COVID-19 Vaccination Program FAQs
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Following a review of the use of the COVID-19 AstraZeneca vaccine, the Australian Technical Advisory Group on Immunisation (ATAGI) recommends that the COVID-19 vaccine by Pfizer is preferred over the COVID-19 vaccine by AstraZeneca in adults aged under 50 years. Find out more.
The COVID-19 vaccines being used in Australia have been approved by the Australian Government’s Therapeutic Goods Administration (TGA) and administered under the advice of the COVID-19 Vaccine and Treatments for Australia – Science and Industry Technical Advisory Group and the Australian Technical Advisory Group on Immunisation (ATAGI).
Before any vaccine is registered for use, it is tested extensively during development and then in thousands of people. Testing begins with laboratory research, then animal studies and finally human clinical trials. Clinical trials involve testing the vaccine in volunteers, and are conducted in phases.
Before any vaccine is approved for use in Australia, including a COVID-19 vaccine, it must pass the TGA’s rigorous assessment and approval processes. This includes assessment of its safety, quality and effectiveness.
The TGA is actively monitoring COVID-19 vaccine development both in Australia and around the world, and is also part of a network of international regulators that meet regularly to discuss the development of COVID-19 vaccines.
The TGA is engaging early with vaccine developers, undertaking a thorough and efficient review of vaccine candidates and discussing the application process. Early engagement will not affect the comprehensive review process that clinical trial results are subject to in Australia.
The COVID-19 vaccines are thoroughly tested for safety before they are approved for use in Australia. This includes careful analysis of clinical trial data, ingredients, chemistry, manufacturing and other factors.
The Therapeutic Goods Administration (TGA) will approve all COVID-19 vaccines being used in Australia to ensure that extremely high safety standards are met. The vaccines available do not use the live or whole virus that causes COVID-19.
With more than 300 million people vaccinated globally with these vaccines, real world data is now showing high effectiveness for both vaccines. We can be confident that both vaccines are safe and provide protection against serious illness and death from COVID-19.
In addition to providing approval for the COVID-19 vaccines to be used in Australia, the Therapeutic Goods Association (TGA) tests every batch of COVID-19 vaccines – checking how potent they are ensuring they have not been contaminated – before they are dispatched for delivery.
Vaccine recipients may also be followed up with an automated text message three days and then eight days after get the vaccine. You may be asked if you have had any side effects, and the information will contribute to AusVaxSafety’s national COVID-19 vaccine safety surveillance.
AusVaxSafety is a world-leading national vaccine safety system, led by the National Centre for Immunisation Research and Surveillance.
All available resources and efforts have been directed towards finding an effective vaccine, due to the urgency of protecting people from the COVID-19 virus.
Some of the reasons behind this rapid progress include:
Some countries have used emergency use authorisation to roll the COVID-19 vaccine out more quickly. Emergency use authorisation is not a full approval of a vaccine. In countries facing significant COVID-19 outbreaks, the benefits of rolling out a vaccine before full regulatory assessment may outweigh the risk of waiting for a full analysis.
Due to the proactive management of COVID-19 in Australia, we have been able to wait for the Therapeutic Goods Administration (TGA) to make an assessment through the provisional registration pathway. This allows the TGA to undertake its comprehensive regulatory assessment of the safety and effectiveness of vaccine candidates.
Before any vaccine is registered for use, it is tested extensively during development and then in thousands of people. Testing begins with laboratory research, then animal studies and finally human clinical trials. Clinical trials involve testing the vaccine in volunteers, and are conducted in phases.
Clinical trials must provide scientific evidence which demonstrates that the benefits of a vaccine greatly outweigh any risks.
There are different types of clinical trials:
For COVID-19 vaccines, some of these phases have been combined. For example, in Phase 1 and 2 trials, results are analysed after the first few dozen volunteers are studied. The trial then proceeds in hundreds more people. Some Phase 3 studies have started once preliminary data from Phase 1 and 2 trials are available. Having these ‘overlapping’ timeframes has helped develop COVID-19 vaccines quickly, to make them available earlier to save lives.
No. The vaccines have been through clinical trials and have been approved by the Therapeutic Goods Administration (TGA) for use in Australia through a rigorous assessment and approval processes. This includes assessment of their safety, quality and effectiveness.
Millions of people across the world have now received at least one dose of a COVID-19 vaccine.
The person vaccinating you will have completed COVID-19 vaccination training. In South Australia, two trained staff members check the dosage prior to vaccination as an additional safety measure.
The Australian Government partnered with the Australian College of Nursing to develop and deliver the accredited training modules. This will ensure vaccinators can safely manage and administer COVID-19 vaccines.