Australia won’t rush COVID vaccine approval despite being behind US, UK

Aviation and tourism groups warn the delay could leave borders closed and their industries on the backfoot as the post-COVID world returns to normal.

Australia is set to take up to 12 times longer than the US to begin giving the COVID-19 vaccine with a rollout that will be as much as six times slower than that of the UK.

The revelation comes as aviation and tourism groups warn the Therapeutic Goods Administration’s “provisional approval pathway” process on the vaccine’s approval could leave our borders closed and their industries on the backfoot as the post-COVID world returned to normal.

“Other countries are rolling out the vaccine as fast as they can and I think we need to fast-track it here too,” ­global aviation expert Geoffrey Thomas said.

“We need to be in step with the rest of the world.”

Australian Deputy Prime Minister Michael McCormack. Picture: Lukas Coch/Getty Images)

The aviation and tourism industries have been on the front foot over the inter­national border situation with Qantas now offering inter­national flights from July 1, a move that prompted Deputy Prime Minister Michael McCormack to warn that it would be the government and not the airline that decided when borders will open again.

Tourism Accommodation Australia chief executive Michael Johnson applauded Qantas’s decision.

“Flights generate accommodation and we cannot be anything but supportive of such optimism,” he said. “It is saying ‘come on, let’s get on with it’.”

“The sooner we can get a vaccine, the sooner we get ­stability with borders open and can start to recover.”

Having avoided a health emergency, the federal government and its medical ­advi­sers have been pursuing a ­sup­er-safe “general approval” pro­cess that is long drawn out compared to the “emergency use authorisation” the US and the UK had to follow after failing to contain COVID.

The first western country to approve a coronavirus ­vaccine was the UK, which granted Pfizer’s COVID-19 vaccine a temporary emer­gency use authorisation on December 2.

Its independent regulator said “strict standards of safety, quality and effectiveness” had been met.

The first shot was given in the UK six days later, to grandmother Margaret Keenan. Within 13 days, 522,000 people had been inoculated.

The US gave emergency use authorisation of the same treatment on December 11, ­reportedly following analysis of extra raw trial data.

Three days after, New York nurse Sandra Lindsay became the first American to get the jab. She had her second dose this week and is now fully vaccinated, like Ms Keenan.

Typically the UK would wait for the European Medicines Agency to approve a vaccine before a Briton got it.

But in October it changed a regulation so its own Medicines and Healthcare products Regulatory Agency (MHRA) could give temporary authorisation.  

Margaret Keenan, 91, receiving her second dose of the Pfizer/BioNtech COVID-19 vaccine in the UK. Picture: Jonny Weeks/ NHS England

Australia’s Therapeutic Goods Administration has been considering coronavirus vaccines under a “provisional approval pathway”, a process in use since 2018.

This process appears to cut approval time by a third, to a maximum of 220 working days, although it will not take that long for coronavirus jabs.

The MHRA’s temporary authorisation was based on data submitted by Pfizer as far back as October 1.

However, the TGA’s granting to Pfizer of a “provisional determination” on October 14 was based on “factors such as the evidence of a plan to submit comprehensive clinical data”.

The US Food and Drug ­Administration (FDA) briefing document on its authorisation of the Pfizer vaccine said a request for use was submitted on November 20.

That suggests the FDA’s clearance took just three weeks.

The TGA’s “provisional registration” is expected to be granted by the end of January, which will be more than three months after the provisional determination.

After provis­ional registration, the TGA’s Laboratories Branch will test vaccine bat­ches for strength, purity and potency over 14 days.

Rollout is due to begin by early March, or as much as 36 days after registration.

Federal Health Minister Greg Hunt told 2GB on Tuesday “safety trumps everything” and Australia was not adopting “the practices of those countries that have had the greatest challenges, Europe and North America, in terms of the virus”.