National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2020 (Cth)

National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No.2) 2020

I, Hope Peisley, delegate of the Minister for Health, make the following Determination.

Dated 2 June 2020

Hope Peisley

Assistant Secretary

Immunisation Branch

Office Of Health Protection

Chief Medical Officer Group

Department of Health  

Contents

1  Name........................................................................................................................................ 2

2  Commencement........................................................................................................................ 2

3  Authority.................................................................................................................................. 2

4  Schedules................................................................................................................................. 2

Schedule 1—Amendments  3

National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1)      3

1  Name

This instrument is the National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2020.

2  Commencement

(1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	The day after this instrument is registered.

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

This instrument is made under subsections 9B(2) and (5) of the National Health Act 1953.

4  Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1)

1  After subsection 7(12)

Insert:

(13)  For item 114 of Schedule 1, a designated vaccine mentioned in that item may be provided in the following circumstances:

(a)    the following number of doses and booster doses may be provided to a person who is an Aboriginal and Torres Strait Islander:

(i)if aged at least 2 months of age at start of vaccine course – 2 primary doses with at least 8 weeks between doses and a booster aged at least 12 months;

(ii)if aged under 2 years of age at start of vaccine course and the person has not received a dose of the vaccine under subparagraph (i) – 2 primary doses with at least 8 weeks between doses and a booster at least 8 months after the second dose was provided;

(b)   a person who is an Aboriginal and Torres Strait Islander; and

(i)who has one of the following medical conditions known to increase the risk of Invasive Meningococcal Disease (IMD):

(A)    defects in, or deficiency of, complement components, including factor H, factor D or properdin deficiency; or

(B)     current or future treatment with eculizumab (a monoclonal antibody directed against complement component C5); or

(C)     functional or anatomical asplenia, including sickle cell disease or other haemoglobinopathies, and congenital or acquired asplenia; or

(D)    HIV, regardless of disease stage or CD4⁺ cell count; or

(E)     haematopoietic stem cell transplant;

(ii)may be provided the following number of doses and booster doses:

(A)    if aged at least 2 months of age at start of vaccine course – 3 primary doses with at least 8 weeks between doses and a booster aged at least 12 months;

(B)     if aged under 2 years of age at start of vaccine course  – 3 primary doses with at least 8 weeks between doses and a booster at least 6 months after the third dose was provided;

(c)    The following number of doses and booster doses may be provided to a person who has congenital or acquired asplenia (e.g. splenectomy) or hyposplenia, a person who has complement deficiency or a person undergoing eculizumab treatment:

(i)if aged 6 weeks to 5 months of age at start of vaccine course – 3 primary doses with at least 8 weeks between doses and a booster dose aged at least 12 months;

(ii)if aged between 6 and 11 months at start of vaccine course – 2 primary doses with at least 8 weeks between doses and a booster dose aged at least 12 months;

(iii)if aged at least 12 months of age at start of vaccine course – 2 primary doses with at least 8 weeks between doses.

2Part 1 of Schedule 1 (after table item 113)

Insert:

114 Vaccine
Multicomponent meningococcal group B (4CMenB)
Circumstances
Vaccine may be provided in the circumstances set out in subsection 7 (13) Bexsero Injection (0.5mL) 50 µg Neisseria meningitidis serogroup B Neisseria heparin binding antigen fusion protein
50 µg Neisseria meningitidis serogroup B Neisseria adhesion A protein
50 µg Neisseria meningitidis serogroup B factor H binding protein fusion protein
25 µg outer membrane vesicles from Neisseria meningitidis serogroup B strain NZ98/254 (measured as amount of total protein containing the PorA P1.4) As described in subsection 7(13)