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Purpose

This procedure describes the process of receipting, storing, transporting and drawing up the COVID-19 ComirnatyTM (Pfizer) dilute to use (concentrate) multidose for 5 to ˂12 years of age formulation vaccine (Comirnaty (Pfizer) 5 to <12 years formulation vaccine) in NSW Health clinics.

Responsibility

Staff preparing the refrigerated Comirnaty (Pfizer) 5 to <12 years formulation vaccine for administration must follow this procedure. When working in pairs, it is the responsibility of both people to continue to follow this procedure and observe all local COVID-19 precautions, including maintaining social distancing where possible.

Overview

The Comirnaty (Pfizer) 5 to <12 years formulation vaccine must be thawed before use following removal from an ultra-low temperature storage environment.

Once thawed, the Comirnaty concentrate vaccine vial must not be returned to an ultra-low temperature environment for re-freezing. A closed lid vial carton can be stored at +2 to +8°C for up to 10 weeks.

Each vial carton contains 10 vials. If removing less than the full quantity of vials from the carton within the refrigerator, ensure that the carton remains enclosed, after removal of the required number of vials. Note each vial provides 10 doses when using low dead space needles and syringes for drawing up.

An equipment sparing strategy is to extract 7 doses using low dead space needles and syringes, and 3 doses using 1mL tuberculin syringes and 25G needles.

Moving from thawed concentrate vaccine to vaccine for administration

This procedure covers the process from the removal of vials of thawed concentrate vaccine from the vial carton in the refrigerator, dilution of the concentrate vaccine, and drawing up individual doses into a syringe to the point of administration.

This procedure may be adapted to suit one of the following models:

  • The vaccine preparer performing dilution under observation by an authorised immuniser. The preparer will then draw up individual doses from the diluted vial into syringes for immediate administration at the point of care; or
  • The dilution and drawing up of individual doses into syringes by the authorised immuniser that are independently checked and verified, labelled and subsequently administered to the patients.
  • The dilution and drawing up of individual doses into syringes by the preparer that are independently checked and verified, labelled and subsequently supplied to the authorised immuniser. This model requires additional local risk assessment including cold chain management, workflow considerations that consider diluted vaccine stability and mitigation to reduce the risk of needle stick injuries on transfer of prepared syringes between individuals.

Procedure

  1. Removal of thawed concentrate vaccines from the refrigerator
    1. Check the temperature display and ensure that the refrigerator has not deviated from between +2°C and +8°C. If a deviation has been observed, DO NOT USE the multi-dose vial, quarantine the vials, advise your senior executive and contact the Commonwealth Vaccine Operations Centre (VOC) using the NSW Health COVID-19 vaccine cold chain breaches reporting form. Refer to NSW Health policy directive PD2020_028 Vaccine Storage and Cold Chain Management.  
    2. Perform hand hygiene with either soap and water or an alcohol-based hand rub (ABHR) before gathering supplies or handling vials.
    3. Remove only the required number of thawed concentrate vaccine vials from the vial carton in the refrigerator. If there is more than one vial carton, use the vials with the shortest post-thaw expiry. One vial contains sufficient vaccine for ten doses when diluted and using low dead space needles and syringes.
    4. To reduce waste, the number of vials removed should generally be enough to cover no more than approximately 1 hour of anticipated usage when stored at room temperature. Note: The vial does not contain antimicrobial preservatives therefore 6 hours storage of the diluted vial is recommended unless the vials are diluted using a method that minimises risk of microbial contamination. If the following conditions are met the diluted vial can be managed in accordance with the TGA PI and can be used for up to 12 hours. The vial must be diluted:
      • by dedicated trained operators preparing vaccines aseptically
      • in an appropriate clean environment with minimal air movement
      • under the oversight of a pharmacist with experience in aseptic preparation
      • the vaccine is protected from light, returned to the refrigerator and stored at +2 to +8C when not in use to further minimise antimicrobial growth.
    5. Seal the concentrate vaccine vials that have been removed from the fridge into a zip lock bag.
    6. Document either by Completing a 'Concentrate Room Temperature Bag Expiry Label' (see Appendix 1B of this procedure) or via an electronic process e.g., iPharmacy. Include:
      • Date and time concentrate vaccine vial was removed from the refrigerator (Use 24-hour clock format)
      • Date and time of expiry. (i.e. date and time vial must be diluted before or discarded after). The expiry is 12 hours from the point the concentrate vaccine vials are removed from the refrigerator and kept at room temperature
      • Batch number of the concentrate vaccine vials
      • Signature of person completing the label (electronic system is permitted e.g. configured from Username and Password).
    7. Attach the label to the zip lock bag containing the concentrate vaccine vial. (One per zip lock bag)
    8. Obtain a check (of the time removed from fridge, calculated expiry and batch number) from a second person. The second person must document this check by signing the label or by electronic means.
    9. Take the bag to the vaccine preparation station and place it in an empty lidded box labelled 'CONCENTRATE VACCINE VIALS'. Confirm this box is empty before adding the new bag of vials. Close the lid on the box. If using a monitored cold storage bag at +2oC to +8oC, vaccine cold chain management must comply with the National Vaccine Storage Guidelines Strive for Five and NSW Health policy directive PD2020_028 Vaccine Storage and Cold Chain Management.  
  2. Workstation preparation
    1. The workstation must be clean and clear of any other materials or objects, other than what is necessary for the preparation and drawing up of the vaccine.
    2. Clean the workstation with a neutral detergent wipe and discard into a general waste bin.
    3. Perform hand hygiene with either soap and water or an alcohol-based hand rub (ABHR).
    4. Ensure a yellow sharps container with enough free capacity is available.
    5. Ensure an indelible black pen is available.
    6. Perform hand hygiene to prepare the Comirnaty (Pfizer) 5 to <12 years formulation vaccine.
    7. Put on an apron and any additional PPE including face mask and gloves
  3. Dilution
    1. Assemble the following materials required to perform dilution:
      • Sodium chloride 0.9% injection polyamp X 1 (must be preservative free)
      • 3 mL syringe x 1
      • 21G needle x 1
      • Single use 70% alcohol swab x 2
      • 'Vial Label after Dilution' label x 1 (appendix 1C)
      • Opaque container.
    2. Remove a single vial of concentrated Comirnaty (Pfizer) 5 to <12 years formulation vaccine from the zip lock bag within the lidded box labelled 'CONCENTRATE VACCINE VIALS'. Close the lid of the box. If using a monitored cold storage box, check the temperature prior to removing a vial, and ensure that the temperature is within range.
    3. Inspect the vial to ensure it has thawed and is within expiry with its integrity maintained. Note that a frozen vial should be allowed to thaw in a refrigerator, and this can take up to 4 hours. If removed directly from the ULT freezer, this can take up to 30 minutes at room temperature.
    4. Allow the vaccine vial to come to room temperature if recently removed from the fridge.
    5. Prior to dilution, the thawed concentrate suspension may contain white to off-white opaque amorphous particles.
    6. Slowly and gently invert the vial 10 times to thoroughly mix the concentrate suspension, DO NOT SHAKE.
    7. Remove the protective plastic cap from the top of the vial and inspect the bung to ensure integrity.
    8. Cleanse the vaccine vial stopper with a single use 70% alcohol swab and discard the swab into a clinical waste bin. Set the concentrate vaccine vial to one side.
    9. Cleanse the top and shoulders of the polyamp of sodium chloride 0.9% injection with a single use 70% alcohol swab and discard the swab into a clinical waste bin.
    10. Attach a 21G needle to a 3 mL syringe. A Luer lock syringe is preferred if available.
    11. Using aseptic technique, snap the top off the sodium chloride 0.9% injection polyamp and use the 3 mL syringe and 21G needle to draw up 1.3 mL of sodium chloride 0.9% injection.
    12. Check the volume of sodium chloride 0.9% injection drawn up is 1.3 mL (a second person check is recommended).
    13. Discard the remainder of the sodium chloride 0.9% injection polyamp into an appropriate waste container. The sodium chloride 0.9% injection polyamp is single use. Do not draw up further volumes of diluent from the polyamp. The remainder of the volume must be discarded and not used for another vial.
    14. Dilute the concentrate vaccine vial by adding the 1.3 mL of sodium chloride 0.9% injection to the vial.
    15. The needle should be inserted at a 45–60° angle with the opening of the needle tip facing up (i.e., away from the stopper). A small amount of pressure is applied, and the angle is gradually increased as the needle enters the vial. The needle should be at a 90° angle just as the needle bevel passes through the stopper.

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    16. Slowly inject the 1.3 mL solution towards the inner wall of the vial in a single step. Do not use any other type of diluent.
    17. Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.3 mL air into the empty diluent syringe, and then remove the needle/syringe from the vial.
    18. Gently invert the diluted suspension 10 times. DO NOT SHAKE.
    19. After dilution, each vial contains 2.6 mL from which 10 doses of 0.2 mL can be extracted using low dead space needles and syringes. Alternatively, an equipment sparing strategy is to extract 7 doses using low dead space needles and syringes, and 3 doses using 1mL tuberculin syringes and 25G needles.  
    20. The diluted vaccine should present as an off-white solution with no particulates visible. If particulates or discolouration appears to be present, verify with a second person and quarantine/retain this vial and notify your pharmacist or team leader. Do not use this vial for administration.
    21. Document the date & time of the dilution on the 'Vial expiry label after dilution' label (appendix 1C) write the date and time of dilution and sign. Obtain a check (of time diluted and volume of vial appears consistent with being diluted) from a second person. The second person must document this check by signing the label or by an electronic method as described previously.
    22. Once the label is complete attach to the prepared diluted vaccine vial. The vial of diluted vaccine is viable for 6 hours from the point of dilution when kept at room temperature, however consideration for microbial contamination should be risk assessed locally if not used immediately. Note: The vial does not contain antimicrobial preservatives therefore 6 hours storage of the diluted vial is recommended unless the vials are diluted using a method that minimises risk of microbial contamination. If the following conditions are met the diluted vial can be managed in accordance with the TGA PI and can be used for up to 12 hours. The vial must be diluted:
      • by dedicated trained operators preparing vaccines aseptically
      • in an appropriate clean environment with minimal air movement
      • under the oversight of a pharmacist with experience in aseptic preparation
      • the vaccine is protected from light, returned to the refrigerator and stored at +2 to +8C when not in use to further minimise antimicrobial growth
    23. The diluted vaccine vial should be protected from light and refrigerated unless it is to be used for drawing up immediately. Once vaccine has been diluted, do not re-freeze the vial.
    24. Do not remove another vial of concentrate vaccine from the lidded box until the vial of diluted vaccine has left the preparation workspace or has been discarded.
    25. Use a new, sterile low dead space syringe (LDS) with fixed needle. If LDS syringe is not available use a 1 mL tuberculin syringe with 25G needle (preferably Luer lock if available) to draw up each new 0.2 mL dose by re-puncturing the bung.
    26. Ensure each re-puncture occurs at a different site on the bung.
    27. Recap the clean needle using either a single-handed technique, forceps, or a suitable protective guard designed for re-sheathing. The needle must be properly recapped, and the sheath must not be held in the fingers.
    28. If the syringe is not being administered immediately document the vial batch number, vial expiry, prepared syringe expiry and sign. This may be documented using a Syringe Label (appendix 1D or via an electronic system).
    29. ATAGI recommends that when possible, pre-drawn doses in syringes should be used within 1 hour if kept at room temperature, and within 6 hours if kept at +2°C to +8°C. This is to minimise any risk of microbial contamination. If the requirements of section 1.4 are met the pre-drawn syringe can be stored at room temperature (+2°C to + 25°C) for 12 hours post-dilution of the vial.
    30. Obtain a check (of vial batch, vial expiry, calculated prepared syringe expiry) from a second person. The second person must document this check by signing the label or an electronic means.
    31. The syringe is ready to administer the vaccine using the affixed needle that was used to draw up the dose. Do not affix a new needle for administration as this will result in partial loss of the drawn-up dose due to the dead space in the new needle.
  4. Handover of prepared vaccine syringes to immuniser/administrator
    1. Where vaccines are prepared and administered by different people the handover process must be clearly documented as per local guidelines.
  5. Administration of vaccine
    1. Assemble the following materials required to administer prepared syringes:
      • Prepared syringe (needle attached) of 0.2 mL Comirnaty (Pfizer) 5 to <12 years formulation vaccine x 1
      • Kidney dish for prepared syringes
      • Cotton wool
      • Band-Aid
      • Sharps container.
    2. Check the prepared vaccine syringe is within the expiry date and time (6 hours post dilution or 12 hours if requirements of section 1.4 are met). If the prepared syringe is past the expiry time DO NOT USE and notify the pharmacist or team leader.
    3. If the Comirnaty (Pfizer) 5 to <12 years formulation vaccine is being administered within the same clinical space as the adult formulation, it is mandatory to check the prepared vaccine syringe with a second person.
    4. Administration of prepared vaccines should be in accordance with local policy and the Australian Immunisation Handbook.
    5. Sit patient and carer(s) in vaccination area, ensuring privacy if required.
    6. Perform patient identification and pre-vaccination assessment.
    7. Administer vaccine intramuscularly (preferred site of administration is the deltoid muscle of the upper arm).
    8. Immediately discard used syringe and needle into sharps container (do not re-sheath the needle).
    9. Provide patient and carer(s) with relevant post vaccination advice.
    10. Ensure patient remains in centre for observation for at least 15 minutes post vaccination (or 30 minutes for people with a history of anaphylaxis or who carry an adrenaline autoinjector (eg EpiPen).

    Appendix 1

    1. Concentrate fridge temperature bag expiry label (to be used when concentrated vaccine is removed from ULT freezer)
    2. Concentrate room temperature bag expiry vial preparation label
    3. Vial label after dilution


    4. Syringe label
Current as at: Monday 16 May 2022
Contact page owner: Health Protection NSW