National Health (Immunisation Program – Designated Vaccines) Variation Determination 2012 (No. 3)[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             21 December 2012

 

 

 

 

 

 

 

 

JULIANNE QUAINE

Assistant Secretary

Immunisation 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. 3).

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) as amended.

 

Schedule 1 Variations

[1] subsection 7(5)

 

 omit

206

 

 substitute

207

 

[2] section 7

 

insert

 (6) For item 206 of Schedule 1, a designated vaccine mentioned in those items may be provided to:

 (a) a person who is at least 65 years; or

 (b) an Aboriginal and Torres Strait Islander person who is at least 15 years; or

 (c) a person who is at least 5 years

 (i) who:

 (A) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or

 (B) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or

 (C) has another chronic illness requiring regular medical follow-up or hospitalisation in the preceding year, including diabetes mellitus, chronic metabolic diseases, chronic renal failure, haemoglobinopathies and impaired immunity (including drug-induced immune impairment); or

 (D) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or

 (E) has impaired immunity, including HIV infection; or

 (F) is aged 5 to 10 years and is receiving long-term aspirin therapy; or

 (G) is pregnant.

 

[3] Schedule 1

omit

 Part 2  

substitute

Part 2 Viral vaccines

 

Item

Vaccine and the circumstances in which vaccine may be provided

Brand

Formulation

Active ingredient and strength

Number and timing of doses

201

Vaccine

Hepatitis A (monovalent)

Circumstances

Vaccine may be provided to a child:

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

 (b) who is at least 1 year old but less than 5 years of age; and

 (c) who lives in Queensland, Western Australia, South Australia or the Northern Territory

VAQTA Paediatric/ Adolescent

Injection (0.5mL)

Hepatitis A virus protein — 25 units of the hepatitis A virus protein

2 doses, with the second dose given 6 months after the first dose

202

Vaccine

Hepatitis B (monovalent adult)

Circumstances

Vaccine may be provided to a child who is at least 10 years old but less than 14 years of age.

HBVax II

Vial for injection (1mL)

Hepatitis B surface antigen protein 10 µg

2 doses, with the second dose given 4 to 6 months after the first dose

203

Vaccine

Hepatitis B (monovalent paediatric)

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (4)

EngerixB

Vial for injection (0.5mL)

Hepatitis B surface antigen protein 10 µg

1 dose or 3 doses

204

Vaccine

Hepatitis B (monovalent paediatric)

Circumstances

Vaccine may be provided to a newborn infant as soon as practicable after birth but no later than 7 days after birth.

HBVax II

Vial for injection (0.5mL)

Hepatitis B surface antigen protein 5 µg

1 dose

205

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (5)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaxigrip or Influvac or Fluarix

Injection (0.5mL)

 

 

For children older than 6 months but less than 9 years, 2 doses at least 1month apart for the first vaccination and 1 dose per calendar year after that. For persons 9 years and above, 1 dose per calendar year.

Note – For children aged between 6 months and less than 3 years the dose is 0.25ml

206

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (6)

 

Fluvax

Injection (0.5mL)

 

 

For children older than 5 years but less than 9 years, 2 doses at least 1 month apart for the first vaccination and 1 dose per calendar year after that. For persons 9 years and above, 1 dose per calendar year.

207

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (5)

Vaxigrip Junior

Injection (0.25mL)

 

For children older than 6 months but less than 3 years, 2 doses at least 1 month apart for the first vaccination and 1 dose per calendar year after that.

208

Vaccine

Measles, mumps and rubella

Circumstances

Vaccine may be provided to a child who is about 12 months old or 4 years of age.

MMR II

Refrigerated lyophilised preparation for injection (0.5mL)

Each of the following live attenuated viruses:

 (a) measles virus (Edmonston strain) — 1000 TCID50;

 (b) mumps virus (Jeryl Lynn strain) — 5000 TCID50;

 (c) rubella virus (Wistar RA 27/3 strain) — 1000 TCID50

2 doses

209

Vaccine

Measles, mumps and rubella

Circumstances

Vaccine may be provided to a child who is about 12 months old or 4 years of age.

Priorix

Refrigerated lyophilised preparation for injection (0.5mL)

Each of the following live attenuated viruses:

 (a) measles virus (Schwarz strain) — 103.0 CCID50;

 (b) mumps virus (RIT 4385 derived from the Jeryl Lynn strain) — 103.7 CCID50;

 (c) rubella virus (Wistar RA 27/3 strain) — 103.0 CCID50

2 doses

210

Vaccine

Measles, mumps, rubella and varicella

Circumstances

The Vaccine may be provided to a child who is about 18 months of age

Priorix-Tetra

Powder for injection vial with diluent syringe (0.5mL)

Each of the following live attenuated viruses:

(a)    measles virus (Schwarz strain) – 103.0 CCID50

(b)    mumps virus (RIT 4385 strain,derived from Jeryl Lynn strain) - 104.4CCID50

(c)    rubella virus (Wistar RA 27/3 strain) – 103.0 CCID50

(d)   varicella virus (Oka strain) - 103.3 PFU

1 dose

211

Vaccine

Poliomyelitis

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 6 months old or 4 years of age, if all other vaccines containing poliovirus are unsuitable

IPOL

Injection (0.5mL)

Each of the following killed whole polioviruses:

 (a) type 1 (Mahoney) — 40 Dantigen units;

 (b) type 2 (MEF1) — 8 Dantigen units;

 (c) type 3 (Saukett) — 32 Dantigen units

No more than 4 doses

212

Vaccine

Varicella

Circumstances

Vaccine may be provided to:

 (a) a child who is about 18 months old; or

 (b) a child who is at least 10 years old but less than 14 years of age, if the child:

 (i) has not had varicella; and

 (ii) has not been vaccinated against varicella.

Varilrix

Refrigerated lyophilised preparation for injection (0.5mL)

Live attenuated Oka strain of the varicellazoster virus — 103.3 PFU

1 dose

213

Vaccine

Varicella

Circumstances

Vaccine may be provided to:

 (a) a child who is about 18 months old; or

 (b) a child who is at least 10 years old but less than 14 years of age, if the child:

 (i) has not had varicella; and

 (ii) has not been vaccinated against varicella.

Varivax Refrigerated

Refrigerated lyophilised preparation for injection (0.5mL)

Live attenuated Oka/Merck strain of the varicellazoster virus — at least 1350 PFU

1 dose

214

Vaccine

Human papillomavirus (HPV)

Circumstances

Vaccine may be provided to:

 (a) a person who is at least 12 years old but less than 14 years of age; or

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

Gardasil

Injection (0.5mL)

Each of the following:

 (a) HPV 6 L1 protein — 20 µg;

 (b) HPV 11 L1 protein — 40 µg;

 (c) HPV 16 L1 protein — 40 µg;

 (d) HPV 18 L1 protein — 20 µg

3 doses

215

Vaccine

Human papillomavirus (HPV)

Circumstances

Vaccine may be provided to:

a female who is at least 12 years old but less than 14 years of age.

Cervarix

Injection (0.5mL)

Each of the following:

(a)   HPV 16 L1 protein - 20μg; 

(b)   HPV 18 L1 protein - 20μg 

 

3 doses

216

Vaccine

Rotavirus

Circumstances

Vaccine may be provided to a child who:

 (a) is about 2 or 4 months old.

Rotarix

Oral suspension (1.5mL) in oral applicator

Human rotavirus vaccine, live attenuated, RIX 4414 strain (G1P[8]) — not less than 106 CCID50

2 doses:

 (a) first dose given at 6 to 14 weeks of age;

 (b) second dose given at 14 to 24 weeks of age

217

Vaccine

Rotavirus

Circumstances

Vaccine may be provided to a child who:

 (a) is about 2, 4 or 6 months old.

RotaTeq

Oral solution (2.0mL)

Live pentavalent reassortant vaccine containing each of the following:

 (a) G1 — 2.2 x 106 IU;

 (b) G2 — 2.8 x 106 IU;

 (c) G3 — 2.2 x 106 IU;

 (d) G4 — 2.0 x 106 IU;

 (e) P1 (8) — 2.3 x 106 IU

3 doses:

 (a) first dose given at 6 to 14 weeks old;

 (b) second dose given at 14 to 24 weeks old;

   (c) third dose given before 32 weeks old

 

Note
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