The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia. The Pfizer vaccine has met strict standards for safety, quality and efficacy.

The TGA provisional approval is for individuals 16 years of age and older. Two doses will be required – at least 21 days apart.

A priority group of Australians are expected to now receive their first dose of the vaccine as soon as it can be received from Pfizer and the necessary checks are undertaken by the TGA, prior to its distribution.

The latest advice given to the Government from Pfizer is that shipping and the first vaccinations are expected to be in late February.

If there are delays in shipping or production, the possibility remains that commencement could be in early March, however guidance remains for late February.

Prime Minister Scott Morrison said the TGA approval was an important step in the fight against COVID-19.

In Australia the vaccine will be rolled out in five phases over the coming months and, over time, will involve more than 1,000 vaccination administration sites. 

As the rollout begins across 30 - 50 hospital sites, people who need protection the most will get the vaccine first. This includes aged care and disability care residents and workers, frontline health care workers, and quarantine and border workers.

The priority groups have been determined based on the advice of the Australian Technical Advisory Group on Immunisation (ATAGI) which oversees Australia’s highly successful immunisation program.

“We will also continue our work on the regulatory review for potential approval of other vaccines, notably the AstraZeneca and Novavax vaccines, as well as vaccines delivered through the COVAX facility”, said Head of the TGA, Adjunct Professor John Skerritt.