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COVID-19 vaccine: Pfizer Australia - COMIRNATY BNT162b2 (mRNA) - approved for use in individuals 12 years and older
On 22 July 2021 the Therapeutic Goods Administration (TGA) granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, in individuals aged 12 years and older.
This decision follows the provisional approval granted by the TGA to COMIRNATY on 25 January 2021 for used in individuals aged 16 years and older. Pfizer subsequently made an application to the TGA to vary the original approval to include children between 12 and 15 years of age.
As for previous COVID-19 vaccine applications, this assessment was expedited by the TGA through the provisional approval pathway. The TGA has decided that this vaccine meets the high safety, efficacy and quality standards required for use in Australia following a thorough and independent review of Pfizer's submission.
Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.
Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard. The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
The TGA will continue to actively monitor the safety of the Pfizer vaccine both in Australia and overseas and will not hesitate to take action if safety concerns are identified. As an extra check, the TGA laboratories will undertake batch assessment of each batch of the vaccine before it can be supplied in Australia.
Supporting regulatory documents
The provisional approval pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.
The following regulatory documents are made available as part of this process:
- Product Information (PI)
- Consumer Medicine Information (CMI)
- COMIRNATY Decision Summary
The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.
- AusPAR: COMIRNATY - BNT162b2 (mRNA) - initial provisional registration
- AusPAR: COMIRNATY - BNT162b2 (mRNA) - Extension of indication, use in individuals 12 - 15 years and older
An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
- Advisory Committee on Vaccines meeting statement, meeting 18, 15 January 2021
An independent expert committee that provides advice on an application to register a new vaccine.
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Pfizer) Labelling Exemption 2021
- COVID-19 vaccine: Information for consumers and health professionals
Post-approval changes to COVID-19 vaccines
- Post-approval changes to COVID-19 vaccines
- TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
- Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved
- Updated storage conditions: -20 °C for 2 weeks