The Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.

Following a thorough and independent review of Pfizer's submission, the TGA has decided that this vaccine meets the high safety, efficacy and quality standards required for use in Australia.

COMIRNATY is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for active immunisation to prevent coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, in individuals 16 years of age and older.

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. COMIRNATY has been shown to prevent COVID-19 however, it is not yet known whether it prevents transmission or asymptomatic disease.

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) (pdf,992kb)
• Consumer Medicine Information (CMI) (pdf,206kb)
• 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)
  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

Further information

COVID-19 vaccine: Provisional registrations

Labels for COVID-19 vaccines

Batch release assessment of COVID-19 vaccines

Getting vaccinated for COVID-19 on health.gov.au