Australian-made AstraZeneca COVID-19 vaccine approved by Therapeutic Goods Administration

The first batch of Australian-made doses of the AstraZeneca vaccine have been given the green light in what experts say is a “major step in Australia’s response to the COVID-19 pandemic”.

The Therapeutic Goods Administration (TGA) announced on Tuesday evening that 832,000 doses produced in Melbourne had been approved and is “now available for Australians”.

The nation’s medical regulator released the supplies following Sunday’s announcement it had signed off on domestic manufacture of the vaccine, describing it as a “critical and very exciting milestone in Australia’s response to the COVID-19 pandemic”.

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Since Sunday, the Australian-made doses have been going through batch testing in Canberra to ensure “that the locally-manufactured vaccine has the exactly the same composition and performance as the overseas-manufactured vaccine, the same quality, and is free of contaminants”, the TGA said in a statement.

Each batch of vaccine supplied undergoes a TGA “batch release”, which involves “a review of documents describing how it was made, tested, shipped and stored as well as testing by the TGA’s in-house lab to ensure it’s been made according to required standards”.

Australia’s first four batches have since been cleared with the TGA calling it “a major step in Australia’s response to the COVID-19 pandemic”.

“We will now be able to provide secure access to large numbers of doses of a domestically-produced vaccine,” it said.

TGA approval is required for each and every batch of any vaccine supplied in Australia.

The Australian government says it will produce 50 million doses of the vaccine locally “in the coming months” manufactured on its behalf by CSL.

The vaccine will be manufactured at two sites in suburban Melbourne. CSL-Behring Australia in Broadmeadows is making the active raw vaccine material, while the final doses are being manufactured and vials filled and packaged at CSL company Seqirus in Parkville.

Health Department secretary Brendan Murphy said the AstraZeneca vaccine was Australia’s “workhorse”.

He said domestic production of the jab will allow authorities to expand the rollout, adding the vaccine was “safe and effective”.

All subsequent batches of the Melbourne-manufactured vaccine completed in the coming weeks and months will go through the same individual batch testing and release process by the TGA.

The Australian-produced AstraZeneca vaccine will be progressively available through more than 4,000 distribution points, including general practices, GP-led respiratory clinics, and Aboriginal Health Services.

AstraZeneca Australia is the largest national manufacturer of pharmaceuticals.

At least 281,500 people have already been vaccinated across Australia.


It comes the day after more than six million Australians will become eligible for the COVID-19 vaccine on Monday as more than 1000 GP clinics start vaccinating people.

The phase 1b rollout came into effect on Monday, with the first of the general population included in the cohort set to be vaccinated.

It covers the over 70s, healthcare workers, Aboriginal and Torres Strait Islander adults over 55 and adults with a specified medical condition.

Critical and high-risk workers including Defence, police, fire, emergency services and meat processing are also included under phase 1b.

1000 GP clinics joined the COVID-19 vaccination program as part of the rollout.

Deputy chief medical officer Michael Kidd conceded flooding across Australia, particularly in NSW, would cause “some delays” in the rollout that state, but elsewhere it would happen “as anticipated”.

“We have had practices where we haven’t been able to yet deliver the first doses of the vaccine because roads are closed and of course we have some practices which themselves have had to close,” he said.

“Obviously safety first is paramount at this time, so once it is safe and the roads are reopened, those deliveries will take place and people in those areas will be able to start getting their first doses of the AstraZeneca vaccine.”

Health Minister Greg Hunt has said the government “clearly and unequivocally” continued to support the AstraZeneca rollout.

“The TGA does not have any evidence of a biologically plausible relationship that could suggest a cause and effect relationship during vaccination and blood clots,” he told parliament.

It comes as a US health agency raised concerns that AstraZeneca may have included out-of-date information during trials of its COVID-19 vaccine, the day after the company said its drug was highly effective in preventing the disease.

AstraZeneca had said Monday that stage three US trials had shown its vaccine was 79 per cent effective at preventing the disease. It said the jab was 79 per cent effective at preventing symptomatic COVID-19 in the overall population, 100 per cent effective at preventing severe disease and hospitalisation and 80 per cent effective at preventing the disease in the elderly.

— with Newswire

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Pembroke’s Olive Downs coal mine approved despite department’s concerns about waterways

A massive coal mine that was a key platform in Queensland Premier Annastacia Palaszczuk’s election campaign gained approvals despite the environmental regulator raising serious concerns behind the scenes about lasting impacts on surrounding waterways, ABC Investigations can reveal.

Pembroke Resources has received approval for a coking coal mine south-west of Moranbah in central Queensland that will straddle the Isaac River and impact on almost 4,000 hectares of floodplain.

The Olive Downs mine will be the third largest in the state, producing up to 15 million tonnes a year and employing 1,500 people.

Pembroke wants more than 1,000 hectares of Paul Harris’s grazing property, Old Bombandy, for the mine.

Mr Harris owns a prime Wagyu beef operation that runs more than 7,000 head of cattle on the farm.

“It’s going to reduce greatly the supply of water in the river,” said Mr Harris, who uses water from the Isaac River for his stock.

Right to Information documents obtained by ABC Investigations show the Department of Environment and Science was also concerned.

They reveal the department repeatedly warned the then-coordinator-general during the environmental approval process in 2018 and 2019 of the serious risks of leaving huge mine pits — also called “voids” — on the Isaac River floodplain after the mine is closed.

In letters and submissions, the department said the voids would permanently draw groundwater into them, reduce river water, permanently alter the floodplain and change flood velocities.

It said the ongoing impacts on the groundwater, the nearby Isaac River and floodplain had not been sufficiently assessed.

The company is also seeking to use a vast section of a grazing property managed by Roy Rogers for the mine.

Mr Rogers said any impacts on the river system could devastate their cattle operation.

“Because it affects people like us on the bottom line that are raising cattle, that’s our livelihood,” he said.

Pembroke Resources plans to leave three large voids on the Isaac River floodplain after the mine has closed, including one on the grazing property managed by Mr Rogers and owned by Queensland businessman Jim Gorman.

Queensland’s history of environmental disasters caused by mine voids on floodplains led to a recent state ban on leaving them after a mine was closed.

But the ban does not apply to Pembroke and several other mines in Queensland because they started their environmental applications before the laws came into effect in November 2019.

The then-coordinator-general Barry Broe oversaw the company’s environmental approval process and received advice from various government departments.

Right to Information documents reveal that in October 2018 the Department of Environment and Science expressed serious concerns about the company’s draft Environmental Impact Statement (EIS).

In a letter to Mr Broe, it said it “considers the work completed to date by Pembroke Resources to be insufficient in detail and lacking the necessary commitments in relation to the rehabilitation of these voids”.

Its submission detailed concerns that the company failed to properly assess the impact of the voids on the groundwater and ecosystems that rely on it, the Isaac River, the flood risks on neighbouring properties, how they would be rehabilitated and justify why it should be allowed to leave them on the floodplain at all.

Hydrologist Matt Currell has examined ABC Investigations’ Right to Information documents.

The documents show the department sought extra information on Pembroke’s plan for ensuring the safety and stability of the voids in the long term.

“That sort of information is really needed before a clear decision can be made that the environmental effects of this mine are able to be managed properly,” he said.

“There was [also] concern raised by the department that leaving those mine voids there would cause this long-term ongoing seepage of water from the river that would reduce flows in the river as well as affecting the ecosystems and water users that depend on groundwater in the area.”

In May 2019, the department again wrote to the coordinator-general, this time in response to Pembroke’s final EIS.

It found Pembroke’s proposal to build permanent rock waste emplacements and leave “final voids” was lacking in information and did not demonstrate it would meet “the government’s expectations and best practice environmental management”.

It said the residual risk was high and the rehabilitation conditions Pembroke suggested for the final environment permit were “unacceptable”.

Ten days later, and after meeting with the department’s director-general Jamie Merrick, the coordinator-general gave his environmental approval for the mine despite the concerns.

In an email to Mr Merrick, the coordinator-general said: “Our conclusion is that the impacts are manageable and stringent conditions have been formulated to ensure this outcome occurs.”

“Disturbed areas would be rehabilitated to be safe, stable, non-polluting and able to sustain identified land uses,” he wrote.

The department later granted the final state environmental approval by issuing the company its environmental authority with conditions.

Managing lawyer of the Environmental Defenders Office in Queensland, Revel Pointon, believes the correspondence reveals major flaws in the environmental approval process in the state.

“It’s highly concerning that the coordinator-general is ignoring that [the department’s] advice and going ahead and providing for recommendations of approval around a mine such as this,” she said.

“This really does raise serious questions around the wasted resources of the experts in the Department of Environment and Science.

Farm manager Roy Rogers said the case did not give him much faith in the environmental approval process.

“Not much faith at all … they’ve got to do their homework,” Mr Rogers said.

“Everybody up and down that river that’s grazing stock needs that river to draw water to supplement their cattle.”

Mr Rogers is concerned about impacts to the water levels under the riverbed where they pump from due to the seasonal nature of the Isaac River.

“If it impacts the underground water levels in the river, it could cause all sorts of problems,” Mr Rogers said.

Fellow grazier Paul Harris agrees.

“At the moment it’s got water in it. Most of the year it normally doesn’t have water in it, it’s just sand … when it’s really dry, our water supply is hard to find.”

Pembroke Resources and the current and former coordinator-generals all declined to be interviewed.

In a statement, Pembroke Resources said: “Olive Downs will engage in more modern progressive rehabilitation reducing the impact of workings throughout the life of the mine and the final voids will be engineered to protect surrounding areas.”

The current coordinator-general, Toni Power, said additional information was sought from Pembroke in relation to the Department of Environment and Science requests in October 2018 and May 2019, including on groundwater, groundwater ecosystems and flood risks to neighbouring properties.

“All impacts were assessed on merit and conditions were included in the evaluation report that he [the former coordinator-general] regarded as appropriate to ensure that, post-mining, the land will be stable, safe and non-polluting,” Ms Power said.

“Subsequent to the May 2019 submission from the Department of Environment and Science, the-then coordinator-general sought further information from the proponent in relation to the proposal to leave final voids and waste rock emplacements.”

She said the additional information provided was considered by the-then coordinator-general prior to his recommendation of approval and the company’s proposed rehabilitation conditions were consistent with regulations.

The Department of Environment and Science said the final environmental authority included “strict conditions imposed by the coordinator-general” on how the voids would be rehabilitated.

However groundwater hydrologist Matt Currell said those conditions were vague and a lot of the detailed work to understand the voids’ impacts had been deferred to a later date.

“It’s only after approval is given that the mining company has to produce detailed plans for how it’s going to manage and monitor some of these really important environmental impacts,” he said.

The next step for Pembroke was gaining mining lease approvals, which are decided personally by the state mining minister, who was Anthony Lynham at the time.

In 2018, the company engaged a lobbying firm called Next Level Strategic Services.

One of the firm’s two directors is high-profile Labor figure Cameron Milner, a former Queensland state secretary and previous chief of staff to Bill Shorten.

Contact logs analysed by ABC Investigations show that in August alone Next Level Strategic Services secured 11 discussions about Pembroke’s project with the chiefs of staff of Mr Lynham and Treasurer Cameron Dick.

One month later, and just days before last year’s state election was called, Mr Lynham approved the mining leases.

Premier Annastacia Palaszczuk announced the Pembroke approval surrounded by TV cameras on a mine site.

However, it soon emerged that as well as his firm lobbying the Palaszczuk government, Mr Milner was also working for Labor’s state election campaign.

Transparency International CEO Serena Lillywhite said this raised potential integrity concerns.

The Premier, Treasurer, Mr Milner, and former mining minister Mr Lynham all declined to be interviewed, providing written statements instead.

A spokesman for the Palaszczuk government said a Labor government introduced the current lobbying code of conduct.

“Lobbyists are required to follow the code at all times and ensure appropriate disclosures are made. Perceived or potential conflicts are appropriately dealt with.”

The spokesman for the Treasurer Cameron Dick said: “Neither the Treasurer nor the Treasury has any role in the granting of a mining lease.”

Mr Milner said all work for clients adhered to the Queensland Integrity Act, including declaring lobbying contacts publicly.

“Any ALP activity is done as an ALP member of 30 years, on an unpaid basis and having been involved in every Queensland state election since 1992,” he said.

Grazier Paul Harris believes the timing of the approval was political.

He and Jim Gorman objected to the mining leases over water impacts, which meant the case went to the Land Court. However, the court recommended the approval in July last year.

Mr Harris has appealed against the decision in a judicial review to the Supreme Court and is awaiting the outcome.

Three mining leases have been approved so far, with the two that cover Paul Harris and Jim Gorman’s properties yet to be approved by the minister.

He is angry the mining leases were approved despite outstanding court action.

“You can have checks and balances, but if they’re all ignored, well, it’s not going to do anything is it?” he said.

Pembroke Resources said the mining leases were granted after more than “four years of detailed environmental, technical and engineering work including wide consultation with a diverse range of stakeholders”.

The current Mining Minister Scott Stewart said: “It’s not uncommon to have objectors to mining leases and environmental authority applications.”

“Objectors are able to seek judicial reviews of the land court recommendations which recommend the granting of leases.”

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Boggo Road Gaol development application approved

The development application from Brisbane property company Stockwell has been a point of contention for neighbouring residents, many of whom say it is not appropriate for the site, places too much weight on car parking, and will increase traffic congestion.

After months of delays as the council sought more information on the proposed development, the application, which includes shops and offices, was given the green light late on Friday afternoon.

The 1880s-era Boggo Road Gaol sits in a key precinct connecting the University of Queensland via the Eleanor Schonell Bridge to the Princess Alexandra and Mater Hospital precinct in Woolloongabba.

It also has two schools next door — the new Brisbane South State Secondary College and Dutton Park State School — and will back onto the new Cross River Rail station at Boggo Road once that station is completed.

The train station is expected to serve 22,000 commuters daily by 2036.

Stockwell lodged the application for a two-storey office and retail development between the heritage-listed gaol and the neighbouring CSIRO sciences building in 2019 after a larger design was scrapped two years earlier.

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Music event Backyard Fest approved for Elphinstone despite local objections

A one-off weekend music festival that could attract up to 1,500 people has been granted approval, with conditions, by the Mount Alexander Shire Council despite 17 objections.

Backyard Fest is scheduled to go ahead in Elphinstone in November, with organisers wanting to run the event on land on Allendale Road which is zoned for farming.

Nikki Medwell, who runs an animal shelter on a neighbouring property, objected to the festival, saying the noise would be detrimental to wildlife.

“Wildlife generally have a 10-kilometre-radius home base and that sort of noise is going to send wildlife scattering,” she said.

“We work with a senior veterinary surgeon who has a business here and we rehabilitate injured and sick wildlife; the reason he is working with us is because of the greenbelt and the silence and the location that recovering wildlife receive.”

The festival will start on a Friday night showcasing bands and DJs, with more performances and yoga and art installations the following day.

Elphinstone resident and Red Box Wildlife and Veterinary Hospital senior veterinarian Mark Sayer said the land surrounding the proposed festival location was pristine and home to wildlife populations that had previously been in decline.

“Elphinstone is an area where the farming community are farming sustainably, and they are also in concert with the local wildlife to the point where phascogales, a carnivorous marsupial on the highly endangered list, can be found.

“It shows how well the local area is looking after its wildlife.”

Despite the objections and recommendation from council staff to deny approval of the event in its current form, councillors agreed to the application.

“Under COVID there hasn’t been much happening in the community,” Mayor Tony Cordy said.

“A lot of people enjoy live music, they wanted to give this event the opportunity to go ahead so there was something positive for people.”

He said there were still plenty of challenges ahead for the organisers.

“There were concerns about fire safety, the proximity of the venue to the freeway, and there was a lot of support on council for the event to go ahead,” he said.

“It was really around moving forward, seeing the community move forward, have an event to look forward to and something for young people to do.”

The Mayor said the council was not convinced one weekend of activities would adversely affect wildlife.

“The wildlife experts are entitled to their point of view. We had an applicant objector meeting in relation to this event, but at the end of the day, the majority of councillors voted for this event to go ahead.”

Event organisers will have to seek approval from the Country Fire Authority to mitigate fire risk and flagged road management issues to meet council guidelines.

Backyard Fest co-director Blake Van Leeuwen said he was thrilled with council’s vote and would work to make the event a success for young people and the community.

“Music really is our passion, and to create a festival in order to share that passion really brings us great joy.

“Albeit we haven’t seen the conditions as yet, we are very confident that we can fulfil the needs of the council to get our little festival of the ground.

“We are very excited to work with locals in the area and simply can’t wait for Backyard Fest to be in full swing.”

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Royal Adelaide Show officials approved ride that killed Adelene Leong despite operators never returning safety checklist

A ride that caused the death of a young girl at the Royal Adelaide Show should not have been cleared to run because its operators had not returned a final safety checklist, a coronial inquest has heard.

Eight-year-old Adelene Leong died in hospital after she was thrown from the Airmaxx 360 ride at the Royal Adelaide Show in September 2014.

South Australia’s Deputy State Coroner Ian White is currently hearing an inquest into Adelene’s death.

The inquest was told on Friday that the operators of the ride were required to return a safety checklist created by the Royal Agricultural and Horticultural Society, which runs the Royal Adelaide Show.

The inquest heard the checklist, which was intended to confirm that an engineer or so-called “competent person” had inspected the ride, was never returned.

Judith Noble, project manager for the Royal Agricultural and Horticultural Society, told the court she only became aware after the incident that the checklist had never been returned by the Airmaxx 360 operators.

Ms Noble told the court it was one of several documents required to be returned by all operators.

She said she could not recall if there were any other ride managers that also did not return the checklist.

She agreed with a proposition by the coroner that the Airmaxx 360 should not have been cleared to operate by the society without the checklist.

There were several complaints made about the Airmaxx 360 before it went to Adelaide.(ABC News: Giulio Saggin)

Harness and seatbelt checked twice

The court also heard evidence from Amanda Minniken, 36, who said it was her job to “lock and load” customers as the only official deck attendant on the ride that day.

Ms Minniken told the court she checked Adelene’s harness and seatbelt at least twice before the ride began.

“I recall checking her two, maybe three times, I recall twice asking her to go all the way back [on her seat], I realised she didn’t speak English,” she said.

“I tried to explain slowly, she didn’t quite understand … I pushed the harness down, locked it in.”

Ms Minniken told the court a mother on the ride, two seats away from Adelene, was yelling at her at the time.

She said after that she gave the ride operator a ‘thumbs up’.

Ms Minniken told the court she only realised something went wrong when the ride came to a very quick stop.

The inquest has previously heard that the Airmaxx 360 ride had been plagued by complaints before coming to the Royal Adelaide Show with 22 injury reports made in three days at the Royal Melbourne Show.

It heard the ride had some design and condition flaws that should have been identified and that it was operating at a height limit of 120 centimetres which was 20 centimetres less than what was suggested by the ride manufacturers.

The inquest continues.

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Attendance of up to 30,000 a day approved for Melbourne’s Australian Open

Victoria’s Chief Health Officer has given approval for between 25,000 to 30,000 people a day to attend the Australian Open in Melbourne next month.

Minister for Sport Martin Pakula today announced that the event’s COVID-safe plan would allow a daily crowd capacity of 30,000 for first eight days of the tournament and then 25,000 per day from the start of the quarter-finals — about half the average attendance in recent years.

The State Government said “rigorous” infection control and prevention measures would be enforced.

Nearly 1,000 Australian Open players and officials have undertaken hotel quarantine over the past fortnight, with the last to be released on Sunday.

More to come.

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Pfizer COVID vaccine approved by TGA, NSW Police to watch 2021 Australia Day celebrations, Victoria records no local COVID-19 cases

However, there are many unknowns –this is a provisional approval, rather than full registration. It remains unclear if the vaccine will have any effect on reducing the transmission of the virus. It also remains unclear what effect the vaccine has on asymptomatic COVID-19, as people in the trial were only tested for COVID-19 if they had symptoms.

It also remains unclear just how long the vaccine will be effective. In monkeys, declining antibody and immune-cell levels over five weeks were noted.

On the basis of the data at hand, the TGA decided to approve the vaccine only for people aged over 16.

For the very frail – people aged over 85 – the TGA recommends nurses and doctors vaccinate on a “case by case basis”, as the potential benefits of the vaccine must be weighed against the risks of exposing a very frail person to the vaccine’s standard flu-like side-effects.

They will also need to decide themselves whether to jab pregnant women, with the TGA saying there is only limited human data to guide advice. The same goes for people with autoimmune disorders or those with compromised immune systems.

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Pfizer COVID vaccine provisionally approved by TGA

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

Prime Minister Scott Morrison said the approval was a formal approval under the normal processes of the TGA and not an emergency approval.

“I have a simple message to Australia, thank you Australia,” he said. “Thank you that you have put us in a situation that is the envy of most countries in the world today. We intend to keep it that way. We intend to remain vigilant.”

A certified medical assistant prepares a dose of the Pfizer-BioNTech COVID-19 vaccine at a vaccination.Credit:AP

The provisional approval is for individuals 16 years of age and older, with two doses required at least 21 days apart. There will be about 80,000 doses carried out per week from late February, with the rollout set to increase in doses administered once the vaccine doses manufactured in Australia could be distributed. The process is expected to be completed in October.

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Pfizer COVID-19 vaccine approved for use by TGA in Australia ahead of rollout

The nation’s medical regulator the Therapeutic Goods Administration has approved Pfizer’s COVID-19 vaccine for use in Australia.

The TGA said following a thorough and independent review of Pfizer’s submission, it was decided the vaccine met the high safety, efficacy and quality standards required.

It is the first COVID-19 jab to be approved for use in Australia.

The approval is on a provisional basis, meaning it is valid for two years.

It allows the vaccine to be supplied in Australia for people aged 16 and older. Two doses will be required at least 21 days apart.

Prime Minister Scott Morrison welcomed the decision.

“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator,” he said.

“Our priority has always been to keep Australians safe and protect lives and livelihoods.

“Today’s approval is another big step forward for our community, particularly in the protection of our most vulnerable people.”

COVID-19 vaccine not mandatory

The Government wants to start rolling out the vaccine in February, prioritising groups such as healthcare workers and Australians in aged care homes.

The vaccine will not be mandatory, even for staff in aged care homes.

Minister for Health Greg Hunt said the TGA “placed safety above all else”.

“The TGA’s processes are, I believe, the best in the world, and we have ensured that they are thorough,” he said.

“This approval and the upcoming rollout of the vaccine will play an important part in our ability to manage the pandemic in 2021.”

The TGA said it would continue to monitor the safety of the Pfizer vaccine both in Australia and overseas and “will not hesitate to take action if safety concerns are identified”.

Australia has purchased 10 million doses of the vaccine.

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How will COVID-19 vaccines be approved for use in Australia?

Some Australians could be receiving a COVID-19 vaccine within weeks.

Amid the continued spread of the virus and emergence of highly contagious variants, the federal government has accelerated the start of the roll out – initially set for March 2021 – to February.

Read more: The Oxford vaccine has unique advantages, as does Pfizer’s. Using both is Australia’s best strategy

Other countries, who have been less successful in containing the virus, have already begun vaccination programs. While this has been met by celebration around the world, there have also been concerns about possible side-effects.

It is expected the Therapeutic Goods Administration (TGA) will approve the Pfizer vaccine for use in Australia any day now. Approval for the AstraZeneca vaccine is expected in early February.

Given the uncertainty surrounding the virus and the speed at which vaccines have been developed, what processes are in place to assure Australians’ safety?

What is the TGA?

The TGA is part of the federal Health Department. Its job is to regulate any product that carries a therapeutic claim. This includes prescription drugs, medical devices, certain food supplements, and of course vaccines.

It maintains the Australian Register of Therapeutic Goods (ARTG), which records every therapeutic good available in the country.

The TGA regulates therapeutic goods in two main ways. First, it authorises products so they can be put on the ARTG and distributed. This involves its experts reviewing safety and efficacy data.

It then monitors products once they are in use. This includes collecting, analysing and reacting to data from health-care providers, patients, manufacturers, and overseas regulatory authorities.

How does it work?

The TGA says it adopts a “risk-based approach”. That is, it must be satisfied a vaccine or medication’s benefits outweigh its risks.

The TGA therefore is not tasked with the impossible goal of avoiding all risks. Rather, it must make sure that only products carrying acceptable risks can be marketed.

Read more: Bad reactions to the COVID vaccine will be rare, but Australians deserve a proper compensation scheme

So, for example, common minor side effects (such as a stomach ache) associated with certain painkillers are deemed acceptable compared to their benefit. Similarly, a severe but rare side effect can be acceptable where the medical benefit is significant. This is the case with vaccines.

Along with internal scientific and medical staff, the TGA is advised by seven committees, providing independent expert advice on scientific and technical matters. There includes a specific committee for vaccines.

Vaccine approval under ‘normal’ circumstances

The TGA requires a manufacturer or importer (the “sponsor”) to demonstrate the safety and efficacy of their product.

That is, companies need to show not only that their product is not harmful, but it does what it is supposed to do.

Sponsors must submit a substantive body of clinical data, gathered according to Good Clinical Practice guidelines, which are developed in keeping with world’s best practice.

The TGA also reviews the data using internationally recognised guidelines from the European Medicines Agency.

Read more: Australia’s vaccine rollout will now start next month. Here’s what we’ll need

The key data for approval arises from the third phase of clinical trials. These test a new product on very large groups, which can number in the tens of thousands. The TGA review can take up to eleven months.

If a therapeutic good is approved, but a problem later emerges, the TGA can recall it.

Special provisions for COVID-19 vaccines

The devastating speed of the COVID-19 pandemic has prompted regulatory authorities across the world to speed up approval processes.

Almost all have used existing special provisions to fast-track their reviews. Importantly, clinical trials have been conducted at unprecedented speed thanks to unlimited funding and motivated volunteers.

The scientific consensus is that the rigour of clinical evaluation has not been compromised.

Similarly, the TGA can conduct a speedier review of clinical data.

Instead of reviewing all the data prior to registration, the TGA conducts a preliminary assessment. This is followed by rolling submission of clinical data, leading to provisional registration. In other words the process is accelerated by allowing the TGA to look at data on an ongoing basis.

This special pathway is in place for treatments or vaccines for life-threatening diseases.

A provisional registration means the vaccine is approved for a set period of time (to be determined by the TGA), during which vaccinations can start under close monitoring. Following this, the vaccine proceeds to full registration.

Benefits outweigh risk

Both the Pfizer and AstraZeneca vaccines have conducted phase three trials on tens of thousands of participants. Additionally, the TGA stresses it will only approve provisional registrations when the data so far makes clear

In the context of COVID-19 vaccines, provisional registration reduces bureaucratic hurdles, while maintaining the highest possible scientific rigour.

Working with the international community

The TGA does not operate in a vacuum either.

Regulatory authorities worldwide and the World Health Organisation have committed to work together on COVID-19 vaccines and medicines to improve “regulatory alignment”.

The TGA is a member of the International Coalition of Medicines Regulatory Authorities, which has committed to full cooperation and transparency between its members, particularly with regard to sharing data.

The TGA is also part of the Access Consortium alongside regulatory authorities from Singapore, Canada, Switzerland and the United Kingdom.

So, while the speed of development of the first COVID-19 vaccines is unprecedented, so is the level of global monitoring over their safety and efficacy.

Authors: Marco Rizzi – Senior Lecturer in Law, University of Western Australia | Katie Attwell – Senior Lecturer, University of Western Australia The Conversation

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