Australia’s TGA authorizes Pfizer COVID vaccine

Regulatory NewsRegulatory News | 25 January 2021 |  By 

The Therapeutic Goods Administration (TGA) on Monday granted provisional approval to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for individuals aged 16 and older, making it the first COVID-19 vaccine authorized for use in Australia.
The approval follows a provisional determination by the agency in October allowing for the submission of the application under the provisional pathway. TGA has also granted provisional determinations for vaccines developed by AstraZeneca, Janssen and Novavax, paving the way for provisional approval of those vaccines in the future. (RELATED: TGA gives Pfizer COVID vaccine provisional determination, Regulatory Focus 14 October 2020).
Rollout of the two-dose mRNA vaccine is expected to begin next month with priority groups such as frontline healthcare workers and residential care patients, according to the country’s Department of Health. Australia has secured 10 million doses of the vaccine, enough for about one-fifth of its population, with the option to purchase additional doses.
TGA’s provisional approval pathway allows for the accelerated registration of a prescription medicine based on preliminary clinical data and allows for a medicine to be marketed for two years, with the potential to extend the license up to a maximum of six years.
“Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard,” TGA said. “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.”
TGA says it will actively monitor the safety of the vaccine domestically and abroad and will act if safety concerns are identified. The Pfizer-BioNTech vaccine was the first western-developed vaccine to be authorized by a stringent regulatory authority, after the UK’s Medicines and Healthcare products Regulatory Agency issued a temporary authorization for the vaccine on 2 December 2020. The vaccine has since been authorized on an emergency or temporary basis in more than two dozen jurisdictions, and has been conditionally authorized in the EU and granted an emergency use listing (EUL) by the World Health Organization.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy