Australia’s medical regulator has approved the first COVID vaccine in the country, with the first doses of the Pfizer jab to be delivered within weeks.
Manufactured in Europe and the United States, 10 million doses of Pfizer’s world-leading jab, known as COMIRNATY, will arrive in Australia over the course of 2021, according to the pharma giant.
But worldwide production and shipping issues could see Australia’s spruiked “mid-to-late February” timeline for first vaccinations pushed back to early March.
The Therapeutic Goods Administration’s final tick of approval on Monday – after a careful but expedited consideration process – is a big step but it’s a long way before October, when the government hopes to have all Australians vaccinated.
The TGA has today provisionally approved the Pfizer/BioNTech #COVID19 vaccine for use in Australia. This is an important step in our fight against this terrible virus. Read more: https://t.co/Mjkzhj7RUy
— Scott Morrison (@ScottMorrisonMP) January 25, 2021
Here’s what you need to know:
What happened on Monday with the Pfizer vaccine?
After months of consideration, the TGA – Australia’s medical regulator – has finally given approval to Pfizer’s COVID vaccine.
The TGA said it was “the first COVID-19 vaccine to receive regulatory approval in Australia”.
“Following a thorough and independent review of Pfizer’s submission, the TGA has decided that this vaccine meets the high safety, efficacy and quality standards required for use in Australia,” the regulator said on Monday.
The approval is “provisional”, which means it can be supplied to Australians by doctors but is “subject to certain strict conditions”.
This includes Pfizer giving the TGA a rolling set of information on long-term efficacy and safety, following ongoing trials and worldwide usage.
Prime Minister Scott Morrison praised the TGA, saying Australians “should take confidence in the thorough and careful approach taken by our world-class safety regulator”.
When will vaccinations start?
Mr Morrison had recently said the government hoped to begin administering the vaccine in “mid-to-late February”.
However, due to well-documented supply issues faced by Pfizer, that timetable may be slightly delayed.
“If there are delays in shipping or production, the possibility remains that commencement could be in early March, however guidance remains for late February,” Mr Morrison said on Monday.
The government’s previously stated goal of four million vaccinations by the end of March may also be kicked a bit further back, with Mr Morrison saying “that is going to be achieved in early April”.
“That is the reality of dealing with international arrangements. These are things that are beyond our control with these initial shipments,” he said in Canberra.
Vaccinations will begin with about 80,000 jabs per week.
The government plans to significantly scale that up in the early stages. To reach four million vaccinations by April would require some 100,000 jabs per day.
The New Daily has contacted Pfizer for comment on delivery schedules.
Who will get it?
The TGA has given approval for the Pfizer jab to be given to anyone above the age of 16.
However, Australia only has supply of the two-dose Pfizer jab enough for five million people.
That likely means those to get that vaccine will be the groups listed on the first stages of the government’s vaccine roadmap.
Phase 1a includes frontline health workers, residents and staff in aged care, and quarantine and border workers.
Phase 1b includes more older Australians, and more health staff.
Most Australians can expect to receive the AstraZeneca vaccine, of which Australia has secured nearly 54 million doses, and which the TGA is still considering for approval.
How effective is it?
The answer to the question “how good is the Pfizer vaccine?” (to borrow a favourite phrase from the Prime Minister) is “we don’t exactly know yet”.
Clinical trials show Pfizer’s vaccine has an efficacy up to 95 per cent – however, its effectiveness varies in stopping illness and death, versus stopping transmission.
“COMIRNATY has been shown to prevent COVID-19, however it is not yet known whether it prevents transmission or asymptomatic disease,” the TGA said in its approval.
Health department secretary Professor Brendan Murphy, Australia’s chief medical officer through the pandemic’s early stages, said clinical trials were continuing and that all the answers were not yet clear.
“What we do know is that the two vaccines that we are rolling out now are both very good at preventing clinical COVID disease and particularly severe disease,” he said.
“That is going to stop people getting clinically sick and hopefully people getting sick and needing treatment and unfortunately dying.
“We don’t yet know how effective they are at preventing the transmission of the virus.”
Professor Murphy said the Pfizer jab would “prevent, to some degree, transmission of the virus but we don’t know how effective they are at doing that”.
“Our strategy at the moment is to protect the population, to protect people from getting sick from COVID. Then we will re-evaluate what the impact is on transmission,” he said.
Professor Murphy also suggested that people may need additional booster shots of the vaccine, like the flu shot.
He said this may be needed “possibly even annually”.
“These things are completely unknown at the moment,” he said.
What about the other vaccines?
While Monday was all about Pfizer, Mr Hunt also shared new details of the AstraZeneca rollout.
That vaccine, from the University of Oxford, makes up the bulk of Australia’s vaccine plan.
Australia will source 3.8 million doses from overseas suppliers, then produce 50 million at the CSL plant in Melbourne.
The health minister said the international supplies would likely arrive “slightly earlier than had previously been anticipated”, in early March.
“The domestic AstraZeneca production via CSL is likely to see supplies of approximately one million doses per week commencing in late March,” Mr Hunt said.
He said Australia had “paid a premium” for access to a vaccine that could be made onshore, and not subject to the whims of global supply schedules.
“That puts Australia in a vastly more secure position than almost any other country in the world,” he said.
A company spokesperson told The New Daily that “AstraZeneca remains on track to commence delivery of its vaccine to the Australian government aligned with the government’s vaccination strategy, pending approval from TGA”.
The TGA told TND that vaccine remains “under consideration”, but it hopes to have it approved in February.