Pfizer said, Ground Transportation of the Pfizer-BioNTech Vaccine is OK
Time for Doug Ford to get those vaccines out of freezers
General Hillier admitted he made a mistake by not vaccinating on a daily basis through the holidays. It was an oversight that bothered many physicians, especially those caring for those struck with severe or critical COVID19 illness in hospital.
Personally, I was most troubled by the vaccines languishing in freezers and being told that those who needed to be vaccinated must travel to the site of the freezers. Surely, any vaccine would not be that fragile? I found it hard to reconcile the differences in handling between it and the Moderna vaccine. I wrote Pfizer on the weekend and questioned the transportation guidelines once thawed:
The PDF file following this article was attached to their email. However, the relevant excerpt answering my query is below:
______________________
IS THERE DATA TO SUPPORT TRANSPORTATION OF THE UNDILUTED VACCINE VIALS AT REFRIGERATED TEMPERATURES FROM A CENTRAL SITE TO THE VACCINATION SITE? IS THAT TRANSPORTATION TIME INCLUDED IN THE ALLOWABLE 5 DAYS AT REFRIGERATED TEMPERATURE?
Pfizer has conducted a transportation study to mimic the conditions that the vaccine may be exposed to during temporary elevated temperature excursions, such as transportation from a central site to a vaccination site. The study exposed thawed vials to shaking and vibration profiles anticipated during ground transportation. The product was tested and shown to maintain all its measured quality attributes at 2ºC to 8ºC for up to 12 hours of simulated ground transportation. (1) This transportation time should be recorded and counts as part of the allowable time in the refrigerator (5 days or 120 hours).(1).
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So, the vials are viable for 5 days at refrigerated temperatures, once thawed. And, they may be transported by ground from the site of the deep freezer.
This means that there are no remaining reasons to hamper delivery of the Pfizer-BioNTech vaccine to doctor’s offices, clinics, vaccination sites all over Ontario. Moderna, or the latter vaccine, can be used in most settings in Ontario — Only a refrigerator is required. Physicians and nurses from all over the province have volunteered to give vaccine.
Our goal must be to increase vaccinations to 40–50K per day. Strategies must be devised to expedite this process. I remain hopeful we can meet this challenge. If we fail, our hospitals will soon be overwhelmed with COVID19 patients and we will be unable to care for other health care problems. January and February will be most difficult, regardless.
PDF FILE FROM PFIZER:
Pfizer Pfizer-BioNTech COVID-19 Vaccine — Storage and Handling of FROZEN Vials Outside of Recommendations in the Product Monograph
Please refer to the authorized Product Monograph on important treatment considerations for the Pfizer-BioNTech COVID-19 Vaccine (COVID-19 mRNA Vaccine) via the following link: https://www.pfizermedicalinformation.ca/en-ca/pfizer-biontech-covid-19-vaccine. In the event this link does not work, please access the product’s authorized Product Monograph at https://www.pfizer.ca/pfizer-biontech-covid-19-vaccine-covid-19-mrna-vaccine or www.pfizer.ca. Note: select product monograph information is excerpted further in the document.
PFIZER-BIONTECH COVID-19 VACCINE is indicated for: Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The use of PFIZER-BIONTECH COVID-19 VACCINE is permitted under an interim authorization delivered in accordance with section 5 of the COVID-19 Interim order (IO)*. Patients should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the Market Authorization Holder to ascertain the continued quality, safety and efficacy of the product. For further information on authorization under this pathway, please refer to Health Canada’s IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
This letter regarding the Pfizer-BioNTech COVID-19 Vaccine includes information that is inconsistent with the product uses described in the authorized Product Monograph. Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the authorized Product Monograph.
TEMPERATURE EXCURSIONS
Pfizer has conducted stability studies to support temporary inadvertent temperature excursions.1 Note that the data provided below are based on physical stability testing only; product stored outside the recommended temperature range was not tested or evaluated for clinical immunogenicity or efficacy.
This information is not intended to recommend storage of Pfizer-BioNTech COVID-19 Vaccine at temperatures other than those recommended in the authorized Product Monograph. Pfizer does not suggest or recommend the use of Pfizer-BioNTech COVID-19 Vaccine that has been stored or handled outside of the approved recommendations as per the authorized Product Monograph.
Healthcare Professionals (HCPs) should consider these data, including the limitations, in determining whether Pfizer-BioNTech COVID-19 Vaccine exposed to temperatures outside of the recommended storage and handling conditions remains suitable for patient use. It is the responsibility of the vaccination provider to evaluate these data in the context of the actual temperature excursion and the duration of excursion that occurred. Pfizer is unable to make any treatment recommendations for individual patients.
The expiry date on the product packaging label reflects the shelf-life of the product when stored in accordance with the product labelling recommendations. Pfizer cannot make any claims as to the shelf life of the product subjected to storage conditions outside of those recommended in the authorized product labelling.
Please take note product specifications and manufacturing standards may change over time. As such, previously provided information may require updating.
TOPICS COVERED IN THIS DOCUMENT
• WHAT ARE THE RECOMMENDED STORAGE AND HANDLING REQUIREMENTS FOR THE FROZEN VIALS OF PFIZER-BIONTECH COVID-19 VACCINE PRIOR TO DILUTION?
Pfizer Pfizer-BioNTech COVID-19 Vaccine — Storage and Handling of FROZEN Vials Outside of Recommendations in the Product Monograph
• WHAT DATA IS AVAILABLE REGARDING THE STABILITY AND VIABILITY OF THE FROZEN VIALS FOLLOWING EXPOSURE TO TEMPERATURE EXCURSIONS ABOVE -60ºC PRIOR TO DILUTION? (i.e. Inadvertent storage in a non-ultra-low freezer, freezer malfunction, thermal container gets too warm, dry ice inadvertently runs out, etc.)
• WHAT DATA IS AVAILABLE FOR STABILITY OR VIABILITY OF THE FROZEN VIALS WHEN STORED AT TEMPERATURES LOWER THAN -60ºC?
• IF I AM UNABLE TO OBTAIN DRY ICE, CAN I USE LIQUID NITROGEN INSTEAD?
• IS THERE DATA TO SUPPORT TRANSPORTATION OF THE UNDILUTED VACCINE VIALS AT REFRIGERATED TEMPERATURES FROM A CENTRAL SITE TO THE VACCINATION SITE? IS THAT TRANSPORTATION TIME INCLUDED IN THE ALLOWABLE 5 DAYS AT REFRIGERATED TEMPERATURE?
• IS THERE DATA TO SUPPORT THE USE OF FROZEN OR THAWED VIALS THAT DO NOT REMAIN UPRIGHT DURING STORAGE AND/OR TRANSPORTATION?
WHAT ARE THE RECOMMENDED STORAGE AND HANDLING REQUIREMENTS FOR THE FROZEN VIALS OF PFIZER-BIONTECH COVID-19 VACCINE PRIOR TO DILUTION?
Product Monograph
Storage and Stability
Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials (after dilution each vial contains 5 doses of 0.3 mL) arrive in thermal containers with dry ice. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the Pfizer-BioNTech COVID 19 Vaccine Storage and Handling Reference Guide provided (also available at CVDvaccine.ca). Once received, remove the vial cartons immediately from the thermal container and store in the freezer between — 80°C to — 60°C (-112°F to -76°F). Vials must be kept frozen between -80°C to -60°C (-112°F to -76°F) and protected from light, in the original cartons, until ready to use.2
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 re-filled 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.2
Thawed Vials Prior to Dilution
Prior to dilution, multiple dose vials of Pfizer-BioNTech COVID-19 Vaccine 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 in less time. Vials may be stored in the refrigerator for up to 5 days (120 hours). Frozen vials may also be thawed at room temperature [up to 25°C (77°F)]. Prior to dilution, the multiple dose vial 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.2
Pfizer Pfizer-BioNTech COVID-19 Vaccine — Storage and Handling of FROZEN Vials Outside of Recommendations in the Product Monograph
Vials After Dilution
After dilution, multiple dose vials of Pfizer-BioNTech COVID-19 Vaccine 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. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. After dilution, the vaccine vials can be handled in room light conditions. Do not freeze. If the vaccine is frozen, it must be discarded.2
For further information regarding the authorization, please refer to the Product Monograph for the Pfizer-BioNTech COVID-19 Vaccine.
WHAT DATA IS AVAILABLE REGARDING THE STABILITY AND VIABILITY OF THE FROZEN VIALS FOLLOWING EXPOSURE TO TEMPERATURE EXCURSIONS ABOVE -60ºC PRIOR TO DILUTION? (I.e. inadvertent storage in a non-ultra-low freezer, freezer malfunction, thermal container gets too warm, dry ice inadvertently runs out, etc.)
Product Monograph
Storage and Stability
Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials (after dilution each vial contains 5 doses of 0.3 mL) arrive in thermal containers with dry ice. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the Pfizer-BioNTech COVID 19 Vaccine Storage and Handling Reference Guide provided (also available at CVDvaccine.ca). Once received, remove the vial cartons immediately from the thermal container and store in the freezer between
-80°C to — 60°C (-112°F to -76°F). Vials must be kept frozen between -80°C to -60°C (-112°F to -76°F) and protected from light, in the original cartons, until ready to use.2
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 re-filled 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.2
Thawed Vials Prior to Dilution
Prior to dilution, multiple dose vials of Pfizer-BioNTech COVID-19 Vaccine 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 in less time. Vials may be stored in the refrigerator for up to 5 days (120 hours). Frozen vials may also be thawed at room temperature [up to 25°C (77°F)]. Prior to dilution, the multiple dose vial 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.2
Internal Data
The intended label storage condition for Pfizer-BioNTech COVID-19 Vaccine is 6 months at — 75°C ± 15°C. Some vials distributed as part of initial launch supplies may be labeled with the storage condition of -70°C ± 10°C. The Fact Sheet for these vials allows storage at -75°C ± 15°C without it being considered an excursion. Vials of Pfizer-BioNTech COVID-19 Vaccine are shipped in the Pfizer Thermal Shipper which maintains -75°C ± 15°C. The Pfizer Thermal Shipper can also be used as a storage container when refilled with dry ice and monitored per the guide included with the shipper.1
Pfizer Pfizer-BioNTech COVID-19 Vaccine — Storage and Handling of FROZEN Vials Outside of Recommendations in the Product Monograph
Pfizer has evaluated the stability of Pfizer-BioNTech COVID-19 Vaccine by exposing the frozen vaccine to various temperatures above -60ºC. These studies mimic the conditions that the vaccine may be exposed to during temporary elevated temperature excursions, such as freezer malfunction or issues related to dry ice not maintaining a thermal shipper at a temperature above -60ºC. Based on temperature stability studies, the product was tested and shown to maintain all its measured quality attributes under the following in-use conditions:1
- 2 weeks at -60ºC to -30ºC
- 2 weeks at -25ºC to -15ºC
- *See note below for excursions -15ºC to -4ºC
- 1 week at 2ºC to 8ºC
- 12 hours at 25°C ± 2°C
- 12 hours at 30°C ± 2°C
For most* temperatures between study ranges, apply the stability data from the next warmest condition. For example, for a vaccine exposed to 15ºC use the study range for the range of 25°C ± 2°C which supports the vaccine maintaining all its measured quality attributes for a timeframe up to 12 hours.1
*There is one exception to this guidance for temperatures between -15ºC and -4ºC. If the vaccine has been exposed to temperatures in this range for up to 60 minutes, it should be treated as a #freeze/thaw excursion and can be refrozen. If the maximum number of freeze/thaw excursions has been reached, or the vaccine is within this temperature range for more than 60 minutes, it should be placed at 2–8°C for use and not refrozen. See below for further details regarding freeze/thaw excursions. For temperatures above -4°C refer to the storage condition stability data above for time limits.1
Freezing and Thawing
One freeze/thaw excursion is acceptable for the point of use (please see “#freeze/thaw excursion” in the paragraphs above and below for what should be considered a freeze/thaw excursion). Exposure to temperatures greater than -15°C are considered a #freeze/thaw excursion. Additionally, if the point of use has access to the Shipment Quality Report and can confirm that the product did not go through a freeze/thaw excursion during transportation (i.e. reports as “no excursion”), it is acceptable to have a second freeze/thaw excursion at the point of use.1
If the temperature was not monitored during the excursion and/or the time of exposure is not known, it must be considered a #freeze/thaw excursion.1
Storage at temperatures less than -15ºC are not considered a freeze/thaw excursion. Refer to the storage condition stability data above from time limits.1
As noted above, if the vaccine has been exposed to temperatures between -15°C and -4°C for up to 60 minutes, it should be treated as a #freeze/thaw excursion and can be refrozen. If the maximum number of freeze/thaw excursions has been reached, or the vaccine is within this temperature range for more than 60 minutes, it should be placed at 2–8°C for use and not refrozen.1
Room Temperature
Closed-lid vial trays containing 195 vials removed from frozen storage (less than -60°C) may be at room temperature (<25°C) for up to 5 minutes for transfer between ultra-low temperature environments.1
Open-lid vial trays, or vials trays containing less than 195 vials removed from frozen storage (less than -60°C) may be at room temperature (<25°C) for up to 3 minutes for transfer between ultra-low temperature environments or to remove vials for thawing or use.1
After vial trays are returned to frozen storage following room temperature exposure, they must remain in frozen storage for at least 2 hours before they can be removed again.1
Pfizer Pfizer-BioNTech COVID-19 Vaccine — Storage and Handling of FROZEN Vials Outside of Recommendations in the Product Monograph
Handling within these times is not considered a freeze/thaw excursion.1
If visual inspection of a vial confirms thawing has occurred, then it must be considered a #freeze/thaw excursion. If the temperature was not monitored during the excursion and/or the time of exposure is not known, it must be considered a #freeze/thaw excursion. Removal of individual frozen vials from a vial tray should be considered a #freeze/thaw excursion if removed for longer than 30 seconds.1
Pfizer-BioNTech COVID-19 Vaccine must be thawed before use. It is recommended to thaw in the refrigerator (2 to 8°C). It will take about 3 hours for an entire 195 count tray to thaw in the refrigerator. A smaller number of vials, or those spaced apart, will thaw more quickly. Vials needed for immediate use can be thawed at room temperature. They will typically thaw in less than 10 minutes, but it is recommended to wait approximately 30 minutes to ensure complete thawing. Vials thawed at room temperature may be returned to the refrigerator for storage if necessary, but total time at room temperature must be tracked to ensure the vial stays within the 2 hours at room temperature limit. It is also recommended to allow vials to come to room temp (not cold to touch) prior to dilution to ensure thawing is complete. No impact to vaccine stability is anticipated if diluent is added to a vial with a small amount of undetected unthawed product remaining. No data is available if diluent is added directly into a vial of frozen vaccine.1
Pfizer has not conducted stability studies for exposure of the vaccine to temperatures >32°C. If the vaccine has been exposed to temperatures >32°C, it should not be used and should be discarded.1
WHAT DATA IS AVAILABLE FOR STABILITY OR VIABILITY OF THE FROZEN VIALS WHEN STORED AT TEMPERATURES LOWER THAN -60ºC?
The authorized Product Monograph states that cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials (after dilution each vial contains 5 doses of 0.3 mL) arrive in thermal containers with dry ice. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Reference Guide provided (also available at CVDvaccine.ca). Once received, remove the vial cartons immediately from the thermal container and store in the freezer between -80°C to -60°C (-112°F to -76°F). Vials must be kept frozen between — 80°C to -60°C (-112°F to -76°F) and protected from light, in the original cartons, until ready to use. 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 re-filled 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.2
For further information regarding the authorization, please refer to the Product Monograph for the Pfizer-BioNTech COVID-19 Vaccine.
Internal Data
Pfizer has determined that no instability is expected at temperatures colder than -60°C. Stability data from the labeled storage condition may be applied to excursions below -90°C. Integrity of the vial/stopper container closure is assured to at least -92°C. If the vaccine is stored at temperatures less than -92ºC at the point of use, the vaccine should not be used and should be discarded, however, there may be more lot-specific information available for lower temperature exposures (down to -97ºC). If you wish to obtain this information, please contact Pfizer Medical Information and provide the lot number of the affected vaccine.1
Pfizer Pfizer-BioNTech COVID-19 Vaccine — Storage and Handling of FROZEN Vials Outside of Recommendations in the Product Monograph
1. Pfizer-BioNTech COVID-19 Vaccine. Data on file (28). Pfizer.
2. Pfizer-BioNTech COVID-19 vaccine (COVID-19 mRNA Vaccine). Product Monograph Authorization. Pfizer/BioNTech. Available at: www.pfizer.ca.
IF I AM UNABLE TO OBTAIN DRY ICE, CAN I USE LIQUID NITROGEN INSTEAD?
Storage in liquid nitrogen is not supported. The temperature of liquid nitrogen is well below the recommended storage condition and the container closure of the vial may be compromised if stored at those temperatures. Vials stored in liquid nitrogen should be discarded.1
IS THERE DATA TO SUPPORT TRANSPORTATION OF THE UNDILUTED VACCINE VIALS AT REFRIGERATED TEMPERATURES FROM A CENTRAL SITE TO THE VACCINATION SITE? IS THAT TRANSPORTATION TIME INCLUDED IN THE ALLOWABLE 5 DAYS AT REFRIGERATED TEMPERATURE?
Pfizer has conducted a transportation study to mimic the conditions that the vaccine may be exposed to during temporary elevated temperature excursions, such as transportation from a central site to a vaccination site. The study exposed thawed vials to shaking and vibration profiles anticipated during ground transportation. The product was tested and shown to maintain all its measured quality attributes at 2ºC to 8ºC for up to 12 hours of simulated ground transportation.1 This transportation time should be recorded and counts as part of the allowable time in the refrigerator (5 days or 120 hours).1
IS THERE DATA TO SUPPORT THE USE OF FROZEN OR THAWED VIALS THAT DO NOT REMAIN UPRIGHT DURING STORAGE AND/OR TRANSPORTATION?
Frozen vials should be stored upright whenever possible. It is understood the vials may roll around in the trays when being moved in and out of frozen storage. Caution should be taken while handling frozen vial trays to avoid damage to vials. It is recommended that, whenever possible, frozen vials are transported in unopened, full cartons. During transportation, frozen vials that are unsecured could become damaged. Thawed vials should be kept upright during refrigerated storage. An appropriate container should be used to minimize the potential for vials to be jostled. If vials are inadvertently bumped, they should be righted, however the risk to the product is minimal and vials which are temporarily knocked over may still be used. Thawed vials should be securely packed when transported.1
REFERENCES
