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The Therapeutic Goods Administration (TGA) has today approved the AstraZeneca COVID-19 vaccine for use in Australia following a full and thorough assessment process.
The vaccine has met the required standards for safety, quality and efficacy and will be provided free to Australians.
This means Australia now has two safe and effective COVID-19 vaccines available.
Initial supply into Australia will be imported from overseas. In the coming months, the AstraZeneca vaccine will be manufactured in Australia. Australia is one of a small number of countries in the world that can manufacture its own COVID-19 vaccine.
The AstraZeneca COVID-19 vaccine is provisionally approved in Australia for active immunisation to prevent coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, in individuals 18 years of age and older.
Prime Minister Scott Morrison welcomed the announcement.
“The TGA has found the AstraZeneca COVID-19 vaccine to be safe and effective and I welcome their thorough assessment process,” the Prime Minister said.
“Safety is our number one priority and our own medical experts have carefully made their assessments before giving approval of the vaccine.”
The TGA has reviewed all of the available evidence and determined that two doses of the AstraZeneca vaccine can be safely administered to an individual 4-12 weeks apart.
Drawing from the advice of the TGA and also from the implementation of the program internationally, the Australian Technical Advisory Group on Immunisation has determined that to create the very best immune response, ensure the most effective clinical protection and maximise broader community coverage, the two doses of the vaccine should be administered 12 weeks apart.
However, if this preferred interval is not possible, for example because of imminent travel, cancer chemotherapy, or major elective surgery, a minimum interval of 4 weeks between doses can be used.
The AstraZeneca vaccine can be handled and stored like most other vaccines. For a large country like Australia, this provides some distinct benefits in relation to distribution and storage, particularly in rural and remote areas, including Indigenous communities.
Today’s announcement follows a rigorous and independent assessment of the vaccine’s safety, quality and efficacy by the TGA. The approval is subject to certain strict conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on the safety, efficacy and quality of the vaccine.
Minister for Health and Aged Care Greg Hunt said the AstraZeneca vaccine will help save lives and protect lives.
“Data from clinical trials tells us that the AstraZeneca vaccine will stop people becoming seriously unwell with COVID-19. This is – and must – be our first priority. It would be irresponsible of us to put anything ahead of this,” Minister Hunt said.
“The global evidence is of overwhelming protection against serious illness, hospitalisation and loss of life.”
Overnight the World Health Organization said, “This regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.”
On the 3 February 2021 the Lancet Journal said, “COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death in the primary analysis of Phase III trials.”
Minister Hunt said, “Importantly the TGA has conducted a full and thorough, and world class assessment process.”
“As the rollout begins, the people in priority groups who need the most protection will receive a vaccine first. This includes aged care and disability care residents and workers, frontline healthcare workers, and quarantine and border workers.”
The Australian Government has secured 53.8 million doses of the AstraZeneca vaccine, with 50 million doses being manufactured here in Australia.
Every safety and regulatory box has been ticked for provisional approval – and further ones will now be ticked in the lead up to March.
The Pfizer vaccine remains on track to be rolled out from 22 February 2021.
Further details are available at aus.gov.au

Tens of thousands of aged care residents in Australia will soon receive their first vaccine dose against COVID-19 next week.
The Australian Government is ensuring those who are particularly vulnerable to the worst effects of the coronavirus receive the earliest protection, so priority is being given to residential aged care facility staff and residents.
The vaccination program will begin in every state and territory and will include regional and rural aged care facilities. It is anticipated that the roll out to aged care facilities will take approximately six weeks.
Minister for Health and Aged Care, Greg Hunt, said the vaccine implementation plan for residential aged care aimed to administer vaccines to more than 240 aged care facilities in the first week.
“Vaccination for residents and staff will be made available through residential aged care facilities where they live or work, and it will be administered through an in-reach workforce provider,” Minister Hunt said.
“Healthcare Australia will be providing the vaccination workforce in New South Wales and Queensland, and Aspen Medical will be responsible for the other states and territories.
“The Primary Health Network in each region will be supporting the Commonwealth delivery to each of the aged care facilities in their area and the process is expected to draw from the extensive experience in delivering influenza vaccines to aged care residents.”
Residential aged care facilities will be grouped, up to a maximum of eight facilities within a 30 kilometre radius to ensure efficient delivery of the vaccine.
Vaccination for home and community aged care recipients and staff will occur in the community, and these people will receive information relevant to their situation shortly.
It’s anticipated that people aged over 70 years who do not reside in residential aged care facilities, along with in-home and community aged care staff, will be able to go to specified central locations or medical facilities to receive their COVID 19 vaccination, as the time comes for their vaccination.
Minister for Senior Australians and Aged Care Services, Richard Colbeck, said the Australian Government would be responsible for leading the implementation of the COVID-19 vaccination program in the aged care sector.
“We are consulting with relevant peak bodies and state and territory governments, but the responsibilities are clearly delineated so all parties understand their role in this critical and complex program,” Minister Colbeck said.
“The New South Wales, Victorian and South Australian governments will maintain responsibility for vaccinating residents and staff of the public sector residential aged care and disability care facilities in their state.
“It is vital residents and families understand what information is available to them as the vaccine strategy is rolled out. I would encourage residents and family members to ask if they need help understanding the vaccine program and how it will affect them.
“Importantly, the vaccine providers will be providing information about the vaccine and seeking consent from aged care residents or their substitute decision maker, to ensure they understand the risks and benefits of receiving the vaccine.”
Everyone responsible for providing the vaccine in aged care settings will be required to have completed the relevant training, including on the use of multi-dose vials, cold storage and infection control.
In the coming weeks, the vaccination program will reach more than 2,600 residential aged care facilities, more than 183,000 residents and 339,000 staff.
Families seeking additional information and support can visit: https://www.australia.gov.au/

Australian Greens Housing spokesperson Senator Mehreen Faruqi has said reports that Labor may scrap commitments to wind back negative gearing and reduce capital gains tax (CGT) deductions would only benefit the wealthy.
Senator Faruqi said:
“For decades, Australian governments have created a housing system that actively impoverishes people and makes inequality worse.
“Not too long ago, Labor was calling out negative gearing and the CGT discount as “tax subsidies” that “benefit the wealthiest Australians” and are “skewed to high income earners”.
“This seems to be an opposition in name only. There is no good policy reason for backing down on negative gearing and capital gains. Any back down would be purely political and would only benefit the rich. It will do nothing to provide a home for everyone.
“Covid-19 has put the inequity and inhumanity of our housing system starkly in the spotlight. Labor should be strengthening its policies on negative gearing and capital gains, not abolishing them.
“I’m urging Labor not to shrink away from what are very modest policies. In reality, we should dismantle this rigged system through comprehensive reform and winding back CGT deductions and negative gearing.”

Today’s comments from Agriculture Minister, David Littleproud, that he is open to adopting net zero emissions by 2050 but wants to see concrete plans before signing up to the pledge begs the question: what has he been doing for the last four years?
Greens spokesperson for Agriculture and Rural Affairs, Peter Whish-Wilson, said evidence of climate change impacts on farming is hardly new information and you’d be forgiven for thinking setting climate targets for 30 years’ time is a joke.
“In the past eight years the Coalition have torn up nearly all existing climate policies like the carbon price and clean energy package, ramped up fossil fuel exploration and production, whilst not providing a single credible policy that will tackle global warming,” Senator Whish-Wilson said.
“I welcome today’s indication from Agriculture Minister, David Littleproud, that he is open to adopting net zero emissions targets by 2050.
“However, his desire to see concrete plans before signing up to a 2050 target also begs the question: what on earth he has been doing as Agriculture Minister for the past four years?
“The Nationals have been ignoring farming groups that clearly feel the agricultural sector has an important role to play in climate action. This includes the National Farmers Federation who have backed an economy-wide target of 2050, and The Meat and Livestock Association who have an industry target to be carbon neutral by 2030.
“Australia has within this past decade gone from being a global leader on climate action to a global embarrassment.
“The Nationals are now left playing catch up and David Littleproud’s comments today scream of a face-saving gesture – if he was legit he would be leading on getting a plan for net zero by 2050 developed.
“Few industries are more impacted by climatic disruption to ecosystems and biodiversity than farming and it’s beyond belief that The Nationals – the self-professed ‘farmers friends’ – are so deeply divided on climate change.
“The Greens urge The Nationals to unite with farming groups advocating for real ambition on tackling climate change, ahead of tomorrow’s Coalition meeting.”

The Greens say Mr Morrison must announce a permanent increase to the Jobseeker payment and guarantee that nobody is worse off under any new system.
“Mr Morrison is once again muddying the waters with a suggestion that the JobSeeker payment could be paid at a flat rate and targeted supplements abolished. A permanent increase to Jobseeker is the highest priority” Australian Greens spokesperson on Family and Community Services Senator Rachel Siewert said.
“The income support system needs reform as it is not fit for purpose but right now people need to know that they won’t be dumped back to $40 a day on April 1.
“People in our community are living in situations of extreme anxiety and in many cases distress.
“It is just plain cruelty to be keeping 1.3 million people in limbo on whether they are going back to living on $40 a day.
“The Government must guarantee that no one will be worse off under any reforms they make to the income support system, it is untenable that people may be worse off under any so called reforms.
“Mr Morrison should be able to walk and chew gum. We need an announcement on a long term increase to JobSeeker that is above the poverty line and a commitment to reforming our outdated income support system which has needed an overhaul for decades.”

The Morrison Government today reinforces its commitment to protecting the health and wellbeing of older Australians with landmark reform to keep seniors safer.
The Aged care legislation amendment (Serious Incident Response Scheme and other measures) Bill 2020 will ensure tangible steps toward the prevention of incidence of abuse and neglect of older Australians in care.
The SIRS legislation will also provide a range of broader powers for the Aged Care Quality and Safety Commissioner, consistent with the Regulatory Powers Act.
It follows the passing of the Aged Care Legislation Amendment (Improved Home Care Payment Administration No.2) Bill 2020 aimed at improving the way home care subsidies are paid to providers for care recipients.
Minister for Senior Australians and Aged Care Services Richard Colbeck said the measures reaffirmed the Government’s commitment to prioritising the needs of ageing Australians.
“The Commonwealth continues to build on and strengthen the aged care sector as we anticipate the final recommendations from the Royal Commission later this month,” Minister Colbeck said.
“As the Royal Commission has carried out its important work, we have continued to reform the sector.
“Importantly, these latest measures offer security and peace-of-mind for all older Australians in residential and in-home care settings and for their families.
“The Commonwealth Government is listening and acting to ensure the needs of older Australians are met while Labor continues to deliver nothing but spin and rhetoric.”
Minister Colbeck said the SIRS is intended to drive quality and safety improvements to residential aged care at the individual service and broader system level.
Residential aged care providers will be required to manage all incidents, with a focus on the safety and wellbeing of consumers and reduce preventable incidents from reoccurring.
The SIRS will expand the responsibilities of residential aged care providers in relation to identifying, recording, managing, resolving and reporting assaults and a broader range of serious incidents in residential aged care.
Reporting under the SIRS will include a range of new matters such as sexual misconduct, neglect, psychological abuse, inappropriate use of restraint, and unexpected death amongst others.
Significantly, the SIRS will lift the current exemption on the reporting of resident-on-resident incidents, where the perpetrator has an assessed cognitive impairment.
The first stage of the SIRS will start on 1 April.
Minister Colbeck said consumers expect continuity of care and safeguards across an end-to-end aged care system, which is why the Government has already committed to a prevalence and feasibility study of a SIRS in home and community care settings.
The study is being undertaken by KPMG and is expected to be finalised by late June and will inform Government decisions on a SIRS for home and community care.
Minister Colbeck said the Morrison Government is delivering record investment across the aged care system – from $13.3 billion in 2012-13 under Labor, growing to $24.3 billion in 2020-21 under the Morrison Government.
It is estimated that funding for aged care will grow to more than $27 billion by 2023-24.
“Senior Australians are increasingly choosing to remain in their own homes for longer and the Government is committed to supporting this choice,” Minister Colbeck said.
Since the 2018-19 Budget, the Government has invested an additional $5.5 billion for an additional 83,105 home care packages.
Home care packages are estimated to increase from 60,308 in 2012–13 when we came to Government, to 195,597 during 2020–21.

As part of Ovarian Cancer Awareness Month, the Morrison Government will provide a further $1 million to Ovarian Cancer Australia for their work supporting those living with ovarian cancer.
Each year in Australia, approximately 1,500 women are diagnosed with ovarian cancer. Tragically, more than 1,000 will die. While ovarian cancer is more commonly diagnosed in women over the age of 50, it can occur at any age.
Ovarian Cancer Australia’s Teal Support Program is built on a psychosocial support case management model, including using telehealth to provide care and support to both ovarian cancer patients and their families.
Women diagnosed with ovarian cancer face extraordinary challenges: it has the lowest 5-year survival rate of all gynaecological cancers (46%) with recurrence rate of up to 70%. The psychological impact of this prognosis is overwhelming and 40% of women diagnosed with ovarian cancer experience clinical levels of anxiety or depression.
Supporting patients and their families now is important, but research remains our best hope of defeating ovarian cancer in the long term.
Since 2011, the Government has invested more than $71 million for ovarian cancer research through the National Health and Medical Research Council and is the single biggest funder of cancer research in Australia.
In addition, through the Government’s $20 billion Medical Research Future Fund, we are supercharging the growth of Australia’s health and medical research capabilities.
To date, more than $16.9 million from the Fund has been invested in ground-breaking ovarian cancer projects, like the work done by Ovarian Cancer Australia.
Our Government also provides funding for a range of other measures to support women with ovarian cancer and their families, including the listing of life-saving and life-changing medications on the Pharmaceutical Benefits Scheme (PBS).
This includes the recent extension of the PBS listing of Lynpara, meaning an additional 300 Australian women with ovarian cancer each year will have access to a medicine that would otherwise cost $140,500 per course of treatment. Instead, they will pay as little as $41.30 per script, or $6.60 with a concession card.
In August 2020, we also saw two new Medicare items become available for genetic testing for BRCA variants. This is in addition to Medicare rebates for gynaecology, oncology, radiology and pathology.
While we have made great progress in tackling this disease, there is more work to be done.
Today, at the Teal Ribbon Breakfast, our Government reaffirms its commitment to ensuring women with ovarian cancer in Australia know more about the symptoms and risks of this condition so they get the treatment, information and support they need both now and into the future.
2021 also marks the 20th Anniversary of Ovarian Cancer Australia. The Morrison Government congratulates OVA on this milestone and commends its work in supporting woman and their families.