"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," the TGA said in a statement.
The provisional approval is said to be valid for two years. The two-dose vaccine will be administered to individuals who are 16 years of age and older, according to the regulator.
Australia's Department of Health has so far confirmed more than 28,700 cases of COVID-19 since the start of the pandemic, including 909 deaths.