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

Authoritative Version
Determinations/Health as made
This instrument revokes and replaces the previous determination adding two new Trivalent Influenza Vaccines, and additional circumstances for the provision of the MMR vaccines Priorix and MMR-II.
Administered by: Health
Made 29 Aug 2014
Registered 22 Sep 2014
Tabled HR 23 Sep 2014
Tabled Senate 24 Sep 2014

Description: Commonwealth Coat of Arms

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.