Federal Register of Legislation - Australian Government

Skip to primary navigation Skip to primary content
Federal Register of Legislation Skip to Content
SearchOpen search

Primary content

Bookmark

this version | go to latest

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

Authoritative Version
Determinations/Health as amended, taking into account amendments up to National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2023
Administered by: Health and Aged Care
Registered 28 Feb 2023
Start Date 06 Feb 2023

Commonwealth Coat of Arms of Australia

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

made under subsections 9B(2) and (5) of the

National Health Act 1953

Compilation No. 24

Compilation date:                              6 February 2023

Includes amendments up to:            F2023L00084

Registered:                                         28 February 2023

About this compilation

This compilation

This is a compilation of the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) that shows the text of the law as amended and in force on 6 February 2023 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  

Contents

1        Name of Determination                                                                                                   1

4        Definitions                                                                                                                        1

5        Designated vaccines                                                                                                         2

6        Circumstances in which designated vaccines may be provided                                      2

7        Circumstances in which designated vaccines may be provided — particular vaccines 2

Schedule 1 Designated vaccines and circumstances in which vaccines may be provided     12

Part 1  Bacterial vaccines                                                                                             12

Part 2  Viral vaccines                                                                                                    28

Part 3  Combined bacterial and viral vaccines                                                             49

Endnotes                                                                                                                                  54

Endnote 1—About the endnotes                                                                                    57

Endnote 2—Abbreviation key                                                                                       58

Endnote 3—Legislation history                                                                                     59

Endnote 4—Amendment history                                                                                   61

 

1               Name of Determination

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

4               Definitions

µg means microgram.

Act means the National Health Act 1953.

CCID50 means cell culture infectious dose 50%, being the quantity of an infectious agent that when inoculated onto a number of susceptible cell cultures will infect 50% of the individual cultures.

FHA means filamentous haemagglutinin.

FIM 2+3 means fimbrial agglutinogens 2+3.

IU means International Unit.

member of a medical risk group means a person mentioned in any of the following paragraphs:

                (a)    a person who has congenital immune deficiency (including symptomatic IgG subclass or isolated IgA deficiency) other than a person who requires monthly immunoglobulin infusion;

               (b)    a person who has sufficient immune reconstitution for a vaccine response to be expected and is receiving a course of:

                          (i)    immunosuppressive therapy, including corticosteroid therapy equivalent to greater than 2mg/kg per day of prednisone for more than 2 weeks; or

                         (ii)    radiation therapy;

                (c)    a person who has compromised splenic function because of:

                          (i)    sickle haemoglobinopathies; or

                         (ii)    congenital or acquired functional or anatomical asplenia;

               (d)    a person who has an HIV infection, either before or after the development of AIDS;

                (e)    a person who has:

                          (i)    renal failure; or

                         (ii)    relapsing or persistent nephrotic syndrome;

                (f)    a person who has Down’s syndrome;

                (g)    a person who has heart disease associated with cyanosis or cardiac failure;

               (h)    a person who was a premature infant and who has, or has had, chronic lung disease;

                (i)    a person who was born at less than 28 weeks gestation;

                (j)    a person who has cystic fibrosis;

               (k)    a person who has insulin‑dependent diabetes mellitus;

                (l)    a person who has proven or presumptive cerebrospinal fluid leak;

              (m)    a person who has an intracranial shunt;

               (n)    a person who has a cochlear implant.

PFU means plaque forming units.

PRN means pertactin.

PT means pertussis toxoid.

TCID50 means tissue culture infectious dose 50%, being the quantity of an infectious agent that when inoculated onto a number of susceptible tissue cultures will infect 50% of the individual cultures.

5               Designated vaccines

                For subsection 9B (2) of the Act, a vaccine mentioned in column 2 of Schedule 1 is a designated vaccine.

6               Circumstances in which designated vaccines may be provided

                For subsection 9B (5) of the Act, a designated vaccine may be provided in the circumstances mentioned for it in Schedule 1.

7               Circumstances in which designated vaccines may be provided — particular vaccines

      (1A)   For item 108A of Schedule 1, the following number of doses and booster doses of a designated vaccine mentioned in that item may be provided to a person who has congenital or acquired asplenia (e.g. splenectomy) or hyposplenia; a person who has complement deficiency or a person undergoing eculizumab treatment:

                (a)    Primary doses according to the following number of doses:

                          (i)    if aged 6 weeks to 5 months at the start of their vaccine course – 4 doses;

                         (ii)    if aged 6 to 11 months at the start of their vaccine course – 3 doses; or

                        (iii)    if aged 12 months or older at the start of their vaccine course – 2 doses;

               (b)    plus booster doses according to the following number and timing of doses:

                        (iv)    if they completed their primary schedule at less than or equal to 6 years of age ‑ 1 booster dose 3 years after completing the primary schedule, and then 1 booster dose every 5 years after that; or

                         (v)    if they completed their primary schedule at 7 years of age or older ‑ 1 booster dose every 5 years after completing the primary schedule.

      (1B)   For item 108C of Schedule 1, the following number of doses and booster doses of a designated vaccine mentioned in that item may be provided to a person who has congenital or acquired asplenia (e.g. splenectomy) or hyposplenia; a person who has complement deficiency or a person undergoing eculizumab treatment:

                (a)    primary doses according to the following number of doses:

                          (i)    if aged 12 months old or older at the start of their vaccine course – 2 doses;

               (b)    plus booster doses according to the following number and timing of doses:

                          (i)    if they completed their primary doses at less than or equal to 6 years of age ‑ 1 booster dose 3 years after completing the primary doses, and then 1 booster dose every 5 years after that; or

                         (ii)    if they completed their primary doses at 7 years of age or older ‑ 1 booster dose every 5 years after completing the primary doses.  

         (1)   For item 110 of Schedule 1, a designated vaccine in that item may be provided in the following circumstances:

       (a)   a dose of the vaccine may be provided to a child:

                          (i)    who is an Aboriginal and/or Torres Strait Islander; and

                         (ii)    who is about 6 months; and

                        (iii)    who lives in Queensland, Western Australia, South Australia or the Northern Territory;

       (b)   a dose of the vaccine may be provided to a person:

                          (i)    who is about 6 months of age and has one or more of the following medical risk conditions:

                                   (A)     functional or anatomical asplenia including sickle cell disease, other haemoglobinopathies, congenital or acquired asplenia (e.g. splenectomy) or hyposplenia; or

                                   (B)     immunocompromising conditions including congenital or acquired immune deficiency including symptomatic IgG subclass or isolated IgA deficiency, haematological malignancies, solid organ transplant haematopoietic stem cell transplant (HSCT) or HIV infection; or

                                   (C)     chronic respiratory disease including suppurative lung disease, bronchiectasis and cystic fibrosis or chronic lung disease of prematurity; or

                                   (D)     chronic renal disease including: end stage renal disease –  eGFR <15mL/min or relapsing or persistent nephrotic syndrome; or

                                    (E)     proven or presumptive cerebrospinal fluid (CSF) leak; or

                                    (F)     cochlear implants; or

                                   (G)     intracranial shunts; or

                                   (H)     previous episode of invasive pneumococcal disease (IPD); or

                                     (I)     born less than 28 weeks gestation; or

                                    (J)     trisomy 21; or

                                   (K)     chronic heart disease including cyanotic heart disease and heart failure;

                         (ii)    who is at least 12 months and less than 5 years of age and has been newly diagnosed with one or more of the medical risk conditions contained in subparagraph (b)(i);

                        (iii)    who is at least 5 years of age and has been newly diagnosed with one or more of the medical risk conditions contained in subparagraphs (b)(i)(A)‑(H);

                (c)    a dose of the vaccine may be provided to a person:

                          (i)    who is an Aboriginal and/or Torres Strait Islander; and

                         (ii)    who is at least 50 years.

               (d)    a dose of the vaccine may be provided to a person:

                          (i)    who is not an Aboriginal and/or Torres Strait Islander; and

                         (ii)    who is at least 70 years.

         (2)   For item 112 of Schedule 1, a designated vaccine 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 at least 4 years but less than 6 years and has one or more of the following medical risk conditions:

                                   (A)     functional or anatomical asplenia including sickle cell disease or other haemoglobinopathies, congenital or acquired asplenia (e.g. splenectomy) or hyposplenia; or

                                   (B)     immunocompromising conditions including congenital or acquired immune deficiency including symptomatic IgG subclass or isolated IgA deficiency, haematological malignancies, solid organ transplant haematopoietic stem cell transplant (HSCT) or HIV infection; or

                                   (C)     chronic respiratory disease including suppurative lung disease, bronchiectasis and cystic fibrosis or chronic lung disease of prematurity; or

                                   (D)     chronic renal disease including end stage renal disease –  eGFR <15mL/min, relapsing or persistent nephrotic syndrome; or

                                    (E)     proven or presumptive cerebrospinal fluid (CSF) leak; or

                                    (F)     cochlear implants; or

                                   (G)     intracranial shunts; or

                                   (H)     previous episode of invasive pneumococcal disease (IPD); or

                                     (I)     born less than 28 weeks gestation; or

                                    (J)     trisomy 21; or

                                   (K)     chronic heart disease including cyanotic heart disease and heart failure;

                         (ii)    who is aged at least 5 years and has been newly diagnosed with one or more of the medical risk conditions contained in subparagraphs (a)(i)(A)‑(H);

                        (iii)    who is an Aboriginal and/or Torres Strait Islander aged at least 4 years but less than 6 years and who lives in Queensland, Western Australia, South Australia or the Northern Territory;

                        (iv)    who is an Aboriginal and/or Torres Strait Islander aged at least 50 years and who has not received a dose of the vaccine under (ii);

               (b)    a second dose of the vaccine may be provided to a person mentioned in paragraph (a) at least 5 years after the first dose was provided to the person under paragraph (a).

         (3)   For item 113 of Schedule 1, a designated vaccine mentioned in that item may be provided to a person:

                (a)    who is at least 15 years; and

               (b)    who is one of the following:

                          (i)    an abattoir worker;

                         (ii)    a sheep shearer;

                        (iii)    a sheep, dairy or beef cattle farmer;

                        (iv)    an employee of a sheep, dairy or beef cattle farmer;

                         (v)    a member of the family of a sheep, dairy or beef cattle farmer who works on the sheep, dairy or beef cattle farm;

                        (vi)   an employee of a tannery; and

                (c)    who has had a Q‑Vax skin test and has received a negative result for that test; and

               (d)    who has had a Coxiella burnetii antibody serum study and has received a negative result for that study.

         (4)   For item 203 of Schedule 1, a designated vaccine mentioned in that item may be provided in the following circumstances:

                (a)    a dose of the vaccine may be provided to a newborn infant as soon as practicable after birth but no later than 7 days after birth;

               (b)    a first dose of the vaccine may be provided to a child who is at least 10 years but less than 14 years;

                (c)    a second dose of the vaccine may be provided to a child mentioned in paragraph (b) 1 month after the first dose was provided to the child under paragraph (b);

               (d)    a third dose of the vaccine may be provided to a child mentioned in paragraph (b) 5 months after the second dose was provided to the child under paragraph (c).

         (5)   For items 205, 208, 209 and 210 of Schedule 1, a designated vaccine mentioned in those items may be provided to:

                (a)    a person who is at least 65 years; or

               (b)    an Aboriginal and/or Torres Strait Islander person who is:

                          (i)    aged at least 6 months but less than 5 years; or

                         (ii)    15 years or older; or

                (c)    a person who is at least 6 months

                          (i)    who:

                                   (A)     has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or

                                   (B)     has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or

                                   (C)     has another chronic illness requiring regular medical follow‑up or hospitalisation in the preceding year, including diabetes mellitus, chronic metabolic diseases, chronic renal failure, haemoglobinopathies and impaired immunity (including drug‑induced immune impairment); or

                                   (D)     has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or

                                    (E)     has impaired immunity, including HIV infection; or

                                    (F)     is aged 6 months to 10 years and is receiving long‑term aspirin therapy; or

                                   (G)     is pregnant.

(6) For item 206 of Schedule 1, a designated vaccine mentioned in that item may be provided to a person who is at least 65 years of age.

(7) For item 207 of Schedule 1, a designated vaccine mentioned in those items may be provided to:

(a)    a person who is at least 65 years; or

(b)    an Aboriginal and/or Torres Strait Islander person who is at least 15 years; or

(c)    a person who is at least 5 years

(i)    who:

                                   (A)     has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or

                                   (B)     has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or

                                   (C)     has another chronic illness requiring regular medical follow‑up or hospitalisation in the preceding year, including diabetes mellitus, chronic metabolic diseases, chronic renal failure, haemoglobinopathies and impaired immunity (including drug‑induced immune impairment); or

                                   (D)     has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or

                                    (E)     has impaired immunity, including HIV infection; or

                                    (F)     is aged 5 to 10 years and is receiving long‑term aspirin therapy; or

                                   (G)     is pregnant.

(8) For item 207A, 207B and 207F of Schedule 1, a designated vaccine mentioned in that item may be provided to any of the following:

(a)    a person who is at least 65 years old or

(b)    an Aboriginal or Torres Strait Islander person who is at least 6 months old; or

(c)    a child who is at least 6 months old but less than 5 years old; or

(d)    a person who is at least 6 months old and who:

(i)     has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or

(ii)    has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or

(iii)   has another chronic illness requiring regular medical follow‑up or hospitalisation in the preceding year, including diabetes mellitus, chronic metabolic diseases, chronic renal failure, haemoglobinopathies and impaired immunity (including drug‑induced immune impairment); or

(iv)   has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or

(v)    has impaired immunity, including HIV infection; or

(e)    a person who is at least 6 months old but is less than 11 years old and is receiving long‑term aspirin therapy; or

(f)    a woman who is pregnant.

 

(8A) For item 207C of Schedule 1, a designated vaccine mentioned in that item may be provided to:

(a)    a person who is at least 65 years; or

(b)    an Aboriginal or Torres Strait Islander person who is aged at least 5 years; or

(c)                a person who is at least 5 years who:

(i)     has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or

(ii)    has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or

(iii)   has another chronic illness requiring regular medical follow‑up or hospitalisation in the preceding year, including diabetes mellitus, chronic metabolic diseases, chronic renal failure, haemoglobinopathies and impaired immunity (including drug‑induced immune impairment); or

(iv)   has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or

(v)    has impaired immunity, including HIV infection; or

(d)                a woman who is pregnant.

 

          (9)   For item 208A of Schedule 1, a designated vaccine mentioned in that item may be                     provided to:

                  (a)an Aboriginal and/or Torres Strait Islander person who is:

                            (i)aged at least 6 months but less than 3 years; or

                  (b)a person who is at least 6 months but less than 3 years

                            (i)who:

                                      (A) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or

                                       (B) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or

                                       (C) has another chronic illness requiring regular medical follow‑up or hospitalisation in the preceding year, including diabetes mellitus, chronic metabolic diseases, chronic renal failure, haemoglobinopathies and impaired immunity (including drug‑induced immune impairment); or

                                       (D) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or

                                       (E) has impaired immunity, including HIV infection; or

                                       (F) is receiving long‑term aspirin therapy.

 

        (10)   For an item in Schedule 1 that specifies circumstances in which a designated

         vaccine may be provided to a child that include the specification of an age not

         more than 4 years, the vaccine may be provided to a child if:

(a)   the child did not receive the vaccine at the age specified in the item; and

(b)   the child is less than 10 years of age.

 

            Note: For example, if a vaccine is intended to be provided for the immunisation of a child               at 2 months, 4 months and 6 months of age but the child does not receive the vaccine at those            ages, the doses of vaccine may be provided at any time before the child’s 10th birthday.

(11)   For each one of items 101, 102, 106, 107, 108, 202, 202A, 211, 212, 213, 214, 215, 216, 217, 218 and 219 of Schedule 1, in addition to the circumstances specified in the item in which the designated vaccine may be provided to an individual, the vaccine may be provided to an individual if:

(a)   the individual is 10 years of age or older but less than 20 years of age; and

(b)   the individual did not receive the vaccine at an age mentioned in the circumstances of the item or in accordance with the circumstances described at subsection 7(10). 

(12)  For each one of items 101, 102, 202, 202A, 211, 212, 215, 216 and 217 of Schedule 1, in addition to the circumstances specified in the item in which the designated vaccine may be provided to an individual, the vaccine may be provided to an individual if:

(a)   the individual is 20 years of age or older;

(b)   the individual did not receive the vaccine at an age mentioned in the circumstances of the item or in accordance with the circumstances described in subsection 7(10) or 7(11); and

(c)   the individual holds a subclass of visa from one of the following types of visa subclasses issued under the Migration Regulations 1994 as in force from time to time:

         (i) Subclass 200 visa;

         (ii) Subclass 201 visa;

         (iii) Subclass 202 visa;

         (iv) Subclass 203 visa; or

         (v) Subclass 204 visa.

 

 

 [NOTE:  The subclasses of visa mentioned in paragraph (c) relate to visas for refugees and humanitarian entrants to Australia]

(13)  For item 114 of Schedule 1, a designated vaccine mentioned in that item may be provided in the following circumstances:

(a)   the following number of doses and booster doses may be provided to a person who is an Aboriginal and Torres Strait Islander:

(i)     if aged at least 2 months of age at start of vaccine course – 2 primary doses with at least 8 weeks between doses and a booster aged at least 12 months;

(ii)    if aged under 2 years of age at start of vaccine course and the person has not received a dose of the vaccine under subparagraph (i) – 2 primary doses with at least 8 weeks between doses and a booster at least 8 months after the second dose was provided;

(b)   a person who is an Aboriginal and Torres Strait Islander; and

(i)     who has one of the following medical conditions known to increase the risk of Invasive Meningococcal Disease (IMD):

(A)    defects in, or deficiency of, complement components, including factor H, factor D or properdin deficiency; or

(B)    current or future treatment with eculizumab (a monoclonal antibody directed against complement component C5); or

(C)    functional or anatomical asplenia, including sickle cell disease or other haemoglobinopathies, and congenital or acquired asplenia; or

(D)    HIV, regardless of disease stage or CD4+ cell count; or

(E)     haematopoietic stem cell transplant;

(ii)    may be provided the following number of doses and booster doses:

(A)    if aged at least 2 months of age at start of vaccine course – 3 primary doses with at least 8 weeks between doses and a booster aged at least 12 months;

(B)    if aged under 2 years of age at start of vaccine course  – 3 primary doses with at least 8 weeks between doses and a booster at least 6 months after the third dose was provided;

(c)   The following number of doses and booster doses may be provided to a person who has congenital or acquired asplenia (e.g. splenectomy) or hyposplenia, a person who has complement deficiency or a person undergoing eculizumab treatment:

(i)     if aged 6 weeks to 5 months of age at start of vaccine course – 3 primary doses with at least 8 weeks between doses and a booster dose aged at least 12 months;

(ii)    if aged between 6 and 11 months at start of vaccine course – 2 primary doses with at least 8 weeks between doses and a booster dose aged at least 12 months;

(iii)   if aged at least 12 months of age at start of vaccine course – 2 primary doses with at least 8 weeks between doses.

       (14)   For item 218A of Schedule 1, three doses of a designated vaccine mentioned in that item may be provided to a person who:

                (a)    is at least 12 years of age but less than 26 years of age; and

               (b)    has impaired immunity;

                with the three doses provided 6 to 12 months apart.

 

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)  a child who is at least 10 years but less than 18 years old; or

(b)  a person who is pregnant.

 

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)  a child who is at least 10 years but less than 18 years old; or

(b)  a person who is pregnant.

 

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)

 

102A

Vaccine

Diphtheria, tetanus and pertussis (child)

Circumstances

Vaccine may be provided to a child who is about 18 months of age.

 

Infanrix

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

 

1 dose (booster)

 

102B

Vaccine

Diphtheria, tetanus and pertussis (child)

Circumstances

Vaccine may be provided to a child who is about 18 months of age.

Tripacel

Injection (0.5mL)

Each of the following:

   (a)  diphtheria toxoid — not less than 30 IU;

  (b)  tetanus toxoid — not less than 40 IU;

   (c)  PT — 10 µg;

  (d)  FHA — 5 µg;

   (e)  PRN — 3 µg

   (f)     FIM 2+3 — 5 µg

 

1 dose (booster)

103

Vaccine

Haemophilus influenzae type b (Hib) (monovalent PRP‑T)

Circumstances

Vaccine may be provided to:

   (a)  a child who is about 18 months old; or

  (b)  a person who is at least 5 years old and who has congenital or acquired asplenia (e.g. splenectomy) or hyposplenia and did not receive childhood vaccinations.

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

108A

Vaccine

Meningococcal polysaccharide serogroups A, C, W‑135 and Y conjugate

Circumstances

Vaccine may be provided to:

   (a)  a child who is 12 months old; or

  (b)  a person who is at least 14 years old but less than 20 years of age; or

   (c)  a person who has congenital or acquired asplenia (e.g. splenectomy) or hyposplenia; or

  (d)  a person who has complement deficiency; or

   (e)  a person undergoing eculizumab treatment.

Nimenrix

Injection (0.5mL)

After reconstitution, each of the following:

(a)  Meningococcal polysaccharide ‑ Serogroup A[1] — 5 μg

(b)  Meningococcal polysaccharide ‑ Serogroup C1 — 5 μg

(c)  Meningococcal polysaccharide ‑ Serogroup W‑1351 — 5 μg

(d) Meningococcal polysaccharide ‑ Serogroup Y1 —  5 μg

1 dose

If in circumstances (c), (d) or (e): 2 to 4 doses of a primary course plus booster doses as described in subsection 7(1A)

108B

Vaccine

Meningococcal (Groups A,C,W‑135 and Y) Oligosaccharide CRM197 Conjugate Vaccine (Men ACWY‑CRM)

Circumstances

Vaccine may be provided to:

(a) a person aged at least 14 years old but less than 17 years old as part of a school based program; or

(b) a person aged at least 14 years old but less than 19 years old who did not receive the vaccination as part of a school based program.

Menveo

Injection (0.5mL)

Each 0.5 mL reconstituted dose contains:

·         (a) 10 µg Meningococcal polysaccharide serogroup A conjugated to 16.7–33.3 µg Corynebacterium diphtheriae CRM197 protein

·         (b) 5 µg Meningococcal polysaccharide serogroup C conjugated to 7.1–12.5 µg C. diphtheriae CRM197 protein

·         (c) 5 µg Meningococcal polysaccharide serogroup W‑135 conjugated to 3.3–8.3 µg C. diphtheriae CRM197 protein

·         (d) 5 µg Meningococcal polysaccharide serogroup Y conjugated to 5.6–10 µg C. diphtheriae CRM197 protein

1 dose

108C

Vaccine  

Meningococcal Neisseria meningitidis, Meningococcal polysaccharide serogroups A, C, W‑135 and Y conjugate serogroups A, C, W and Y

Circumstances

Vaccine may be provided to:

(a)    a child who is 12 months old; or

(b)   a person who is at least 14 years old but less than 20 years of age; or

(c)    a person aged at least 12 months old who has congenital or acquired asplenia (e.g. splenectomy); or hyposplenia); or

(d)   a person aged at least 12 months old who has complement deficiency; or

a person aged at least 12 months old undergoing eculizumab treatment.

MenQuadfi®

Injection (0.5mL)

After reconstitution, each of the following:

(a)    Meningococcal polysaccharide* group A 10.0 µg/dose

(b)   Meningococcal polysaccharide* group C 10.0 µg/dose

(c)    Meningococcal polysaccharide* group Y 10.0 µg/dose

(d)   Meningococcal polysaccharide* group W‑135 10.0 µg/dose

* Each of the four polysaccharides is conjugated to tetanus toxoid (approximately 55 µg /dose)

 

For persons that the circumstances in (a) and (b) of column 2 of this item apply:

(a)    1 dose

 

For persons that the circumstances in (c), (d) or (e) of column 2 of this item apply:

2 doses of a primary course plus booster doses as described in the circumstances set out in subsection 7(1B).

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:

i.      about 2 months old, and

ii.     about 4 months old; and

iii.    at least 12 months old but less than 24 months old; and

(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

 

2 or 3 doses of a primary course plus a booster dose

 

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

114

Vaccine

Multicomponent meningococcal group B (4CMenB)

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (13)

Bexsero

Injection (0.5mL)

50 µg Neisseria meningitidis serogroup B Neisseria heparin binding antigen fusion protein

50 µg Neisseria meningitidis serogroup B Neisseria adhesion A protein

50 µg Neisseria meningitidis serogroup B factor H binding protein fusion protein

25 µg outer membrane vesicles from Neisseria meningitidis serogroup B strain NZ98/254 (measured as amount of total protein containing the PorA P1.4)

As described in subsection 7(13)

 

Part 2         Viral vaccines

Item

Vaccine and the circumstances in which vaccine may be provided

Brand

Formulation

Active ingredient and strength

Number and timing of doses

201

Vaccine

Hepatitis A (monovalent)

Circumstances

Vaccine may be provided to a child:

   (a)  who is Aboriginal and/or Torres Strait Islander; and

  (b)  who is at least 1 year old but less than 5 years of age; and

   (c)  who lives in Queensland, Western Australia, South Australia or the Northern Territory

VAQTA Paediatric/ Adolescent

Injection (0.5mL)

Hepatitis A virus protein — 25 units of the hepatitis A virus protein

2 doses, with the second dose given 6 months after the first dose

202

Vaccine

Hepatitis B (monovalent adult)

Circumstances

Vaccine may be provided to a child who is at least 10 years old but less than 14 years of age.

H‑B‑Vax II

Vial for injection (1mL)

Hepatitis B surface antigen protein — 10 µg

2 doses, with the second dose given 4 to 6 months after the first dose

202A

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 until either:

(i)                 the Department has been notified by the person who is the responsible person for the supply of item 202 of Schedule 1, that item 202 is available for supply in Australia; and

(ii)               the information provided by the responsible person is sufficient to satisfy the Department to that effect; or

(iii)             the end of 30 June 2022;

whichever were to occur first.

 

(iv)             the Department has been notified by the person who is the responsible person for the supply of item 202 of Schedule 1, that item 202 is available for supply in Australia; and

(v)               the information provided by the responsible person is sufficient to satisfy the Department to that effect; or

(vi)             the end of 30 June 2022;

whichever were to occur first.

Engerix‑B

Injection (1mL)

Hepatitis B surface antigen protein ‑ 20μg

2 doses, with the second dose given 4 to 6 months after the first dose

203

Vaccine

Hepatitis B (monovalent paediatric)

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (4)

Engerix‑B

Vial for injection (0.5mL)

Hepatitis B surface antigen protein — 10 µg

1 dose or 3 doses

204

Vaccine

Hepatitis B (monovalent paediatric)

Circumstances

Vaccine may be provided to a newborn infant as soon as practicable after birth but no later than 7 days after birth.

H‑B‑Vax II

Vial for injection (0.5mL)

Hepatitis B surface antigen protein — 5 µg

1 dose

205

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (5)

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                     

Vaxigrip or Influvac or Fluarix

Injection (0.5mL)

 

 

For children older than 6 months but less than 9 years, 2 doses at least 1month apart for the first vaccination and 1 dose per calendar year after that. For persons 9 years and above, 1 dose per calendar year.

Note – For children aged between 6 months and less than 3 years the dose is 0.25ml

206

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (6)

 

Intanza 15 micrograms

Injection (0.1mL)

 

For persons aged 65 years and over. 1 dose per calendar year.

207

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (7)

 

Fluvax

Injection (0.5mL)

 

 

For children older than 5 years but less than 9 years, 2 doses at least 1 month apart for the first vaccination and 1 dose per calendar year after that. For persons 9 years and above, 1 dose per calendar year.

 207A

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7(8)

Fluarix Tetra

Injection (0.5mL)

 

For children 6 months and older but less than 9 years, 2 doses at least 1 month apart for the first vaccination and 1 dose per calendar year after that.  For persons 9 years and above, 1 dose per calendar year.

 207B

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7(8).

FluQuadri

Injection (0.5mL)

 

For children aged 6 months and older, but less than 9 years – 2 doses at least 1 month apart for the first vaccination and 1 dose per calendar year after that.

For persons 9 years and above, 1 dose per calendar year.

207C

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7 (8A).

Afluria Quad

Injection (0.5mL)

 

1 dose per calendar year.

207D

Vaccine

Influenza

Circumstances

Vaccine may be provided to a person who is at least 65 years of age.

Fluzone High Dose

Injection (0.5mL)

 

1 dose per calendar year

207E

Vaccine

Influenza

Circumstances

Vaccine may be provided to a person who is at least 65 years of age.

Fluad

Injection (0.5mL)

 

1 dose per calendar year

 

207F

 

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7(8)

VaxiGrip Tetra

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.

 

207G

Vaccine

Influenza

Circumstances

Vaccine may be provided to a person who is at least 65 years of age.

Fluad Quad

Injection (0.5mL)

 

1 dose per calendar year.

 

208

Vaccine

Influenza

Circumstances

Vaccine may be provided to a child that is older than 6 months but less than 3 years, in the circumstances set out in subsection 7 (5)(c).

Vaxigrip Junior

Injection (0.25mL)

 

For children older than 6 months but less than 3 years, 2 doses at least 1 month apart for the first vaccination and 1 dose per calendar year after that.

208A

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7(9)

FluQuadri Junior

Injection (0.25mL)

 

For children 6 months and older but less than 3 years, 2 doses at least 1 month apart for the first vaccination and 1 dose per calendar year after that.

209

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7(5).

Agrippal

Injection (0.5mL)

 

For children older than 6 months but less than 9 years, 2 doses at least 1month apart for the first vaccination and 1 dose per calendar year after that. For persons 9 years and above, 1 dose per calendar year.

Note – For children aged between 6 months and less than 3 years the dose is 0.25ml

210

Vaccine

Influenza

Circumstances

Vaccine may be provided in the circumstances set out in subsection 7(5).

Fluvirin

Injection (0.5mL)

 

 

For children older than 6 months but less than 9 years, 2 doses at least 1month apart for the first vaccination and 1 dose per calendar year after that. For persons 9 years and above, 1 dose per calendar year.

Note – For children aged between 6 months and less than 3 years the dose is 0.25ml

211

Vaccine

Measles, mumps and rubella

Circumstances

Vaccine may be provided to a child who is:

a.   about 12 months old; or

b.   about 4 years of age if MMRV was not given at 18 months; or

c.   about 18 months old when administered concurrently with a monovalent varicella vaccine.

M‑M‑R II

Refrigerated lyophilised preparation for injection (0.5mL)

Each of the following live attenuated viruses:

   (a)  measles virus (Edmonston strain) — 1000 TCID50;

  (b)  mumps virus (Jeryl Lynn strain) — 5000 TCID50;

   (c)  rubella virus (Wistar RA 27/3 strain) — 1000 TCID50

1 or 2 doses

212

Vaccine

Measles, mumps and rubella

Circumstances

Vaccine may be provided to a child who is;

a.   about 12 months old; or

b.   about 4 years of age if MMRV was not given at 18 months; or

c.   about 18 months old when administered concurrently with a monovalent varicella vaccine.

Priorix

Refrigerated lyophilised preparation for injection (0.5mL)

Each of the following live attenuated viruses:

   (a)  measles virus (Schwarz strain) — 103.0 CCID50;

  (b)  mumps virus (RIT 4385 derived from the Jeryl Lynn strain) — 103.7 CCID50;

   (c)  rubella virus (Wistar RA 27/3 strain) — 103.0 CCID50

1 or 2 doses

213

Vaccine

Measles, mumps, rubella and varicella

Circumstances

Vaccine may be provided to a child who is about 18 months of age

Priorix‑Tetra

Powder for injection vial with diluent syringe (0.5mL)

Each of the following live attenuated viruses:

(a)  measles virus (Schwarz strain) – 103.0 CCID50

(b)  mumps virus (RIT 4385 strain,derived from Jeryl Lynn strain) ‑ 104.4CCID50

(c)  rubella virus (Wistar RA 27/3 strain) – 103.0 CCID50

(d)  varicella virus (Oka strain) ‑ 103.3 PFU

1 dose

214

Vaccine

Measles, mumps, rubella and varicella

Circumstances

Vaccine may be provided to a child who is about 18 months of age

ProQuad

Injection (0.5mL)

Each of the following live attenuated viruses:

(a)  measles virus derived from Enders’ attenuated Edmonston  strain) – 103.0 TCID50

(b)  mumps virus (Jeryl Lynn™ (B Level) strain) ‑ 104.3TCID50

(c)  rubella virus (Wistar RA 27/3 strain) – 103.0 TCID50

(d)  Varicella‑zoster virus (Oka/Merck strain) ‑ 103.99 PFU

1 dose

215

Vaccine

Poliomyelitis

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 6 months old or 4 years of age, if all other vaccines containing poliovirus are unsuitable

IPOL

Injection (0.5mL)

Each of the following killed whole polioviruses:

   (a)  type 1 (Mahoney) — 40 D‑antigen units;

  (b)  type 2 (MEF‑1) — 8 D‑antigen units;

   (c)  type 3 (Saukett) — 32 D‑antigen units

No more than 4 doses

216

Vaccine

Varicella

Circumstances

Vaccine may be provided to:

   (a)  a child who is about 18 months old; or

  (b)  a child who is at least 10 years old but less than 14 years of age, if the child:

         (i)   has not had varicella; and

        (ii)   has not been vaccinated against varicella.

Varilrix

Refrigerated lyophilised preparation for injection (0.5mL)

Live attenuated Oka strain of the varicella‑zoster virus — 103.3 PFU

1 dose

217

Vaccine

Varicella

Circumstances

Vaccine may be provided to:

   (a)  a child who is about 18 months old; or

  (b)  a child who is at least 10 years old but less than 14 years of age, if the child:

         (i)   has not had varicella; and

        (ii)   has not been vaccinated against varicella.

Varivax Refrigerated

Refrigerated lyophilised preparation for injection (0.5mL)

Live attenuated Oka/Merck strain of the varicella‑zoster virus — at least 1350 PFU

1 dose

217A

Vaccine

Herpes zoster (shingles)

Circumstances

Vaccine may be provided to an immunocompetent person who:

(a)  is 70 years of age;  or

(b)  is at least 71 and less than 80 years of age and presents for vaccination before 1 November 2023.

 

Zostavax

Injection (0.65mL)

Each Oka/Merck strain of VZV – 19,400 PFU 

 

1 dose

218

Vaccine

Human papillomavirus (HPV)

Circumstances

Vaccine may be provided to:

   (a)  a person who is at least 12 years old but less than 14 years of age; or

  (b)  A male who, between 1 February 2013 and 31 December 2015, is at least 13 years old but less than 16 years old.

Gardasil

Injection (0.5mL)

Each of the following:

   (a)  HPV 6 L1 protein — 20 µg;

  (b)  HPV 11 L1 protein — 40 µg;

   (c)  HPV 16 L1 protein — 40 µg;

  (d)  HPV 18 L1 protein — 20 µg

3 doses

218A

Vaccine

Human papillomavirus (HPV) (9‑valent)

Circumstances

Vaccine may be provided to:

(a)    a person who is at least 12 years of age but less than 14 years of age; or

(b)   a person who is at least 12 years of age but less than 26 years of age who has not received a single dose of HPV vaccine. 

 

Gardasil 9

Injection (0.5mL)

Each of the following:

(a)  HPV 6 L1 protein ‑ 30μg;

(b)  HPV 11 L1 protein ‑ 40μg;

(c)  HPV 16 L1 protein ‑ 60μg; 

(d)  HPV 18 L1 protein ‑ 40μg;

(e)  HPV 31 L1 protein ‑ 20μg; 

(f)  HPV 33 L1 protein ‑ 20μg;

(g)  HPV 45 L1 protein ‑ 20μg; 

(h)  HPV 52 L1 protein ‑ 20μg;

(i)   HPV 58 L1 protein ‑ 20μg.

 

1 dose

219

Vaccine

Human papillomavirus (HPV)

Circumstances

Vaccine may be provided to:

a female who is at least 12 years old but less than 14 years of age.

Cervarix

Injection (0.5mL)

Each of the following:

(a)  HPV 16 L1 protein ‑ 20μg; 

(b)  HPV 18 L1 protein ‑ 20μg 

 

2 doses

220

Vaccine

Rotavirus

Circumstances

Vaccine may be provided to a child who:

   (a)  is about 2 or 4 months old.

Rotarix

Oral suspension (1.5mL) in oral applicator

Human rotavirus vaccine, live attenuated, RIX 4414 strain (G1P[8]) — not less than 106 CCID50

2 doses:

   (a)  first dose given at 6 to 14 weeks of age;

  (b)  second dose given at 14 to 24 weeks of age

221

Vaccine

Rotavirus

Circumstances

Vaccine may be provided to a child who:

   (a)  is about 2, 4 or 6 months old.

 

RotaTeq

Oral solution (2.0mL)

Live pentavalent reassortant vaccine containing each of the following:

   (a)  G1 — 2.2 x 106 IU;

  (b)  G2 — 2.8 x 106 IU;

   (c)  G3 — 2.2 x 106 IU;

  (d)  G4 — 2.0 x 106 IU;

   (e)   P1 (8) — 2.3 x 106 IU

3 doses:

   (a)  first dose given at 6 to 14 weeks old;

  (b)  second dose given at 14 to 24 weeks old;

   (c)  third dose given before 32 weeks old

 

Part 3         Combined bacterial and viral vaccines

Item

Vaccine and the circumstances in which vaccine may be provided

Brand

Formulation

Active ingredient and strength

Number and timing of doses

301

Vaccine

Diphtheria, tetanus, pertussis and poliomyelitis

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 6 months old, or between 3 years and 6 months and 4 years of age.

Infanrix‑IPV

Injection (0.5mL)

Each of the following:

   (a)  diphtheria toxoid — not less than 30 IU;

  (b)  tetanus toxoid — not less than 40 IU;

   (c)  PT — 25 µg;

  (d)  FHA — 25 µg;

   (e)  PRN — 8 µg;

   (f)  inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;

   (g)  inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;

  (h)  inactivated poliovirus type 3 (Saukett) —32 D‑antigen units

4 doses

302

Vaccine

Diphtheria, tetanus, pertussis and poliomyelitis

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 6 months old, or between 3 years and 6 months and 4 years of age.

Quadracel

Vial for injection (0.5mL)

Each of the following:

   (a)  diphtheria toxoid — not less than 30 IU;

  (b)  tetanus toxoid — not less than 40 IU;

   (c)  PT — 20 µg;

  (d)  FHA — 20 µg;

   (e)  PRN — 3 µg;

   (f)  FIM 2+3 — 5 µg;

   (g)  inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;

  (h)  inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;

   (i)  inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units

4 doses

303

Vaccine

Diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 6 months old.

Infanrix‑Penta

Injection (0.5mL)

Each of the following:

   (a)  diphtheria toxoid — not less than 30 IU;

  (b)  tetanus toxoid — not less than 40 IU;

   (c)  PT — 25 µg;

  (d)  FHA — 25 µg;

   (e)  PRN — 8 µg;

   (f)  inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;

   (g)  inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;

  (h)  inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units;

   (i)  recombinant hepatitis B surface antigen — 10 µg

3 doses

304

Vaccine

Diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib)

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 6 months old.

Pediacel

Injection (0.5mL)

Each of the following:

   (a)  diphtheria toxoid — not less than 30 IU;

  (b)  tetanus toxoid — not less than 40 IU;

   (c)  PT — 20 µg;

  (d)  FHA — 20 µg;

   (e)  PRN — 3 µg;

   (f)  FIM 2+3 — 5 µg;

   (g)  inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;

  (h)  inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;

   (i)  inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units;

   (j)  purified Hib capsular polysaccharide conjugated to tetanus toxoid — 10 µg

3 doses

305

Vaccine

Diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b (Hib)

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 6 months old.

Infanrix‑Hexa

Injection (0.5mL) combination pack

Each of the following:

   (a)  diphtheria toxoid — not less than 30 IU;

  (b)  tetanus toxoid — not less than 40 IU;

   (c)  PT — 25 µg;

  (d)  FHA — 25 µg;

   (e)  PRN — 8 µg;

   (f)  inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;

   (g)  inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;

  (h)  inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units;

   (i)  recombinant hepatitis B surface antigen — 10 µg;

   (j)  purified Hib capsular polysaccharide conjugated to tetanus toxoid — 10 µg

3 doses

 305A

Vaccine

Diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b (Hib)

Circumstances

Vaccine may be provided to a child who is about 2, 4 or 6 months old.

Hexaxim

Injection (0.5mL)

Each of the following:

   (a)  diphtheria toxoid — not less than 20 IU;

  (b)  tetanus toxoid — not less than 40 IU;

   (c)  PT — 25 µg;

  (d)  FHA — 25 µg;

   (e)  inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;

   (f)  inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;

   (g)  inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units;

  (h)  recombinant hepatitis B surface antigen — 10 µg;

   (i)      Hib polysaccharide (Polyribosylribitol Phosphate) — 12 µg

   (j)  Hib polysaccharide conjugated to tetanus protein — 22‑36 µg

 

 

3 doses

305B

Vaccine

Diphtheria, tetanus, pertussis and poliomyelitis, hepatitis B, and Haemophilus influenzae type b (DTPa‑HB‑IPV‑Hib)

Circumstances

Vaccine may be provided to a child who is about 2, 4 and 6 months old, from 6 weeks of age.

 

Vaxelis®

Injection (0.5mL)

Each of the following:

   (a)  diphtheria toxoid — not less than 20 IU;

  (b)  tetanus toxoid — not less than 40 IU;

   (c)  PT — 20 µg;

  (d)  FHA — 20 µg;

   (e)  PRN — 3 µg;

   (f)   FIM — 3 µg;

   (g)    Hepatitis B surface antigen— 10 µg;

  (h)  inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;

   (i)  inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;

   (j)  inactivated poliovirus type 3 (Saukett) —32 D‑antigen units

  (k)  hepatitis B surface antigen — 10 µg;

   (l)  Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) — 3 µg

    (m) Conjugated to meningococcal protein2 — 50 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

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

 

Endnote 2—Abbreviation key

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

Sub‑Ch = Sub‑Chapter(s)

cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

commenced or to be commenced

 

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

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

F2014L01255

23 Sept 2014 (s 2)

 

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

F2014L01822

1 Jan 2015 (s 2)

—

National Health (Immunisation Program ‑ Designated Vaccines) Variation Determination 2015 (No. 1)

F2015L00715

1 June 2015 (s 2)

—

National Health (Immunisation Program ‑ Designated Vaccines) Variation Determination 2015 (No. 2)

F2015L01713

Sch 1 (items 4, 7): 31 Oct 2015 (s 2)
Sch 1 (items 1, 2, 5, 6): 1 Nov 2015 (s 2)
Sch 1 (item 3): 1 Jan 2016 (s 2)

—

National Health (Immunisation Program ‑ Designated Vaccines) Variation Determination 2016 (No. 1)

F2016L00661

Sch (items 1‑3): 6 May 2016 (s 2(a))
Sch (item 4): 1 July 2016 (s 2(b))

—

National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No. 2)

F2016L01468

22 Sept 2016 (s 2)

—

National Health (Immunisation Program ‑ Designated Vaccines) Variation Determination 2017 (No.1)

F2017L00589

24 May 2017 (s 2)

—

National Health (Immunisation Program ‑ Designated Vaccines) Variation Determination 2017 (No. 2)

F2017L01186

18 Sept 2017 (s 2)

—

National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 1) 2018

F2018L00126

21 Feb 2018 (s 2)

—

National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 2) 2018

F2018L00714

7 June 2018 (s 2)

—

National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 3) 2018

F2018L01267

7 Sept 2018 (s 2)

—

National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 4) 2018

F2018L01530

2 Nov 2018 (s 2)

—

National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 5) 2018

F2019L00034

10 Jan 2019 (s 2)

—

National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2019

4 Apr 2019 (F2019L00524)

5 Apr 2019 (s 2)

—

National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No.2) 2019

6 Nov 2019 (F2019L01427)

7 Nov 2019 (s 2(1) item 1)

—

National Health (Immunisation Program — Designated Vaccines) Amendment Determination (No. 3) 2019

19 Dec 2019 (F2019L01671)

20 Dec 2019 (s 2(1) item 1)

—

National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2020

1 May 2020 (F2020L00543)

2 May 2020 (s 2(1) item 1)

—

National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2020

4 June 2020 (F2020L00669)

5 June 2020 (s 2(1) item 1)

—

National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No.3) 2020

31 Aug 2020 (F2020L01097)

1 Sept 2020 (s 2(1) item 1)

—

National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No.4) 2020

10 Dec 2020 (F2020L01560)

11 Dec 2020 (s 2(1) item 1)

—

National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2021

20 Oct 2021 (F2021L01447)

21 Oct 2021 (s 2(1) item 1)

—

National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2023

5 Feb 2023 (F2023L00084)

6 Feb 2023 (s 2(1) item 1)

—

Endnote 4—Amendment history

 

Provision affected

How affected

s 2………………………….

rep LIA s 48D

s 3………………………….

rep LIA s 48C

s 7………………………….

am F2014L01822; F2015L01713; F2016L00661; F2016L01468; F2017L00589; F2017L01186; F2018L00714; F2018L01267; F2018L01530; F2019L00034

 

ed C15

 

am F2019L00524; F2019L01427; F2019L01671; F2020L00543; F2020L00669; F2020L01097; F2023L00084

 

ed C24

Sch 1, Part 1, Item 101……

rs F2018L00126

Sch 1, Part 1, Item 102……

rs F2018L00126

Sch 1, Part 1, Item 102A.....

ad F2015L00715

Sch 1, Part 1, Item 102B….

ad F2015L01713

Sch 1, Part 1, Item 103……

rs F2018L00126; am F2018L00714; am F2020L00543

Sch 1, Part 1, Item 108A….

ad F2018L00126; rs F2018L01530; am F2020L00543

Sch 1, Part 1, Item 108B….

ad F2020L01097

Sch 1, Part 1, Item 108C….

ad F2023L00084

Sch 1, Part 1, Item 110……

rs F2018L00714; am F2020L00543; ed C19

Sch 1, Part 1, Item 114……

ad F2020L00669

Sch 1, Part 2……………….

am F2014L01822

Sch 1, Part 2, Item 202A....

ad F2018L01267; am F2019L01427; am F2020L01560

Sch 1, Part 2, Item 207A.....

am F2019L00524; am F2020L01097

Sch 1, Part 2, Item 207B….

ad F2016L00661; am F2019L01671

Sch 1, Part 2, Item 207C….

ad F2016L01468

Sch 1, Part 2, Item 207D….

ad F2018L00126; am F2018L00714

Sch 1, Part 2, Item 207E….

ad F2018L00126; am F2018L00714

Sch 1, Part 2, Item 207F.....

ad F2019L01427; am F2020L01097

Sch 1, Part 2, Item 207G.....

ad F2019L01671

Sch 1, Part 2, Item 217A….

ad F2016L00661

 

am F2021L01447

Sch 1, Part 2, Item 218……

rep F2016L00661

Sch 1, Part 2, Item 218A….

ad F2017L01186

 

rs F2023L00084

Sch 1, Part 2, Item 219……

ad F2016L00661

Sch 1, Part 3, Item 305A….

ad F2015L01713

Sch 1, Part 3, Item 305B….

ad F2023L00084

Endnote 5—Editorial changes

In preparing this compilation for registration, the following kinds of editorial change(s) were made under the Legislation Act 2003.

Subsection 7(11)

Kind of editorial change

Give effect to the misdescribed amendment as intended

Details of editorial change

Schedule 1 item 2 of the National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2023 instructs to omit “218A,” from subsection 7(11).

The text “218A,” does not appear in subsection 7(11). However, the text “, 218A” does appear.

This compilation was editorially changed to omit “, 218A” from subsection 7(11) to give effect to the misdescribed amendment as intended.

 


[1] conjugated to tetanus toxoid carrier protein 44 μg