Typically vaccines take many years of research and testing before they are available in a clinic, but in 2020 scientists around the world worked hard to produce safe and effective COVID-19 vaccines as quickly as possible. We now have several approved vaccines which are being rolled out in many countries, and more than 1.09 billion vaccine doses have been administered worldwide.
Phase 1a of the vaccine rollout in Australia commenced on 22 Feb 2021, and this covered those most at risk of COVID-19, including Australia’s frontline health workers, aged care residents and staff and quarantine and border workers. Phase 1b commenced on 22 March 2021, and this phase is for adults 70 years and over, Aboriginal and Torres Strait Islander people aged 55 and over, healthcare workers not already vaccinated, adults with a specified medical condition and critical and high risk workers (defence, police, fire, emergency services and meat processing).
Phase 2a commenced on 3 May 2021, so all adults over the age of 50 are now eligible for a vaccine.
More than 4.24 million COVID-19 vaccine doses have been given in Australia, either the Pfizer/BioNTech vaccine or the Oxford/AstraZeneca vaccine.
The Therapeutic Goods Administration (TGA) has approved both the Pfizer/BioNTech vaccine and the Oxford/AstraZeneca vaccine. They test vaccines rigorously before use to ensure they meet Australia’s strict quality standards. Neither of these vaccines contain any live virus, nor can they give you COVID-19.
As of 8 April 2021, the Australian Technical Advisory Group on Immunisation (ATAGI) recommends that the COVID-19 vaccine by Pfizer is preferred over the AstraZeneca vaccine in adults aged under 50 years. This recommendation is based on a potentially increased risk of thrombosis with thrombocytopenia syndrome (TTS) following AstraZeneca vaccine among those aged under 50 years. This condition is very rare, and ATAGI estimates that the overall rate of TTS is about 4-6 cases per million people vaccinated, but the rate is currently estimated to be higher (20-40 cases per million) in those under 50 years of age.
The AstraZeneca vaccine can still be used in adults aged under 50 years where the benefits are likely to outweigh the risks for that individual, or when the individual has had one dose without any problems. Informed consent is required.
The AstraZeneca vaccine is recommended for adults in Australia over 50 years of age. The majority of deaths and severe illness associated with COVID-19 around the world involve older people. The AstraZeneca vaccine is highly effective at preventing severe illness and death due to COVID-19 and the benefits to people aged 50 years and above greatly outweigh any risk of TTS.
AstraZeneca doses are being reallocated in a recalibrated vaccine rollout plan. As of 3 May 2021, the AstraZeneca vaccine is available to all people aged 50 or over through GP-led Respiratory Clinics (GPRCs) and state and territory clinics. As of 17 May 2021, the AstraZeneca vaccine is also available through general practices, to people aged 50 or over.
The Pfizer vaccine is an mRNA vaccine which needs to be given in two doses, 21 days apart. It contains the genetic code for an important part of the SARS-CoV-2 virus (which causes COVID-19) called the spike protein. After getting the vaccine, your body makes copies of the spike protein, and your immune system will learn to recognise and fight against the SARS-CoV-2 virus.
The Pfizer vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for active immunisation to prevent COVID-19 in individuals 16 years of age and older.
Trials have shown the Pfizer vaccine to be very effective at preventing Covid-19 disease. In one large clinical trial, people who had two doses of the vaccine were about 95 per cent less likely to get COVID-19 than people who did not get the vaccine. It was equally effective in
people over the age of 65 years, and in people with some stable pre-existing medical conditions.
Protection against COVID-19 starts from about 2–3 weeks after the first dose of the Pfizer vaccine. While one dose may give some protection, it could only last for the short-term. Two doses will give optimal protection.
Australia’s regulator declared in April 2021 that the Pfizer COVID-19 vaccine can now be kept at normal freezer temperatures for up to two weeks during transport and at regular refrigerator temperatures for up to five days. Previously, the vaccine needed to be kept at sub-zero temperatures of between -90C and -60C, which made the logistics of transporting the vaccine quite challenging.
The pharmaceutical company AstraZeneca Pty Ltd collaborated with the University of Oxford to develop a viral vector vaccine. The vaccine is included in the ARTG for immunisation of people 18 years and older. Like the Pfizer vaccine, the AstraZeneca vaccine needs to be give in two doses. However the AstraZeneca vaccine is approved for a gap of 4-12 weeks between doses. ATAGI has recommended that the interval between doses is 12 weeks, but if this isn’t possible (such as with cases of cancer chemotherapy or major elective surgery) a minimum interval of 4 weeks between doses can be used.
Initially supply of this vaccine had been imported from overseas, and now ongoing supply is being manufactured in Australia by Melbourne-based company CSL in collaboration with AstraZeneca. 50 million doses will be produced in monthly batches.
The AstraZeneca vaccine is a viral vector vaccine, which uses an adenovirus from chimpanzees as the vector. It can be stored at 2-8 degrees Celsius (normal refrigerator temperatures) so it can be distributed with relative ease. A preprint manuscript in The Lancet shows the vaccine demonstrated 82.4% efficacy after two standard doses three months apart. It is likely, but not proven, that this vaccine prevents transmission as well as disease.
As with all vaccine approvals, the TGA will actively monitor the vaccine in Australia and overseas and undertake laboratory batch assessment of each batch of the vaccine before it can be supplied in Australia.
What other vaccines will be available to Australians?
The Government has also secured 51 million doses of the Novovax vaccine, pending TGA approval. This vaccine is expected to arrive here from overseas later in 2021. A UK trial found the vaccine to be 89% effective in two doses, but the delivery of this vaccine has been set back due to supply shortages.
Australia has now also bought 25 million doses of Moderna’s vaccine, which is another mRNA vaccine (like Pfizer’s). Moderna has announced that it can supply 10 million doses of the vaccine to Australia by the end of the year and another 15 million doses in 2022. This second batch will be the booster or variant-specific version of the vaccine. The vaccine is yet to receive regulatory approval from the TGA. In clinical trials, the Moderna vaccine had 94% efficacy against symptomatic COVID-19 and 100% efficacy against severe COVID-19.
The COVID-19 vaccines from Pfizer, AstraZeneca, Novavax and Moderna all work by training the immune system to recognise and fight the spike proteins which are on the SARS-CoV-2 virus. However they each use different technologies to do this. The Novovax vaccine is the only one that contains exactly the same spike protein as the virus. It is a protein subunit vaccine and can be considered a more tradition type of vaccine. Spike proteins are produced in cells in the laboratory using the genetic sequence of the spike protein in SARS-CoV-2. The protein is then concentrated, purified and mixed with other chemicals to ensure a strong immune response in the body.
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Australian Government’s COVID-19 Vaccine and Treatment Strategy
The Government of Australia has invested around $363 million to support research and development of vaccines, and now the Commonwealth Government has allocated over $6 billion to support the vaccine program with contracts for over 195 million COVID-19 vaccines.
The role of ATAGI
ATAGI is a group of highly qualified professionals and specialists. Their role is to advise the Minister for Health on the medical administration of vaccines that are available in Australia, including those vaccines that are available through the the National Immunisation Program (NIP) . It plays a crucial part in the launch and rollout of the vaccine.
ATAGI also advises research organisations on current immunisation research and areas that need additional focus. ATAGI also works with other related organisations in ensuring the implementation of immunisation procedures, policies and safety of the vaccine.
The COVID-19 vaccine approval process in Australia
When it comes to approval of vaccines, Australia has a meticulous and rigid testing and approval system. Before a vaccine can be registered for use, it is tested in detail during the development phases, and then tested on thousands of people.
Testing typically commences with laboratory research, then animal studies and finally clinical trials on humans. These clinical trials include testing the vaccine on volunteers, and they are conducted in various phases. These trials help in providing a strong scientific evidence base. The evidence shows what the TGA is looking for: that the advantages of the vaccine outweigh any disadvantages.
When it comes to registering a vaccine, a sponsor must submit a detailed dossier to the TGA. This will include information about risk management, chemistry, toxicology studies, etc.
After the TGA approves the vaccine, the vaccine is added to the ARTG as an officially registered medicine. It can be supplied in Australia by the sponsor.
What is the priority order for the vaccine?
As per ATAGI and the Government, the following people are prioritised:
- employees working in services that are important to functioning of society
- those who are at a high chance of getting infected with and transmitting COVID-19
- those who are vulnerable to developing severe diseases.
This complies with the guidelines issued by the World Health Organisation (WHO).
Why do some Australians get the vaccine before others?
There is a high demand worldwide for an effective vaccine to help in the battle against COVID-19. Because of this demand, high numbers of doses aren’t available immediately everywhere, but certain groups will be prioritised as the quantities become available.
These groups are chosen considering the public health, epidemiological evidence and medical proof on who will be more impacted if infected with SARS-CoV-2.
Is it essential for everyone to get the vaccine?
It isn’t mandatory to get the vaccine in Australia, and currently there aren’t any compulsory vaccines in the country. Although the Government supports and encourages immunisation, it is up to every individual on whether or not they want to get vaccinated.
The Government’s goal is to have as many Australians vaccinated as possible by the end of 2021.
What is COVAX?
The Australian Government has joined the COVAX Facility as part of a global effort to support fair, rapid and equitable access to COVID-19 vaccines. This participation helps the global effort to control Covid-19 and also enables us to purchase vaccine doses for Australia as they become available. Currently 188 countries around the world have become a part of the COVAX Facility. The participation of higher income countries like Australia means the facility can invest in a diverse portfolio of potential COVID-19 vaccines and support vaccine manufacturers.
COVAX is coordinated by Gavi the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. The initial aim is to have 2 billion doses available by the end of 2021, which should be enough to protect high risk and vulnerable people, as well as frontline healthcare workers.