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TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
On Monday 24 May 2021, the TGA approved an application from Pfizer Australia Pty Ltd to change its current storage conditions for its COVID-19 vaccine, COMIRNATYTM. The TGA received the application on Thursday May 20, 2021.
This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal refrigerator after taking out of deep-freeze conditions) at the point of use from five days up to one month (31 days). The changed storage requirements will enable much greater flexibility in the distribution of the vaccine and have a significant impact on the roll out of the vaccine across Australia.
The TGA made this decision based on review of additional stability study data submitted by Pfizer – and follows recent similar approvals in some other countries. Changes to storage conditions are included in the Product Information for COMIRNATY, users are reminded to refer to this document for correct and up to date information.
Further information on the COVID-19 vaccines can be found on the TGA's website.