TGA gives provisional approval to Pfizer-BioNTech vaccine in Australia

The TGA has provisionally approved the Pfizer/BioNTech Covid-19 vaccine for individuals 16 years of age and older with two doses required at least 21 days apart.

The Covid-19 mRNA vaccine Comirnaty, which has met strict standards for safety, quality and efficacy, according to the TGA, will be prioritised by the Department of Health according to the populations identified in guidance from the ATAGI (Australian Technical Advisory Group on Immunisation) Covid-19 Working Group.

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 says the TGA approval is an important step in the fight against Covid-19.

“I welcome the TGA’s approval of the Pfizer vaccine, with our own Australian experts finding it is safe, effective and of a high standard,” the Prime Minister says.

Minister for Health Greg Hunt says the-world class regulators at the TGA have been working tirelessly to introduce a safe and effective Covid-19 vaccine in Australia.

“The TGA’s processes are I believe the best in the world and we have ensured that they are thorough,” Minister Hunt says.

“The TGA has placed safety above all else.

“Australia’s high bar has been met; the vaccine has been approved as effective in stopping severe disease.

“This approval and the upcoming roll out of the vaccine will play an important part in our ability to manage the pandemic in 2021.

“Australia’s vaccination program has been based on the medical advice from the medical expert panel led by Professor Brendan Murphy.

“As a result, we are in the fortunate position of having secured 140 million doses of vaccine, one of the highest per capita rates in the world.

“We will continue to review the medical advice and monitor and adapt to developments around the world,” Minister Hunt says.

The Government continues to work with Pfizer on the final date of delivery of vaccines, noting that Pfizer has experienced some temporary production delays from its European manufacturing plant as it ramps up production to meet extraordinary global demand.

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.

Head of the TGA, Adjunct Professor John Skerritt says the TGA has been working non-stop to get the Pfizer vaccine assessed, while maintaining the most rigorous standards of safety, quality and efficacy.

“We’re thrilled to have this product pass the rigorous regulatory process and receive provisional approval,” Adjunct Professor Skerritt says.

“Our job is by no means done. In fact, the monitoring of vaccine safety post-approval is an important part of the regulatory review of vaccines.

“We now check the individual batches of vaccines that are destined for Australians while closely monitoring the safety and efficacy of the vaccine as it is rolled out.

“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.”

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.

“There is intense ongoing work which will continue over the coming month, including batch testing of newly arrived doses, establishing cold storage facilities for the vaccine, training health providers to administer it, finalising distribution sites with states and territories, checking sites and protective equipment for safety, and scaling up systems for ongoing safety monitoring,” Minister Hunt says.


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