)

Vial storage prior to use

• Vials may arrive frozen at ultra-cold conditions in thermal containers with dry ice.
• Frozen vials may be immediately transferred to the refrigerator (2°C to 8°C). Thawed and stored for a single period of up to 10 weeks.
• The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer.
• A carton of 10 vials may take up to 6 hours to thaw at this temperature.
• Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C for up to 12 months from the date of manufacture.
• Do not store vials at -25°C to -15°C.
• Once vials are thawed, do not refreeze.
• Vials may also arrive at 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.
• Vaccines should not be used after 12 months from the date of manufacture.

Vials storage during use 

• If the vial is not already thawed at 2°C to 8°C, thaw at room temperature (up to 25°C) for 30 minutes.
• Vials may be stored at room temperature up to 25°C for a total of 12 hours prior to the first puncture.
• DO NOT DILUTE PRIOR TO USE.
• After first puncture, the vial should be stored at 2°C to 25°C. Vials should be discarded 12 hours after first puncture.
• Thawed vials can be handled in room light conditions.

To learn more, please visit the following product monograph, including patient medication information: Pfizer BA.1 Bivalent COVID-19 Vaccine (Pfizer, October 21, 2022)

5 mL multidose vials (red cap)

• The Moderna COVID-19 Vaccine multiple-dose vial contains a frozen suspension and must be thawed prior to administration.
• Thaw the required number of vials in refrigerated conditions between 2° to 8°C for 2 hours and 30 minutes. After thawing, let the vial stand at room temperature for 15 minutes before administering. Alternatively, thaw at room temperature between 15° to 25°C for 1 hour.
• Do not refreeze.
• Swirl vial gently after thawing and between each withdrawal. Do not shake.
• The Moderna vaccine is a white to off-white dispersion. It may contain white or translucent product-related particulates.
• Visually inspect the vials for foreign particulate matter and/or discoloration prior to administration. If either of these conditions exists, do not administer the vaccine.
• A needle length of ≥1 inch should be used to administer the vaccine intramuscularly as shorter needles may be of insufficient length to penetrate muscle tissue in some adults.
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
• Use a new sterile needle and syringe for each vaccine withdrawal and injection.
• Pierce the stopper at a different site each time. Do not puncture the vial more than 20 times.
• Use the dose in the syringe as soon as possible. The vial must be used within 24 hours after first puncture.
• The Moderna COVID-19 Vaccine must not be reconstituted, mixed with other medicinal products, or diluted.

2.5 mL multidose vials (royal blue cap)

• The Moderna COVID-19 Vaccine multiple-dose vial contains a frozen suspension and must be thawed prior to administration.
• Thaw the required number of vials in refrigerated conditions between 2° to 8°C for 2 hours. After thawing, let the vial stand at room temperature for 15 minutes before administering. Alternatively, thaw at room temperature between 15° to 25°C for 45 minutes.
• Do not refreeze.
• Swirl vial gently after thawing and between each withdrawal. Do not shake.
• The Moderna vaccine is a white to off-white dispersion. It may contain white or translucent product-related particulates.
• Visually inspect the vials for foreign particulate matter and/or discoloration prior to administration. If either of these conditions exists, do not administer the vaccine.
• A needle length of ≥1 inch should be used to administer the vaccine intramuscularly as shorter needles may be of insufficient length to penetrate muscle tissue in some adults.
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
• Use a new sterile needle and syringe for each vaccine withdrawal and injection.
• Pierce the stopper at a different site each time. Do not puncture the vial more than 10 times.

Frozen vials prior to use

• The Moderna COVID-19 vaccine should be stored at temperatures of -50ºC to -15ºC.

Unpunctured vials

• Unpunctured vials can be stored refrigerated between 2° to 8°C for up to 30 days prior to first use.
• Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 24 hours.
• Do not refreeze thawed vials.
• If vials were transported in a liquid state at 2° to 8°C (for up to 12 hours), vials should not be refrozen and should be stored at 2° to 8°C until use.

Punctured vials

• Once punctured, the vial can be stored at room temperature or refrigerated
• Punctured vials must be discarded after 24 hours. Do not refreeze.

Bivalent 2.5 mL multidose vials (royal blue cap, green label)

• The Moderna BA.1 Bivalent COVID-19 vaccine multidose vials contain a frozen dispersion with no preservative and must be thawed prior to administration. 
• Thaw the required number of vial(s) in refrigerated conditions between 2° to 8°C for 2 hours. After thawing, let the vial(s) stand at room temperature for 15 minutes before administering. Alternatively, thaw at room temperature between 15° to 25°C for 45 minutes. 
• Do not refreeze. 
• Swirl vial(s) gently after thawing and between each withdrawal. Do not shake. 
• The Moderna BA.1 Bivalent COVID-19 vaccine is a white to off-white dispersion. It may contain white or translucent product-related particulates. 
• Visually inspect the vials for foreign particulate matter and/or discoloration prior to administration. If either of these conditions exist, do not administer the vaccine. 
• A needle length of ≥1 inch should be used to administer the vaccine intramuscularly as shorter needles may be of insufficient length to penetrate muscle tissue in some adults. 
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab. 
• Use a new sterile needle and syringe for each vaccine withdrawal and injection (ideally a low dead-volume syringe and/or needle). 
• Pierce the stopper at a different site each time. 
• Use the dose in the syringe as soon as possible, and no later than 24 hours after the first puncture. 
• The Moderna BA.1 Bivalent COVID-19 vaccine must not be reconstituted, mixed with other medicinal products, or diluted.
  

Frozen vials prior to use

• The Moderna Bivalent COVID-19 vaccine should be stored at temperatures of -50º to -15ºC. They should be stored in the original carton to avoid light. 

Unpunctured vials

• Unpunctured vials can be stored refrigerated between 2° to 8°C for up to 30 days prior to first use. 
• Unpunctured vials may be stored between 8° to 25°C for up to 24 hours. 
• Do not refreeze thawed vials. 
• If vials were transported in a liquid state at 2° to 8°C (for up to 12 hours), vials should not be refrozen and should be stored at 2° to 8°C until use. 

Punctured vials

• Once punctured, the vial can be stored at room temperature or refrigerated 
•   Punctured vials must be discarded after 24 hours. Do not refreeze.

Thawing Vials Prior to Use 

•   Required number of vial(s) must be thawed before use. Vials should not be refrozen after thawing.

To learn more, please visit the following product monograph, including patient medication information: Moderna Bivalent COVID-19 Vaccine (Moderna, September 1, 2022). 

Bivalent multidose vials 2.5mL (royal blue cap, gray label) 

• The Moderna BA.4/5 Bivalent COVID-19 vaccine multidose vials contain a frozen dispersion with no preservative and must be thawed prior to administration. 
• Thaw the required number of vial(s) in refrigerated conditions between 2° to 8°C for 2 hours. After thawing, let the vial(s) stand at room temperature for 15 minutes before administering. Alternatively, thaw at room temperature between 15° to 25°C for 45 minutes.  
• Do no refreeze. 
• Swirl vial(s) gently after thawing and between each withdrawal. Do not shake.  
• The Moderna BA.4/5 Bivalent COVID-19 vaccine is a white to off-white dispersion. It may contain white or translucent product-related particulates.  
• Visually inspect the vials for foreign particulate matter and/or discoloration prior to administration. If either of these conditions exist, do not administer the vaccine.  
• A needle length of ≥1 inch should be used to administer the vaccine intramuscularly as shorter needles may be of insufficient length to penetrate muscle tissue in some adults. 
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab. 
• Use a new sterile needle and syringe for each vaccine withdrawal and injection (ideally a low dead-volume syringe and/or needle). 
• Pierce the stopper at a different site each time.  
• Use the dose in the syringe as soon as possible, and no later than 24 hours after the first puncture.  
• The Moderna BA.4/5 Bivalent COVID-19 vaccine must not be reconstituted, mixed with other medicinal products, or diluted. 

Frozen vials prior to use

• The Moderna BA.4/5 Bivalent COVID-19 vaccine should be stored at temperatures of -50º to -15ºC. They should be stored in the original carton to avoid light.  

Unpunctured vials

• Unpunctured vials can be stored refrigerated between 2° to 8°C for up to 30 days prior to first use.  
• Unpunctured vials may be stored between 8° to 25°C for up to 24 hours.  
• Do not refreeze thawed vials.  
• If vials were transported in a liquid state at 2° to 8°C (for up to 12 hours), vials should not be refrozen and should be stored at 2° to 8°C until use.  

Punctured vials

• Once punctured, the vial can be stored at room temperature or refrigerated  
•  Punctured vials must be discarded after 24 hours. Do not refreeze. 

Thawing Vials Prior to Use 

• Required number of vial(s) must be thawed before use. Vials should not be refrozen after thawing 

To learn more, please visit the following product monograph, including patient medication information: Moderna BA.4/5 Bivalent COVID-19 Vaccine (Moderna, November 3, 2022)

• Prior to use, Janssen COVID-19 vaccine may be stored and/or transported at a refrigerated temperature of 2°C to 8°C until expiry date.
• While it is not a recommended storage or shipping temperature range, Janssen COVID-19 Vaccine is stable for a total of 12 hours at 9°C to 25°C.
• The vaccine must be stored in the original package in order to protect from light. Do not freeze.
• Do not discard unpunctured vials prior to the expiration date. As the expiration date approaches, check to see if the expiration date has been extended (see Product Monograph, including patient medication information: Janssen COVID-19 Vaccine for details).
• Before administering a dose of vaccine, carefully mix the contents of the multi-dose vial by swirling gently in an upright position for 10 seconds. Do not shake.
• Visually inspect the Janssen COVID-19 vaccine for particulate matter and discolouration prior to administration. The vaccine is a colourless to slightly yellow, clear to very opalescent suspension. The vial should be inspected visually for cracks or any abnormalities. If any of these should exist, do not administer the vaccine.
• The Janssen vaccine is one dose of 0.5 mL is administered intramuscularly in the deltoid muscle by syringe.
• A needle length of ≥1 inch should be used as needles <1 inch may be of insufficient length.
• After first puncturing the vial:
  • Janssen COVID-19 vaccine can be held at 2°C to 8°C for up to 6 hours
  • Or at room temperature (maximum 25°C) for up to 3 hours
  • The vaccine must be discarded if not used within this time
• The vial must be kept in the original package in order to protect from light during storage. Do not freeze.
• Janssen COVID-19 vaccine must not be reconstituted, mixed with other medicinal products, or diluted.

Unpunctured Vials

• Janssen COVID-19 vaccine should be stored in a refrigerator (2 to 8ºC)  in the outer carton  to protect from light. Do not freeze the vial.
• The vaccine must be used by the expiration date. The method of determining the expiration date differs based on the type of label included (i.e., Orange label vs White label). For details, see pages 13-14 of the Product Monograph, including patient medication information: Janssen COVID-19 Vaccine.

Punctured Vials

• Once punctured, the vial can be stored:
  • at 2°C to 8°C for up to 6 hours
  • at room temperature (maximum 25°C) for up to 3 hours
• Discard if the vaccine is not used within this time.

• Each vial contains at least the number of doses stated. When low dead volume syringes and/or needles are used, the amount remaining in the vial may be sufficient for an additional dose.
  • Where a full 0.5 mL dose cannot be extracted, the remaining volume should be discarded. Do not pool excess vaccine from multiple vials.
• The AstraZeneca COVID-19 vaccine does not contain any preservative.
• The vaccine can be stored in a refrigerator (2 to 8ºC). Do not freeze the vaccine.
• After first opening, use the vial within:
  • 6 hours when stored at room temperature (up to 30ºC), or
  • 48 hours when stored in a refrigerator (2 to 8ºC ).
• The vial can be re-refrigerated, but the cumulative storage time at room temperature must not exceed 6 hours. The vial must be discarded if the total cumulative storage time after opening exceeds 48 hours. The vaccine must be used by the expiration date on the label.
• AstraZeneca COVID-19 Vaccine must not be reconstituted, mixed with other medicinal products, or diluted.

Unpunctured Vials

• The AstraZeneca COVID-19 vaccine should be stored in a refrigerator (2 to 8ºC). Do not freeze the vial. Use the product before the expiration date on the vial label.

Punctured Vials

• Once punctured, the vial can be stored:
  • at room temperature (up to 30ºC) for 6 hours
  • in a refrigerator (2 to 8ºC ) for 48 hours
• The vial can be re-refrigerated but the cumulative storage time at room temperature must not exceed 6 hours.
• The vial must be discarded if total cumulative storage time after opening exceeds 48 hours.
• The vaccine must be used by the expiration date on the label.

• Novavax must not be reconstituted, mixed with other medicinal products, or diluted.
• The vaccine is colourless to slightly yellow, clear to mildly opalescent suspension, free of particles.
• Gently swirl the multidose vial before and in between each dose withdrawal. Do not shake.
• Visually inspect the contents of the vial for visible particulate matter and/or discolouration prior to administration. Visually inspect the vial for cracks or any abnormalities, such as evidence of tampering. If the visual inspection fails, do not administer the vaccine.
• Use a sterile needle and sterile syringe to administer the vaccine through intramuscular injection. Do not inject intravascularly, subcutaneously, or intradermally.
• The Novavax COVID-19 vaccine must not be mixed with any other vaccines or medicinal products in the same syringe. 
• Do not pool excess vaccine from multiple vials. 
• Time and date of discard must be recorded on the vial label. Any unused vaccine must be discarded 6 hours after vial puncture.

• Do not freeze the vials.
• Keep the vials in the outer carton to protect from light.

Storage prior to use

• Store unopened Novavax vials in the refrigerator between 2° to 8°C (36° to 46°F) for a maximum of 9 months.

Storage of Punctured vials

• Store the opened vial between 2°C to 25°C for up to 6 hours after first puncture.
• Novavax does not contain a preservative.

Preparing the vials

• Mixing of the Medicago antigen with the adjuvant is required prior to administration.
• Check the expiry date on the antigen and adjuvant vials.
• Allow both the antigen and adjuvant vials to reach room temperature after removing from the refrigerator  (no less than 20 minutes, no more than 60 minutes).
• Gently invert each vial 5 times or until homogeneity is obtained. Do not vortex, shake or mix vigorously.
• Inspect each vial for foreign matter, change in colour and / or leakage prior to mixing. If one of these conditions exists, the antigen or AS03 adjuvant vial must be discarded.
  • The antigen content should be transparent to opalescent, colorless to yellowish liquid suspension. It may contain visible white particulates.
  • The AS03 adjuvant content should be whitish to yellowish homogenous milky liquid emulsion.

Mixing

• Strict adherence to aseptic techniques must be followed.
• Hold and keep the adjuvant vial upside down. Use a 5 mL syringe (at least 21- gauge needle) to fully withdraw the entire content of the adjuvant vial and transfer it to the larger antigen vial.
• Do not mix with other products/vaccines in the same syringe.
• Gently invert the vial containing the mixed content a minimum of 5 times or until homogeneity is obtained. Do not shake.
• The concentration of the mixed vaccine, an emulsion for injection is 7.5 mcg / mL.
• Before use, inspect for foreign matter, change in colour and/or leakage. If one of these conditions exists, do not use the vaccine.
• The mixed vaccine should be a whitish to yellowish homogeneous milky liquid emulsion.
• Record the time that the components were mixed on the antigen vial label.

Administration

• Use the vaccine within 6 hours of mixing.
• Before each administration, gently invert the vial until homogeneity is obtained.
• Before administering, inspect for foreign matter, change in colour and/or leakage. If any of these conditions exists, do not administer.
• Cleanse the vial stopper with a single-use antiseptic swab, allow to dry.
• A 1 mL syringe with a 23-gauge needle for vaccine withdrawal and injection is recommended. Choose needle length based on the patient’s weight and make sure that the needle is tightly attached to the syringe.
• Withdraw a dose (0.5 mL) and administer into the deltoid muscle

• Store unopened vials in a refrigerator (2 °C to 8 °C). Do not freeze. If frozen, discard.
• Check the expiry date on the antigen and adjuvant vials. The shelf-life on outer cartons, containing both vials, is based on the component with the shorter expiry date.
• After mixing the antigen and adjuvant components, the vaccine must be used within 6 hours.
• Handle and store mixed vaccine at room temperature (20 °C to 30 °C). Protect from light. Do not refrigerate after mixing. If the vaccine is refrigerated, it must be discarded.

Are there other vaccines of this type available in Canada?

• No. These are the first mRNA vaccines available in Canada.

Are there COVID-19 vaccines of this type approved by Health Canada?

• Pfizer-BioNTech and Moderna are currently the only approved mRNA vaccines.

How do these vaccines work?

• mRNA vaccines contain genetic material from the COVID-19 virus (called mRNA) that gives human cells instructions to make specific COVID-19 proteins.
• After our cells make copies of the protein, our cells destroy the mRNA.
• The human immune system learns to recognize these COVID-19 proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

• No. mRNA vaccines only contain part of COVID-19’s genetic material (mRNA), and do not contain any of its proteins.

Can these vaccines cause COVID-19 disease?

• No. mRNA vaccines don’t contain the entire COVID-19 genome or any of its proteins, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

• Advantages:
  • Immune response is strong as it involves B cells and T cells
  • No live components, so no risk of the vaccine triggering disease
  • Relatively easy to manufacture
• Disadvantages:
  • Some RNA vaccines require ultra-cold storage
  • Never been licensed in humans
  • Booster shots may be required

Are there other vaccines of this type available in Canada?

• No. There are no DNA vaccines approved in Canada for diseases other than COVID-19.

Are there COVID-19 vaccines of this type approved by Health Canada?

• No. There are no COVID-19 vaccines of this type approved by Health Canada at this time.

How do these vaccines work?

• DNA vaccines contain genetic material (DNA) that gives human cells instructions to make specific COVID-19 proteins.
• The DNA is first inserted into a circular piece of bacterial DNA, which is called a plasmid (these are widely used in genetic engineering).
• Plasmids are then injected into a person’s muscle. Different vaccines use different approaches to make sure that the plasmid can enter human cells once inside the muscle.
• Once the plasmid is inside our cells, our cells make copies of the COVID-19 protein.
• The human immune system learns to recognize these COVID-19 proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

• No. DNA vaccines only contain genetic material (DNA) with some of COVID-19’s genes, and do not contain any of its proteins.

Can these vaccines cause COVID-19 disease?

• No. DNA vaccines don’t contain the entire COVID-19 genome, or any of its proteins, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

• Advantages:
  • Immune response is strong as it involves B cells and T cells
  • No live components, so no risk of the vaccine triggering disease
  • Relatively easy to manufacture
• Disadvantages
  • Never been licensed in humans
  • Booster shots may be required

Are there other vaccines of this type available in Canada?

• Yes, including the SHINGRIX shingles vaccine.

Are there COVID-19 vaccines of this type approved by Health Canada?

• Novavax Nuvaxovid is the only vaccine of this type approved by Health Canada at this time.

How do these vaccines work?

• Subunit vaccines contain pieces of the COVID-19 virus (in this case, pieces of COVID-19 proteins).
• The human immune system learns to recognize these proteins and creates antibodies, which provides immunity against COVID-19 in the future.
• Because the COVID-19 proteins cannot infect cells, only part of the immune system (i.e. antibodies) can react to them. Adjuvant medications and/or booster doses may be required.

Are these “whole virus” vaccines?

• No. Protein subunit vaccines only contain pieces of specific COVID-19 proteins, and do not contain all of its proteins, or any genetic material.

Can these vaccines cause COVID-19 disease?

• No. Protein subunit vaccines don’t contain all of COVID-19’s proteins, or any of its genes, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

• Advantages:
  • Well-established technology
  • Suitable for people with compromised immune systems
  • No live components, so no risk of the vaccine triggering disease
  • Relatively stable
• Disadvantages
  • Relatively complex to manufacture
  • Adjuvants and booster shots may be required
  • Determining the best antigen combination (i.e., mix of protein pieces) takes time

Are there other vaccines of this type available in Canada?

• Yes, including all HPV vaccines.

Are there COVID-19 vaccines of this type approved by Health Canada?

• The Medicago vaccine is the only vaccine of this type approved by Health Canada at this time.

How do these vaccines work?

• Virus-like particle vaccines contain COVID-19 proteins that are assembled into something resembling a COVID-19 virus, but without COVID-19’s genetic material.
• The human immune system learns to recognize these COVID-19 proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

• No. Although virus-like particle vaccines physically resemble the virus to a degree, they do not contain any of COVID-19’s genetic material, and do not contain all of its proteins.

Can these vaccines cause COVID-19 disease?

• No. Virus-like particle vaccines don’t contain all of COVID-19’s proteins, or any of its genes, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

• Advantages:
  • Immune response is strong as it involves B cells and T cells
  • Suitable for people with compromised immune systems
  • No live components, so no risk of the vaccine triggering disease
• Disadvantages:
  • Relatively complex to manufacture
  • Relatively temperature sensitive, so careful storage necessary

Are there other vaccines of this type available in Canada?

• No. There are no viral vector vaccines approved for other human diseases in Canada, there are viral vector vaccines available in other countries, such as the Merck Ebola vaccine.

Are there COVID-19 vaccines of this type approved by Health Canada?

• Yes. Oxford-AstraZeneca and the Janssen (Johnson & Johnson) vaccine are both approved by Health Canada.

How do these vaccines work?

• Viral vector vaccines contain a weakened version of a live virus that is not the COVID-19 virus. This weakened virus (which is often an adenovirus), is called a “viral vector”, and has genetic material from the COVID-19 virus inserted inside it.
• Once the viral vector is inside human cells, the COVID-19 genetic material gives cells instructions so that they can make specific COVID-19 proteins.
• The immune system learns to recognize these proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

• No. Viral vector vaccines only contain certain genetic material from COVID-19, not the entire genome, and the protein “shell” containing these pieces of genetic material belongs to a different type of virus (e.g., a harmless adenovirus).

Can these vaccines cause COVID-19 disease?

• No. Viral vector vaccines don’t contain the entire COVID-19 genome or any of its proteins, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

• Advantages:
  • Immune response is strong as it involves B cells and T cells
  • Well-established technology
• Disadvantages:
  • Previous exposure to the vector (e.g., adenovirus) could reduce effectiveness
  • Relatively complex to manufacture

Are there other vaccines of this type available in Canada?

• Yes, including all flu shots (nasal spray is live-attenuated).

Are there COVID-19 vaccines of this type approved by Health Canada?

• No. There are no COVID-19 vaccines of this type approved by Health Canada at this time.

How do these vaccines work?

• Inactivated vaccines contain whole COVID-19 viruses whose genetic material has been destroyed by heat, chemicals or radiation.
• These viruses cannot infect cells and replicate, and therefore may be safer than live-attenuated vaccines for those who are immunocompromised.
• Because the inactivated viruses cannot infect cells, only part of the immune system (i.e. antibodies) can react to them. Adjuvant medications and/or booster doses may be required.

Are these “whole virus” vaccines?

• Yes, but the virus is not live as its genetic material has been destroyed.

Can these vaccines cause COVID-19 disease?

• No. Inactivated vaccines cannot cause COVID-19 disease because the COVID-19 genetic material has been destroyed.

What are some of the advantages and disadvantages of this type of vaccine?

• Advantages:
  • Well-established technology
  • Suitable for people with compromised immune systems
  • No live components, so no risk of the vaccine triggering disease
  • Relatively simple to manufacture
  • Relatively stable
• Disadvantages
  • Booster shots may be required

Are there other vaccines of this type available in Canada?

• Yes, including all MMR and MMRV vaccines.

Are there COVID-19 vaccines of this type approved by Health Canada?

• No. There are no COVID-19 vaccines of this type approved by Health Canada at this time.

How do these vaccines work?

• Live-attenuated vaccines use a form of the COVID-19 virus that has been weakened in the laboratory, which can still grow and replicate, but causes mild or no illness.
• Because these are live COVID-19 viruses, they are able to infect human cells, and the human immune system can respond to these viruses almost as well as it does to the “wild-type” virus.
• The weakened virus enters human cells, and provides instructions so that cells make specific COVID-19 proteins.
• The immune system learns to recognize these proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

• Yes, but the virus has been weakened so that it only produces mild or no illness.

Can these vaccines cause COVID-19 disease?

• Yes. In very rare cases, the live-attenuated virus may mutate and revert back to a more pathogenic form.

What are some of the advantages and disadvantages of this type of vaccine?

• Advantages:
  • Immune response is strong as it involves B cells and T cells
  • Well-established technology
  • Relatively simple to manufacture
• Disadvantages:
  • Unsuitable for people with compromised immune systems
  • May trigger disease in very rare cases
  • Relatively temperature sensitive, so careful storage necessary