Each country has its own process for making vaccine recommendations.

Before any vaccine can be used in Australia, it must be approved by the Therapeutic Goods Administration (TGA)

The TGA checks each vaccine to make sure it meets strict standards for quality, safety and effectiveness. If these standards are met, the vaccine is legally approved for use and listed on the Australian Register of Therapeutic Goods.

The Australian Technical Advisory Group on Immunisation (ATAGI) then reviews evidence from clinical trials, scientific studies and real-world data to determine how the vaccine should be used.

Based on the review, ATAGI makes recommendations to government about:

  • who should receive the vaccine
  • when and how often the vaccine should be given
  • which groups should be prioritised. 

These recommendations are reviewed by the National Health and Medical Research Council and included in the Australian Immunisation Handbook, which immunisation providers use to make decisions in consultation with their patients.

Last updated September 2025