Purpose

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.

Scope

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).

Requirements

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.

Responsibility

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.

Procedure

Receiving vaccine delivery

  • The Moderna elasomeran COVID-19 (SpikevaxTM) vaccine will arrive frozen, between -50°C and -15°C.
  • Each box contains 10 multi-dose vials and each multidose vial contains 10 doses of 0.5mL.
  • Each carton contains 12 boxes of 10x5mL (Dimensions of the box are approximately 12cm x 4cm x 6cm (LxWxH). The dimensions of the outer carton containing 12 boxes is 25cm x 13cm x 13cm
  • Store vaccine in a freezer or refrigerator- see below for each storage unit.
  • Examine the shipment for signs of damage.
  • Open the box and remove TagAlert Temperature Monitor from box (placed in the inner box next to vaccine)
  • Check the TagAlert temperature monitoring device by pressing the blue "start and stop" button.
    • Left arrow points to a green checkmark: The vaccine is ready to use. Store the vaccine at proper temperatures immediately (frozen at -25°C and -15°C).
    • Right arrow points to a red X: The numbers 1 and/or 2 will appear in the display. Store the vaccine at proper temperatures and label DO NOT USE! Contact SHEOC on 9859 5690 for advice.
  • The expiry date can be found on the packaging.

Storage in a Freezer

Unopened vials may be stored in the freezer between -25°C and -15°C (and can be stored from -50°C to -15°C).

  • Store in the original packaging
  • Protect from light
  • Do NOT store with dry ice, or below -50°C.
  • The vaccines should be transferred between the transportation and freezer storage as quickly as possible and must occur within 30 minutes at a temperature of +2°C and +25°C

Storage in a refrigerator

Unopened thawed vaccine vials may be stored in the refrigerator between +2°C and +8°C for up to 30 days.

  • Do NOT refreeze thawed vaccine
  • Thawed vaccine can be handled in room light. It should however be protected from light when stored in the refrigerator.
  • Monitor how long the vaccine has been in the refrigerator using a 'Fridge temperature bag expiry label (appendix 1A)' or via an electronic syste
  • Remove the box from frozen storage
  • Complete the information on the storage label.
  • Attach it to the carton holding the vaccine vials.
  • Once labeled, place vaccine in the refrigerator.
  • The unopened vaccine may be stored at +8°C to +25°C up to 24 hours after removal from refrigerated conditions

Thawing

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).

Transportation of vials

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.

Appendix 1

1. A. Fridge temperature bag expiry label

(to be used when vaccine is removed from freezer and placed in a fridge)


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