EXPLANATORY STATEMENT
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2026
Purpose and operation
The National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2026 (the Amendment Determination) amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) (the Determination) to list Capvaxive as a designated vaccine for the prevention of pneumococcal disease in:
- at-risk adults who are at least 18 years of age;
- Aboriginal and Torres Strait Islander adults who are at least 25 years of age;
- all adults who are at least 65 years of age; and
- a person is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan).
These amendments act on recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI) and the Pharmaceutical Benefits Advisory Committee (PBAC).
Listing of Capvaxive
In November 2025, the PBAC recommended adding Capvaxive as a designated vaccine on the National Immunisation Program (the NIP) for the prevention of pneumococcal disease in adults who are either at least 18 years of age and have one or more specified medical risk conditions; who are an Aboriginal person or Torres Strait Islander and are at least 25 years of age; or who are at least 65 years of age.
In July 2022, PBAC recommended listing Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. In May 2025, PBAC further recommended the listing Empavali (pegcetacoplan) to allow the initial treatment with pegcetacoplan. Individuals undergoing treatment or those who will commence treatment with Empavali are at serious risk of infection caused by encapsulated bacteria and would need access to currently listed vaccines for pneumococcal.
Background
The National Immunisation Program (NIP)
The NIP is a joint initiative of the Commonwealth and State and Territory governments and is funded through a National Partnership on Essential Vaccines. The NIP provides free vaccines to eligible people, including children, adolescents, the elderly, pregnant women, and Aboriginal and Torres Strait Islander people.
PBAC recommendations
Subsection 9B(7) of the National Health Act 1953 (the Act) relevantly provides that a vaccine must not be specified in a determination under subsection 9B(2) of the Act unless the PBAC has recommended to the Minister that the vaccine be a designated vaccine.
Authority
Subsection 9B(1) of the Act provides that the Minister may provide, or arrange for the provision of, designated vaccines and goods or services that are associated with, or incidental to, the provision or administration of designated vaccines.
Subsection 9B(2) provides that the Minister may, by legislative instrument, determine that a specified vaccine is a designated vaccine for the purposes of the Act.
Reliance on subsection 33(3) of the Acts Interpretation Act 1901
Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.
Commencement
The Amendment Determination commences on the day after it is registered.
Consultation
The PBAC’s membership structure facilitates a formal and continuing process of consultation with interested parties. The PBAC is an independent expert body established under section 100A of the Act, which makes recommendations to, and advises the Minister about, the determination of specified vaccines as designated vaccines under section 9B of the Act for the purposes of the NIP. The PBAC members are appointed from nominations by organisations and associations representing industry, consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications or experience in a field relevant to the functions of the PBAC that would enable them to contribute meaningfully to the deliberations of the PBAC.
When recommending the listing of a designated vaccine on the NIP and the circumstances in which the vaccine should be provided, the PBAC considers the target population for which the vaccine has been approved for use in Australia and its clinical effectiveness, safety and cost-effectiveness. The PBAC also receives advice from ATAGI regarding the clinical aspects of the disease and the vaccine.
Pharmaceutical companies are consulted throughout the process of the listing of their vaccine on the NIP and in relation to changes to those listings. This includes the company submission to the PBAC to have their vaccine listed, and involvement throughout the PBAC process.
As part of the PBAC process, patients, carers, members of the public, health professionals or members of consumer interest groups may provide comments and feedback on vaccines being considered by the PBAC via a web interface or in writing over a period of six weeks prior to PBAC meetings. These are provided to the PBAC for consideration alongside the company submission.
Further consultation on the Amendment Determination was not considered necessary due to the consultation already undertaken through the PBAC.
General
This Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
Details of this Amendment Determination are set out in Attachment A.
This Amendment Determination is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.
ATTACHMENT A
Details of the National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2026
Section 1 – Name
Section 1 provides that the name of the instrument is the National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2026.
Section 2 - Commencement
Section 2 provides that this instrument commences the day after it is registered.
Section 3 - Authority
Section 3 provides that this instrument is made under subsection 9B(2) of the National Health Act 1953.
Section 4 - Schedules
Section 4 provides that this instrument is amended as set out in Schedule 1.
Schedule 1 - Amendments
Schedule 1 amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination).
Item 1 – After subsection 7(1C)
Item 1 inserts a new subsection 7(1D) after subsection 7(1C) of the Determination to specify circumstances in which the designated vaccine Capvaxive may be provided to a person. This includes:
- A person who is at least 18 years of age and who has at least one medical condition that is listed in paragraph 7(1D)(a); or
- A person who is an Aboriginal person or Torres Strait Islander and who is at least 25 years of age; or
- A person who is at least 65 years of age; or
- A person who is undergoing treatment or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria.
Item 2 – After item 111B of the table in Part 1 of Schedule 1
Item 2 inserts new table item 111C in Part 1 of Schedule 1 to provide that Capvaxive, a vaccine for the prevention of pneumococcal disease in adults, is a designated vaccine for the purposes of the National Health Act 1953.
New table item 111C provides that 1 dose of Capvaxive may be provided to a person in one of the circumstances set out in new subsection 7(1D). A person should only receive one dose, even if they are eligible under more than one of the circumstances set out in subsection 7(1D).
For example, if a person is an Aboriginal person or Torres Strait Islander and is at least 18 years of age and has one of the medical conditions listed is paragraph 7(1D)(a), then they should not receive a second dose once they turn 25 years of age (noting they would then become eligible under paragraph 7(1D)(b)).
ATTACHMENT B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2026
This Disallowable Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Disallowable Legislative Instrument
The National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2026 (the Amendment Determination) amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) (the Determination) to list Capvaxive as a designated vaccine for the prevention of pneumococcal disease in:
- at-risk adults who are at least 18 years of age;
- Aboriginal and Torres Strait Islander adults who are at least 25 years of age;
- all adults who are at least 65 years of age; and
- a person is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan).
These amendments act on recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI) and the Pharmaceutical Benefits Advisory Committee (PBAC).
Listing of Capvaxive
In November 2025, the PBAC recommended adding Capvaxive as a designated vaccine on the National Immunisation Program (the NIP) for the prevention of pneumococcal disease in adults who are either at least 18 years of age and have one or more specified medical risk conditions; who are an Aboriginal person or Torres Strait Islander and are at least 25 years of age; or who are at least 65 years of age.
In July 2022, PBAC recommended listing Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. In May 2025, PBAC further recommended the listing Empavali (pegcetacoplan) to allow the initial treatment with pegcetacoplan. Individuals undergoing treatment or those who will commence treatment with Empavali are at serious risk of infection caused by encapsulated bacteria and would need access to currently listed vaccines for pneumococcal.
Human Rights Implications
The Amendment Determination engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The Amendment Determination supports the right to the attainment of the highest standard of health, by providing free access for eligible people to a designated vaccine and protecting individuals and the community against vaccine preventable disease.
Conclusion
The Amendment Determination is compatible with human rights because it promotes the right to health.
Dave McNally
Assistant Secretary
Immunisation Assessment, Systems & Access Branch
Health Security and Immunisation Division