After months of constant research and effort, various COVID-19 vaccine contenders are now in the third phase of human trials, and some have already been rolled out across different countries. Social segments who are most at risk of the virus, like healthcare workers, are being prioritised when it comes to the administering the vaccine.
The United Kingdom has approved a vaccine as an emergency reply to the devastating 58,000 cases of COVID-19 daily. Britain has also imposed an extended lockdown as of the first week of January. In Australia, the government has generally indicated that a national rollout should be expected by March 2021, however no fixed date has been offered.
Who will regulate the vaccine for COVID-19?
When it comes to being administered in Australia, any COVID-19 vaccine will have to pass the rigorous checks of the Therapeutic Goods Administration (TGA) and their approval process. This will include testing the effectiveness, quality and safety of the vaccine.
Currently, the result of the vaccination across the world is being closely examined by the TGA. The Australian regulator is also part of an international network of regulators working together to supervise the development of COVID-19 vaccines.
The TGA is also in close contact with developers of vaccines and undertaking a brief and practical evaluation of the vaccine candidates, in addition to the application process. However, the evaluation process that the clinical trials are subject to in Australia will be unaffected by the early engagement.
Australian Government’s COVID-19 Vaccine and Treatment Strategy
Currently, the Government of Australia has invested around $363 million to support research and development of vaccines. This is the Government’s way of playing its role in finding vaccines and treatments that are successful and will help stop the spread of COVID-19.
Australia has four separate agreements for the vaccine supply if everything goes well with clinical trials and approvals. Through these four agreements, the Australian Government has invested $3.3 billion. This huge investment will increase Australia’s access to effective vaccines once they are made available.
Oxford/AstraZeneca: 53.5 million doses on their way to Straya
The vaccine developed by University of Oxford and pharmaceutical company AstraZeneca is one of the most progressed vaccines developed across the globe. As per the results drawn from testing of 24,000 people in Britain, South Africa and Brazil, the vaccine is safe and 70% effective against the virus.
As a part of the ‘COVID-19 Vaccine and Treatment Strategy’, if the vaccine is proven to be safe and is approved to be used in Australia, it will be made accessible from early 2021. So far, 53.8 million doses of the vaccine have been secured by Australia, with 3.8 million to be procured first. Around 50 million more amounts will be produced locally in monthly batches. The vaccine will be produced by Melbourne-based company CSL, in collaboration with AstraZeneca. The AstraZeneca vaccine is one of nine other ones that are supported by the Coalition for Epidemic Preparedness Innovations (CEPI), an international collaboration to accelerate the development of an effective vaccine.
What other vaccines will be available to Australians?
Pharma giant Pfizer and BioNTech are also producing a vaccine for the coronavirus. If it is safe and successful, the Aussie government has already secured a large order. These doses will be developed in Germany, the US and Belgium. In the early period of 2021, there will be 10 million doses of the vaccine available to us.
Another company that has an agreement with Australia is Novavax Inc. Their vaccine is in Phase 3 of its clinical trials, and the placebo-controlled trial will be administered to 30,000 people in 115 locations across the US and Mexico.
The role of ATAGI
The Australian Technical Advisory Group on Immunisation or ATAGI is a group of highly qualified professionals and specialists. Their role is to advise the Minister for Health on the National Immunisation Program (NIP) and other related issues. It will play a crucial part in the launch and rollout of the vaccine.
The job of ATAGI is to work closely with the Minister for Health and advise it on the medical administration of vaccines that are available Down Under, including those vaccines that are available through the NIP.
It also advises research organisations on the current immunisation research/trials, and areas that need additional focus. ATAGI will also work 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/approval system. Before a vaccine can be registered for use, it will be 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: 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 Australian Register of Therapeutic Goods (ARTG) as an officially registered medicine. It can be supplied in Australia by the sponsor.
Who will be prioritised when it comes to the vaccine?
As per the Australian Technical Advisory Group on Immunisation (ATAGI), and the Government, the following people will be 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.
- Healthcare frontline workers
- Border and quarantine frontline staff
- Aged care and disability home residents
- Aged care and disability home workers and staff
This complies with the guidelines issued by the World Health Organisation (WHO).
Why will some Australians get the vaccine before others?
There is an increased demand for an effective vaccine to help in the battle against COVID-19. Because of this demand, high doses won’t be instantly available, 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 is in full support of immunisation, it is up to every individual on whether or not they want to get vaccinated.
Once the vaccine is made available, the Government’s goal will be to have as many Australians vaccinated as they possibly can.