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.
Transferring COVID-19 ComirnatyTM (Pfizer) 5 to <12 years formulation vaccine from the ULT freezer to a refrigerator.
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.
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)
Single carton holds 10 vials
90 doses using standard stock needles and syringes
100 doses using low dead space needles and syringes (recommended)
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.