Purpose

This procedure describes the process of receipting, storing, transporting and drawing up the COVID-19 AstraZeneca (ChAdOx1 S) vaccine in NSW Health clinics.

This procedure must not be used for any other COVID-19 vaccine.

Responsibility

Staff preparing the refrigerated COVID-19 Vaccine AstraZeneca (ChAdOx1-S) 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 COVID-19 Vaccine AstraZeneca (ChAdOx1-S) can be stored unopened at between +2° to +8°C for up to 6 months.

Each vial contains 4 mL or 5 mL of solution in an 8 or 10-dose vial (clear type I glass) with stopper (elastomeric with aluminium overseal). It comes in packs of 10 multidose vials.

Each vial contains at least the number of doses stated on the label. It is normal for liquid to remain in the vial after withdrawing the final dose. When low dead volume syringes and/or needles are used, the amount remaining in the vial may be sufficient for an additional dose. Care should be taken to ensure a full 0.5 mL dose is administered. Where a full 0.5 mL dose cannot be extracted, the remaining volume should be discarded. Do not pool excess vaccine from multiple vials.

Removing vaccines from the refrigerator for administration

This procedure covers the process from the removal of vials of vaccine from the refrigerator and drawing up individual doses into a syringe to the point of administration.

Procedure

1. Vaccine stock and cold chain management

1. All deliveries of the COVID-19 Vaccine AstraZeneca (ChAdOx1-S) must be accepted by appropriately trained staff at the site. The AstraZeneca (ChAdOx1-S) delivery must be receipted in CVAS by 9pm local time on the day of delivery. This online form must be used by all sites and completed by a person authorised to accept deliveries of the vaccine.  
2. All vaccine must be inspected and transferred to appropriately monitored vaccine fridge in accordance with PD2020_028 Vaccine Storage and Cold Chain Management
3. At the end of each day sites with vaccine should complete and submit the Australian Government Vaccine Stock Management Form   
4. Standard cold chain (+2°C to +8°C) procedures should be followed for all transport, storage and handling of the COVID-19 Vaccine AstraZeneca (ChAdOx1-S) (Please refer to the Strive for 5 guidelines and the My Health Learning Vaccine Storage and Cold Chain Management training).
5. The Multi Dose Vials should be stored in their original outer box packaging to protect them from light. 
6. The vaccine can be stored in cold chain conditions of +2°C to +8°C for a maximum of 6 months as per the expiry date printed on the vial. Do not freeze the vaccine.   

7. The vaccine vial does not contain antimicrobial preservatives therefore 6 hours storage at room temperature (up to 30°C) of the opened vial is recommended unless prepared using a method that minimises risk of microbial contamination. If the following conditions are met the opened vial can be managed in accordance with the TGA PI and can be used for up to 48 hours (if stored in a refrigerator at +2°C to 8°C). The preparation must be conducted:

   • 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°C to +8°C when not in use to further minimise antimicrobial growth.

8. Each dose should be used as soon as practical once withdrawn from the vial. You may pre-draw multiple doses from one vial. 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 1.7 are met the pre-drawn syringe can be stored at room temperature (up to 30°C) for up to 6 hours from first vial puncture. The 6 hours in the pre-drawn syringe must be within the vial expiry (i.e. 6 hours or 48 hours if conditions of 1.7 are met) following the first access of the vial.
   
   If any doses remain in the vial, refrigerate the multi-dose vial between +2°C and +8°C immediately after you finish the vaccine draw-up.   

2. Removal of vaccine 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 vials from the refrigerator, using the vials with the earliest expiry first. One 5mL vial contains sufficient vaccine for 10 doses when using standard needles and syringes (8 doses if it is a 4 mL vial).
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.
5. 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.

3. 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 COVID-19 Vaccine AstraZeneca (ChAdOx1-S).
7. Put on an apron and any additional PPE including face mask and gloves.

4. Dose preparation

1. Assemble the following materials required to perform drawing up:
• Single use 70% alcohol swab x 2
• Opaque container.
2. Inspect the vial to ensure its integrity maintained. The vaccine will appear clear to slightly opaque and colourless to slightly brown. There should be no visible particles within the MDV. Do not shake while inspecting the vial.
3. Remove the protective stopper (elastomeric with aluminium overseal) from the top of the vial and inspect the bung to ensure integrity.
4. Cleanse the vaccine vial stopper with a single use 70% alcohol swab and discard the swab into a clinical waste bin. If all doses are not being drawn up at the same time and it is the first time the vial has been accessed, complete and attach the "vial access label" (appendix 1 or electronically generated label). If the vial has been previously accessed ensure it has not reached its 'maximum time since opening' (i.e., 6 hours or 48 hours if requirements of 1.7 are met).
5. The vial contents do not require dilution.
6. Use a new, sterile 23G or 25G 25mm length needle (or 23G/25G 38mm needle for people who are obese) and 1 mL tuberculin syringe (preferably Luer lock if available) to draw up each new 0.5 mL dose by re-puncturing the bung.
7. Draw up 0.5 mL of air into the syringe.
8. Ensure each re-puncture occurs at a different site on the bung. 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.
   
   Image source: https://innovationcompounding.com/tutorial-coring/
   
9. Inject the 0.5 mL air into the vial and draw up a 0.5 mL dose of vaccine ensuring that aseptic technique is maintained. Air should be injected prior to drawing up the first dose and then to equalise the pressure as required. If leakage is occurring the injection of air may only be required, every second dose.
10. Withdraw the syringe and needle and recap the 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.
11. Apply user applied 'Syringe Label' (appendix 1) or use electronically produced labels if drawing up is not completed at the point of care to be used immediately. Complete vial batch number, vial expiry, prepared syringe expiry (i.e., six hours after vial first access date and time) and sign. 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.
12. 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.
13. The drawn-up vaccine should be administered as close to the time of preparation as possible and within the labelled expiry date/time), i.e., within six hours from when the vial was first accessed.

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.  

Do not remove another vial vaccine from the refrigerator until the prepared vaccine syringes have left the preparation workspace or have been discarded.

5. Handover of prepared vaccine syringes to immuniser/administrator

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

6. Administration of vaccine

1. Assemble the following materials required to administer prepared syringes:
• Prepared syringe (needle attached) of 0.5 mL COVID-19 Vaccine AstraZeneca (ChAdOx1-S) 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 (i.e., 6 hours from when the vial was first accessed). If the prepared syringe is past the expiry time DO NOT USE and notify the pharmacist 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 assessment.
6. Administer vaccine intramuscularly (preferred 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 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 (e.g., EpiPen).

7. Wastage

In the event of a potential or actual wastage incident (e.g. damaged vials or breach of cold chain requirements), that exceeds the threshold (5 or more vials at a time), the facility must notify the senior executive and contact the Commonwealth Vaccine Operations Centre (VOC) using the NSW Health COVID-19 vaccine cold chain breaches reporting form.

Appendix 1

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)

Syringe label

(to be applied to each prepared syringe)