The Therapeutic Goods Administration (TGA) is responsible for assessing vaccines and other medicines before they can be used in Australia. We only register a vaccine for use in Australia if its benefits are much greater than its risks.
What is a vaccine?
Vaccines are medicines that protect you against specific diseases, such as measles, influenza (flu) or whooping cough. Vaccination is the act of receiving a vaccine. In most cases, this involves having the vaccine injected with a needle, in other cases, vaccines can be administered orally or as a nasal spray.
Vaccines can contain:
- dead viruses or bacteria
- severely weakened forms of viruses or bacteria
- small, purified components of viruses or bacteria
- messenger RNA (mRNA).
After receiving a vaccine, your body's immune system can remember the virus or bacterium and fight off an infection much more effectively than if it was encountering the virus or bacterium for the first time.
Vaccines protect you and the people around you from serious and life-threatening diseases. There are some people in the community who cannot be vaccinated because they are too young or too sick. Widespread vaccination helps protect these people by making it more difficult for a disease to spread.
Some people experience minor side effects following vaccination, such as mild fever or pain, redness, or swelling at the injection site. Serious side effects, like allergic reactions, are very rare.
The TGA assesses vaccines before they can be used in Australia
The TGA rigorously assesses vaccines for safety, quality and efficacy before they can be used in Australia. Vaccines receive the same high level of scrutiny as other prescription medicines and related therapeutic goods.
We use the best available scientific evidence to assess the risks and benefits of each vaccine. Our evidence requirements are based on international guidelines developed by the European Medicines Agency.
Clinical trials are a key part of the scientific evidence that we review during the assessment of a new vaccine. A clinical trial is a scientific study where a promising new medicine is given to a group of people to assess its risks and benefits.
We carefully assess the results of clinical trials and the way in which the trials were conducted. We require well-designed trials of a sufficient length with a sufficient number of people who represent the people for whom the vaccine is intended. The results must demonstrate that the benefits of the vaccine greatly outweigh the risks.
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.
TGA decisions are informed by independent advice
The TGA's decision of whether to register a vaccine for use in Australia is informed by the advice of the Advisory Committee on Vaccines (ACV).
The ACV is an independent committee appointed by the Australian Government Minister for Health. It is composed of members with expertise in science, medicine and public health.
The ACV complements our expertise in the TGA, ensuring that our assessments of vaccines are as robust as possible.
The TGA monitors vaccines after they are supplied in Australia
The TGA monitors vaccines for safety after they are supplied in Australia. If you experience an adverse event (side effect) from a vaccine, you should seek assistance from a health professional and report the adverse event to the TGA.
We receive adverse event reports from consumers, health professionals, the companies who supply vaccines, and state and territory health departments. We publish these reports in the publically available Database of Adverse Event Notifications (DAEN).
Reporting serious adverse events is mandatory for the companies who supply vaccines in Australia. These companies must also develop and implement risk management plans for their vaccines.
Our laboratories also help monitor vaccine safety. Alongside assessing the quality of all vaccine batches before they are supplied in Australia, our laboratories may also test the quality of selected vaccine batches after they are supplied in Australia. Laboratory testing results are published on our website.
If we suspect there is a problem with a vaccine, we will launch an investigation. In some cases, this could mean suspending the use of a vaccine during the investigation. We notify the community of safety concerns through the publication of alerts on our website.
Where can I find more information?
- The Australian Government Department of Health immunisation page includes information on getting vaccinated, vaccine safety, the National Immunisation Schedule and other topics. You can also call the National Immunisation Hotline on 1800 671 811.
- The Australian Government Department of Health 'Get the facts' website includes additional information about vaccinating your children.
- The NPS Medicinewise website includes information about vaccines and other medicines in the consumer information section. You can also call their Medicines Line on 1300 MEDICINE (1300 633 424).
- The National Centre for Immunisation Research and Surveillance (NCIRS) website includes a range of vaccine information, including factsheets on vaccine preventable diseases and vaccine safety.
- The Australian Academy of Science website includes information on the science of immunisation.
Frequently asked questions
Does the TGA consider all of the ingredients in a vaccine before registering it for use?
Yes. The TGA considers the safety, quality and efficacy of every ingredient in a vaccine before we register the vaccine for use in Australia.
Vaccines contain an active ingredient from the target virus or bacterium. They also contain other ingredients for particular purposes, such as stimulating the body's immune response and stabilising the vaccine during storage. The TGA assesses all of these ingredients for safety, quality and efficacy before the vaccine can be used in Australia.
Are there any differences in the registration process for seasonal flu vaccines?
Yes. The registration process has been customised to ensure timely availability of seasonal influenza (flu) vaccines.
The composition of seasonal flu vaccines changes every year because there are new strains of flu viruses every year. This short timeframe means that it is not practical to conduct clinical trials for annual virus updates to seasonal flu vaccines. To ensure timely availability of seasonal flu vaccines, the TGA does not require clinical trial data for annual virus updates for vaccines that are already on the Australian Register of Therapeutic Goods (ARTG). We take this approach because there have been many years of safe and effective use of seasonal flu vaccines in several million people. This registration process only applies for seasonal flu vaccines where the manufacturing process is the same as a previously registered vaccine and the only change is to the strains of virus.
The Australian Influenza Vaccine Committee (AIVC) provides advice to the TGA on the composition of the seasonal influenza vaccine to be supplied in Australia. AIVC recommendations are published on our website.