The AstraZeneca vaccine has been tentatively approved by the medical regulator, paving the way for all Australians to get a coronavirus vaccine by the end of the year

Professor John Skerritt of the Therapeutic Goods Administration said the vaccine is safe in adultsCredit: Alex Ellinghausen

Head of TGA Professor John Skerritt said Australia was only the second regulator in the world to give “full conditional approval of the vaccine” and said the approval “has no age limit”

“Our analysis of the data gives no reason to believe that the vaccine is not fully effective in older groups,” he said Tuesday afternoon

Prime Minister Scott Morrison said Australia’s relatively low case numbers allowed the TGA to go through a full approval process instead of a faster emergency process like the one seen in several other countries, including the U.S., and denied claims that the approval process is slow / p>

“This was, in my opinion, the most efficient and timely process the TGA has ever done on a vaccine, and they did it in a way that didn’t cut corners,” he said

“The vaccine has met standards, safety, quality and efficacy requirements and is being made available to Australians free of charge This means Australia now has two safe and effective COVID-19 vaccines available

“Australia is one of the few countries in the world that can manufacture its own COVID-19 vaccine here from CSL”

The Pfizer vaccine was tentatively approved last month, and people will start receiving those vaccinations starting next Monday

“We expect at least 240 elderly care facilities to join the vaccination program next week, which is a very important step forward in protecting our elderly Australians,” he said

Mr. Hunt thanked TGA for “putting in exceptional hours ticking each box, evaluating everything and ensuring that safety, security and protection are a top priority”

“You and our healthcare professionals and all of the companies involved have literally been working 24/7 for a long, long period of time,” he said,

The AstraZeneca vaccine is the second coronavirus vaccine to be approved in Australia after the Pfizer vaccine was tentatively approved last month, over 140000 doses of Pfizer vaccine arrived on Monday, a major vaccination milestone Pfizer will deliver a total of 20 million doses to Australia

The country will have 538 million doses of the AstraZeneca vaccine, of which 38 million were imported from overseas and 50 million made by CSL in Australia.The imported doses will arrive in the first week of March and the first locally made vaccines from CSL will be in later be available this month

Most Australians will receive the AstraZeneca vaccine, which Mr Hunt previously referred to as the “ace in the hole” of the national rollout

Unlike the Pfizer vaccine, which requires storage at minus 70 degrees, which poses a number of logistical challenges for widespread distribution, the AstraZeneca vaccine only needs to be stored at 2 to 8 degrees like this most vaccines do

“We don’t have a crystal ball and we don’t know and maybe the vaccines will give two or three years of protection, but no life. Maybe people need a booster Nobody knows that yet,” he said

“There’s no advice to say you don’t have it”And of course we are lucky in Australia that the numbers are small. But a number of other countries vaccinate people with coronavirus There is no adverse event,” he said

Professor Skerritt said pregnant women are not included in vaccine studies because the pregnancy excludes volunteers from clinical trials for safety reasons

“However, there were a number of people who did not know they were pregnant or became pregnant during the studies, and there were no reports of adverse results

“As the weeks and months go by, we will know a lot more about pregnancy with these vaccines”

The vaccine was developed by researchers from Oxford University and the pharmaceutical company AstraZeneca and is a “non-replicating viral vector vaccine” Scientists have taken a virus that normally catches chimpanzees but is harmless to humans and genetically engineered it to look like SARS-CoV-2, the virus that causes COVID-19, to trigger an immune response

Most people get their AstraZeneca vaccine during phases 2a and 2b of the rollout at a general practitioner vaccination center, their local family doctor, or an approved pharmacy

Earlier this month, CSL announced to The Sydney Morning Herald and The Age that it was confident that AstraZeneca could manufacture updated versions of the COVID-19 vaccine to cover any virus variants it may encounter

Our Morning Edition newsletter is a curated guide to the most important and interesting stories, analysis and insight. Sign up for The Sydney Morning Herald newsletter here, The Age here, Brisbane Times here, and WAtoday today

Rachel Clun is a federal health policy reporter for The Sydney Morning Herald and The Age

AstraZeneca vaccine

World News – AU – AstraZeneca vaccine approved, trailblazer for home grown cans

Source: https://www.smh.com.au/politics/federal/astrazeneca-vaccine-approved-paving-way-for-home-grown-doses-20210212-p571tx.html