New Delhi (NVI): Australia’s health regulator, Therapeutic Goods Administration (TGA), today granted provisional approval to Pfizer/BioNTech COVID-19 vaccine, COMIRNATY, making it the first coronavirus vaccine to receive regulatory approval in the country.
Following the formal approval of the vaccine, the first doses are expected to be administered in late February.
The 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.
— TGA Australia (@TGAgovau) January 24, 2021
“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,” Therapeutic Goods Administration (TGA) said in a statement.
The vaccine had been provisionally approved by the Therapeutic Goods Administration’s (TGA) for Australians aged 16 years and over, Prime Minister Scott Morrison told a media briefing, noting it was a year since the first coronavirus case was detected in the country.
“I note this is not an emergency approval, as has been done in some other jurisdictions around the world,” Morrison said.
“This is a formal approval under the ordinary processes of the TGA and we are one of the first countries… to have gone through that comprehensive and thorough process here in Australia to ensure the approval of that vaccine,” he added.
Notably, Australia has secured 10 million doses from Pfizer — enough to vaccinate five million people — with healthcare workers and the elderly expected to receive the first jabs.
TGA in an official statement noted that, 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,” TGA added.
The country has also secured more than 50 million doses of the Oxford/AstraZeneca vaccine, with the majority set to be manufactured locally, but the TGA is yet to grant approval.
Largely virus-free Australia has fared comparatively well in its Covid-19 response, with 909 deaths from about 28,700 cases in a population of 25 million.