National Health (Immunisation Program — Designated Vaccines) Determination 2008 (No.2)1
National Health Act 1953
I, CATHERINE FARRELL, Delegate of the Minister for Health and Ageing, make this Determination under subsections 9B (2) and (5) of the National Health Act 1953.
Dated 22 July 2008
CATHERINE FARRELL
Acting Assistant Secretary
Targeted Preventions Program Branch
Population Health Division
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
Contents
1 Name of Determination 2
2 Commencement 2
3 Revocation 2
4 Definitions 2
5 Designated vaccines 3
6 Circumstances in which designated vaccines may be provided 3
7 Circumstances in which designated vaccines may be provided — particular vaccines 3
Schedule 1 Designated vaccines and circumstances in which vaccines may be provided 6
Part 1 Bacterial vaccines 6
Part 2 Viral vaccines 10
Part 3 Combined bacterial and viral vaccines 17
Schedule 2 Q‑vax area — Waikerie 22
1 Name of Determination
This Determination is the National Health (Immunisation Program — Designated Vaccines) Determination 2008 (No.2).
2 Commencement
This Determination commences on the day after it is registered.
3 Revocation
The National Health (Immunisation Program — Designated Vaccines) Determination 2008 is revoked.
4 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 of 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 has sufficient immune reconstitution for a vaccine response to be expected and 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;
(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.
5 Designated vaccines
For subsection 9B (2) of the Act, a vaccine mentioned in column 2 of Schedule 1 is a designated vaccine.
6 Circumstances in which designated vaccines may be provided
For subsection 9B (5) of the Act, a designated vaccine may be provided in the circumstances mentioned for it in Schedule 1.
7 Circumstances in which designated vaccines may be provided — particular vaccines
(1) For item 109 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 110 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;
(vii) a person who, at any time in the period beginning on 31 August 2007 and ending at the end of 30 August 2008, resided in the area described in Schedule 2; 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 5 and 6)
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
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
Adacel
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 — 2.5 µg;
(d) FHA — 5 µg;
(e) PRN — 3 µg
(f) FIM 2+3 — 5 µg
1 dose (booster)
103
Vaccine
Haemophilus influenzae type b (Hib) (monovalent PRP‑T)
Circumstances
Vaccine may be provided to a child who is about 12 months
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)
104
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
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 2007, 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 106 or 107
Meningitec
Injection (0.5mL)
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 2007, 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 107
Menjugate
Refrigerated lyophilised preparation for injection (0.5mL) with separate diluent
Meningococcal group C oligosaccharide conjugated to diphtheria protein — 10 µg
1 dose
107
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 2007, 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
NeisVac‑C
Injection (0.5mL)
Meningococcal group C oligosaccharide conjugated to tetanus toxoid protein — 10 µg
1 dose
108
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
109
Vaccine
Pneumococcal (polysaccharide, 23‑valent)
Circumstances
Vaccine may be provided in the circumstances set out in subsection 7 (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
110
Vaccine
Q fever
Circumstances
Vaccine may be provided in the circumstances set out in subsection 7 (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 7 (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 7 (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
211
Vaccine
Human papillomavirus (HPV)
Circumstances
Vaccine may be provided to:
(a) a female who is at least 12 years but less than 14 years; or
(b) a female who, between 1 March 2007 – 30 June 2009, is at least 13 years but less than 27 years
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
212
Vaccine
Human papillomavirus (HPV)
Circumstances
Vaccine may be provided to:
(a) a female who is at least 12 years but less than 14 years; or
(b) a female who, between 1 March 2007 – 30 June 2009, is at least 13 years but less than 27 years
Cervarix
Injection (0.5mL)
Each of the following:
(a) HPV 16 L1 protein - 20μg;
(b) HPV 18 L1 protein - 20μg
3 doses
213
Vaccine
Rotavirus
Circumstances
Vaccine may be provided to a child who:
(a) is born on or after 1 May 2007; and
(b) is about 2 or 4 months
Rotarix
Powder for oral suspension (1.0mL) with separate diluent
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
214
Vaccine
Rotavirus
Circumstances
Vaccine may be provided to a child who:
(a) is born on or after 1 May 2007; and
(b) is about 2, 4 or 6 months
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
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 who is about 2, 4 or 6 months
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 who is about 2, 4 or 6 months
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
Schedule 2 Q‑vax area — Waikerie
(subparagraph 7 (2) (b) (vii))
1. The area within the area of the District Council of Loxton Waikerie in South Australia bounded by a notional line commencing on Searle Road at the south‑west corner of block H700600 S271 then running progressively:
1
east along the southern boundary of blocks H700600 S271, H700600 S163, H700600 S256, H700600 S257, H700600 S164, H700600 S165, H700600 S166 and H700600 S167;
2
north along the eastern boundary of blocks H700600 S167, H700600 S141, H700600 S140, H700600 S493 and D48753 A6;
3
west along the northern boundary of block D48753 A6;
4
north along the eastern boundary of block D48753 A6;
5
north‑west along the boundary of block D48753 A6;
6
south‑west along the boundary of block D48753 A6;
7
west along the boundary of block D48753 A6;
8
south along Holder Top Road to the eastern corner of block H700600 S445;
9
north‑west along the north‑east boundary of blocks H700600 S445 and F7216 A2;
10
north along Holder Bottom Road to the eastern boundary of block F177372 A166;
11
west along the northern boundary of block F177372 A166;
12
south and then south‑east along the River Murray to the north‑west corner of block D31912 A2;
13
south along the western boundary of blocks D31912 A2 and D58284 A3;
14
south along the eastern side of Railway Terrace to Ohlmeyer Road;
15
east along Ohlmeyer Road to the north‑western corner of block H700600 S487;
16
south along the western boundary of block H700600 S487;
17
east along the southern boundary of block H700600 S487;
18
north along Searle Road to the point of commencement.
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.
