Purpose

This procedure describes the process of unpacking frozen COVID-19 ComirnatyTM (Pfizer) dilute to use (concentrate) multidose for 5 to ˂12 years of age formulation vaccine (Comirnaty (Pfizer) 5 to <12 years formulation) vials and cartons and transferring them into a refrigerator to thaw.

Scope

Transferring COVID-19 ComirnatyTM (Pfizer) 5 to <12 years formulation vaccine from the ULT freezer to a refrigerator.

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 thawing, managing and storing the COVID-19 ComirnatyTM (Pfizer) 5 to <12 years formulation vaccine.

Vials

2mL type 1 glass preservative free

A single dose of COMIRNATY™ is 0.2mL once diluted and drawn up

9 doses per vial using standard stock needles and syringes

10 doses per vial using low dead space needles and syringes (recommended)

Cartons

Single carton holds 10 vials

90 doses using standard stock needles and syringes

100 doses using low dead space needles and syringes (recommended)

Procedure

  1. Complete one Pfizer thaw label for each vial carton detailing
    • Time and date removed from the shipper or ULT freezer
    • Time and date of thawed expiry i.e., 10 weeks from removal from the shipper or ULT freezer
    • Batch number
    • Signature of person completing the label
  2. A second person check is required to verify
    • The time and date removed from the shipper or ULT freezer for thawing
    • The thawed expiry date
    • The batch number
    • That there are the same number of completed Pfizer thaw labels as there are vial cartons
    • Initial the labels to confirm the information is correct.
  3. Attach one Pfizer thaw label to each of the vial cartons, ensuring not to cover any original labels on the carton. It may be necessary to use tweezers or ask the other person to peel the label off its backing if this cannot be done while wearing gauntlets.
  4. Transfer the vial cartons into the refrigerator. This should be undertaken in a timely manner to reduce the duration of exposure at room temperature (see 'Removing vial cartons from ULT environment' diagram below).
  5. Managing the thawed vaccine vials:
    • Based on current stability studies, a carton of 10 vials may take up to 4 hours to thaw in the refrigerator, whereas a smaller number of vials may thaw in less time.
    • Thawed vials may be stored in the refrigerator for up to 10 weeks.
    • If less than a full carton is repacked for redistribution, the hub will need to provide a smaller packaging unit that is transported via reputable courier or a temperature control vehicle (TCV).
    • Repacking should be done in a 2°to 8°C environment whenever possible. Otherwise, time at room temp (8°C to 25°C) should be tracked and minimised to stay within the 12-hour allowance for room temperature.
    • If using 2°to 8°C for transportation, any time used for transport counts against the 10 week time limit for storage.

Removing vial cartons from ULT environment

Closed-lid, 10 Vial (Full) CartonsOpen-lid, and/or Less Than 10 Vial Cartons

Closed-lid vial cartons containing 10 vials removed from storage (<-60°C) may be at room temperature (<25°C) for up to 5 minutes for transfer between the ultra-low temperature freezer.

Open-lid vial cartons, or vials containing less than 10 vials removed from frozen storage (<-60°C) may be at room temperature (<25°C) for up to 3 minutes for transfer between ultra- low temperature environments or to remove vials for thawing or use

After vial cartons are returned to frozen storage following room temperature exposure, they must remain in frozen storage for at least 2 hours before they can be moved again.

Individual vials: once an individual vial is removed from a vial carton at room temperature, it should not be returned to frozen storage. It should be thawed for use. Vials may be stored at room temperature (up to 25C) for up to 12 hours.

 

Do not re-freeze thawed vials.

 

Current as at: Wednesday 22 December 2021
Contact page owner: Health Protection NSW