National Health (Immunisation Program Designated Vaccines) Variation Determination 2013 (No. 1) (Cth)
National Health (Immunisation Program – Designated Vaccines) Variation Determination 2013 (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 17th May 2013
JULIANNE QUAINE
Assistant Secretary
Immunisation Branch
Department of Health and Ageing
Delegate of the Minister for Health
Name of Determination
This Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2013 (No. 1).
Commencement
This Determination will commence on the day after it is registered on Federal Register of Legislative Instruments.
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] section 7
omit
(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.
insert
(6) For item 206 of Schedule 1, a designated vaccine mentioned in that item may be provided to a person who is at least 65 years of age.
(7) For item 207 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.
[4] 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) | Intanza | Injection (0.1mL) | For persons aged 65 years and over. 1 dose per calendar year. | |
| 207 | Vaccine Influenza Circumstances Vaccine may be provided in the circumstances set out in subsection 7 (7) | 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. | |
| 208 | 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. | |
| 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. | 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 |
| 210 | 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 |
| 211 | Vaccine Measles, mumps, rubella and varicella Circumstances 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 |
| 212 | Vaccine Measles, mumps, rubella and varicella Circumstances Vaccine may be provided to a child who is about 18 months of age | ProQuad | Injection (0.5mL) | Each of the following live attenuated viruses: (a) measles virus derived from Enders’ attenuated Edmonston strain) – 103.0 TCID50 (b) mumps virus (Jeryl Lynn™ (B Level) strain) - 104.3TCID50 (c) rubella virus (Wistar RA 27/3 strain) – 103.0 TCID50 (d) Varicella-zoster virus (Oka/Merck strain) - 103.99 PFU | 1 dose |
| 213 | 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 |
| 214 | 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 |
| 215 | 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 |
| 216 | 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 |
| 217 | 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 |
| 218 | 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 |
| 219 | 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
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