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At the Therapeutic Goods Administration (TGA), we regulate annual influenza (flu) vaccines. These vaccines help protect people against the flu virus. Flu vaccines change each year because the virus constantly changes. We decide which flu strains are covered in the vaccines for Australia.
About the flu virus
The flu virus infects the throat, nose, airways and sometimes the lungs. It can cause mild to severe illness including death. You may end up in hospital. Visit the healthdirect website to learn more about flu including symptoms and treatment.
How flu vaccines work
Being immunised is the process of having a vaccine to become immune (resistant) to an infection or disease. Vaccines produce an immune response in the body without causing illness. When you get a vaccine your immune system responds and creates antibodies to protect you against future infection. You then create and retain a memory of an antibody designed to:
- recognise and fight that virus
- rapidly release thousands of copies the next time it meets the same virus.
Your immune system then skips the process of making a new antibody when seeing this infection or disease in the future. This means it can act much faster and prevent infections before they start causing symptoms. Visit the Department of Health and Aged Care website to learn more about:
Why we have a new flu vaccine each year
The flu virus may change over the year. As it changes, your immune system may not recognise it. That’s why we review and update the vaccine composition before each flu season. The vaccines are updated to fight the flu strains research shows will be common that year.
How we choose vaccine composition
To decide which flu strains to include in Australia’s flu vaccines we:
- take advice from the Australian Influenza Vaccine Committee (AIVC) which considers World Health Organization flu vaccine composition recommendations
- analyse data on virus circulation in Australia.
Read about the Influenza vaccine: Influenza vaccine: the annual Southern Hemisphere influenza vaccine production and the regulatory approval timeline.
We regulate all flu vaccines for use in Australia. They must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. This also applies to imported and exported flu vaccines.
To enter a vaccine into the ARTG, manufacturers or sponsors must provide data to us about the vaccine. We evaluate this data to ensure the benefits outweigh the risks.
The data we get about a vaccine supports the vaccine’s:
- quality
- safety
- efficacy.
Efficacy means that a product does what it claims to do.
Testing program
We test vaccines before we approve them for release into Australia. This includes assessing each batch of vaccine for its:
- production data
- quality control data
- sterility
- potency.
Vaccine legislation
We regulate all flu vaccines for use in Australia under the Therapeutic Goods Act 1989.
Reporting a vaccine side effect
If you experience an unexpected side effect from the flu vaccine, you should:
- speak to a health professional
- report the side effect to us.
Your report helps us learn more about unknown side effects. Find out how to report a problem or side effect.