TGA provisionally approves Pfizer/BioNTech COVID-19 vaccine for use in Australia
The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia.
The first priority groups in Australia will start receiving a vaccine in February.
This registration means Pfizer’s vaccine has met the TGA’s rigorous standards for safety, quality and efficacy, and will be provided for free to all Australian residents.
It has been provisionally approved in Australia for people 16 years of age and over.
Two doses will be required, administered at least 21 days apart.
The approval is subject to strict conditions, and Pfizer will be required to continue providing information to the TGA on the safety, efficacy and quality of the vaccine.
Priority groups such as aged care and disability care residents and workers, frontline health care workers, and quarantine and border workers will be the first to receive a COVID-19 vaccine.
The Pfizer vaccine will be delivered at up to 50 hospital sites across Australia, and in residential aged care and disability care facilities.
The National Rollout Strategy details how the vaccine will be distributed more widely over coming months through over 1,000 distribution sites.
The next steps in the process will include batch testing these newly arrived doses, establishing cold storage facilities for the vaccine, training health providers to administer it, and finalising distribution sites.
This Australian Government has several agreements for the supply of COVID-19 vaccines in place, including those produced by AstraZeneca and Novavax.
- Read the Prime Minister's statement on the provisional approval of the Pfizer/BioNTech COVID-19 vaccine.
- Read the TGA's statement about the Pfizer/BioNTech vaccine.
- Find out more about the Pfizer/BioNTech COVID-19 vaccine.