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.
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.
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.
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.
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:
Each dose should be used as soon as practical once withdrawn from the vial.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.
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.
Where vaccines are prepared and administered by different people the handover process must be clearly documented as per local guidelines.
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.
(to be applied to the vial if all doses are not being drawn up at the same time and at time of first access)
(to be applied to each prepared syringe)