This procedure describes the process of receiving frozen Moderna elasomeran COVID-19 (SpikevaxTM) vaccine cartons and vials, transferring them to a freezer (-25°C to -15°C) or to a refrigerator (+2°C to +8°C), and ensuring subsequent appropriate transport, storage and handling.
Transferring frozen Moderna elasomeran COVID-19 (SpikevaxTM) vaccine cartons and vials from delivery, to the freezer (-25°C to -15°C) or to a refrigerator (+2°C to +8°C).
The freezer/refrigerator's must be plugged into an uninterrupted power supply and must be continually data logged with back to base alarm to individual/s that are available to respond immediately 24 hours a day. The data logging report must be downloaded and reviewed at least weekly. The freezer/refrigerator must also have an audible alarm.
The freezer/refrigerator's current/minimum/maximum temperatures must be visualised and manually recorded four times a day, twice in the morning and twice in the afternoon/evening, including at the beginning and end of the shift (in addition to recording each time the freezer/refrigerator is accessed). A staff member must be allocated for each shift to undertake this duty. A freezer temperature monitoring chart is available to order from
Stream Solutions to record this.
Local procedures must be in place to respond to cold chain breaches and power failures, including reporting temperatures outside -15°C to -50°C range (for freezer) or +2°C to +8°C range (for refrigerator) immediately to senior executive and also to the State Health Emergency Operations Centre (SHEOC) on 9859 5690.
Vaccines must not be discarded until advice is received from the SHEOC.
Cold chain breaches resulting in vaccine wastage or recall, and revaccination of patients must be reported in the NSW Health Incident Management System (IMS+) to facilitate investigation, resolution and minimise the risk of future incidents.
All staff involved in the handling, preparation and administration of the Moderna elasomeran COVID-19 (SpikevaxTM) vaccine must be appropriately trained (i.e. have undertaken the Australian Government COVID-19 training program and the Health Education and Training module in Vaccine Storage and Cold chain management.
When working in pairs, it is the responsibility of both people to continue to observe all local COVID-19 measures. Staff following this procedure are responsible for adhering to the appropriate time frames for managing and storing the Moderna elasomeran COVID-19 (SpikevaxTM) vaccine.
Unopened vials may be stored in the freezer between -25°C and -15°C (and can be stored from -50°C to -15°C).
Unopened thawed vaccine vials may be stored in the refrigerator between +2°C and +8°C for up to 30 days.
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).
If vials are transported frozen specialized equipment and couriers are required to ensure that the vaccines do not thaw.
Available data supports transportation of one or more thawed vials for up to 12 hours at +2°C to +8°C. Vials may be transported using a temperature monitored container protected from light. Once thawed and transported at +2°C to +8°C, vials must NOT be refrozen and should be stored at +2°C to +8°C until use.
If the vials are removed from a freezer and transported refrigerated at +2°C to +8°C, the vaccines should be labelled with the date and time they are removed from the freezer. The 30 days until expiry commences at this time.
(to be used when vaccine is removed from freezer and placed in a fridge)