Australia Approves COVID-19 Vaccine For Local Use

The Therapeutic Goods Administration (TGA) of Australia granted a two-year provisional approval to Pfizer Australia Pty Ltd on January 25, 2021, for its COVID-19 vaccine, COMIRNATY, 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.

The TGA's press release stated: '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, 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-assessments of the vaccine before it can be supplied in Australia.'

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

During the COVID-19 pandemic, Australia reported 909 fatalities related to the new disease. The vast majority of COVID-19 cases have been reported in Victoria.