The Therapeutic Goods Administration (TGA) has recently approved wider storage and transportation conditions for the Pfizer COVID-19 vaccine in Australia (COMIRNATY – BNT162b2). These changes will enable greater flexibility in storage, transport and deployment of the Pfizer COVID-19 vaccine across Australia.
While longer term storage at dry ice or ultra-cold temperatures (-90C to -60°C) is still required, for unopened vials, storage and transportation at domestic freezer temperatures (-25°C to -15°C) is now permitted for up to 2 weeks. Vials stored or transported in this manner can also be returned to ultra-cold longer term storage within the original shelf life of the product.
In addition, unopened vials can now be stored for up to 5 days at domestic refrigerator temperatures (2°C to 8°C). Within this 5 day period, up to 12 hours may be used for transportation, but the time used for transport of unopened vials at refrigerator temperatures counts against the 5 day limit for storage at 2°C to 8°C. Once thawed, COMIRNATY should not be re-frozen.
COMIRNATY is diluted with saline prior to administration. The diluted vaccine, in either vials or syringes can be stored or transported at room temperatures of up to 30°C for up to 6 hours. The preparer of the reconstituted vaccine must be careful to manage microbiological risks and package integrity, particularly for prepared dosing syringes.
