Australia has approved the nation’s first COVID-19 vaccine, allowing the first jabs to be rolled out within weeks, beginning with frontline hotel quarantine workers.
News.com.au has confirmed that the independent Therapeutic Goods Administration has ticked off on the Pfizer jab, announcing the decision on Monday morning.
With the approval, the COVID-19 vaccination will be available to teenagers over the age of 16 and adults, with the first Australians to be vaccinated from late next month.
Frontline workers and health workers will be the first to be vaccinated before attention turns to aged care staff, seniors and other vulnerable communities.
The two-dose regimen could not be imported into Australia until it was approved by the TGA and today’s announcement means millions of doses of the drug can now be shipped from overseas.
When it arrives, a rapid phase of final batch testing will commence before the rollout begins.
In a statement, the TGA said provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia.
“The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia,’’ it said.
“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.”
Careful monitoring of the vaccine and any side effects will continue as the rollout commences.
“Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard,” the TGA said.
“The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
“The TGA will continue to actively monitor the safety of the Pfizer vaccine both in Australia and overseas and will not hesitate to take action if safety concerns are identified.
“As an extra check, the TGA laboratories will undertake batch assessment of each batch of the vaccine before it can be supplied in Australia.”
The TGA, an independent agency, was awaiting final data from Pfizer before granting the new vaccine final approval.
“We will only register a vaccine if its benefits are much greater than its risks,’’ the TGA had said.
Outlining the road map for the rollout earlier this month, Prime Minister Scott Morrison revealed the timetable has been brought forward from March.
In a statement, Pfizer told news.com.au that the logistics of the rollout will be co-ordinated by the Morrison Government.
“During the initial pandemic stage, our contracts are with the government, and we will provide doses according to the government’s preferred channel and designated locations,” a spokeswoman said.
“Our role is to ensure that, if our vaccine candidate is authorised for use, we supply our vaccine doses through a robust process, consistent with the agreement we’ve entered into with the Australian government.”
The PM confirmed on Friday that the final approval was just days away.
“And when they say it’s safe, when they give it the tick, then I’ll take the jab,’’ Mr Morrison said.
“And I think all Australians can, too. And, but our process is world leading. It’s world class. It’s a process that I believe Australians can have a lot of confidence in.”
He said the TGA was taking the time to ensure the vaccine was safe and the normal processes for approval were carefully followed.
“We’re not rushing this, nor are we delaying it. We are getting it right,’’ he said. “That’s what matters. We’re getting it right. And by getting it right I think Australians can have a lot of confidence. We’re learning a lot from what’s happening overseas.”
More to come …