Responsibility

Staff preparing the Moderna elasomeran (SpikevaxTM) COVID-19 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 Moderna elasomeran (SpikevaxTM) COVID-19 vaccine must be thawed before use following removal from a frozen storage environment. Refer to 'Management of COVID-19 Moderna (SPIKEVAX) vaccine from a standard temperature freezer to refrigerator' for information on this procedure.  

Once thawed, the Moderna elasomeran (SpikevaxTM) COVID-19 vaccine must not be re-frozen. Note the thawing process in a refrigerator (2°C to 8°C) takes 2 hours and 30 minutes or 1 hour at room temperature (15°C to 25°C).

A thawed vial can be stored at +2 to +8°C for 30 days.  

Each carton contains 10 multidose vials. Each multidose vial contains 10 doses of 0.5mL. The vial DOES NOT require a diluent to be added. Once thawed the vaccine is ready to use.

Procedure

Removal of thawed 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 State Health Emergency Operations Centre (SHEOC) on 9859 5690. 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 vaccine vials from the refrigerator. If there is more than one vial tray, use the vials with the shortest expiry. One vial contains sufficient vaccine for ten doses.
  4. To reduce waste, the number of vials removed should be enough to cover no more than approximately 1 hour of anticipated usage when stored at room temperature. Note: the thawed unpunctured vials of Moderna elasomeran (SpikevaxTM) COVID-19 vaccine can be stored at room temperature (between +8°C and +25°C) for up to 24 hours.
  5. Seal the vaccine vials that have been removed from the fridge into a zip lock bag.
  6. Each vial removed from the refrigerator should have an expiry date and time applied by completing a 'Room Temperature Expiry Label' (see Appendix 1A of this procedure) or via an electronic process e.g. iPharmacy. Include:
    • Date and time vaccine vial was removed from the refrigerator (Use 24-hour clock format).
    • Date and time of expiry. The expiry is 24 hours from the point the vaccine vials are removed from the refrigerator and kept at room temperature (between +8°C and +25°C).
    • Batch number of the 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 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 '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 +2 to +8°C, 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
  • 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. Ensure that there are no previously drawn up vials remaining in the workspace.
    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 a permanent black pen is available.
    6. Put on an apron and any additional PPE including face mask and gloves.
    7. Perform hand hygiene.
  • Drawing up Procedure

    1. Remove a single vial of Moderna elasomeran (SpikevaxTM) COVID-19 vaccine from within the lidded box labelled '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.
    2. Inspect the vial to ensure it has thawed and is within expiry with its integrity maintained. Note the thawing process in a refrigerator (2°C to 8°C) takes 2 hours and 30 minutes or 1 hour at room temperature (15°C to 25°C).
    3. The vaccine contains no antimicrobial preservative, therefore ATAGI recommends that punctured vials (i.e. after the first dose has been withdrawn) should preferably be held between +2°C and +8°C, and cumulative storage of opened vials at +2°C to +25°C should not exceed 6 hours.
    4. Prior to use, the thawed vaccine should be white to off white in colour and may contain white or translucent product-related particulates. 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.
    1. DO NOT dilute.
      1. Do not shake. Swirl the vial a few times gently after thawing and before each withdrawal.  
      2. Remove the protective plastic cap from the top of the vial and inspect the bung to ensure integrity.
      3. Cleanse the vaccine vial stopper ('scrub the hub' and allow to dry) with a single use 70% alcohol swab and discard the swab into a general waste bin.

    The procedure used to draw up the vaccine will be dependent on the preferred drawing up method that has been agreed on for consistent use at the hub/clinic i.e. multiple puncture or single puncture technique. This technique should subsequently be consistently used by all individuals involved in the drawing up process in that hub/clinic.

    Multiple puncture Technique

    1. Swirl the vial gently a few times before each withdrawal.
    2. 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.
    3. Use a new, sterile 23G or 25G 25mm length needle (or 23G/25G 38mm needle for people who are obese) and 1 mL syringe (Luer Lock, Leur Slip or fixed needle) to draw up each new 0.5 mL dose by re-puncturing the bung.
    4. Ensure each re-puncture occurs at a different site on the bung.
    5. 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.
    6. If the dose is not being administered immediately document the vial batch number, vial expiry, prepared syringe expiry (i.e. six hours after first dose removed from vial date and time) and sign. This may be documented using a Syringe Label (appendix 1C or via an electronic system). Obtain a check (of vial batch, vial expiry, calculated prepared syringe expiry) from a second authorised worker. The second authorsied must document this check by signing the label or an electronic means.
    7. The dose is ready for administration 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.
    8. The drawn-up vaccine should be administered as close to the time of preparation as possible and within the labelled expiry date/time. 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 2-8°C. This is to minimise any risk of microbial contamination.
    9. Repeat until all 10 doses are drawn up.
    10. Place vaccine vial in the tray with the 10 completed syringes.
    11. If drawing up all doses at once the vial stopper does not need to be cleaned between drawing up each dose if aseptic technique is used and maintained. If all doses are not being drawn up at the same time the vial should be returned to the fridge as soon as possible and the vial stopper should be cleansed with a single use 70% alcohol swab prior to each access. Initial access time should be documented using a vial label (Appendix 1B or via an electronic system).
    12. Do not remove another vial of vaccine from the lidded box until the vial has left the preparation workspace or has been discarded.
    13. The pre-drawn syringes should be returned to a fridge (+2°C to +8°C) and protected from light if they are not for immediate administration.

    Innovation Compounding - Proper Aseptic Technique to Prevent Coring of Sterile Vials 

    Single puncture Technique

    1. Swirl the vial gently a few times before each withdrawa
    2. 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.

     

    Innovation Compounding - Proper Aseptic Technique to Prevent Coring of Sterile Vials

    1. Use a 1mL syringe (Luer Lock or Leur Slip) and 21G or 22G needle to withdraw 0.5mL.
    2. Using forceps, remove the syringe, leaving the needle in the vial.
    3. Attach a new, sterile 23G or 25G 25mm length needle (or 23G/25G 38mm needle for people who are obese).
    4. Using forceps to steady the vial, attach a new 1mL syringe and withdraw another 0.5mL
    5. Repeat these steps to draw up all doses
    6. Document the vial batch number, this may be documented using a 'Syringe Label' (appendix 1C) or via an electronic system. Include vial expiry, prepared syringe expiry (i.e. 6 hours after initial puncture date and time) and sign. Noting that 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 2-8°C. This is to minimise any risk of infection.  
    7. Place vaccine vial (needle removed) in the tray with the 10 completed syringes.
    8. Obtain a check (of vial batch, vial expiry, calculated prepared syringe expiry and volume of vaccine) from an authorised health care practitioner. The authorised health care practitioner must document this check by signing the label or an electronic means.
    9. The pre-drawn syringes should be returned to a fridge (+2°C to +8°C) and protected from light if they are not for immediate administration.
    10. If using forceps, single use forceps must be discarded into the sharps container after each 2 hour drawing up session. If re-useable forceps are used these must be cleaned using a 70% alcohol swab after each 2 hour drawing up session.

    Handover of prepared vaccine syringes to immuniser/administrator

    Where vaccines are prepared and administered by different staff the handover process must be clearly documented as per local guidelines.

    Administration of vaccine

    1. Assemble the following materials required to administer prepared syringes:
      • Prepared syringe (needle attached) of 0.5 mL Moderna elasomeran (SpikevaxTM) COVID-19 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. If the prepared syringe is past the expiry time DO NOT USE and notify the pharmacist and/or team leader.
    3. Administration of prepared vaccines should be in accordance with local policy and the Australian Immunisation Handbook.
    4. Sit patient in vaccination area, ensuring privacy if required.
    5. Perform patient identification and pre-vaccination screening and assessment.
    6. Administer vaccine intramuscularly (recommended site of administration is the deltoid muscle of the upper arm).
    7. Immediately discard used syringe and needle into sharps container (do not re-sheath the needle).
    8. Provide patient with relevant post vaccination advice.
    9. Ensure patient remains in the 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).
  • Additional advice

  • For additional clinical advice including advice on interrupted doses and diluent leakage when reconstituting, see COVID-19 vaccine – Clinical considerations.

    Appendix 1

    1.A Room temperature expiry vial preparation label (to be used when vials are removed from fridge and stored at room temperature prior to drawing up)

     
    1.B Vial label (to be applied to the vial if all doses are not being drawn up at the same time and at time of first access)

     

    1.C Syringe label (to be applied to each prepared syringe)


    Current as at: Thursday 28 October 2021
    Contact page owner: Health Protection NSW