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.
H‑B‑Vax 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)
Engerix‑B
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.
H‑B‑Vax 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.
M‑M‑R 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 D‑antigen units;
  (b)  type 2 (MEF‑1) — 8 D‑antigen units;
   (c)  type 3 (Saukett) — 32 D‑antigen 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 varicella‑zoster 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 varicella‑zoster 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

 
[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.comlaw.gov.au