EXPLANATORY STATEMENT
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2025
Purpose and operation
The National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2025 (the Amendment Determination) amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) (the Determination) to:
- list Fluzone, Flucelvax and Flublok as designated vaccines for influenza; and
- amend the circumstances for the currently listed influenza vaccine Vaxigrip to align with the Childhood Immunisation Schedule.
These amendments act on recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI) and the Pharmaceutical Benefits Advisory Committee (PBAC).
Transition of influenza vaccines
In late 2023, the World Health Organization (WHO) and the Australian Influenza Vaccine Committee recommended that the B/Yamagata lineage component of quadrivalent influenza vaccines was no longer necessary because the Yamagata lineage of the influenza B virus has not been detected globally since March 2020. The WHO recommended that trivalent vaccines be used in the 2024-25 influenza season in the Northern Hemisphere.
On 29 August 2024, ATAGI issued clinical advice that studies comparing egg-based quadrivalent vaccines with trivalent vaccines have shown no significant difference in safety and reactogenicity outcomes. ATAGI advised that effectiveness of the two types was largely comparable across all age groups.
In accordance with the WHO’s recommendations, companies supplying influenza vaccines for the National Immunisation Program are transitioning their existing quadrivalent formulations to trivalent formulations.
At the July 2025 PBAC meeting, PBAC recommended Fluzone, Flublok and Flucelvax containing trivalent formulations of influenza vaccines be designated vaccines as part of the transition, and also recommended specific changes to circumstances for currently designated trivalent influenza vaccine Vaxigrip to coincide with the Childhood Immunisation Schedule.
Listing of Fluzone
Fluzone is the trivalent influenza version of the currently designated quadrivalent influenza vaccine FluQuadri. The Amendment Determination lists Fluzone as a designated vaccine with the same circumstances that are listed for FluQuadri, which is specified under subsection 7(8) of the Determination.
Listing of Flucelvax
Flucelvax is the trivalent influenza version of the currently designated quadrivalent influenza vaccine Flucelvax Quad. The Amendment Determination lists Flucelvax as a designated vaccine with the same circumstances that are listed for Flucelvax Quad, which is specified under subsection 7(9A) of the Determination.
Listing of Flublok
The Amendment Determination lists trivalent influenza Flublok as a designated vaccine for people who are at least 65 years of age.
Amendment to Vaxigrip
The Amendment Determination amends the eligibility criteria for Vaxigrip to expand access to a child who is at least six months old but less than 5 years old, and to expand access to Aboriginal or Torres Strait Islander children who are between 5 and 14 years old. This change will align with the Childhood Immunisation Schedule which outlines the routine childhood immunisations recommended for all children in Australia.
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 involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. 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.
It was considered that further consultation on the Amendment Determination was unnecessary due to the nature of the consultation that had already taken place with 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) 2025
Section 1 – Name
Section 1 provides that the name of the instrument is the National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2025.
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 – Paragraph 7(5)(c)
Item 1 repeals paragraph 7(5)(c) and substitutes with new paragraphs to reference a person who is at least 6 months old under paragraph 7(5)(c), a person who is at least 6 months old but is less than 11 years old under paragraph 7(5)(d), and a person who is pregnant under paragraph 7(5)(e).
Subsection 7(5) specifies the circumstances in which the designated vaccines listed under items 205, 208, 209 and 210 of Schedule 1 of the Determination may be provided. This is an administrative change only to more clearly specify the existing eligibility cohorts under each separate paragraph.
Item 2 – Subsection 7(8)
Item 2 amends subsection 7(8) to omit the words “item 207A, 207B and 207F” and substitute it with “items 207A, 207B, 207F, 210B and 210C”.
Subsection 7(8) specifies the circumstances in which the designated vaccines listed under items 207A, 207B and 207F of Schedule 1 of the Determination may be provided. This changes amends subsection 7(8) to include the items 210B and 210C, which are for the influenza vaccines Vaxigrip and Fluzone respectively, into the subsection.
Item 3 – Subsection 7(9A)
Item 3 amends subsection 7(9A) to omit the words ‘item 210A’ and substitute it with ‘items 210A and 210D’. Subsection 7(9A) specifies the circumstances in which the designated vaccines listed in item 210A of Schedule 1 of the Determination may be provided.
This change amends subsection 7(9A) to include item 210D, which is the item for the influenza vaccine Flucelvax, into the subsection.
Item 4 – Part 2 of Schedule 1 (table item 205, column headed “Brand”)
Item 4 amends table item 205 in Part 2 of Schedule 1 for the designated vaccines Vaxigrip, Influvac and Fluarix to omit the words “Vaxigrip or”. This change removes the brand name “Vaxigrip” from item 205.
Item 5 – After item 210A of the table in Part 2 of Schedule 1
Item 5 inserts new table items 210B, 210C, 210D and 210E in Part 1 of Schedule 1 to provide that Vaxigrip, Fluzone, Flucelvax and Flublok, which are all vaccines for the prevention of influenza, are designated vaccines for the purposes of the National Health Act 1953.
Table item 210B inserts the influenza vaccine Vaxigrip and specifies that this vaccine may be provided in the circumstances set out in subsection 7(8) of the Determination. Table item 210B specifies that two doses at least one month apart for the first vaccination and subsequently one dose per calendar year after that can be provided to children who are at least 6 months but less than 9 years old. One dose per calendar year can provided to a person who is nine years old or older.
Table item 210C inserts the influenza vaccine Fluzone and specifies that this vaccine may be provided in the circumstances set out in subsection 7(8) of the Determination. Table item 210C specifies that two doses at least one month apart for the first vaccination and subsequently one dose per calendar year after that can be provided to children who are at least 6 months but less than 9 years old. One dose per calendar year can provided to a person who is nine years old or older.
Table item 210D inserts the influenza vaccine Flucelvax and specifies that this vaccine may be provided in the circumstances set out in subsection 7(9A) of the Determinaion. Table item 210D specifies that two doses at least one month apart for the first vaccination and subsequently one dose per calendar year after that can be provided to children who are at least 6 months but less than 9 years old. One dose per calendar year can be provided to a person who is at least nine years old but less than 65 years of age.
Table item 210E inserts the influenza vaccine Flublok and specifies that this vaccine may be provided to a person who is at least 65 years of age. Table item 210E specifies that one dose per calendar year can be provided to this age cohort.
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) 2025
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) 2025 (the Amendment Determination) amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) (the Determination) to:
- list Fluzone, Flucelvax and Flublok as designated vaccines for influenza; and
- amend the circumstances for the currently listed influenza vaccine Vaxigrip to align with the Childhood Immunisation Schedule.
These amendments act on recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI) and the Pharmaceutical Benefits Advisory Committee (PBAC).
Transition of influenza vaccines
In late 2023, the World Health Organization (WHO) and the Australian Influenza Vaccine Committee recommended that the B/Yamagata lineage component of quadrivalent influenza vaccines was no longer necessary because the Yamagata lineage of the influenza B virus has not been detected globally since March 2020. The WHO recommended that trivalent vaccines be used in the 2024-25 influenza season in the Northern Hemisphere.
On 29 August 2024, ATAGI issued clinical advice that studies comparing egg-based quadrivalent vaccines with trivalent vaccines have shown no significant difference in safety and reactogenicity outcomes. ATAGI advised that effectiveness of the two types was largely comparable across all age groups.
In accordance with the WHO’s recommendations, companies supplying influenza vaccines for the National Immunisation Program are transitioning their existing quadrivalent formulations to trivalent formulations.
At the July 2025 PBAC meeting, PBAC recommended Fluzone, Flublok and Flucelvax containing trivalent formulations of influenza vaccines be designated vaccines as part of the transition, and also recommended specific changes to circumstances for currently designated trivalent influenza vaccine Vaxigrip to coincide with the Childhood Immunisation Schedule.
Listing of Fluzone
Fluzone is the trivalent influenza version of the currently designated quadrivalent influenza vaccine FluQuadri. The Amendment Determination lists Fluzone as a designated vaccine with the same circumstances that are listed for FluQuadri, which is specified under subsection 7(8) of the Determination.
Listing of Flucelvax
Flucelvax is the trivalent influenza version of the currently designated quadrivalent influenza vaccine Flucelvax Quad. The Amendment Determination lists Flucelvax as a designated vaccine with the same circumstances that are listed for Flucelvax Quad, which is specified under subsection 7(9A) of the Determination.
Listing of Flublok
The Amendment Determination lists trivalent influenza Flublok as a designated vaccine for people who are at least 65 years of age.
Amendment to Vaxigrip
The Amendment Determination amends the eligibility criteria for Vaxigrip to expand access to a child who is at least six months old but less than 5 years old, and to expand access to Aboriginal or Torres Strait Islander children who are between 5 and 14 years old. This change will align with the Childhood Immunisation Schedule which outlines the routine childhood immunisations recommended for all children in Australia.
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
Planning and Assessment Support Branch
National Immunisation Division