National Health (Immunisation Program — Designated Vaccines) Determination 2014 (No. 1)

Link to law: https://www.comlaw.gov.au/Details/F2014L01255

National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1)
made under subsection 9B (2) and (5) of the
National Health Act 1953
 
I, JULIANNE QUAINE, Delegate of the Minister for Health, make this Determination under subsections 9B (2) and (5) of the National Health Act 1953.
Dated 29 August 2014
Julianne Quaine
Assistant Secretary
Immunisation Branch
Department of Health
Delegate of the Minister for Health
 
Contents
                        1      Name of Determination                                                                       3
                        2      Commencement                                                                                  3
                        3      Revocation                                                                                         3
                        4      Definitions                                                                                          3
                        5      Designated vaccines                                                                           4
                        6      Circumstances in which designated vaccines may be provided             4
                        7      Circumstances in which designated vaccines may be provided — particular vaccines            4
Schedule 1                  Designated vaccines and circumstances in which vaccines may be provided        8
Part 1                             Bacterial vaccines                                                                               8
Part 2                             Viral vaccines                                                                                   17
Part 3                             Combined bacterial and viral vaccines                                                17
 
1              Name of Determination
                This Determination is the National Health (Immunisation Program — Designated Vaccines) Determination 2014 (No.1).
2              Commencement
                This Determination commences on the day after it is registered.
3              Revocation
                The National Health (Immunisation Program — Designated Vaccines) Determination 2012 (No.1) 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, 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 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
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
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.
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 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 an Aboriginal or a Torres Strait Islander; and
  (b)  who is at least 1 year old but less than 5 years of age; and
   (c)  who lives in Queensland, Western Australia, South Australia or the Northern Territory
VAQTA Paediatric/ Adolescent
Injection (0.5mL)
Hepatitis A virus protein — 25 units of the hepatitis A virus protein
2 doses, with the second dose given 6 months after the first dose

202
Vaccine
Hepatitis B (monovalent adult)
Circumstances
Vaccine may be provided to a child who is at least 10 years old but less than 14 years of age.
H‑B‑Vax II
Vial for injection (1mL)
Hepatitis B surface antigen protein — 10 µg
2 doses, with the second dose given 4 to 6 months after the first dose

203
Vaccine
Hepatitis B (monovalent paediatric)
Circumstances
Vaccine may be provided in the circumstances set out in subsection 7 (4)
Engerix‑B
Vial for injection (0.5mL)
Hepatitis B surface antigen protein — 10 µg
1 dose or 3 doses

204
Vaccine
Hepatitis B (monovalent paediatric)
Circumstances
Vaccine may be provided to a newborn infant as soon as practicable after birth but no later than 7 days after birth.
H‑B‑Vax II
Vial for injection (0.5mL)
Hepatitis B surface antigen protein — 5 µg
1 dose

205
Vaccine
Influenza
Circumstances
Vaccine may be provided in the circumstances set out in subsection 7 (5)
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                     
Vaxigrip or Influvac or Fluarix
Injection (0.5mL)
 
 
For children older than 6 months but less than 9 years, 2 doses at least 1month apart for the first vaccination and 1 dose per calendar year after that. For persons 9 years and above, 1 dose per calendar year.
Note – For children aged between 6 months and less than 3 years the dose is 0.25ml

206
Vaccine
Influenza
Circumstances
Vaccine may be provided in the circumstances set out in subsection 7 (6)
 
Intanza 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.

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.

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

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

218
Vaccine
Human papillomavirus (HPV)
Circumstances
Vaccine may be provided to:
a female who is at least 12 years old but less than 14 years of age.
Cervarix
Injection (0.5mL)
Each of the following:
(a)    HPV 16 L1 protein - 20μg; 
(b)   HPV 18 L1 protein - 20μg 
 
3 doses

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.
 
 
 
 
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

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 Legislative Instruments kept under the Legislative Instruments Act 2003. See www.comlaw.gov.au.
 
Read Entire Law on www.comlaw.gov.au