Sop Transportation Covid Vaccines
Sop Transportation Covid Vaccines
Sop Transportation Covid Vaccines
PROCEDURE –
TRANSPORTATION OF COVID-19
VACCINES:
Pfizer BioNTech and Moderna Vaccines
Department of Health
Public Health New Brunswick
November 2021
TABLE OF CONTENTS
INTRODUCTION ........................................................................................................................................... 1
PURPOSE ..................................................................................................................................................... 1
1. PROCESS ................................................................................................................................................. 1
Planning Principles ........................................................................................................................ 1
1.1. Storage Requirements for COVID Vaccines ......................................................................... 2
1.2. Guidelines for Redistribution ................................................................................................. 4
2. RECOMMENDATIONS FOR ONWARD TRANSPORTATION ................................................................ 6
2.1. Packing for Just in time Use .................................................................................................. 6
2.2. How to Pack an Insulated Cooler ........................................................................................... 7
2.3. Transportation to and arrival at clinic site ............................................................................ 7
2.4. Receipt of the vaccine ............................................................................................................. 8
2.5. Temperature excursions ......................................................................................................... 8
RESOURCES ................................................................................................................................................ 9
APPENDIX A – PACKING INSTRUCTIONS SMALL ................................................................................ 10
APPENDIX B – PACKING INSTRUCTIONS MEDIUM .............................................................................. 13
APPENDIX C – TEMP TALES IMINI USB PHARMA ................................................................................ 15
APPENDIX D – TRANSPORTER REGISTER COVID-19 VACCINES ...................................................... 16
APPENDIX E – RECEIVER REGISTER COVID-19 VACCINES ............................................................... 17
APPENDIX F – PUBLIC HEALTH COMMUNICABLE DISEASE TEAM CONTACT LIST ....................... 18
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TRANSPORTATION OF COVID-19 VACCINES
INTRODUCTION
Pfizer does not recommend redistribution of Pfizer BioNTech’s COVID-19 vaccine as part of regular
operations because of increased risks to the vaccine. Moderna states that the Moderna COVID-19 vaccine
should be shipped in the frozen state at -25°C to -15°C and should not be shipped or stored below -40°C.
Understanding that redistribution may be required and encouraged by local regulatory authorities, both
Pfizer BioNTech and Moderna have provided guidance to reduce the risks to the vaccine during
redistribution at 2°C to 8°C.
Movement of the vaccine is permitted in New Brunswick under strict conditions. Information is based on
Pfizer’s Redistribution Considerations for Pfizer-BioNTech COVID-19 Vaccines, Moderna Memorandum to
Health Canada, and from the Ontario Ministry of Health COVID-19: Vaccine Storage and Handling Guidance
- Pfizer-BioNTech and Moderna COVID-19 Vaccines.
The storage and handling information differ depending on which presentation of the vaccine is considered.
For Pfizer storage and handling information refer to Home | CVDVACCINE
PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to outline a process for redistribution of the
Pfizer BioNTech vaccine and the Moderna vaccine.
This SOP will provide guidelines for movement of the vaccine at 2 to 8°C.Vaccines are to be transported for
use at a clinic site, or for storage at a facility.
Potential redistribution example scenarios:
• Transport to long term care facilities (LTCF)
• Transport to an off-site or satellite clinic
• Transport to remote communities
• Transport to another site.
1. PROCESS
Vaccines can lose their potency if exposed to temperatures outside the recommended temperature range
for the specific product. Storage requirements for COVID vaccine products (ultra-low, frozen, and
refrigerated temperatures) are described below.
Staff at designated sites where vaccine is stored, i.e. hospital pharmacy sites or McKesson, are responsible
for preparing vaccine into smaller portable packaging for redistribution.
Department of Health is responsible for identifying requirements to the Regional Health Authorities for
redistribution such as shipping containers, temperature monitors, and packing guidelines that meet the cold
storage requirements for the vaccine; and for ensuring appropriate transporters have been selected for
redistribution of the vaccine. Department of Health is also responsible to ensure contingency plans are in
place, i.e. in the event of inclement weather or vehicle breakdown.
The Department of Health should be contacted if exceptional circumstances arise that warrant a process
not included in this standard operating procedure.
Planning Principles
The following principles are to be used for planning by the Department of Health and the Regional Health
Authorities before redistribution is considered. To see more information about current priority groups:
https://www2.gnb.ca/content/gnb/en/corporate/promo/covid-19/vaccine.html#strat
1. Secure Transportation: To ensure that vaccine wastage is minimized, it is critical that vaccine
potency is protected by maintaining cold chain at all times during transportation. Manufacturer
guidelines should be followed. (See details below)
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TRANSPORTATION OF COVID-19 VACCINES
2. Integrity: The main supply of vaccine should be housed at a facility with a Drug Establishment
License (DEL), i.e. with McKesson. It is recommended that all immunizers, clinic and pharmacies
continue to have contingency plans in place for any vaccine inventory.
3. Accessibility: Moving vaccine onward should be considered for all vaccines and across all
priority groups in at all stages to ensure that citizens have access to vaccination clinics in all
health zones at readily accessible clinic sites.
4. Equity: Vaccine should be distributed on a proportional basis as per determined vaccine
allocation that would provide coverage as per the eligibility at a given time in the vaccine roll out.
5. Consolidation: Consideration should be given to immunize on a location basis (i.e. vaccinate
an entire facility at once), where applicable and supported from a logistical perspective (i.e.
residents, workers and essential visitors in a single session - could be over several days if the
vaccine storage and use guidelines are adhered to).
6. Consistency: Best practice encourages clients to receive the same vaccine for first and second
dose where at all possible. Also, to minimize errors, clinic locations should have processes in
place if more than one vaccine product will be administered on site at the same time.
7. Redistribution: Vaccine uptake will be continuously monitored, and as such vaccine may be
required to be redistributed across the province. (i.e. if a zone has low uptake, it may be
distributed to another part of the province).
8. Reduce Wastage: To avoid wastage, vaccines that cannot be used at the clinic site should be
stored refrigerated at 2 to 8°C with a temperature monitoring device, min-max thermometer, with
the overall storage time recorded and monitored to ensure use of the vaccine within the approved
time.
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TRANSPORTATION OF COVID-19 VACCINES
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TRANSPORTATION OF COVID-19 VACCINES
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TRANSPORTATION OF COVID-19 VACCINES
o If using 2 to 8°C for transportation, vials can be moved again as long as total
transportation time does not exceed 12-hours and that all above standards are
followed.
• For the Pfizer pediatric 5 to 11 years:
o There is no limit on transportation time at 2 to 8 degrees Celsius.
o Unpunctured vials can be stored at 2 to 8 degrees Celsius for up to 10 weeks.
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TRANSPORTATION OF COVID-19 VACCINES
• Containers, cartons, and vials of the vaccine must be protected from being dropped.
• Punctured vials should not be transported.
• If using 2 to 8°C for transportation, vials can be moved again as long as the total transportation
does not exceed a 12-hour period, and that all above standards are followed.
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TRANSPORTATION OF COVID-19 VACCINES
• Surround the vaccine with padding material (bubble wrap) to prevent movement
• For smaller shipments, single vials should be bubble wrapped before placing in a box or pill bottle,
using supplies that are already available.
• Do not allow vaccines to come in contact with frozen packs added to the cooler to maintain
temperature.
• Insulated vaccine containers, such as Cryopak coolers, should be prepared as per manufacturer’s
instructions.
• Label the date and time the vaccine is removed from frozen storage as the start time of the total
hours outside the frozen state on labels and attach to the vial or box of vials where it is visible to
receiver when cooler is unpacked.
• Vaccine should be handled with care and protected from shocks, drops, and vibration as much as
possible.
2.2. How to Pack an Insulated Cooler
• Follow insulated container detailed packing instructions for packing the vaccine at 2 to 8°C.
• Insulated vaccine containers, such as Cryopak coolers, should be prepared as per manufacturer’s
instructions. Payload refers to vaccine. See Appendix A.
• Insert a digital temperature monitoring device in the container. A device such as a temp tale or
min- max thermometer must be used for transporting vaccines. See Appendix B Temp Tales I mini
USB Pharma.
• Condition gel packs and the insulated container prior to use by:
o Placing gel packs at 2 to 8°C in the fridge for 24 hours prior to use.
o Store the insulated container at room temperature 24 hours prior to use.
• Clearly mark all insulated containers storing vaccines in a visible location with the following label:
“VACCINES – FRAGILE- DO NOT DROP.
Safe transfer
Designated delivery sites will be notified with transporter information if vaccine will be picked up by a
transporter. Coordination of date and time of pick up of the vaccine and estimated delivery time at
receiving site must be done prior to clinic date. The Transporter Register COVID-19 Vaccines is used
for confirmation and documentation of the transporter. See Appendix C.
2.3. Transportation to and arrival at clinic site
• Vaccine should be transported by designated persons aware of cold chain monitoring or couriers
who specialize in cold chain transport.
• Vaccine should be handled with care and protected from shocks, drops, and vibration as much as
possible.
• The container must be secured in the vehicle to prevent it from moving around.
• The temperature within the vehicle should not be outside room temperature 15ºC to 20ºC.
• Do not expose vaccines to extreme heat or cold during transport. Vaccines in insulated containers
should be placed in the area of the vehicle that maintains room temperature; i.e. not the trunk of
a car.
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TRANSPORTATION OF COVID-19 VACCINES
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TRANSPORTATION OF COVID-19 VACCINES
Regional Public Health will advise the Department of Health (DOH) by contacting Vaccine Operation
Control Center using the following reporting format:
• Subject: Delivery Temp Excursion Report
o Date of Incident
o Vaccine Delivery Site (VDS) Location
o Number of doses impacted by the excursion
o Wastage (number of doses or indicate no wastage)
o Impact on local vaccination efforts
During afterhours:
Regional Public Health will advise the Department of Health (DH) by contacting the Vaccine Operation
Control Center:
Email: [email protected]
The DOH will contact:
• Pfizer: Contact Pfizer Customer Service at 1-833-829-2684 or [email protected].
• Moderna: Contact Innomar QA at 1-833-847-4270 or QA-GMP@innomar - strategies.com.
• The National Operating Centre to advise of the incident, resolution and any impact on provincial
vaccination efforts.
RESOURCES
Canadian Immunization Guide (CIG), Part 1 – Key Immunization for additional general information
New Brunswick Immunization Program Guide Standard 3.4 – Vaccine Storage and Handling
National Vaccine Storage and Handling Guidelines for Immunization Providers, 2015
Pfizer-BioNTech Covid-19 Vaccine: https://www.cvdvaccine.ca/
Pfizer-BioNTech COVID-19 Vaccine (tozinameran) | COVID-19 vaccines and treatments portal (canada.ca)
Canada | Moderna COVID-19 Vaccine Information (modernacovid19global.com)
COVID-19 Vaccine Moderna (mRNA-1273 SARS-CoV-2) | COVID-19 vaccines and treatments portal
(canada.ca)
9 November 2021
APPENDIX A – PACKING INSTRUCTIONS SMALL
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APPENDIX A – PACKING INSTRUCTIONS SMALL
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APPENDIX A – PACKING INSTRUCTIONS SMALL
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APPENDIX B – PACKING INSTRUCTIONS MEDIUM
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APPENDIX B – PACKING INSTRUCTIONS MEDIUM
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APPENDIX C – TRANSPORTER REGISTER COVID-19 VACCINES
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APPENDIX D –TRANSPORTER REGISTER COVID-19 VACCINES
Date y/m/d Time Vaccine Destination Time picked Name of Identification Pharmacy Credo cube return date
arrived up transporter/ (employee card Staff signature and time
or drivers license
number/
Date:
Time:
Date:
Time:
Date:
Time:
Date:
Time:
Date:
Time:
Date:
Time:
Date:
Time:
16 November 2021
APPENDIX E – RECEIVER REGISTER COVID-19 VACCINES
Date y/m/d Time Document Amount of time Note time Number of Clinic Lead Staff Cooler or Credo
Vaccine time on label remaining vaccine started doses signature cube return date
arrived vaccine from room at room and time
started cumulative temperature temperature
refrigerated refrigerated
storage at 2- storage Note on label
8°C condition at 2- (Pfizer= 2
8°C hours;
(i.e., Pfizer = Moderna =
31 days;
Moderna = 30
days)
Date :
Time :
Date :
Time :
Date :
Time :
Date :
Time :
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ANNEXE B – DIRECTIVES D’EMBALLAGE, MOYENNE TAILLE
Zone 7
Miramichi (Regular hours):
Main office (506) 778-6756
Communicable Disease Line (506) 778-6104
East Region After Hours Emergency Number 1-506-856-2004
North Region Zone 4
Edmundston (Regular hours): Edmundston (Regular hours):
Main office (506) 737-4400 Main office: (506) 735-2065
Communicable Disease Line: (506) 735-2626
18 November 2021