National Health (Immunisation Program - Designated Vaccines) Determination 2012 (No. 1)
Description: Commonwealth Coat of Arms
National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1)
as amended
made under subsection 9B (2) and (5) of the
National Health Act 1953
This compilation was prepared on 18 July 2013
taking into account amendments up to National Health (Immunisation Program – Designated Vaccines) Variation Determination 2013 (No.1)
Prepared by the Department of Health, Canberra
Contents
1 Name of Determination
2 Commencement
3 Revocation
4 Definitions
5 Designated vaccines
6 Circumstances in which designated vaccines may be provided
7 Circumstances in which designated vaccines may be provided — particular vaccines
Schedule 1 Designated vaccines and circumstances in which vaccines may be provided
Part 1 Bacterial vaccines
Part 2 Viral vaccines
Part 3 Combined bacterial and viral vaccines
1 Name of Determination
This Determination is the National Health (Immunisation Program — Designated Vaccines) Determination 2012 (No.1).
2 Commencement
This Determination commences on the day after it is registered.
3 Revocation
The National Health (Immunisation Program — Designated Vaccines) Determination 2011 (No. 2) 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 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 or a 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 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.
(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 and 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 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 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.
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 | VaccineDiphtheria, tetanus and pertussis (adult/adolescent)CircumstancesVaccine 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 | VaccineDiphtheria, tetanus and pertussis (adult/adolescent)CircumstancesVaccine may be provided to a child who is at least 10 years but less than 18 years old. | 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 | VaccineHaemophilus influenzae type b (Hib) (monovalent PRP‑T)CircumstancesVaccine 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 | VaccineHaemophilus influenzae type b (Hib) (monovalent PRP‑OMP)CircumstancesVaccine 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 | VaccineHaemophilus influenzae type b (Hib) and Meningococcal CCircumstancesVaccine 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 | VaccineMeningococcal C (conjugate)CircumstancesVaccine 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 | VaccineMeningococcal C (conjugate)CircumstancesVaccine 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 | VaccineMeningococcal C (conjugate)CircumstancesVaccine 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 | VaccinePneumococcal (conjugate, 7‑valent)CircumstancesVaccine 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 | VaccinePneumococcal (conjugate, 13‑valent)CircumstancesVaccine may be provided:to a child who is about 2, 4 or 6 months old; andto a child who is about 12 months of age and is a member of a medical risk group; orVaccine 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 courseor a single supplementary dose. |
| 111 | VaccinePneumococcal (conjugate, 10‑valent)CircumstancesVaccine 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 | VaccinePneumococcal (polysaccharide, 23‑valent)CircumstancesVaccine 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 | VaccineQ feverCircumstancesVaccine 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 | VaccineHepatitis A (monovalent)CircumstancesVaccine 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 | VaccineHepatitis B (monovalent adult)CircumstancesVaccine 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 | VaccineHepatitis B (monovalent paediatric)CircumstancesVaccine 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 | VaccineHepatitis B (monovalent paediatric)CircumstancesVaccine 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 | VaccineInfluenzaCircumstancesVaccine 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 | VaccineInfluenzaCircumstancesVaccine 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 | VaccineInfluenzaCircumstancesVaccine 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 | VaccineInfluenzaCircumstancesVaccine 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 | VaccineMeasles, mumps and rubellaCircumstancesVaccine 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 | VaccineMeasles, mumps and rubellaCircumstancesVaccine 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 | VaccineMeasles, mumps, rubella and varicellaCircumstancesVaccine 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:measles virus (Schwarz strain) – 103.0 CCID50mumps virus (RIT 4385 strain,derived from Jeryl Lynn strain) - 104.4CCID50rubella virus (Wistar RA 27/3 strain) – 103.0 CCID50varicella virus (Oka strain) - 103.3 PFU | 1 dose |
| 212 | VaccineMeasles, mumps, rubella and varicellaCircumstancesVaccine may be provided to a child who is about 18 months of age | ProQuad | Injection (0.5mL) | Each of the following live attenuated viruses:measles virus derived from Enders’ attenuated Edmonston strain) – 103.0 TCID50mumps virus (Jeryl Lynn™ (B Level) strain) - 104.3TCID50rubella virus (Wistar RA 27/3 strain) – 103.0 TCID50Varicella-zoster virus (Oka/Merck strain) - 103.99 PFU | 1 dose |
| 213 | VaccinePoliomyelitisCircumstancesVaccine 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 | VaccineVaricellaCircumstancesVaccine 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 | VaccineVaricellaCircumstancesVaccine 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 | VaccineHuman papillomavirus (HPV)CircumstancesVaccine 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 | VaccineHuman papillomavirus (HPV)CircumstancesVaccine 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:HPV 16 L1 protein - 20μg;HPV 18 L1 protein - 20μg | 3 doses |
| 218 | VaccineRotavirusCircumstancesVaccine 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 | VaccineRotavirusCircumstancesVaccine 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 |
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 | VaccineDiphtheria, tetanus, pertussis and poliomyelitisCircumstancesVaccine 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 | VaccineDiphtheria, tetanus, pertussis and poliomyelitisCircumstancesVaccine 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 | VaccineDiphtheria, tetanus, pertussis, poliomyelitis and hepatitis BCircumstancesVaccine 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 | VaccineDiphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib)CircumstancesVaccine 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 | VaccineDiphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b (Hib)CircumstancesVaccine 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 |
| 306 | VaccineHepatitis B and Haemophilus influenzae type b (Hib)CircumstancesVaccine 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 |
Notes to the National National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1)
Note 1
Note: The National National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1), (in force under subsections 9B (2) and (5) of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.
Note: > Note: Table of Instruments
| Title | Date of FRLI registration | Date ofcommencement | Application, saving ortransitional provisions |
|---|---|---|---|
| National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No. 1) | 27 September 2012 (see F2012L01945) | 28 September 2012 | — |
| National Health (Immunisation Program – Designated Vaccines)Variation Determination 2012 (No. 1) | 5 October 2012 (see F2012L02002) | 6 October 2012 | — |
| National Health (Immunisation Program – Designated Vaccines)Variation Determination 2012 (No. 2) | 16 November 2012 (see F2012L02185) | 19 October 2012 | — |
| National Health (Immunisation Program – Designated Vaccines)Variation Determination 2012 (No. 3) | 8 January 2013 (see F2013L00031) | 9 January 2013 | — |
| National Health (Immunisation Program – Designated Vaccines)Variation Determination 2013 (No. 1) | 14 June 2013(see F2013L00996) | 15 June 2013 |
Note: > Note: Table of Amendments
<table cellspacing="0" cellpadding="0" style="margin-right:auto; margin-left:auto; border-collapse:collapse"><thead><tr><td colspan="2" style="width:405.7pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmendHead" style="margin-right:0pt"><span>ad. = added or inserted</span><span> </span><span>am. = amended</span><span> </span><span>rep. = repealed</span><span> </span><span>rs. = repealed and substituted</span></p></td></tr><tr><td style="width:111.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableColHead"><span>Provision affected</span></p></td><td style="width:283.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableColHead"><span>How affected</span></p></td></tr></thead><tbody><tr><td style="width:111.1pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>S.7(1) </span><span style="width:86.39pt; text-indent:0pt; font-family:'Lucida Console', monospace; display:inline-block">...............</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>am. F2012L02002</span></p></td></tr><tr><td style="width:111.1pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>S.7(2) </span><span style="width:86.39pt; text-indent:0pt; font-family:'Lucida Console', monospace; display:inline-block">...............</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>am. F2012L02002</span></p></td></tr><tr><td style="width:111.1pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>S.7(3)</span></p><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>S.7(5)</span></p><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>S.7(6)</span></p><p class="TableOfAmend" style="margin-right:0pt"><span>s.7(7)</span><span style="width:90.39pt; text-indent:0pt; font-family:'Lucida Console', monospace; display:inline-block">................</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>am. F2012L02002</span></p><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>am. F2013L00031</span></p><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>ad. F2013L0003, rs F2013L00996</span></p><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>ad F2013L00996</span></p><p class="TableOfAmend" style="margin-right:0pt"><span></span></p></td></tr><tr><td style="width:111.1pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span style="font-weight:bold">Schedule 1</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span></span></p></td></tr><tr><td style="width:111.1pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>Part 1</span><span style="width:89.39pt; text-indent:0pt; font-family:'Lucida Console', monospace; display:inline-block">................</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>rs. F2012L02002</span></p></td></tr><tr><td style="width:111.1pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>Part 2</span><span style="width:89.39pt; text-indent:0pt; font-family:'Lucida Console', monospace; display:inline-block">................</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>rs. F2012L02002; F2012L02185, F2013L00031, F2013L00996</span></p></td></tr></tbody></table>