National Health (Immunisation Program Designated Vaccines) Determination 2005 (Cth)
National Health (Immunisation Program — Designated Vaccines) Determination 2005
National Health Act 1953
I, TONY ABBOTT, Minister for Health and Ageing, make this Determination under subsections 9B (2) and (5) of the National Health Act 1953.
Dated 22 December 2005
TONY ABBOTT
Minister for Health and Ageing
Contents
1Name of Determination 2
2Commencement 2
3Definitions 2
4Designated vaccines 3
5Circumstances in which designated vaccines may be provided 3
6Circumstances in which designated vaccines may be provided — particular vaccines 3
Schedule 1Designated vaccines and circumstances in which vaccines may be provided 6
Part 1Bacterial vaccines 6
Part 2Viral vaccines 11
Part 3Combined bacterial and viral vaccines 15
Name of Determination
This Determination is the National Health (Immunisation Program — Designated Vaccines) Determination 2005.
Commencement
This Determination commences on the commencement of Part 1 of Schedule 1 to the National Health Amendment (Immunisation Program) Act 2005.
Definitions
µg means microgram.
Act means the National Health Act 1953.
CCID50 means cell culture infectious dose 50%, being the quantity of an infectious agent that when inoculated onto a number of susceptible cell cultures will infect 50% of the individual cultures.
FHA means filamentous haemagglutinin.
FIM 2+3 means fimbrial agglutinogens 2+3.
IU means International Unit.
member of a medical risk group means a person mentioned in any the following paragraphs:
(a) a person who has congenital immune deficiency (including symptomatic IgG subclass or isolated IgA deficiency) other than a person who requires monthly immunoglobulin infusion;
(b) a person who is receiving a course of:
(i) immunosuppressive therapy, including corticosteroid therapy equivalent to greater than 2mg/kg per day of prednisone for more than 2 weeks; or
(ii) radiation therapy;
if the person has sufficient immune reconstitution for a vaccine response to be expected;
(c) a person who has compromised splenic function because of:
(i) sickle haemoglobinopathies; or
(ii) congenital or acquired functional or anatomical asplenia;
(d) a person who has an HIV infection, either before or after the development of AIDS;
(e) a person who has:
(i) renal failure; or
(ii) relapsing or persistent nephrotic syndrome;
(f) a person who has Down’s syndrome;
(g) a person who has heart disease associated with cyanosis or cardiac failure;
(h) a person who was a premature infant and who has, or has had, chronic lung disease;
(i) a person who was born at less than 28 weeks gestation;
(j) a person who has cystic fibrosis;
(k) a person who has insulin‑dependent diabetes mellitus;
(l) a person who has proven or presumptive cerebrospinal fluid leak;
(m) a person who has an intracranial shunt;
(n) a person who has a cochlear implant.
PFU means plaque forming units.
PRN means pertactin.
PT means pertussis toxoid.
TCID50 means tissue culture infectious dose 50%, being the quantity of an infectious agent that when inoculated onto a number of susceptible tissue cultures will infect 50% of the individual cultures.
Designated vaccines
For subsection 9B (2) of the Act, a vaccine mentioned in column 2 of Schedule 1 is a designated vaccine.
Circumstances in which designated vaccines may be provided
For subsection 9B (5) of the Act, a designated vaccine mentioned in an item of Schedule 1 may be provided in the circumstances mentioned in that item.
Circumstances in which designated vaccines may be provided — particular vaccines
(1) For item 108 of Schedule 1, a designated vaccine mentioned in that item may be provided in the following circumstances:
(a) a first dose of the vaccine may be provided to a person:
(i) who is not an Aboriginal or a Torres Strait Islander; and
(ii) who is at least 65 years;
(b) a first dose of the vaccine may be provided to a person:
(i) who is an Aboriginal or a Torres Strait Islander; and
(ii) who is at least 15 years but less than 50 years; and
(iii) who:
(A) has heart disease; or
(B) has kidney disease; or
(C) has lung disease; or
(D) has asthma; or
(E) has diabetes; or
(F) has an immune compromising condition; or
(G) in the opinion of a medical practitioner, consumes alcohol excessively; or
(H) smokes tobacco;
(c) a first dose of the vaccine may be provided to a person:
(i) who is an Aboriginal or a Torres Strait Islander; and
(ii) who is at least 50 years; and
(iii) who has not received a dose of the vaccine under paragraph (b);
(d) a second dose of the vaccine may be provided to a person mentioned in paragraph (a), (b) or (c) 5 years after the first dose was provided to the person under paragraph (a), (b) or (c);
(e) a third dose of the vaccine may be provided to a person mentioned in paragraph (b) after the later of the following:
(i) the end of 5 years after the second dose was provided to the person under paragraph (d);
(ii) the person turns 50;
(f) a dose of the vaccine may be provided to a child:
(i) who is an Aboriginal or a Torres Strait Islander; and
(ii) who is at least 18 months but not more than 24 months; and
(iii) who lives in Queensland, Western Australia, South Australia or the Northern Territory;
(g) a dose of the vaccine may be provided to a child:
(i) who is at least 4 years but less than 6 years; and
(ii) who is a member of a medical risk group.
(2) For item 109 of Schedule 1, a designated vaccine mentioned in that item may be provided to a person:
(a) who is at least 15 years; and
(b) who is one of the following:
(i) an abattoir worker;
(ii) a sheep shearer;
(iii) a sheep, dairy or beef cattle farmer;
(iv) an employee of a sheep, dairy or beef cattle farmer;
(v) a member of the family of a sheep, dairy or beef cattle farmer who works on the sheep, dairy or beef cattle farm;
(vi) an employee of a tannery; and
(c) who has had a Q-Vax skin test and has received a negative result for that test; and
(d) who has had a Coxiella burnetii antibody serum study and has received a negative result for that study.
(3) For item 203 of Schedule 1, a designated vaccine mentioned in that item may be provided in the following circumstances:
(a) a dose of the vaccine may be provided to a newborn infant as soon as practicable after birth but no later than 7 days after birth;
(b) a first dose of the vaccine may be provided to a child who is at least 10 years but less than 14 years;
(c) a second dose of the vaccine may be provided to a child mentioned in paragraph (b) 1 month after the first dose was provided to the child under paragraph (b);
(d) a third dose of the vaccine may be provided to a child mentioned in paragraph (b) 5 months after the second dose was provided to the child under paragraph (c).
(4) For item 205 of Schedule 1, a designated vaccine mentioned in that item may be provided to:
(a) a person who is at least 65 years; or
(b) an Aboriginal or a Torres Strait Islander:
(i) who is at least 15 years but less than 50 years; and
(ii) who:
(A) has heart disease; or
(B) has kidney disease; or
(C) has lung disease; or
(D) has asthma; or
(E) has diabetes; or
(F) has an immune compromising condition; or
(G) in the opinion of a medical practitioner, consumes alcohol excessively; or
(H) smokes tobacco; or
(c) an Aboriginal or a Torres Strait Islander who is at least 50 years.
Schedule 1 Designated vaccines and circumstances in which vaccines may be provided
(sections 4 and 5)
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 | 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 Haemophilus influenzae type b (Hib) (monovalent PRP‑T) Circumstances Vaccine may be provided to a child: (a) who is about 12 months; and (b) who is not an Aboriginal or a Torres Strait Islander living in Queensland, Western Australia, South Australia or the Northern Territory | 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) |
| 103 | Vaccine Haemophilus influenzae type b (Hib) (monovalent PRP‑OMP) Circumstances Vaccine may be provided to a child who is about 2, 4 or 12 months | Pedvax | Vial for injection (0.5mL) | Purified Hib capsular polysaccharide conjugated to meningococcal protein — 7.5 µg | 3 doses |
| 104 | Vaccine Meningococcal C (conjugate) Circumstances Vaccine may be provided: (a) to a child who is about 12 months; or (b) in the period commencing on 1 January 2006 and ending at the end of 30 June 2006, to a person: (i) who, on 1 January 2003, was at least 1 year but less than 20 years; and (ii) who has not received a vaccine mentioned in this item or item 105 or 106 | Meningitec | Vial for injection (0.5mL) | Meningococcal group C oligosaccharide conjugated to diphtheria protein — 10 µg | 1 dose |
| 105 | Vaccine Meningococcal C (conjugate) Circumstances Vaccine may be provided: (a) to a child who is about 12 months; or (b) in the period commencing on 1 January 2006 and ending at the end of 30 June 2006, to a person: (i) who, on 1 January 2003, was at least 1 year but less than 20 years; and (ii) who has not received a vaccine mentioned in this item or item 104 or 106 | Menjugate | Refrigerated lyophilised preparation for injection (0.5mL) with separate diluent | Meningococcal group C oligosaccharide conjugated to diphtheria protein — 10 µg | 1 dose |
| 106 | Vaccine Meningococcal C (conjugate) Circumstances Vaccine may be provided: (a) to a child who is about 12 months; or (b) in the period commencing on 1 January 2006 and ending at the end of 30 June 2006, to a person: (i) who, on 1 January 2003, was at least 1 year but less than 20 years; and (ii) who has not received a vaccine mentioned in this item or item 104 or 105 | NeisVac‑C | Injection (0.5mL) | Meningococcal group C oligosaccharide conjugated to tetanus toxoid protein — 10 µg | 1 dose |
| 107 | Vaccine Pneumococcal (conjugate, 7‑valent) Circumstances Vaccine may be provided to: (a) a child who is about 2, 4 or 6 months; or (b) a child who is about 12 months 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 |
| 108 | Vaccine Pneumococcal (polysaccharide, 23‑valent) Circumstances Vaccine may be provided in the circumstances set out in subsection 6 (1) | 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 |
| 109 | Vaccine Q fever Circumstances Vaccine may be provided in the circumstances set out in subsection 6 (2) | Q-Vax | Injection (0.5mL) | Killed Coxiella burnetii — 25 µg | 1 dose |
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 but less than 5 years; 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 but less than 14 years | 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 6 (3) | 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 6 (4) | Fluvax or Vaxigrip | Injection (0.5mL) | Like strains of each of the following: (a) A/New Caledonia/20/99 — 15 µg; (b) A/California/7/2004 — 15 µg; (c) B/Malaysia/2506/2004 — 15 µg | 1 dose per calendar year |
| 206 | Vaccine Measles, mumps and rubella Circumstances Vaccine may be provided to a child who is about 12 months or 4 years | 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 |
| 207 | Vaccine Measles, mumps and rubella Circumstances Vaccine may be provided to a child who is about 12 months or 4 years | 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 |
| 208 | Vaccine Poliomyelitis Circumstances Vaccine may be provided to a child who is about 2, 4 or 6 months or 4 years, 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 |
| 209 | Vaccine Varicella Circumstances Vaccine may be provided to: (a) a child who is about 18 months; or (b) a child who is at least 10 years but less than 14 years, 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 |
| 210 | Vaccine Varicella Circumstances Vaccine may be provided to: (a) a child who is about 18 months; or (b) a child who is at least 10 years but less than 14 years, 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 |
Part 3 Combined bacterial and viral vaccines
| Item | Vaccine and the circumstances in which vaccine may be provided | Brand | Formulation | Active ingredient and strength | Number and timing of doses |
| 301 | Vaccine Diphtheria, tetanus, pertussis and poliomyelitis Circumstances Vaccine may be provided to a child who is about 2, 4 or 6 months, or 4 years | Infanrix‑IPV | Injection (0.5mL) | Each of the following: (a) diphtheria toxoid — not less than 30 IU; (b) tetanus toxoid — not less than 40 IU; (c) PT — 25 µg; (d) FHA — 25 µg; (e) PRN — 8 µg; (f) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units; (g) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units; (h) inactivated poliovirus type 3 (Saukett) —32 D‑antigen units | 4 doses |
| 302 | Vaccine Diphtheria, tetanus, pertussis and poliomyelitis Circumstances Vaccine may be provided to a child who is about 2, 4 or 6 months, or 4 years | Quadracel | Vial for injection (0.5mL) | Each of the following: (a) diphtheria toxoid — not less than 30 IU; (b) tetanus toxoid — not less than 40 IU; (c) PT — 20 µg; (d) FHA — 20 µg; (e) PRN — 3 µg; (f) FIM 2+3 — 5 µg; (g) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units; (h) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units; (i) inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units | 4 doses |
| 303 | Vaccine Diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B Circumstances Vaccine may be provided to a child who is about 2, 4 or 6 months | Infanrix‑Penta | Injection (0.5mL) | Each of the following: (a) diphtheria toxoid — not less than 30 IU; (b) tetanus toxoid — not less than 40 IU; (c) PT — 25 µg; (d) FHA — 25 µg; (e) PRN — 8 µg; (f) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units; (g) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units; (h) inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units; (i) recombinant hepatitis B surface antigen — 10 µg | 3 doses |
| 304 | Vaccine Diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib) Circumstances Vaccine may be provided to a child: (a) who is about 2, 4 or 6 months; and (b) who is not an Aboriginal or a Torres Strait Islander living in Queensland, Western Australia, South Australia or the Northern Territory | Pediacel | Injection (0.5mL) | Each of the following: (a) diphtheria toxoid — not less than 30 IU; (b) tetanus toxoid — not less than 40 IU; (c) PT — 20 µg; (d) FHA — 20 µg; (e) PRN — 3 µg; (f) FIM 2+3 — 5 µg; (g) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units; (h) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units; (i) inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units; (j) purified Hib capsular polysaccharide conjugated to tetanus toxoid — 10 µg | 3 doses |
| 305 | Vaccine Diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b (Hib) Circumstances Vaccine may be provided to a child: (a) who is about 2, 4 or 6 months; and (b) who is not an Aboriginal or a Torres Strait Islander living in Queensland, Western Australia, South Australia or the Northern Territory | Infanrix-Hexa | Injection (0.5mL) combination pack | Each of the following: (a) diphtheria toxoid — not less than 30 IU; (b) tetanus toxoid — not less than 40 IU; (c) PT — 25 µg; (d) FHA — 25 µg; (e) PRN — 8 µg; (f) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units; (g) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units; (h) inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units; (i) recombinant hepatitis B surface antigen — 10 µg; (j) purified Hib capsular polysaccharide conjugated to tetanus toxoid — 10 µg | 3 doses |
| 306 | Vaccine Hepatitis B and Haemophilus influenzae type b (Hib) Circumstances Vaccine may be provided to a child who is about 2, 4 or 12 months | Comvax | Vial for injection (0.5mL) | Each of the following: (a) Hepatitis B surface antigen — 5µg; (b) purified Hib capsular polysaccharide conjugated to meningococcal protein — 7.5µg | 3 doses |
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