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COVID-19 vaccine: Information for consumers and health professionals
Find out answers to the common types of questions you may have about how the TGA assesses and monitors a vaccine for safety, quality and effectiveness.
How is a COVID-19 vaccine approved?
The Therapeutic Goods Administration (TGA) is responsible for assessing all COVID-19 vaccines before they can be used in Australia. There are a number of stages in the regulatory process, including:
Find out more about the COVID-19 vaccine approval process.
How does the TGA evaluate a vaccine?
Before a vaccine is approved for use in Australia it must pass the TGA’s rigorous assessment and approval processes. This includes assessment of its safety, quality and effectiveness.
The TGA will formally evaluate the information provided by the vaccine’s sponsor (usually a pharmaceutical company) which includes data on clinical studies, non-clinical/toxicology studies, chemistry, manufacturing, risk management and other information.
The evaluation is carried out in multiple stages by technical experts, and involves seeking further information and clarification from the sponsor as required. The TGA’s evaluation is also informed by the advice of the Advisory Committee on Vaccines, an independent committee of external experts.
The decision to approve a new vaccine is always made by the TGA on the basis that the benefits outweigh the risks for the intended population.
How does the TGA test for safety, quality and effectiveness?
The TGA considers the safety, quality and effectiveness of every ingredient in a vaccine before we register the vaccine for use in Australia.
We carefully assess the results of clinical trials and the way in which the trials were conducted. We look at how trials were designed, if they were conducted for a sufficient amount of time, and if there were enough participants in the trial that represented the people for whom the vaccine is intended.
We also require vaccine manufacturers to meet manufacturing quality standards. As a further check, our laboratories assess the quality of every batch of a vaccine before it can be supplied in Australia.
We are working closely with international regulators to collaborate and share information as evaluations progress.
What is the provisional approval pathway?
The provisional approval pathway is a process that allows for temporary registration of promising new medicines and vaccines where the need for early access outweighs the risks.
It is anticipated that sponsors of COVID-19 vaccines will apply to the TGA for registration using the provisional approval pathway. This approach is consistent with the mechanisms being used by other international regulators to assess and evaluate COVID-19 vaccine applications.
The provisional pathway is only one of a number of pathways that a sponsor may use to apply for the approval of a vaccine. This page will be updated if a different approval process is used. It’s also important to note that an evaluation under the provisional pathway is still a full review, and the TGA does not have a mechanism for emergency use authorisations.
Once the TGA delegate has approved a vaccine for registration, it is included in the Australian Register of Therapeutic Goods (ARTG) as a provisionally registered medicine and available to be administered by health professionals.
The provisional registration is for an initial period of two years, with the option to apply for up to two extensions, up to a maximum of six years.
Sponsors may apply for full registration when there is more clinical data to confirm the safety of the vaccine.
The provisional approval pathway consists of five steps: provisional determination, pre-market registration, the provisional registration period, extension of provisional registration and transition to full registration.
How is the TGA working with international regulators?
The TGA is part of a network of international regulators that meet regularly to discuss the development of COVID-19 vaccines. We will utilise our work-sharing arrangements with comparable international regulators to expedite the evaluation of any new vaccines without compromising on our strict standards of safety, quality and effectiveness.
How will a COVID-19 vaccine be monitored once it’s rolled out?
The TGA monitors vaccines for ongoing safety after they are supplied in Australia. Vaccines, like medicines, can have side effects. Some people experience minor side effects following vaccination, such as mild fever or pain, redness, or swelling at the injection site. Serious side effects from vaccines, like allergic reactions, are very rare.
The TGA has robust procedures in place to investigate any potential new safety issues to help ensure that all vaccines available in Australia meet our rigorous safety standards. We work closely with clinical experts through our Advisory Committee on Vaccines (ACV), state and territory health departments and other expert bodies, such as the National Centre for Immunisation Research and Surveillance (NCIRS). We notify the community of safety concerns by publishing alerts on our website.
We are reviewing and enhancing our vaccine safety monitoring system so that we can rapidly detect, investigate and respond to any emerging safety issues identified for COVID-19 vaccines.
Our post-market monitoring relies on a number of tools including:
- requiring sponsors to have risk management plans describing the activities they will undertake to monitor and minimise risks associated with the vaccines they supply
- reviewing and analysing adverse events reported by health professionals and consumers
- working with international regulators to share information about emerging safety issues
- reviewing medical literature, media and other potential sources of new safety information.
The vaccine sponsor (usually a pharmaceutical company) also has legal obligations to monitor, collect, manage and report on safety data, known collectively as their pharmacovigilance responsibilities. The TGA assesses sponsors’ compliance with their pharmacovigilance responsibilities through the Pharmacovigilance Inspection Program.