National Health Amendment (Passive Immunological Products) Bill 2026

The majority voted against an amendment introduced by One Nation, which means it failed. The amendment would have required all vaccines to be tested against an inert saline placebo in order to fall under the definition of ‘vaccine’.

Why aren't placebo-controlled trials always conducted?

According the John Hopkins Bloomberg School of Public Health:

While placebo-controlled trials are often considered the gold standard for evaluating medical interventions, the use of inert placebos (e.g., the injection of saline solution) is not always required for vaccine trials and in fact is sometimes unethical. Trials of new vaccines may instead use comparison groups that receive the current vaccine or another established vaccine so that children receive some benefit from participating, as it would be unethical to withhold an established vaccine with demonstrated effectiveness. For example, if a hypothetical new measles vaccine were being tested, it would be unethical to withhold established measles vaccines and leave children vulnerable to disease. In this case, one group of children would receive the new vaccine, while the comparison group would receive the current measles vaccine.

Other vaccine trials may involve the use of placebos that contain vaccine components, such as adjuvants or stabilizers, but not the target antigen. By including almost all the same ingredients as the vaccine, researchers can determine if potential side effects are due to the antigen itself or one of the other ingredients.

Rebellion

South Australian Senator Alex Antic (Liberal) crossed the floor to vote "Yes" against the rest of the Liberal Party.

Amendment text

(1) Schedule 1, page 3 (after line 8), at the end of the Schedule, add:

2 Subsection 9B(7)

After "unless", insert "the vaccine has been tested against an inert saline placebo to international standard ICH E6(R3), titled Guideline for Good Clinical Practice, adopted by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use on 6 January 2025, and".

3 At the end of subsection 9B(7)

Add:

Note: The text of Guidelines adopted by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) could in 2026 be accessed through the ICH's website (https://www.ich.org/).