The Therapeutic Goods Administration, the country’s medical regulatory agency, has provisionally approved the Pfizer COVID-19 vaccine for use in Australia

Prime Minister Scott Morrison said the approval was a formal approval as part of TGA’s normal processes and not an emergency measure, but warned that the crisis is far from over

“I have a simple message for Australia, thank you Australia,” he said, “Thank you for putting us in a situation that most countries in the world envy today. We want to keep it that way We want to stay vigilant.” p>

“Once the vaccines start, it doesn’t mean you can get on a plane to Bali the next day to have the masks or quarantine arrangements go away”This will build up, it will start on a small scale, but it is not a silver bullet”

The provisional approval is for people aged 16 and over, requiring two doses at least 21 days apart It is a temporary approval to meet public needs where the benefits of early approval outweigh the risks

From the end of February there will be around 80000 doses will be administered and the rate will rise once the Australian-made doses – which hit a maximum of 1 million doses per week – can be distributed, the rollout is expected to be completed in October

“Around August last year we made a decision that we didn’t want to be in a situation where we were completely dependent on overseas manufacturing of vaccines,” said Morrison. “We have taken precautions to ensure that we can make our own vaccine here in Australia and that is happening now ”

He said Australia “paid a premium” for the capabilities and the federal government was more involved in developing vaccine production facilities in Melbourne

“That was the right decision for Australia because as much as possible you want to be able to control as many things as possible in this country when dealing with COVID-19”

Mr Morrison said the logistical challenge of marketing the vaccine in a country the size of Australia was significant

“There will be swings and roundabouts,” he said. “You can also expect us to explain them as soon as they occur”

Secretary of State Marise Payne has begun to work with the neighbors of Australia’s Pacific Islands on preparations for the administration of the COVID-19 vaccine in the region

“I’ve had some fantastic news from Pacific leaders over the past week,” said Morrison. “They are grateful for the proactive role Australia has taken in ensuring they are able to deliver this vaccine ”

Health Secretary Greg Hunt said the TGA’s world-class regulators had worked tirelessly to bring a safe and effective COVID-19 vaccine to Australia

“I think the TGA processes are the best in the world and we made sure they were thorough,” said Hunt. “The TGA put safety first”

The Head of TGA, Adjunct Professor John Skerritt, thanked the clinical and medical staff, scientists, pharmacists and statistics, laboratory analysis and manufacturing evaluation experts who “worked tirelessly” on evaluating the vaccine

The vaccine was approved after a phase 3 study that was completed in April 43651 people over 16 years took part

Of the 36523 people eligible for the interim analysis, there were 170 confirmed cases of COVID-19 – 162 in people given the placebo

These large numbers allow scientists to rely on their results According to the TGA’s analysis, the vaccine’s effectiveness in preventing symptomatic COVID-19 is 95 percent – or in other words, 97The likelihood that the vaccine will be effective , is at least 90 percent3 percent

It remains unclear whether the vaccine will reduce transmission of the virus.It also remains unclear what effect the vaccine has on asymptomatic COVID-19, as subjects were only tested for COVID-19 when they had symptoms

It also remains unclear how long the vaccine will be effective in monkeys, a decline in antibody and immune cell levels has been noted after five weeks

Get our Coronavirus Update Newsletter with the key developments of the day and the numbers you need to know. Sign up for The Sydney Morning Herald newsletter here and The Age here

Pfizer Vaccine

World News – AU – Pfizer COVID-19 Vaccine, Preliminary Approved For Australian Use

Source: https://www.smh.com.au/politics/federal/pfizer-covid-19-vaccine-provisionally-approved-for-australian-use-20210125-p56wko.html