National Health (Immunisation Program – Designated Vaccines) Variation Determination 2012 (No. 1)[1]

National Health Act 1953

I, JULIANNE QUAINE, Delegate of the Minister for Health, make this Determination under subsections 9B (2) and (5) of the National Health Act 1953.

Dated             4 October 2012

 

 

 

 

 

 

 

 

JULIANNE QUAINE

Assistant Secretary

Health Protection Programs Branch

Department of Health and Ageing

Delegate of the Minister for Health


1 Name of Determination

This Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2012 (No. 1).

2 Commencement

 This Determination will commence on the day after it is registered on Federal Register of Legislative Instruments.

3 Variation of National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No 1)

Schedule 1 varies the National Health (Immunisation Program – Designated     Vaccines) Determination 2012 (No 1)

Schedule 1 Variations

[1] Subsection 7(1)

omit

 109

substitute

 110

[2] Subsection 7(2)

omit

 111

substitute

 112

[3] Subsection 7(3)

omit

 112

substitute

 113

 

 [4]  Schedule 1

omit

 Part 1  

substitute

 

Part 1 Bacterial vaccines

Item

Vaccine and the circumstances in which vaccine may be provided

Brand

Formulation

Active ingredient and strength

Number and timing of doses

101

Vaccine

Diphtheria, tetanus and pertussis (adult/adolescent)

Circumstances

Vaccine may be provided to a child who is at least 10 years but less than 18 years old.

Boostrix

Injection (0.5mL)

Each of the following:

 (a) diphtheria toxoid — not less than 2 IU;

 (b) tetanus toxoid — not less than 20 IU;

 (c) PT — 8 µg;

 (d) FHA — 8 µg;

 (e) PRN — 2.5 µg

1 dose (booster)

102

Vaccine

Diphtheria, tetanus and pertussis (adult/adolescent)

Circumstances

Vaccine may be provided to a child who is at least 10 years but less than 18 years old.

Adacel

Injection (0.5mL)

Each of the following:

 (a) diphtheria toxoid — not less than 2 IU;

 (b) tetanus toxoid — not less than 20 IU;

 (c) PT — 2.5 µg;

 (d) FHA — 5 µg;

 (e) PRN — 3 µg

 (f) FIM 2+3 — 5 µg

1 dose (booster)

103

Vaccine

Haemophilus influenzae type b (Hib) (monovalent PRPT)

Circumstances

Vaccine may be provided to a child who is about 12 months old.

ActHib or Hiberix

Refrigerated lyophilised preparation for injection (0.5mL) with separate diluent

Purified Hib capsular polysaccharide conjugated to tetanus toxoid — 10 µg

1 dose (booster)

104

Vaccine

Haemophilus influenzae type b (Hib) (monovalent PRPOMP)

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 12 months old.

 

Pedvax

Vial for injection (0.5mL)

Purified Hib capsular polysaccharide conjugated to meningococcal protein — 7.5 µg

3 doses

105

Vaccine

Haemophilus influenzae type b (Hib) and Meningococcal C

Circumstances

Vaccine may be provided to a child who is about 12 months old.

Menitorix

Refrigerated lyophilised preparation for injection (0.5mL) with separate diluent

Each of the following :

(a) Hib capsular polysaccharide conjugated to tetanus toxoid- 5 µg

(b) Group C meningococcal polysaccharide conjugated to tetanus toxoid- 5 µg

1 dose

106

Vaccine

Meningococcal C (conjugate)

Circumstances

Vaccine may be provided:

 (a) to a child who is about 12 months old; or

 (b) in the period commencing on 1 January 2006 and ending at the end of 30 June 2007, to a person:

 (i) who, on 1 January 2003, was at least 1 year but less than 20 years of age; and

 (ii) who has not received a vaccine mentioned in this item or item 106 or 107

Meningitec

Injection (0.5mL)

Meningococcal group C oligosaccharide conjugated to diphtheria protein — 10 µg

1 dose

107

Vaccine

Meningococcal C (conjugate)

Circumstances

Vaccine may be provided:

 (a) to a child who is about 12 months old; or

 (b) in the period commencing on 1 January 2006 and ending at the end of 30 June 2007, to a person:

 (i) who, on 1 January 2003, was at least 1 year but less than 20 years of age; and

 (ii) who has not received a vaccine mentioned in this item or item 105 or 107

Menjugate

Refrigerated lyophilised preparation for injection (0.5mL) with separate diluent

Meningococcal group C oligosaccharide conjugated to diphtheria protein — 10 µg

1 dose

108

Vaccine

Meningococcal C (conjugate)

Circumstances

Vaccine may be provided:

 (a) to a child who is about 12 months old; or

 (b) in the period commencing on 1 January 2006 and ending at the end of 30 June 2007, to a person:

 (i) who, on 1 January 2003, was at least 1 year but less than 20 years of age; and

 (ii) who has not received a vaccine mentioned in this item or item 105 or 106

NeisVacC

Injection (0.5mL)

Meningococcal group C oligosaccharide conjugated to tetanus toxoid protein — 10 µg

1 dose

109

Vaccine

Pneumococcal (conjugate, 7valent)

Circumstances

Vaccine may be provided to:

 (a) a child who is about 2, 4 or 6 months old; or

 (b) a child who is about 12 months of age and is a member of a medical risk group

Prevenar

Injection (0.5mL)

Polysaccharides of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F conjugated to diphtheria protein — 2 µg of each of serotypes 4, 9V, 14, 18C, 19F and 23F, and 4 µg of serotype 6B

3 or 4 doses

110

Vaccine

Pneumococcal (conjugate, 13valent)

Circumstances

Vaccine may be provided:

(a)    to a child who is about 2, 4 or 6 months old; and

(b)    to a child who is about 12 months of age and is a member of a medical risk group; or

(c)    Vaccine may be provided in the circumstances set out in subsection 7 (1)

Prevenar 13

Injection (0.5mL)

Polysaccharides of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - 2.2 µg of each of serotype, and 4.4 μg of serotype 6B

3 or 4 doses for a primary course

or a single supplementary dose.

111

Vaccine

Pneumococcal (conjugate, 10valent)

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 6 months old, or 18 months old.

Synflorix

Injection (0.5mL)

Polysaccharides of Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14 and 23F conjugated to protein D (a surface protein from non-typeable Haemophilus influenzae), serotype 18C conjugated to tetanus toxoid protein and serotype 19F conjugated to diptheria toxoid protein – 1 µg of each 1, 4, 6B, 7F, 9V, 14 and 23F and 3 µg of 4, 18C and 19F.

 

4 dose

112

Vaccine

Pneumococcal (polysaccharide, 23valent)

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (2)

PneumoVax 23

Injection (0.5mL)

Polysaccharides of Streptococcus pneumoniae serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F — 25 µg of each serotype

1 to 3 doses

113

Vaccine

Q fever

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (3)

QVax

Injection (0.5mL)

Killed Coxiella burnetii 25 µg

1 dose

 

 [6] Schedule 1, Part 2, Item 212 

  omit

   female

  substitute

   person

[7] Schedule 1, Part 2, Item 212 

  omit

  (b) a female who, between 1 March 2007 – 30 June 2009, is at least 13 years old but less than 27 years old and has received at least one before 1 July 2009.

  substitute

  (b) A male who, between 1 February 2013 and 31 December 2015, is at least 13 years old but less than 16 years old.

 

 

 

 

 

 

 

 

 

 

 


[1]Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.