Untitled document
National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1)
made under subsection 9B (2) and (5) of the
National Health Act 1953
Compilation No. 10
Compilation date: 18 September 2017
Includes amendments up to: F2017L01186
About this compilation
This compilation
This is a compilation of the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) that shows the text of the law as amended and in force on 18/9/17 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
1 Name of Determination 1
4 Definitions 1
5 Designated vaccines 2
6 Circumstances in which designated vaccines may be provided 2
7 Circumstances in which designated vaccines may be provided — particular vaccines 2
Schedule 1 Designated vaccines and circumstances in which vaccines may be provided 9
Part 1 Bacterial vaccines 9
Part 2 Viral vaccines 20
Part 3 Combined bacterial and viral vaccines 37
Endnotes 44
Endnote 1—About the endnotes 44
Endnote 2—Abbreviation key 45
Endnote 3—Legislation history 46
Endnote 4—Amendment history 48
1 Name of Determination
This Determination is the National Health (Immunisation Program — Designated Vaccines) Determination 2014 (No.1).
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 110 of Schedule 1, a designated vaccine in that item may be provided in the following circumstances:
(a) a dose of the vaccine may be provided to a child:
(i) who is an Aboriginal and/or Torres Strait Islander; and
(ii) who is at least 12 months but not more than 18 months; and
(iii) who lives in Queensland, Western Australia, South Australia or the Northern Territory;
(2) For item 112 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 and/or 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 and/or 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 and/or 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 and/or 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.
(3) For item 113 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.
(4) 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).
(5) For items 205, 208, 209 and 210 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/or Torres Strait Islander person who is:
(i) aged at least 6 months but less than 5 years; or
(ii) 15 years or older; or
(c) a person who is at least 6 months
(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 6 months to 10 years and is receiving long-term aspirin therapy; or
(G) is pregnant.
(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/or 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.
(8) For items 207A and 207B 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 or Torres Strait Islander person who is:
(i) aged at least 3 years but less than 5 years; or
(ii) 15 years or older; or
(c) a person who is at least 3 years who:
(i) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or
(ii) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or
(iii) 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
(iv) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or
(v) has impaired immunity, including HIV infection; or
(d) a person who is at least 3 years but less than 11 years and is receiving long-term aspirin therapy; or
(e) a woman who is pregnant.
(8A) For item 207C 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 Torres Strait Islander person who is aged at least 18 years; or
(c) a person who is at least 18 years who:
(i) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or
(ii) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or
(iii) 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
(iv) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or
(v) has impaired immunity, including HIV infection; or
(vi) is pregnant.
(9) For item 208A of Schedule 1, a designated vaccine mentioned in that item may be provided to:
(a) an Aboriginal and/or Torres Strait Islander person who is:
(i) aged at least 6 months but less than 3 years; or
(b) a person who is at least 6 months but less than 3 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 receiving long-term aspirin therapy.
(10) For an item in Schedule 1 that specifies circumstances in which a designated
vaccine may be provided to a child that include the specification of an age not
more than 4 years, the vaccine may be provided to a child if:
(a)the child did not receive the vaccine at the age specified in the item; and
(b)the child is less than 10 years of age.
Note: For example, if a vaccine is intended to be provided for the immunisation of a child at 2 months, 4 months and 6 months of age but the child does not receive the vaccine at those ages, the doses of vaccine may be provided at any time before the child’s 10th birthday.
(11) For each one of items 101, 102, 106, 107, 108, 202, 211, 212, 213, 214, 215, 216, 217, 218, 218A and 219 of Schedule 1, in addition to the circumstances specified in the item in which the designated vaccine may be provided to an individual, the vaccine may be provided to an individual if:
(a)the individual is 10 years of age or older but less than 20 years of age; and
(b)the individual did not receive the vaccine at an age mentioned in the circumstances of the item or in accordance with the circumstances described at subsection 7(10).
(12) For each one of items 101, 102, 202, 211, 212, 215, 216 and 217 of Schedule 1, in addition to the circumstances specified in the item in which the designated vaccine may be provided to an individual, the vaccine may be provided to an individual if:
(a)the individual is 20 years of age or older;
(b)the individual did not receive the vaccine at an age mentioned in the circumstances of the item or in accordance with the circumstances described in subsection 7(10) or 7(11); and
(c)the individual holds a subclass of visa from one of the following types of visa subclasses issued under the Migration Regulations 1994 as in force from time to time:
(i) Subclass 200 visa;
(ii) Subclass 201 visa;
(iii) Subclass 202 visa;
(iv) Subclass 203 visa; or
(v) Subclass 204 visa.
[NOTE: The subclasses of visa mentioned in paragraph (c) relate to visas for refugees and humanitarian entrants to Australia]
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 old. | 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 102A | 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 old. Vaccine Diphtheria, tetanus and pertussis (child) Circumstances Vaccine may be provided to a child who is about 18 months of age. | Adacel Infanrix | Injection (0.5mL) 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 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 | 1 dose (booster) 1 dose (booster) |
| 102B | Vaccine Diphtheria, tetanus and pertussis (child) Circumstances Vaccine may be provided to a child who is about 18 months of age. | Tripacel | 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 — 10 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 old. | 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 old. | Pedvax | Vial for injection (0.5mL) | Purified Hib capsular polysaccharide conjugated to meningococcal protein — 7.5 µg | 3 doses |
| 105 | Vaccine Haemophilus influenzae type b (Hib) and Meningococcal C Circumstances Vaccine may be provided to a child who is about 12 months old. | Menitorix | Refrigerated lyophilised preparation for injection (0.5mL) with separate diluent | Each of the following : (a) Hib capsular polysaccharide conjugated to tetanus toxoid- 5 µg (b) Group C meningococcal polysaccharide conjugated to tetanus toxoid- 5 µg | 1 dose |
| 106 | Vaccine Meningococcal C (conjugate) Circumstances Vaccine may be provided: (a) to a child who is about 12 months old; 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 of age; 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 |
| 107 | Vaccine Meningococcal C (conjugate) Circumstances Vaccine may be provided: (a) to a child who is about 12 months old; 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 of age; 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 |
| 108 | Vaccine Meningococcal C (conjugate) Circumstances Vaccine may be provided: (a) to a child who is about 12 months old; 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 of age; 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 |
| 109 | Vaccine Pneumococcal (conjugate, 7‑valent) Circumstances Vaccine may be provided to: (a) a child who is about 2, 4 or 6 months old; or (b) a child who is about 12 months of age 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 |
| 110 | Vaccine Pneumococcal (conjugate, 13‑valent) Circumstances Vaccine may be provided: (a) to a child who is about 2, 4 or 6 months old; and (b) to a child who is about 12 months of age and is a member of a medical risk group; or (c) Vaccine may be provided in the circumstances set out in subsection 7 (1) | Prevenar 13 | Injection (0.5mL) | Polysaccharides of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - 2.2 µg of each of serotype, and 4.4 μg of serotype 6B | 3 or 4 doses for a primary course or a single supplementary dose. |
| 111 | Vaccine Pneumococcal (conjugate, 10‑valent) Circumstances Vaccine may be provided to a child who is about 2, 4 or 6 months old, or 18 months old. | Synflorix | Injection (0.5mL) | Polysaccharides of Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14 and 23F conjugated to protein D (a surface protein from non-typeable Haemophilus influenzae), serotype 18C conjugated to tetanus toxoid protein and serotype 19F conjugated to diptheria toxoid protein – 1 µg of each 1, 4, 6B, 7F, 9V, 14 and 23F and 3 µg of 4, 18C and 19F. | 4 dose |
| 112 | Vaccine Pneumococcal (polysaccharide, 23‑valent) Circumstances Vaccine may be provided in the circumstances set out in subsection 7 (2) | 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 |
| 113 | Vaccine Q fever Circumstances Vaccine may be provided in the circumstances set out in subsection 7 (3) | 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 Aboriginal and/or 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 15 micrograms | 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. | |
| 207A | Vaccine Influenza Circumstances Vaccine may be provided in the circumstances set out in subsection 7(8) | Fluarix Tetra | Injection (0.5mL) | For children 3 years and older 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. | |
| 207B | Vaccine Influenza Circumstances Vaccine may be provided in the circumstances set out in subsection 7(8). | FluQuadri | Injection (0.5mL) | For children 3 years and older, 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. | |
| 207C | Vaccine Influenza Circumstances Vaccine may be provided in the circumstances set out in subsection 7 (8A). | Afluria Quad | Injection (0.5mL) | 1 dose per calendar year. | |
| 208 | Vaccine Influenza Circumstances Vaccine may be provided to a child that is older than 6 months but less than 3 years, in the circumstances set out in subsection 7 (5)(c). | 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. | |
| 208A | Vaccine Influenza Circumstances Vaccine may be provided in the circumstances set out in subsection 7(9) | FluQuadri Junior | Injection (0.25mL) | For children 6 months and older 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 Influenza Circumstances Vaccine may be provided in the circumstances set out in subsection 7(5). | Agrippal | 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 | |
| 210 | Vaccine Influenza Circumstances Vaccine may be provided in the circumstances set out in subsection 7(5). | Fluvirin | 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 | |
| 211 | Vaccine Measles, mumps and rubella Circumstances Vaccine may be provided to a child who is: a. about 12 months old; or b. about 4 years of age if MMRV was not given at 18 months; or c. about 18 months old when administered concurrently with a monovalent varicella vaccine. | 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 | 1 or 2 doses |
| 212 | Vaccine Measles, mumps and rubella Circumstances Vaccine may be provided to a child who is; a. about 12 months old; or b. about 4 years of age if MMRV was not given at 18 months; or c. about 18 months old when administered concurrently with a monovalent varicella vaccine. | 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 | 1 or 2 doses |
| 213 | 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 |
| 214 | 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 |
| 215 | 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 |
| 216 | 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 |
| 217 | 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 |
| 217A | Vaccine Herpes zoster (shingles) Circumstances Vaccine may be provided to an immunocompetent person who: (a) is 70 years of age; or (b) is at least 71 and less than 80 years of age and presents for vaccination before 1 November 2021. | Zostavax | Injection (0.65mL) | Each Oka/Merck strain of VZV – 19,400 PFU | 1 dose |
| 218 | 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 |
| 218A | Vaccine Human papillomavirus (HPV) (9-valent) Circumstances Vaccine may be provided to a person who is at least 12 years of age but less than 14 years of age. | Gardasil 9 | Injection (0.5mL) | Each of the following: (a) HPV 6 L1 protein - 30μg; (b) HPV 11 L1 protein - 40μg; (c) HPV 16 L1 protein - 60μg; (d) HPV 18 L1 protein - 40μg; (e) HPV 31 L1 protein - 20μg; (f) HPV 33 L1 protein - 20μg; (g) HPV 45 L1 protein - 20μg; (h) HPV 52 L1 protein - 20μg; (i) HPV 58 L1 protein - 20μg. | 2 doses, with the second dose given 6 to 12 months after the first dose |
| 219 | 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 | 2 doses |
| 220 | 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 |
| 221 | Vaccine Rotavirus Circumstances Vaccine may be provided to a child who: (a) is about 2, 4 or 6 months old. Part 3 Combined bacterial and viral vaccines | 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 old, or between 3 years and 6 months and 4 years of age. | 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 old, or between 3 years and 6 months and 4 years of age. | 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 old. | 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 old. | 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 old. | 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 | |
| 305A | 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 old. | Hexaxim | Injection (0.5mL) | Each of the following: (a) diphtheria toxoid — not less than 20 IU; (b) tetanus toxoid — not less than 40 IU; (c) PT — 25 µg; (d) FHA — 25 µg; (e) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units; (f) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units; (g) inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units; (h) recombinant hepatitis B surface antigen — 10 µg; (i) Hib polysaccharide (Polyribosylribitol Phosphate) — 12 µg (j) Hib polysaccharide conjugated to tetanus protein — 22-36 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 old. | 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 | |
Note
All legislative instruments and compilations are registered on the Federal Register of Legislation kept under the Legislation Act 2003. See
Endnotes
Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.
Endnote 2—Abbreviation key
| o = order(s) | |
| ad = added or inserted | Ord = Ordinance |
| am = amended | orig = original |
| amdt = amendment | par = paragraph(s)/subparagraph(s) |
| c = clause(s) | /sub‑subparagraph(s) |
| C[x] = Compilation No. x | pres = present |
| Ch = Chapter(s) | prev = previous |
| def = definition(s) | (prev…) = previously |
| Dict = Dictionary | Pt = Part(s) |
| disallowed = disallowed by Parliament | r = regulation(s)/rule(s) |
| Div = Division(s) | |
| exp = expires/expired or ceases/ceased to have | reloc = relocated |
| effect | renum = renumbered |
| F = Federal Register of Legislation | rep = repealed |
| gaz = gazette | rs = repealed and substituted |
| LA = Legislation Act 2003 | s = section(s)/subsection(s) |
| LIA = Legislative Instruments Act 2003 | Sch = Schedule(s) |
| (md) = misdescribed amendment can be given | Sdiv = Subdivision(s) |
| effect | SLI = Select Legislative Instrument |
| (md not incorp) = misdescribed amendment | SR = Statutory Rules |
| cannot be given effect | Sub‑Ch = Sub‑Chapter(s) |
| mod = modified/modification | SubPt = Subpart(s) |
| No. = Number(s) | underlining = whole or part not |
| commenced or to be commenced |
Endnote 3—Legislation history
| Name | Registration | Commencement | Application, saving and transitional provisions |
| National Health (Immunisation Program — Designated Vaccines) Determination 2014 (No.1) | F2014L01255 | 23 Sept 2014 | _ |
| National Health (Immunisation Program - Designated Vaccines) Variation Determination 2014 (No.1) | F2014L01822 | 1 Jan 2015 | _ |
| National Health (Immunisation Program - Designated Vaccines) Variation Determination 2015 (No.1) | F2015L00715 | 1 June 2015 | _ |
| National Health (Immunisation Program - Designated Vaccines) Variation Determination 2015 (No.2) | F2015L01713 | 31 October 2015 | _ |
| National Health (Immunisation Program - Designated Vaccines) Variation Determination 2015 (No.2) | F2015L01713 | 1 November 2015 | _ |
| National Health (Immunisation Program - Designated Vaccines) Variation Determination 2015 (No.2) | F2015L01713 | 1 January 2016 | _ |
| National Health (Immunisation Program - Designated Vaccines) Variation Determination 2016 (No.1) | F2016L00661 | Sch (items 1-3): 6 May 2016 (s 2(a)) Sch (item 4): 1 July 2016 (s 2(b)) | _ |
| National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No. 2) | F2016L01468 | 22 September 2016 | - |
| National Health (Immunisation Program - Designated Vaccines) Variation Determination 2017 (No.1) | F2017L00589 | 24 May 2017 | - |
| National Health (Immunisation Program - Designated Vaccines) Variation Determination 2017 (No.2) | F2017L01186 | 18September 2017 | - |
Endnote 4—Amendment history
| Provision affected | How affected |
| s. 2…………………………. s. 3…………………………. s. 7 …………………………. Sch 1, Part 1, Item 102A...... Sch 1, Part 1, Item 102B…… Sch 1, Part 2 ……………….. Sch 1, Part 2, Item 207B…… Sch 1, Part 2, Item 207C …. Sch 1, Part 2, Item 217A ….. Sch 1, Part 2, Item 218…….. Sch 1, Part 2, Item 219……... | rep. LIA s. 48D rep. LIA s. 48C am. F2014L01822; F2015L01713; F2016L00661; ad F2016L01468; am. F2017L00589; am 2017L01186 ad. F2015L00715 ad F2015L01713 am. F2014L01822 ad. F2016L00661 ad F2016L01468 ad. F2016L00661 rep. F2016L00661 ad. F2016L00661 |
| Sch 1, Part 3, Item 305A…… | ad F2015L01713 |
| Sch 1, Part 2, Item 218A | ad F2017L01186 |
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