National Health (Immunisation Program – Designated Vaccines) Variation Determination 2012 (No. 3)[1]
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
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
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 |
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