The Therapeutic Goods Administration (TGA) has today provisionally approved the Pfizer\/BioNTech COVID-19 vaccine for use in Australia.
\nThe Pfizer vaccine has met strict standards for safety, quality and efficacy.
\nThe TGA provisional approval is for individuals 16 years of age and older. Two doses will be required \u2013 at least 21 days apart.
\nA 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.
\nThe latest advice given to the Government from Pfizer is that shipping and the first vaccinations are expected to be in late February.
\nIf there are delays in shipping or production, the possibility remains that commencement could be in early March, however guidance remains for late February.
\nPrime Minister Scott Morrison said the TGA approval was an important step in the fight against COVID-19.
\n\u201cI welcome the TGA\u2019s approval of the Pfizer vaccine, with our own Australian experts finding it is safe, effective and of a high standard,\u201d the Prime Minister said.
\n\u201cAustralians should take confidence in the thorough and careful approach taken by our world-class safety regulator.
\n\u201cOur priority has always been to keep Australians safe and protect lives and livelihoods. Today\u2019s approval is another big step forward for our community, particularly in the protection of our most vulnerable people.\u201d
\nMinister for Health Greg Hunt said the-world class regulators at the TGA have been working tirelessly to introduce a safe and effective COVID-19 vaccine in Australia.
\n\u201cThe TGA\u2019s processes are I believe the best in the world and we have ensured that they are thorough.\u201d Minister Hunt said.
\n\u201cThe TGA has placed safety above all else.\u201d
\n\u201cAustralia\u2019s high bar has been met; the vaccine has been approved as effective in stopping severe disease. I thank all those involved in the development and assessment of this COVID-19 vaccine, including the researchers, Pfizer, BioNTech and the medical experts at the TGA who have worked around the clock and over Christmas.\u201d
\n\u201cThis approval and the upcoming roll out of the vaccine will play an important part in our ability to manage the pandemic in 2021.\u201d
\n\u201cAustralia\u2019s 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,\u201d Minister Hunt said.
\nThe 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.
\nThe Government\u2019s latest advice remains that the first doses of Pfizer are expected to arrive and be rolled out in late February. Final dates will be confirmed by Pfizer shortly and are subject to shipping and distribution.
\nIn 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.
\nHead of the TGA, Adjunct Professor John Skerritt said the TGA has been working non-stop to get the Pfizer vaccine assessed, while maintaining the most rigorous standards of safety, quality and efficacy.
\n\u201cI would like to thank our clinical and medical officers, scientists, pharmacists and experts in statistics, laboratory analysis and manufacturing assessment who have worked tirelessly on assessing this vaccine,\u201d Adjunct Professor Skerritt said.
\n\u201cWe\u2019re thrilled to have this product pass the rigorous regulatory process and receive provisional approval.\u201d
\n\u201cOur 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.
\n\u201cWe 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.
\n\u201cWe 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.\u201d
\nAs 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.
\nThe priority groups have been determined based on the advice of the Australian Technical Advisory Group on Immunisation (ATAGI) which oversees Australia\u2019s highly successful immunisation program.
\n\u201cThere 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,\u201d Minister Hunt said.
\nThe Australia Government, states and territories, regulators and the health and medical sectors are working together to finalise arrangements under the Australian Vaccination Strategy and detailed roll out plans. Further information about the Australian Government\u2019s COVID-19 Vaccine National Roll-out Strategy can be found here.<\/p>\n","protected":false},"excerpt":{"rendered":"
The Therapeutic Goods Administration (TGA) has today 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 \u2013 at least 21 days apart. A priority … Continue reading “Pfizer Vaccine Approved”<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-10027","post","type-post","status-publish","format-standard","hentry","category-aussie"],"_links":{"self":[{"href":"http:\/\/www.16news.com.au\/index.php\/wp-json\/wp\/v2\/posts\/10027","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.16news.com.au\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.16news.com.au\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.16news.com.au\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.16news.com.au\/index.php\/wp-json\/wp\/v2\/comments?post=10027"}],"version-history":[{"count":0,"href":"http:\/\/www.16news.com.au\/index.php\/wp-json\/wp\/v2\/posts\/10027\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.16news.com.au\/index.php\/wp-json\/wp\/v2\/media?parent=10027"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.16news.com.au\/index.php\/wp-json\/wp\/v2\/categories?post=10027"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.16news.com.au\/index.php\/wp-json\/wp\/v2\/tags?post=10027"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}