EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health and Ageing
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.1)
Legislation
Subsection 9B(1) of the National Health Act 1953 (‘the Act’) states 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 this Act. Subsection 9B(5) provides that in addition to specifying a vaccine, a determination under subsection (2) may specify the circumstances in which the vaccine may be provided.
Purpose
The National Health (Immunisation Program - Designated Vaccines) Determination 2008 (No.2) (‘the Current Determination’) was made on 22 July 2008 and came into effect on 31 July 2008. It is now necessary for an additional vaccine to be specified as a designated vaccine under subsection 9B(2) in substitution for another vaccine that was designated previously, and for circumstances to be determined under subsection 9B(5) for the vaccine. The Current Determination is being revoked and re-made rather than amended.
Instrument Description
This determination is called the National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.1) (‘the New Determination’) and the only change from the provision of the Current Determination is in respect of:
This determination is called the National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.1) (‘the New Determination’) and the only change from the provision of the Current Determination is in respect of the designation of a new formulation of an existing vaccine against Human Rotavirus (Rotarix®). This change only affects the contents of Schedule 1.
The specification of the new liquid formulation of Rotarix® will allow it to be provided under the National Immunisation Program (the NIP). The new Human rotarvirus (live attenuated oral vaccine), oral suspension, 1.5ml in an oral applicator (Rotarix®) will be provided under the NIP in the same circumstances as the existing Rotarix® powder formulation:
2 doses:
(a) first dose given at 6 to 14 weeks of age;
(b) second dose given at 14 to 24 weeks of age
Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination under subsection 9B(2) unless Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister that it be a designated vaccine.
At an out of session meeting held in June 2008, the PBAC recommended listing of a new liquid formulation of Rotarix®, replacing the lyophilised formulation at the same price. This new formulation was registered by the Therapeutic Goods Administration (TGA) on 8 August 2008.
Impact and Effect
The likely impact and effect of this change is minimal. The change to a new liquid formulation of Rotarix® will allow for a direct oral administration of the 1.5ml dose in an oral applicator with a plunger stopper onto the inside of the infant’s cheek.
Currently, Rotarix® is presented as a white powder for reconstitution with a separately supplied diluent, and a transfer adapter. The syringe/oral plunger containing the diluent is attached to the vial of lyophilised powder via the transfer adapter, and following reconstitution the 1ml dose of the vaccine is administered orally via the syringe/oral plunger onto the inside of the infant’s cheek.
The new liquid formulation of Rotarix® will not require reconstitution or dilution, therefore administering Rotarix® will be safer and more efficient.
The New Determination is substantively identical to the Current Determination except for the specification of the change in formulation of Rotarix®.
Consultation
Positive recommendations made by PBAC in July 2008 were provided to the public via the Department of Health and Ageing website in August 2008, containing information pertaining to the PBAC recommendation to the listing of a new liquid formulation of human rotavirus under the NIP schedule. Letters will be sent to all relevant stakeholders to advise them of the change once the determination takes effect.
In addition, the new formulation and product information of Rotarix® was registered and approved by TGA in August 2008.