Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved

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.

The expiry date for the vaccine can be found on the packaging.

The COMIRNATY Product Information (PI) document contains the most up-to-date storage and transportation conditions, and health professionals are advised to refer to the PI for the latest information.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400