COVID-19 Comirnaty™ (Pfizer®/BioNTech®) vaccine management protocol TEMPLATE V3

Purpose This vaccine management protocol outlines the management of the COVID-19 Comirnaty™ vaccine (Pfizer®/BioNTech®) to ensure appropriate storage conditions and integrity of the vaccine.

Human Rights Act 2019To the extent an act or decision under this document may engage human rights under the HumanRights Act 2019, regard will be had to that Act in undertaking the act or making the decision. Forfurther information on the Human Rights Act 2019 see: https://www.forgov.qld.gov.au/humanrightsVaccine ordering / stock managementSites are required to submit stock management and vaccine wastage to the VCC directly by 9pm daily or the end of their clinic via the VCC inbox - QH.VCC@health.qld.gov.au. Sites to use the state provided Excel template for data submission.

Vaccine deliveryEach thermal shipper has a reusable GPS enabled temperature monitoring device which will be enabled when the shipper is packed. All shipments will be tracked via the onboard GPS monitoring device to ensure end-to-end distribution within required temperatures. Temperature records of the shipment will be provided within 1 hour of pushing the STOP button of the data logger. The Pfizer/BioNTech vaccine will arrive in thermal shippers to the Pfizer hubs. Each delivery should come with the following:

Dry ice handling insert. Safety data sheet for dry ice. Return instructions for GPS loggers and the thermal shipper. Blank label to cover ‘dry ice’ label when container is empty, return shipping

label, outbound shipping label and contents label on the inside flap.Detail who is responsible for receipting the vaccine delivery, including stopping the data logger and reviewing the temperature record from shipment. See Appendix 1 - ‘Unpacking a Pfizer COVID-19 vaccine delivery’ or link to Pfizer website once live.

Proper personal protective equipment (PPE) including gloves must be worn when handling dry ice.

Hubs will receive the required gloves from the Australian Government, Department of Health.

Detail who will be responsible for the following:

COVID-19 Comirnaty™ (Pfizer®/BioNTech®) vaccine management protocol TEMPLATE V3

• Inspecting the labelling and packaging of product delivered is in accordance with the ‘Labelling and Packaging Specifications’

• Visual inspecting the product delivered• Transfer vaccines in original packaging to ultra low temperature freezer,

freezer or fridge• Check vaccine expiry dates. Bring trays with the shortest dates to the front

of the freezer.• Record date, numbers of vaccines received, vaccine type and batch

numbers.• Record details of who to contact if cold chain monitors show a breach or

direct the reader to “see ‘Cold chain breach’ section below” • Report any discrepancies between the vaccines on the delivery docket and

the vaccines received to the Queensland Health Vaccine Command Centre.

A ‘Pfizer Vaccine Acceptance Form’ has been developed for jurisdictional nominated Pfizer Hubs, and any other locations which receive deliveries of Pfizer Vaccines. It must be completed when taking delivery of the Pfizer Vaccines to notify Health of acceptance and any potential issues. The Acceptance Form must be completed on Citizen Space (an Australian Department of Health Consultation Hub) upon arrival of the Product by no later than 9pm (local time) on the day of delivery. The Pfizer Vaccine Acceptance Form must be completed by the Authorised Person in charge of accepting delivering for the Pfizer Hub. Sites must also directly notify the QH VCC of vaccine acceptance as well as the Commonwealth. A copy of the form must also be emailed to: QH.VCC@health.qld.gov.au

The link for completion of the Pfizer Vaccine Acceptance form is https://consultations.health.gov.au/covid19-vaccine-taskforce/c9ead52e Returning the thermal shipper, including the temperature logger to Pfizer

within 30 calendar days of receipt – see ‘Return instructions for GPS loggers and the thermal shipper’ factsheet contained in your delivery.

Temperature monitoring and recordingTo ensure that vaccines have been stored within the recommended temperature range, the temperatures to which vaccines are exposed must be continuously monitored, recorded and reported throughout the cold chain.• Place instructions on how to use the data logger and how to

download data in your facility’s vaccine management manual. Record:– where to store data on the computer– date of purchase – date of last calibration

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– whether the data logger is able to display the minimum, maximum and current temperatures.

• A minimum/maximum thermometer is required if the refrigerator does not have a battery back-up for the inbuilt temperature-monitoring system, generator back-up or uninterrupted power supply (so the refrigerator can be monitored in the event of a power failure): – Ensure that a thermometer is in place to continuously check the

temperature in each vaccine refrigerator.– Place the thermometer probe in an empty vaccine box (not in fluid)

on the middle shelf of the refrigerator.– Check the thermometer and record the temperature twice every

working day. – Record the minimum and maximum temperatures of the refrigerator,

and reset the thermometer. – Provide the location of new temperature recording charts/logbooks.– Provide instructions for how to reset the minimum/maximum

thermometer.– Record the date of the last accuracy check and battery change.

• Cold chain breach

Power failure procedurePower failures occur for many reasons. How a power failure is managed in your organisation may depend on the cause of the power outage, whether prior notice was given and the time of day the outage occurs. The safety and wellbeing of staff should always be considered when managing power failures, particularly when they occur outside business hours.

• Provide instructions for what to do in opening hours. Include specific timeframes actions must occur in. See National Vaccine Storage Guidelines – Strive for 5. Section 8.1 for detail of possible back up plans.

• Provide instructions for what to do out of hours. Include specific timeframes actions must occur in. See National Vaccine Storage Guidelines – Strive for 5. Section 8.1 for detail of possible back up plans.

Cold chain breachIt is essential that vaccine temperatures are maintained during shipment and storage. Failure to store and handle vaccines properly can reduce vaccine potency, resulting in inadequate immune responses in patients and poor protection against disease. This can have significant public health ramifications. A ‘cold chain breach’ occurs when vaccine storage temperatures deviate outside

the recommended

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range (temperature excursion). The Comirnaty™ vaccine (Pfizer®/BioNTech®) has complex storage

requirements and there are multiple points at which a cold chain breach could occur.

When stored in the refrigerator a cold chain breach has occurred if vaccine storage temperatures have

been outside the recommended range of +2°C to +8°C. It excludes fluctuations up to +12°C, lasting no

longer than 15 minutes, as may occur when stock taking or restocking refrigerators.

o Immediately isolate the vaccines and label with “Do Not Use”. o Keep the vaccine stored in the refrigerator or freezer (dependent on

where the breach occurred). o If the breach was due to equipment failure or power outage, transfer to

alternative storage and /or [Insert other local risk mitigating strategies] o [Insert contact details for local representatives]o Do not discard any vaccine until advised to do so by the

Commonwealth or Queensland Health Vaccine Command Centre.In the event of a potential or actual wastage incident (e.g. damaged vials, breach of cold chain requirements) for AstraZeneca, that exceeds the threshold (5 or more vials at a time), each Administration Site or other location which receives deliveries of Vaccines must notify the QH VCC immediately by calling 07 3608 5960. Sites must also submit this data using the state provided Excel template.

Documentation Detail where staff members can find written procedures, instructions and logbooks record equipment maintenance, vaccine transport and staff education.

Equipment maintenance Include: • Instructions for how and when to change batteries — for example, the

batteries in minimum/maximum thermometers require changing at least every 6 to 12 months

• Freezer and refrigerator service contact details — who to contact and when • instructions for when the annual freezer and refrigerator self-audit is to be

performed (include audit sheet as an appendix)• instructions for cleaning the freezer and refrigerator.

Transporting vaccines off siteDuring the national COVID-19 vaccine rollout, sites may be asked to transport

vaccines to another site

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or facilitate an offsite clinic. Vaccines should be packed and monitored during transport and

administration in all venues. Transport would most likely be of a refrigerated product, not frozen, due

to additional handling requirements of dry ice.

Freezing and conditioning ice packs and gel packsIce packsIce packs are water filled and can come out of the freezer at a temperature as low

as −18°C, which is significantly lower than the freezing point of the ice pack. Achieving the lower

temperature will provide a longer cold life for the ice pack.

Condition ice packs as follows:• Remove ice packs from the freezer.• Lay out ice packs in a single row on their sides (where possible), leaving a

5cm space around each ice pack to allow maximum air exposure. This reduces the conditioning time.

• Wait until ice packs begin to sweat. This will take up to 1 hour at +20°C. • The ice pack is conditioned as soon as water begins to ‘slosh’ about slightly

inside the ice pack.

Gel packsCondition gel packs: Usually gel packs will take longer to condition than ice packs. Follow the manufacturer’s instructions for conditioning the gel pack. Although

there is no ‘one rule fits all’ approach, there are some industry standards that can be used to guide conditioning if gel packs have been stored in the freezer at −20°C for a minimum of 36 hours.

Conditioning frozen gel packs for the times prescribed below enables the initial chill factor to be removed from the packs.

Guide to time needed to condition small and large gel packsGel packs weighing less than 750g• If ambient (room) temperature is over +15°C, condition for 45 minutes

before use.• If ambient temperature is under +15°C, condition for 1 hour before use. Gel packs weighing more than 750g• If ambient (room) temperature is over +15°C, condition for 1 hour before

use.• If ambient temperature is under +15°C, condition for 1½ hours before use.

How to correctly pack a coolerOne of the greatest risks to vaccines is freezing during transport in a cooler. The

risk of freezing COVID-19 Comirnaty™ (Pfizer®/BioNTech®) vaccine management protocol TEMPLATE V3 - Standard Page 5 Division NameStandard ownerEffective date

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increases if the ice packs/gel packs are not correctly conditioned. Freezing episodes occur easily in all

coolers, usually in the first 2 hours after packing.

Monitor the temperature every 15 minutes for the first 2 hours, and then at least hourly.

These below instructions are for packing a cooler that can be used for storing vaccines for up to 8

hours. See also Appendix 2 for a printable instruction list.

1. Chill the inside of the cooler before use by placing ice packs/gel packs in it for a few hours, and then remove the ice packs/gel packs.

2. Place polystyrene chips or other suitable insulating material at the bottom of the container. This eliminates ‘hot’ and ‘cold’ spots. Packaging such as polystyrene chips is preferable to bubble-wrap because it promotes air circulation. If using bubble-wrap, avoid wrapping the vaccines tightly.

3. If being transported outside of original trays, vials must be packaged securely to avoid breakage and to prevent vials from rolling during transport. Place vaccine stock on top of the insulating material.

4. Place a minimum/maximum thermometer or data logger in the centre of the vaccine stock.

5. Place the thermometer probe in an empty box to protect it from lying directly on ice.

6. Surround the vaccines with packing material that allows cold air to circulate. 7. Place the conditioned ice packs/gel packs on top of the insulating material,

and close and seal the lid of the cooler. If using a larger cooler, place conditioned ice packs/gel packs around the sides of the cooler as well as on top. Experiment to find the best combination.

8. Ensure that vaccine stock is not in direct contact with the ice packs/gel packs, to minimise the risk of freezing.9. Place the display screen of the minimum/maximum thermometer on the

outside of the cooler for easy monitoring and recording of vaccine temperatures.

10. Commence monitoring before leaving for the session. Monitor the temperature every 15 minutes for the first 2 hours, and then at least hourly throughout the immunisation session, and before administering vaccines (see also National Vaccine Storage Guidelines – Strive for 5. Appendix 8 ‘Checklist and temperature chart for mobile or outreach immunisation clinics, or emergency storage of vaccines’).

Staff education — vaccine managementAll staff involved in handling and administration of vaccines should be familiar with cold chain management procedures. In-house education is provided to freezer and/or refrigerator delegates at least yearly.

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Each site needs to nominate several fridge delegates who will undergo further training on using the temperature monitoring devices and vaccine management. These delegates should also be responsible for orientating new staff to the cold chain procedure.

Insert details of delegates Procedure for orientating new staff and staff with new roles Staff records of ongoing education.

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AppendixAppendix 1 – Unpacking a Pfizer COVID-19 vaccine deliveryThe following information details two different options for unpacking Pfizer deliveries. The one you need for your facility will depend on how they are delivered.Option A (Deliveries from DHL)

1. Please see COVID-19 Vaccine Module 2: Handling and Storage: Pfizer Packaging Demo.

Option B (Deliveries from Pfizer Direct)1. Open the outer box.2. At the top, you will find a data logger fitted within Styrofoam. Remove the

Styrofoam with the data logger inside carefully as it is connected to a probe within the inner box with the vaccines. Turn the Pfizer data logger off.

3. Put on provided dry ice handling PPE such as heavy duty gloves. 4. Remove the inner dry ice tray with handles on top.5. Remove the ‘payload’ (inner box with two finger holes on top) 6. Open the ‘payload’ box and remove vial trays.7. Check vial trays and complete acceptance form when checked.8. Place the Pfizer data logger back into the thermal shipper.

The Pfizer data logger is re-useable and must NOT be disposed of; it must be returned with the thermal shipper it arrived in. The Pfizer data logger probe should be switched off within 24 hours of delivery and the facilities probe needs to be used instead. State and Territory jurisdictions will outline their policy and recommendations on the use of cold chain monitors.

COVID-19 Comirnaty™ (Pfizer®/BioNTech®) vaccine management protocol TEMPLATE V3

Appendix 2 – How to correctly pack a cooler

One of the greatest risks to vaccines is freezing during transport in a cooler. The risk of freezing

increases if the ice packs/gel packs are not correctly conditioned. Freezing episodes occur easily in all

coolers, usually in the first 2 hours after packing.

Monitor the temperature every 15 minutes for the first 2 hours, and then at least hourly.

These below instructions are for packing a cooler that can be used for storing vaccines for up to 8

hours.

1. Chill the inside of the cooler before use by placing ice packs/gel packs in it for a few hours, and then remove the ice packs/gel packs.

2. Place polystyrene chips or other suitable insulating material at the bottom of the container. This eliminates ‘hot’ and ‘cold’ spots. Packaging such as polystyrene chips is preferable to bubble-wrap because it promotes air circulation. If using bubble-wrap, avoid wrapping the vaccines tightly.

3. If being transported outside of original trays, vials must be packaged securely to avoid breakage and to prevent vials from rolling during transport. Place vaccine stock on top of the insulating material.

4. Place a minimum/maximum thermometer or data logger in the centre of the vaccine stock.

5. Place the thermometer probe in an empty box to protect it from lying directly on ice.

6. Surround the vaccines with packing material that allows cold air to circulate. 7. Place the conditioned ice packs/gel packs on top of the insulating material,

and close and seal the lid of the cooler. If using a larger cooler, place conditioned ice packs/gel packs around the sides of the cooler as well as on top. Experiment to find the best combination.

8. Ensure that vaccine stock is not in direct contact with the ice packs/gel packs, to minimise the risk of freezing.9. Place the display screen of the minimum/maximum thermometer on the

outside of the cooler for easy monitoring and recording of vaccine temperatures.

10. Commence monitoring before leaving for the session. Monitor the temperature every 15 minutes for the first 2 hours, and then at least hourly throughout the immunisation session, and before administering vaccines (see also National Vaccine Storage Guidelines – Strive for 5. Appendix 8 ‘Checklist and temperature chart for mobile or outreach immunisation clinics, or emergency storage of vaccines’).

COVID-19 Comirnaty™ (Pfizer®/BioNTech®) vaccine management protocol TEMPLATE V3

References Pfizer Australia Pty Ltd. (2021). Australian Product Information - Comirnaty™

(BNT162b2 [mRNA] COVID-19 Vaccine. https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125-pi.pdf

Commonwealth of Australia. (2020). National Vaccine Storage Guidelines ‘Strive for 5’ Strive for 5. https://www.health.gov.au/resources/publications/national-vaccine-storage-guidelines-strive-for-5

Version ControlVersion Date Comments1 21/2/21 New document

2 March 2021 Update to state reporting requirements

3 1-6-21 Update to Pfizer handling conditions, cold chain breach reporting

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