{"id":"F2014L01255","name":"National Health (Immunisation Program — Designated Vaccines) Determination 2014 (No.1)","slug":"national-health-immunisation-program-designated-vaccines-determination-2014-no-1","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":92273,"registerId":"commonwealth-F2014L01255-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name of Determination","content":"1 Name of Determination\n\nThis Determination is the National Health (Immunisation Program — Designated Vaccines) Determination 2014 (No.1).\n\n","sortOrder":0},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"4 Definitions\n\n> µg means microgram.\n\n> Act means the National Health Act 1953.\n\n> 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.\n\n> FHA means filamentous haemagglutinin.\n\n> FIM 2+3 means fimbrial agglutinogens 2+3.\n\n> IU means International Unit.\n\n> member of a medical risk group means a person mentioned in any of the following paragraphs:\n\n(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;\n\n(b) a person who has sufficient immune reconstitution for a vaccine response to be expected and is receiving a course of:\n\n(i) immunosuppressive therapy, including corticosteroid therapy equivalent to greater than 2mg/kg per day of prednisone for more than 2 weeks; or\n\n(ii) radiation therapy;\n\n(c) a person who has compromised splenic function because of:\n\n(i) sickle haemoglobinopathies; or\n\n(ii) congenital or acquired functional or anatomical asplenia;\n\n(d) a person who has an HIV infection, either before or after the development of AIDS;\n\n(e) a person who has:\n\n(i) renal failure; or\n\n(ii) relapsing or persistent nephrotic syndrome;\n\n(f) a person who has Down’s syndrome;\n\n(g) a person who has heart disease associated with cyanosis or cardiac failure;\n\n(h) a person who was a premature infant and who has, or has had, chronic lung disease;\n\n(i) a person who was born at less than 28 weeks gestation;\n\n(j) a person who has cystic fibrosis;\n\n(k) a person who has insulin‑dependent diabetes mellitus;\n\n(l) a person who has proven or presumptive cerebrospinal fluid leak;\n\n(m) a person who has an intracranial shunt;\n\n(n) a person who has a cochlear implant.\n\n> PFU means plaque forming units.\n\n> PRN means pertactin.\n\n> PT means pertussis toxoid.\n\n> 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.\n\n","sortOrder":1},{"sectionNumber":"5","sectionType":"section","heading":"Designated vaccines","content":"5 Designated vaccines\n\nFor subsection 9B (2) of the Act, a vaccine mentioned in column 2 of Schedule 1 is a designated vaccine.\n\n","sortOrder":2},{"sectionNumber":"6","sectionType":"section","heading":"Circumstances in which designated vaccines may be provided","content":"6 Circumstances in which designated vaccines may be provided\n\nFor subsection 9B (5) of the Act, a designated vaccine may be provided in the circumstances mentioned for it in Schedule 1.\n\n","sortOrder":3},{"sectionNumber":"7","sectionType":"section","heading":"Circumstances in which designated vaccines may be provided — particular vaccines","content":"7 Circumstances in which designated vaccines may be provided — particular vaccines\n\n(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:\n\n(a) Primary doses according to the following number of doses:\n\n(i) if aged 6 weeks to 5 months at the start of their vaccine course – 4 doses;\n\n(ii) if aged 6 to 11 months at the start of their vaccine course – 3 doses; or\n\n(iii) if aged 12 months or older at the start of their vaccine course – 2 doses;\n\n(b) plus booster doses according to the following number and timing of doses:\n\n(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\n\n(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.\n\n(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:\n\n(a) primary doses according to the following number of doses:\n\n(i) if aged 12 months old or older at the start of their vaccine course – 2 doses;\n\n(b) plus booster doses according to the following number and timing of doses:\n\n(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\n\n(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.\n\n(1C) For item 111B of Schedule 1, the circumstances are that a designated vaccine referred to in that item may be provided to:\n\n(a) a child who is about 6 months old and is an Aboriginal person or Torres Strait Islander; or\n\n(b) a child who is about 6 months old and has one or more of the following medical risk conditions:\n\n(i) functional or anatomical asplenia, including sickle cell disease, other haemoglobinopathies, congenital or acquired asplenia (e.g. splenectomy) or hyposplenia; or\n\n(ii) 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 or HIV infection; or\n\n(iv) chronic respiratory disease, including suppurative lung disease, bronchiectasis and cystic fibrosis or chronic lung disease of prematurity; or\n\n(v) chronic renal disease, including end stage renal disease (eGFR <15mL/min) or relapsing or persistent nephrotic syndrome; or\n\n(vi) proven or presumptive cerebrospinal fluid leak; or\n\n(vii) cochlear implants; or\n\n(viii) intracranial shunts; or\n\n(ix) previous episode of invasive pneumococcal disease; or\n\n(x) born less than 28 weeks gestation; or\n\n(xi) trisomy 21; or\n\n(xii) chronic heart disease including cyanotic heart disease and heart failure; or\n\n(c) a child who is at least 12 months old but less than 5 years old and has been newly diagnosed with one or more of the medical risk conditions referred to in paragraph (b); or\n\n(d) a child who is at least 5 years old but less than 18 years old and has been newly diagnosed with one or more of the medical risk conditions referred to in subparagraphs (b)(i) to (ix).\n\n(1) For item 110 of Schedule 1, a designated vaccine in that item may be provided in the following circumstances:\n\n(a) a dose of the vaccine may be provided to a child:\n\n(i) who is an Aboriginal and/or Torres Strait Islander; and\n\n(ii) who is about 6 months; and\n\n(iii) who lives in Queensland, Western Australia, South Australia or the Northern Territory;\n\n(b) a dose of the vaccine may be provided to a person:\n\n(i) who is about 6 months of age and has one or more of the following medical risk conditions:\n\n(A) functional or anatomical asplenia including sickle cell disease, other haemoglobinopathies, congenital or acquired asplenia (e.g. splenectomy) or hyposplenia; or\n\n(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\n\n(C) chronic respiratory disease including suppurative lung disease, bronchiectasis and cystic fibrosis or chronic lung disease of prematurity; or\n\n(D) chronic renal disease including: end stage renal disease – eGFR <15mL/min or relapsing or persistent nephrotic syndrome; or\n\n(E) proven or presumptive cerebrospinal fluid (CSF) leak; or\n\n(F) cochlear implants; or\n\n(G) intracranial shunts; or\n\n(H) previous episode of invasive pneumococcal disease (IPD); or\n\n(I) born less than 28 weeks gestation; or\n\n(J) trisomy 21; or\n\n(K) chronic heart disease including cyanotic heart disease and heart failure;\n\n(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);\n\n(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);\n\n(c) a dose of the vaccine may be provided to a person:\n\n(i) who is an Aboriginal and/or Torres Strait Islander; and\n\n(ii) who is at least 50 years.\n\n(d) a dose of the vaccine may be provided to a person:\n\n(i) who is not an Aboriginal and/or Torres Strait Islander; and\n\n(ii) who is at least 70 years.\n\n(2) For item 112 of Schedule 1, a designated vaccine in that item may be provided in the following circumstances:\n\n(a) a first dose of the vaccine may be provided to a person:\n\n(i) who is at least 4 years but less than 6 years and has one or more of the following medical risk conditions:\n\n(A) functional or anatomical asplenia including sickle cell disease or other haemoglobinopathies, congenital or acquired asplenia (e.g. splenectomy) or hyposplenia; or\n\n(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\n\n(C) chronic respiratory disease including suppurative lung disease, bronchiectasis and cystic fibrosis or chronic lung disease of prematurity; or\n\n(D) chronic renal disease including end stage renal disease – eGFR <15mL/min, relapsing or persistent nephrotic syndrome; or\n\n(E) proven or presumptive cerebrospinal fluid (CSF) leak; or\n\n(F) cochlear implants; or\n\n(G) intracranial shunts; or\n\n(H) previous episode of invasive pneumococcal disease (IPD); or\n\n(I) born less than 28 weeks gestation; or\n\n(J) trisomy 21; or\n\n(K) chronic heart disease including cyanotic heart disease and heart failure;\n\n(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);\n\n(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;\n\n(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);\n\n(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).\n\n(3) For item 113 of Schedule 1, a designated vaccine mentioned in that item may be provided to a person:\n\n(a) who is at least 15 years; and\n\n(b) who is one of the following:\n\n(i) an abattoir worker;\n\n(ii) a sheep shearer;\n\n(iii) a sheep, dairy or beef cattle farmer;\n\n(iv) an employee of a sheep, dairy or beef cattle farmer;\n\n(v) a member of the family of a sheep, dairy or beef cattle farmer who works on the sheep, dairy or beef cattle farm;\n\n(vi) an employee of a tannery; and\n\n(c) who has had a Q‑Vax skin test and has received a negative result for that test; and\n\n(d) who has had a Coxiella burnetii antibody serum study and has received a negative result for that study.\n\n(4) For item 203 of Schedule 1, a designated vaccine mentioned in that item may be provided in the following circumstances:\n\n(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;\n\n(b) a first dose of the vaccine may be provided to a child who is at least 10 years but less than 14 years;\n\n(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);\n\n(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).\n\n(5) For items 205, 208, 209 and 210 of Schedule 1, a designated vaccine mentioned in those items may be provided to:\n\n(b) an Aboriginal and/or Torres Strait Islander person who is:\n\n(i) aged at least 6 months but less than 5 years; or\n\n(ii) 15 years or older; or\n\n(c) a person who is at least 6 months old and who:\n\n(i) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or\n\n(ii) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or\n\n(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\n\n(iv) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or\n\n(d) a person who is at least 6 months old but is less than 11 years old and is receiving long‑term aspirin therapy; or\n\n(e) a woman who is pregnant.\n\n(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.\n\n(7) For item 207 of Schedule 1, a designated vaccine mentioned in those items may be provided to:\n\n(b) an Aboriginal and/or Torres Strait Islander person who is at least 15 years; or\n\n(c) a person who is at least 5 years\n\n(i) who:\n\n(A) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or\n\n(B) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or\n\n(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\n\n(D) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or\n\n(E) has impaired immunity, including HIV infection; or\n\n(F) is aged 5 to 10 years and is receiving long‑term aspirin therapy; or\n\n(G) is pregnant.\n\n(8) For items 207A, 207B, 207F, 210B and 210C of Schedule 1, a designated vaccine mentioned in that item may be provided to any of the following:\n\n(a) a person who is at least 65 years old or\n\n(b) an Aboriginal or Torres Strait Islander person who is at least 6 months old; or\n\n(c) a child who is at least 6 months old but less than 5 years old; or\n\n(d) a person who is at least 6 months old and who:\n\n (i) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or\n (ii) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or\n (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\n (iv) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or\n\n(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\n\n(f) a woman who is pregnant.\n\n(8A) For item 207C of Schedule 1, a designated vaccine mentioned in that item may be provided to:\n\n(b) an Aboriginal or Torres Strait Islander person who is aged at least 5 years; or\n\n(c) a person who is at least 5 years who:\n\n (i) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or\n (ii) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or\n (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\n (iv) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or\n\n(d) a woman who is pregnant.\n\n (9) For item 208A of Schedule 1, a designated vaccine mentioned in that item may be provided to:\n (a) an Aboriginal and/or Torres Strait Islander person who is:\n (i) aged at least 6 months but less than 3 years; or\n (b) a person who is at least 6 months but less than 3 years\n (i) who:\n (A) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or\n (B) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or\n (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\n (D) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or\n (E) has impaired immunity, including HIV infection; or\n (F) is receiving long‑term aspirin therapy.\n\n (9A) For items 210A and 210D of Schedule 1, a designated vaccine mentioned in that item may be provided to any of the following persons:\n (aa) a child who is at least 6 months of age but less than 5 years of age; or\n (a) an Aboriginal or Torres Strait Islander who is at least 6 months of age but less than 65 years of age;\n (b) a person who is at least 6 months of age but less than 65 years of age and who:\n (i) has cardiac disease including cyanotic congenital heart disease, coronary artery disease and congestive heart failure; or\n (ii) has a chronic respiratory condition including suppurative lung disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, chronic emphysema and severe asthma; or\n (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\n (iv) has a chronic neurological condition, including multiple sclerosis, spinal cord injuries, seizure disorders or other neuromuscular disorders; or\n (v) has impaired immunity, including HIV infection;\n (c) a person who is at least 6 months of age but less than 11 years of age and is receiving long‑term aspirin therapy;\n (d) a woman who is pregnant.\n\n (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:\n (a) the child did not receive the vaccine at the age specified in the item; and\n (b) the child is less than 10 years of age.\n\nNote: 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.\n\n> (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:\n\n(a) the individual is 10 years of age or older but less than 20 years of age; and\n\n(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).\n\n> (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:\n\n(a) the individual is 20 years of age or older;\n\n(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\n\n(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:\n\n (i) Subclass 200 visa;\n (ii) Subclass 201 visa;\n (iii) Subclass 202 visa;\n (iv) Subclass 203 visa; or\n (v) Subclass 204 visa.\n\n \\[NOTE: The subclasses of visa mentioned in paragraph (c) relate to visas for refugees and humanitarian entrants to Australia\\]\n\n(13) For item 114 of Schedule 1, a designated vaccine mentioned in that item may be provided in the following circumstances:\n\n(a) the following number of doses and booster doses may be provided to a person who is an Aboriginal and Torres Strait Islander:\n\n (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;\n (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;\n\n(b) a person who is an Aboriginal and Torres Strait Islander; and\n\n (i) who has one of the following medical conditions known to increase the risk of Invasive Meningococcal Disease (IMD):\n\n(A) defects in, or deficiency of, complement components, including factor H, factor D or properdin deficiency; or\n\n(B) current or future treatment with eculizumab (a monoclonal antibody directed against complement component C5); or\n\n(C) functional or anatomical asplenia, including sickle cell disease or other haemoglobinopathies, and congenital or acquired asplenia; or\n\n(D) HIV, regardless of disease stage or CD4+ cell count; or\n\n(E) haematopoietic stem cell transplant;\n\n (ii) may be provided the following number of doses and booster doses:\n\n(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;\n\n(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;\n\n(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:\n\n (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;\n (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;\n (iii) if aged at least 12 months of age at start of vaccine course – 2 primary doses with at least 8 weeks between doses.\n\n(14) For item 218A of Schedule 1, three doses of a designated vaccine mentioned in that item may be provided to a person who:\n\n(a) is at least 12 years of age but less than 26 years of age; and\n\n(b) has impaired immunity;\n\nwith the three doses provided 6 to 12 months apart.\n\n(15) For item 217A of Schedule 1, a designated vaccine mentioned in that item may be provided to a person who is at least 18 years of age and is considered at increased risk of herpes zoster in any of the following circumstances, noting that more than one circumstance may be applicable:\n\n(a) has an underlying condition, including any of the following:\n\n (i) acute haematological malignancies such as acute leukaemia or aggressive lymphomas;\n (ii) chronic haematological malignancies, such as:\n\n(A) myelodysplastic syndromes;\n\n(B) chronic myeloproliferative disorders;\n\n(C) lymphoproliferative malignancies;\n\n(D) plasma cell dyscrasias which includes myeloproliferative neoplasms, chronic lymphocytic leukaemia, indolent non‑Hodgkin lymphoma or multiple myeloma;\n\n (iii) human immunodeficiency virus infection with CD4+ cell count < 200/µL;\n (iv) inborn errors of immunity with ongoing functional deficits including:\n\n(A) humoral e.g., X‑linked agammaglobulinemia;\n\n(B) combined defects, including severe combined immunodeficiency;\n\n(C) phagocytic disorders, including chronic granulomatous disease; or\n\n(D) other inborn errors of immunity except complement disorders, hereditary angioedema and IgA deficiency;\n\n (v) stage 5 kidney disease or on dialysis;\n\n(b) malignancy, autoimmune or inflammatory conditions receiving immunomodulatory or immunosuppressive treatments, including any of the following:\n\n (i) cellular therapies, whether received currently or within the previous 24 months, including:\n\n(A) autologous haematopoietic stem cell transplant;\n\n(B) allogeneic haematopoietic stem cell transplant, including ongoing graft vs host disease with immunosuppressive therapy, where a person is considered high risk beyond a 24 month period; or\n\n(C) chimeric antigen receptor T‑cell therapy;\n\n (ii) B and T‑cell targeted monoclonal antibody therapies, whether received currently or within the last 6 months, including any of the following:\n\n(A) anti‑CD20;\n\n(B) anti B‑cell activating factor;\n\n(C) anti‑CD52;\n\n(D) anti‑thymocyte globulin;\n\n (iii) conventional chemotherapy for:\n\n(A) treatment of haematological malignancy; or\n\n(B) solid organ tumours, currently or within the last 6 months;\n\n (iv) immunosuppressive therapy to prevent organ rejection prior to or following solid organ transplantation, currently or within the last 6 months;\n (v) conventional immunosuppressive agents, currently or within the last 6 months, including any of the following:\n\n(A) high dose methotrexate ≥20mg per week (oral and subcutaneous);\n\n(B) azathioprine ≥3.0mg/kg/day;\n\n(C) 6‑mercaptopurine ≥1.5mg/kg/day;\n\n(D) mycophenolate ≥1g/day;\n\n(E) cyclophosphamide;\n\n(F) systemic calcineurin inhibitors such as tacrolimus or cyclosporin;\n\n(G) mTOR inhibitors;\n\n(H) purine analogues such as cladribine;\n\n (vi) biologic therapies, currently being received or that have been received in the last 6 months, not including lower risk biologics such as anti‑integrins including natalizumab and vedolizumab, anti‑IgE antibodies, anti‑complement antibodies and lower risk interleukin (IL) inhibitors anti‑IL17 antibodies, anti‑IL 12/23 antibodies, anti‑IL23 antibodies, and anti‑IL31 antibodies, but including any of the following:\n\n(A) tumour necrosis factor inhibitors;\n\n(B) T‑cell co‑stimulation modulators such as Abatacept);\n\n(C) soluble TNF receptors;\n\n(D) type I interferon receptor inhibitors;\n\n(E) proteasome inhibitors;\n\n(F) IL inhibitors currently or within the last 6 months, including anti‑IL1 antibodies, anti‑IL4/13 antibodies, anti‑IL5 antibodies, anti‑IL6 antibodies, IL‑6 receptor inhibitors;\n\n (vii) immunomodulatory drugs including sphingosine‑1‑phosphate receptor modulators within the last 6 months;\n (viii) oral small molecule targeted therapies, received currently or within the last 6 months including any of the following:\n\n(A) bruton’s tyrosine kinase inhibitors;\n\n(B) janus kinase inhibitors;\n\n(C) BCR‑ABL inhibitors.\n\n","sortOrder":4},{"sectionNumber":"Sch 1","sectionType":"schedule","heading":"Designated vaccines and circumstances in which vaccines may be provided","content":"Schedule 1 Designated vaccines and circumstances in which vaccines may be provided\n\n(sections 5 and 6)\n\n","sortOrder":5},{"sectionNumber":"Part 1","sectionType":"part","heading":"Bacterial vaccines","content":"Part 1 Bacterial vaccines\n\n| Item | Vaccine and the circumstances in which vaccine may be provided | Brand | Formulation | Active ingredient and strength | Number and timing of doses |\n| ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------- | -------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 101 | VaccineDiphtheria, tetanus and pertussis (adult/adolescent)CircumstancesVaccine 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) |\n| 102 | VaccineDiphtheria, tetanus and pertussis (adult/adolescent)CircumstancesVaccine 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) |\n| 102A | VaccineDiphtheria, tetanus and pertussis (child)CircumstancesVaccine 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) |\n| 102B | VaccineDiphtheria, tetanus and pertussis (child)CircumstancesVaccine 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) |\n| 103 | VaccineHaemophilus influenzae type b (Hib) (monovalent PRP‑T)CircumstancesVaccine 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; or(c) a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | 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) |\n| 104 | VaccineHaemophilus influenzae type b (Hib) (monovalent PRP‑OMP)CircumstancesVaccine may be provided to:(a) a child who is about 2, 4 or 12 months old; or(b) a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | Pedvax | Vial for injection (0.5mL) | Purified Hib capsular polysaccharide conjugated to meningococcal protein — 7.5 µg | 3 doses |\n| 105 | VaccineHaemophilus influenzae type b (Hib) and Meningococcal CCircumstancesVaccine may be provided to:(a) to a child who is about 12 months old; or(b) a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have inadequate an clinical response or are intolerant to treatment with eculizumab or ravulizumab. | 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 |\n| 106 | VaccineMeningococcal C (conjugate)CircumstancesVaccine may be provided:(a) to a child who is about 12 months old; or(b) in the period commencing on 1 January 2006 and ending at the end of 30 June 2007, to a person:(i) who, on 1 January 2003, was at least 1 year but less than 20 years of age; and(ii) who has not received a vaccine mentioned in this item or item 106 or 107; or(c) a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | Meningitec | Injection (0.5mL) | Meningococcal group C oligosaccharide conjugated to diphtheria protein — 10 µg | 1 dose |\n| 107 | VaccineMeningococcal C (conjugate)CircumstancesVaccine may be provided:(a) to a child who is about 12 months old; or(b) in the period commencing on 1 January 2006 and ending at the end of 30 June 2007, to a person:(i) who, on 1 January 2003, was at least 1 year but less than 20 years of age; and(ii) who has not received a vaccine mentioned in this item or item 105 or 107; or(c) a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | Menjugate | Refrigerated lyophilised preparation for injection (0.5mL) with separate diluent | Meningococcal group C oligosaccharide conjugated to diphtheria protein — 10 µg | 1 dose |\n| 108 | VaccineMeningococcal C (conjugate)CircumstancesVaccine may be provided:(a) to a child who is about 12 months old; or(b) in the period commencing on 1 January 2006 and ending at the end of 30 June 2007, to a person:(i) who, on 1 January 2003, was at least 1 year but less than 20 years of age; and(ii) who has not received a vaccine mentioned in this item or item 105 or 106; or(c) a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | NeisVac‑C | Injection (0.5mL) | Meningococcal group C oligosaccharide conjugated to tetanus toxoid protein — 10 µg | 1 dose |\n| 108A | VaccineMeningococcal polysaccharide serogroups A, C, W‑135 and Y conjugateCircumstancesVaccine 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; or(f) a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | 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 doseIf in circumstances (c), (d) or (e): 2 to 4 doses of a primary course plus booster doses as described in subsection 7(1A) |\n| 108B | VaccineMeningococcal (Groups A,C,W‑135 and Y) Oligosaccharide CRM197 Conjugate Vaccine (Men ACWY‑CRM)CircumstancesVaccine 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; or(c) a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | Menveo | Injection (0.5mL) | Each 0.5 mL 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 |\n| 108C | VaccineMeningococcal Neisseria meningitidis, Meningococcal polysaccharide serogroups A, C, W‑135 and Y conjugate serogroups A, C, W and YCircumstancesVaccine 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(e) a person aged at least 12 months old undergoing eculizumab treatment; or(f) a person who undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | MenQuadfi® | Injection (0.5mL) | Each 0.5mL dose contains:(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 doseFor 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). |\n| 109 | VaccinePneumococcal (conjugate, 7‑valent)CircumstancesVaccine may be provided to:(a) a child who is about 2, 4 or 6 months old; or(b) a child who is about 12 months of age and is a member of a medical risk group; or(c) a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | 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 |\n| 110 | VaccinePneumococcal (conjugate, 13 valent)CircumstancesVaccine may be provided:(a) to a child who is about 2, 4 or 12 months old, but less than 24 months old; or(b) in the circumstances set out in subsection 7(1); or(c) to a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | 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 doseor a single supplementary dose |\n| 111 | VaccinePneumococcal (conjugate, 10‑valent)CircumstancesVaccine may be provided to:(a) a child who is about 2, 4, 6 or 18 months old; or(b) to a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | 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 |\n| 111A | VaccinePneumococcal (conjugate, 20‑valent)CircumstancesVaccine may be provided to a child who is:(a) about 2 months old;(b) about 4 months old; or(c) about 12 months old but less than 24 months old | Prevenar 20 | Injection (0.5mL) | Polysaccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to Corynebacterium diphtheriae CRM197 protein | Maximum of 3 doses:(a) one dose given at about 2 months old;(b) one dose given at about 4 months old;(c) one dose given at about 12 months old but less than 24 months old |\n| 111B | VaccinePneumococcal (conjugate, 20‑valent)CircumstancesVaccine may be provided in one of the circumstances set out in subsection 7(1C).If a person has already received a dose under this item, they are not eligible to receive another dose under this item | Prevenar 20 | Injection (0.5mL) | Polysaccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to Corynebacterium diphtheriae CRM197 protein | Maximum of 1 dose |\n| 112 | VaccinePneumococcal (polysaccharide, 23‑valent)CircumstancesVaccine may be provided:(a) in the circumstances set out in subsection 7(2); or(b) to a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | 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 |\n| 113 | VaccineQ feverCircumstancesVaccine may be provided in the circumstances set out in subsection 7 (3) | Q‑Vax | Injection (0.5mL) | Killed Coxiella burnetii — 25 µg | 1 dose |\n| 114 | VaccineMulticomponent meningococcal group B (4CMenB)CircumstancesVaccine may be provided:(a) in the circumstances set out in subsection 7(13); or(b) to a person who is undergoing treatment, or will commence treatment, with Empavali (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate clinical response or are intolerant to treatment with eculizumab or ravulizumab. | Bexsero | Injection (0.5mL) | 50 µg Neisseria meningitidis serogroup B Neisseria heparin binding antigen fusion protein50 µg Neisseria meningitidis serogroup B Neisseria adhesion A protein50 µg Neisseria meningitidis serogroup B factor H binding protein fusion protein25 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) |\n\n","sortOrder":6},{"sectionNumber":"Part 2","sectionType":"part","heading":"Viral vaccines","content":"Part 2 Viral vaccines\n\n```html\n

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

(v) 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)

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

210A

Vaccine

Influenza

Circumstances

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

Flucelvax Quad

Injection (0.5mL)

For children at least 6 months of age but less than 9 years of age, 2 doses at least 1 month apart for the first vaccination and one dose per calendar year after that. For persons at least 9 years of age but less than 65 years of age, one dose per calendar year.

210B

Vaccine

Influenza

Circumstances

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

Vaxigrip

Injection (0.5mL)

For children at least 6 months of age 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.

210C

Vaccine

Influenza

Circumstances

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

Fluzone

Injection (0.5mL)

For children at least 6 months of age 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.

210D

Vaccine

Influenza

Circumstances

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

Flucelvax

Injection (0.5mL)

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

For persons at least 9 years of age but less than 65 years of age, one dose per calendar year.

210E

Vaccine

Influenza

Circumstances

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

Flublok

Injection (0.5mL)

1 dose per calendar year.

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 a person who is:

(a) at least 65 years of age; or

(b) at least 50 years of age and an Aboriginal and/or Torres Strait Islander; or

(c) at least 18 years of age and is considered at increased risk of herpes zoster due to:

(i) an underlying condition set out in subsection 7(15); or

(ii) immunomodulatory or immunosuppressive treatments in the circumstances set out in subsection 7(15).

Shingrix

Powder and suspension for injection (0.5mL)

Recombinant varicella zoster virus glycoprotein E antigen (AS01B Adjuvanted) – 50µg

(a) unless paragraph (b) applies, 2 primary doses, with the second dose given 2 to 6 months after the first dose;

(b) for persons who are immunodeficient, immunosuppressed or likely to become immunosuppressed due to known disease or therapy—2 primary doses can be given 1 to 2 months apart

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

222

Vaccine

respiratory syncytial virus (RSV) stabilised prefusion F subunit

Circumstances

Vaccine may be provided to a person who is pregnant

Abrysvo

Injection (0.5mL)

Each 0.5mL dose contains 120 µg of stabilised prefusion F proteins (60 µg RSV‑A and 60 µg RSV‑B antigens)

1 dose:

(a) at 28 to 36 weeks gestation; or

(b) after 36 weeks gestation, if vaccination is two weeks prior to birth.

223

Vaccine

respiratory syncytial virus (RSV) stabilised prefusion F protein (AS01E adjuvanted)

Circumstances

Vaccine may be provided to person who is:

(a) at least 75 years of age; or

(b) an Aboriginal and/or Torres Strait Islander and aged between 60 and 74 years.

Arexvy

Injection (0.5mL)

Each 0.5mL dose contains 120 μg of recombinant respiratory syncytial virus pre-fusion F protein (RSVPreF3) antigen adjuvanted with AS01E.

1 dose

\n```\n\n","sortOrder":7},{"sectionNumber":"Part 3","sectionType":"part","heading":"Combined bacterial and viral vaccines","content":"Part 3 Combined bacterial and viral vaccines\n\n| Item | Vaccine and the circumstances in which vaccine may be provided | Brand | Formulation | Active ingredient and strength | Number and timing of doses |\n| ---- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------- | ---------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------- |\n| 301 | VaccineDiphtheria, tetanus, pertussis and poliomyelitisCircumstancesVaccine may be provided to a child who is about 2, 4 or 6 months old, or between 3 years and 6 months and 4 years of age. | Infanrix‑IPV | Injection (0.5mL) | Each of the following:(a) diphtheria toxoid — not less than 30 IU;(b) tetanus toxoid — not less than 40 IU;(c) PT — 25 µg;(d) FHA — 25 µg;(e) PRN — 8 µg;(f) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;(g) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;(h) inactivated poliovirus type 3 (Saukett) —32 D‑antigen units | 4 doses |\n| 302 | VaccineDiphtheria, tetanus, pertussis and poliomyelitisCircumstancesVaccine may be provided to a child who is about 2, 4 or 6 months old, or between 3 years and 6 months and 4 years of age. | Quadracel | Vial for injection (0.5mL) | Each of the following:(a) diphtheria toxoid — not less than 30 IU;(b) tetanus toxoid — not less than 40 IU;(c) PT — 20 µg;(d) FHA — 20 µg;(e) PRN — 3 µg;(f) FIM 2+3 — 5 µg;(g) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;(h) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;(i) inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units | 4 doses |\n| 303 | VaccineDiphtheria, tetanus, pertussis, poliomyelitis and hepatitis BCircumstancesVaccine may be provided to a child who is about 2, 4 or 6 months old. | Infanrix‑Penta | Injection (0.5mL) | Each of the following:(a) diphtheria toxoid — not less than 30 IU;(b) tetanus toxoid — not less than 40 IU;(c) PT — 25 µg;(d) FHA — 25 µg;(e) PRN — 8 µg;(f) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;(g) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;(h) inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units;(i) recombinant hepatitis B surface antigen — 10 µg | 3 doses |\n| 304 | VaccineDiphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib)CircumstancesVaccine may be provided to a child who is about 2, 4 or 6 months old. | Pediacel | Injection (0.5mL) | Each of the following:(a) diphtheria toxoid — not less than 30 IU;(b) tetanus toxoid — not less than 40 IU;(c) PT — 20 µg;(d) FHA — 20 µg;(e) PRN — 3 µg;(f) FIM 2+3 — 5 µg;(g) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;(h) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;(i) inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units;(j) purified Hib capsular polysaccharide conjugated to tetanus toxoid — 10 µg | 3 doses |\n| 305 | VaccineDiphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b (Hib)CircumstancesVaccine may be provided to a child who is about 2, 4 or 6 months old. | Infanrix‑Hexa | Injection (0.5mL) combination pack | Each of the following:(a) diphtheria toxoid — not less than 30 IU;(b) tetanus toxoid — not less than 40 IU;(c) PT — 25 µg;(d) FHA — 25 µg;(e) PRN — 8 µg;(f) inactivated poliovirus type 1 (Mahoney) — 40 D‑antigen units;(g) inactivated poliovirus type 2 (MEF‑1) — 8 D‑antigen units;(h) inactivated poliovirus type 3 (Saukett) — 32 D‑antigen units;(i) recombinant hepatitis B surface antigen — 10 µg;(j) purified Hib capsular polysaccharide conjugated to tetanus toxoid — 10 µg | 3 doses |\n| 305A | VaccineDiphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b (Hib)CircumstancesVaccine may be provided to a child who is about 2, 4 or 6 months old. | 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 |\n| 305B | VaccineDiphtheria, tetanus, pertussis and poliomyelitis, hepatitis B, and Haemophilus influenzae type b (DTPa‑HB‑IPV‑Hib)CircumstancesVaccine 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 |\n| 306 | VaccineHepatitis B and Haemophilus influenzae type b (Hib)CircumstancesVaccine may be provided to a child who is about 2, 4 or 12 months old. | Comvax | Vial for injection (0.5mL) | Each of the following:(a) Hepatitis B surface antigen — 5µg;(b) purified Hib capsular polysaccharide conjugated to meningococcal protein — 7.5µg | 3 doses |\n\n> Note: Endnotes\n\n> Note: Endnote 1—About the endnotes\n\nThe endnotes provide information about this compilation and the compiled law.\n\nThe following endnotes are included in every compilation:\n\nEndnote 1—About the endnotes\n\nEndnote 2—Abbreviation key\n\nEndnote 3—Legislation history\n\nEndnote 4—Amendment history\n\nAbbreviation key—Endnote 2\n\nThe abbreviation key sets out abbreviations that may be used in the endnotes.\n\nLegislation history and amendment history—Endnotes 3 and 4\n\nAmending laws are annotated in the legislation history and amendment history.\n\nThe 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.\n\nThe 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.\n\nEditorial changes\n\nThe 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.\n\nIf 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.\n\nMisdescribed amendments\n\nA 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.\n\nIf a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.\n\n> Note: Endnote 2—Abbreviation key\n\n| ad = added or inserted | orig = original |\n| ---------------------------------------------- | ---------------------------------------- |\n| am = amended | p = page(s) |\n| amdt = amendment | para = paragraph(s)/subparagraph(s) |\n| C[x] = Compilation No. x | /sub‑subparagraph(s) |\n| ch = Chapter(s) | pres = present |\n| cl = clause(s) | prev = previous |\n| cont. = continued | (prev…) = previously |\n| def = definition(s) | pt = Part(s) |\n| Dict = Dictionary | r = regulation(s)/Court rule(s) |\n| disallowed = disallowed by Parliament | reloc = relocated |\n| div = Division(s) | renum = renumbered |\n| ed = editorial change | rep = repealed |\n| exp = expires/expired or ceases/ceased to have | rs = repealed and substituted |\n| effect | s = section(s)/subsection(s) |\n| gaz = gazette | /rule(s)/subrule(s)/order(s)/suborder(s) |\n| LA = Legislation Act 2003 | sch = Schedule(s) |\n| LIA = Legislative Instruments Act 2003 | SLI = Select Legislative Instrument |\n| (md) = misdescribed amendment can be given | SR = Statutory Rules |\n| effect | sub ch = Sub‑Chapter(s) |\n| (md not incorp) = misdescribed amendment | sub div = Subdivision(s) |\n| cannot be given effect | sub pt = Subpart(s) |\n| mod = modified/modification | underlining = whole or part not |\n| No. = Number(s) | commenced or to be commenced |\n| Ord = Ordinance | |\n\n> Note: Endnote 3—Legislation history\n\n| Name | Registration | Commencement | Application, saving and transitional provisions |\n| ------------------------------------------------------------------------------------------------- | -------------------------- | --------------------------------------------------------------------------------------------------------------- | ----------------------------------------------- |\n| National Health (Immunisation Program — Designated Vaccines) Determination 2014 (No.1) | F2014L01255 | 23 Sept 2014 (s 2) | |\n| National Health (Immunisation Program ‑ Designated Vaccines) Variation Determination 2014 (No. 1) | F2014L01822 | 1 Jan 2015 (s 2) | — |\n| National Health (Immunisation Program ‑ Designated Vaccines) Variation Determination 2015 (No. 1) | F2015L00715 | 1 June 2015 (s 2) | — |\n| 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) | — |\n| 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)) | — |\n| National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No. 2) | F2016L01468 | 22 Sept 2016 (s 2) | — |\n| National Health (Immunisation Program ‑ Designated Vaccines) Variation Determination 2017 (No.1) | F2017L00589 | 24 May 2017 (s 2) | — |\n| National Health (Immunisation Program ‑ Designated Vaccines) Variation Determination 2017 (No. 2) | F2017L01186 | 18 Sept 2017 (s 2) | — |\n| National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 1) 2018 | F2018L00126 | 21 Feb 2018 (s 2) | — |\n| National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 2) 2018 | F2018L00714 | 7 June 2018 (s 2) | — |\n| National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 3) 2018 | F2018L01267 | 7 Sept 2018 (s 2) | — |\n| National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 4) 2018 | F2018L01530 | 2 Nov 2018 (s 2) | — |\n| National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 5) 2018 | F2019L00034 | 10 Jan 2019 (s 2) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2019 | 4 Apr 2019 (F2019L00524) | 5 Apr 2019 (s 2) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No.2) 2019 | 6 Nov 2019 (F2019L01427) | 7 Nov 2019 (s 2(1) item 1) | — |\n| National Health (Immunisation Program — Designated Vaccines) Amendment Determination (No. 3) 2019 | 19 Dec 2019 (F2019L01671) | 20 Dec 2019 (s 2(1) item 1) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2020 | 1 May 2020 (F2020L00543) | 2 May 2020 (s 2(1) item 1) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2020 | 4 June 2020 (F2020L00669) | 5 June 2020 (s 2(1) item 1) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No.3) 2020 | 31 Aug 2020 (F2020L01097) | 1 Sept 2020 (s 2(1) item 1) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No.4) 2020 | 10 Dec 2020 (F2020L01560) | 11 Dec 2020 (s 2(1) item 1) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2021 | 20 Oct 2021 (F2021L01447) | 21 Oct 2021 (s 2(1) item 1) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 1) 2023 | 5 Feb 2023 (F2023L00084) | 6 Feb 2023 (s 2(1) item 1) | — |\n| National Health (Immunisation Program—Designated Vaccines) Amendment Determination (No. 2) 2023 | 6 Oct 2023 (F2023L01367) | 1 Nov 2023 (s 2(1) item 1) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination 2024 | 28 Aug 2024 (F2024L01064) | 1 Sept 2024 (s 2(1) item 1) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2024 | 28 Nov 2024 (F2024L01513) | 29 Nov 2024 (s 2(1) item 1) | — |\n| National Health (Immunisation Program — Designated Vaccines) Amendment Determination 2025 | 3 July 2025 (F2025L00823) | 4 July 2025 (s 2) | — |\n| National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 2) 2025 | 29 Sept 2025 (F2025L01200) | 30 Sept 2025 (s 2(1) item 1) | — |\n| National Health (Immunisation Program — Designated Vaccines) Amendment Determination 2026 | 18 Feb 2026 (F2026L00113) | 19 Feb 2026 (s 2) | — |\n\n> Note: Endnote 4—Amendment history\n\n| Provision affected | How affected |\n| ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------- |\n| s 2…………………………. | rep LIA s 48D |\n| s 3…………………………. | rep LIA s 48C |\n| s 7…………………………. | am F2014L01822; F2015L01713; F2016L00661; F2016L01468; F2017L00589; F2017L01186; F2018L00714; F2018L01267; F2018L01530; F2019L00034 |\n| | ed C15 |\n| | am F2019L00524; F2019L01427; F2019L01671; F2020L00543; F2020L00669; F2020L01097; F2023L00084 |\n| | ed C24 |\n| | am F2023L01367; F2024L01064; F2024L01513 |\n| | ed C27 |\n| | am F2025L00823 |\n| | ed C28 |\n| | am F2025L01200 |\n| Sch 1, Part 1, Item 101…… | rs F2018L00126 |\n| Sch 1, Part 1, Item 102…… | rs F2018L00126 |\n| Sch 1, Part 1, Item 102A..... | ad F2015L00715 |\n| Sch 1, Part 1, Item 102B…. | ad F2015L01713 |\n| Sch 1, Part 1, Item 103…… | rs F2018L00126 |\n| | am F2018L00714; F2020L00543; F2024L01064 |\n| Sch 1, Part 1, Item 104…… | am F2024L01064 |\n| Sch 1, Part 1, Item 105…… | am F2024L01064 |\n| Sch 1, Part 1, Item 106…… | am F2024L01064 |\n| Sch 1, Part 1, Item 107…… | am F2024L01064 |\n| Sch 1, Part 1, Item 108…… | am F2024L01064 |\n| Sch 1, Part 1, Item 108A…. | ad F2018L00126 |\n| | rs F2018L01530 |\n| | am F2020L00543; F2024L01064 |\n| Sch 1, Part 1, Item 108B…. | ad F2020L01097 |\n| | am F2024L01064 |\n| Sch 1, Part 1, Item 108C…. | ad F2023L00084 |\n| | am F2023L01367;F2024L01064 |\n| Sch 1, Part 1, Item 109…… | am F2024L01064 |\n| Sch 1, Part 1, Item 110…… | rs F2018L00714 |\n| | am F2020L00543 |\n| | ed C19 |\n| | am F2024L01064 |\n| Sch 1, Part 1, Item 111…… | am F2024L01064; F2025L00823 |\n| Sch 1, Part 1, Item 112…… | am F2024L01064 |\n| Sch 1, Part 1, Item 114…… | ad F2020L00669 |\n| | am F2024L01064 |\n| Sch 1, Part 2………………. | am F2014L01822 |\n| Sch 1, Part 2, Item 202A.... | ad F2018L01267; am F2019L01427; am F2020L01560 |\n| Sch 1, Part 2, Item 207A..... | am F2019L00524; am F2020L01097 |\n| Sch 1, Part 2, Item 207B…. | ad F2016L00661; am F2019L01671 |\n| Sch 1, Part 2, Item 207C…. | ad F2016L01468 |\n| Sch 1, Part 2, Item 207D…. | ad F2018L00126; am F2018L00714 |\n| Sch 1, Part 2, Item 207E…. | ad F2018L00126; am F2018L00714 |\n| Sch 1, Part 2, Item 207F..... | ad F2019L01427; am F2020L01097 |\n| Sch 1, Part 2, Item 207G..... | ad F2019L01671 |\n| Sch 1, Part 2, Item 210A..... | am F2023L01367 |\n| | ed C25 |\n| | am F2024L01513 |\n| Sch 1, Part 2 Item 210B..... | ad F2025L01200 |\n| Sch 1, Part 2 Item 210C..... | ad F2025L01200 |\n| Sch 1, Part 2 Item 210D..... | ad F2025L01200 |\n| Sch 1, Part 2 Item 210E..... | ad F2025L01200 |\n| Sch 1, Part 2, Item 217A…. | ad F2016L00661 |\n| | am F2021L01447 |\n| | rs F2023L01367 |\n| | am F2024L01064 |\n| Sch 1, Part 2, Item 218…… | rep F2016L00661 |\n| Sch 1, Part 2, Item 218A…. | ad F2017L01186 |\n| | rs F2023L00084 |\n| Sch 1, Part 2, Item 219…… | ad F2016L00661 |\n| Sch 1, Part 2, Item 222…… | ad F2024L01513 |\n| | ed C27 |\n| Sch 1, Part 2, Item 223…… | ad F2026L00113 |\n| Sch 1, Part 3, Item 305A…. | ad F2015L01713 |\n| Sch 1, Part 3, Item 305B…. | ad F2023L00084 |\n\n---\n\n[\\[1\\]](#_ftnref1) conjugated to tetanus toxoid carrier protein 44 μg","sortOrder":8}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":true,"description":"Scope has expanded materially since the Determination's 2014 origin. The endnotes show repeated amendments adding vaccines, brands, new age/risk categories, dosing and booster rules and new items through 2026 (see Endnotes 3–4), indicating incremental broadening and technical refinement of what the National Immunisation Program may supply."},"complexity_factors":["Large, detailed Schedule 1 listing dozens of vaccines, brands, formulations and strength specifications (Schedule 1, Parts 1–3)","Extensive, conditional eligibility rules keyed to age bands, medical risk groups and geography (see section 7 and many Schedule 1 items)","Technical medical definitions and risk categories (definition of \"member of a medical risk group\" in s 4)","Multiple bespoke dosing and booster schedules for specific items (ss 7(1A)–(1C), 7(13), 7(14), 7(15))","Cross‑references to Migration Regulations visa subclasses for some adult eligibility (s 7(12))","Frequent amendment history and versioning that change item content and commencement (Endnotes 3 and 4)","Operational requirements on providers to verify eligibility and prior receipt (s 7(10)–(12) and Schedule entries), increasing administrative/compliance burden","Treatment‑specific carve outs (e.g. eculizumab, Empavali/pegcetacoplan) and single‑dose limits that add decision points for clinicians (multiple Schedule items)","Detailed age waivers and catch‑up provisions (s 7(10)–(12)) creating numerous edge cases for implementation"],"plain_english_summary":"This Determination lists which vaccines the National Immunisation Program can provide and sets the exact circumstances—ages, medical risk groups, doses and boosters—when those vaccines may be supplied (through Schedule 1). It replaces a generic rule with a detailed catalogue of branded vaccines, formulations and eligibility. \n\nIt affects people eligible for program vaccines, clinicians and clinics who must check eligibility and follow dosing rules, and the Department that administers supply. The rules create specific eligibility cutoffs (including visa and medical‑risk rules) and impose administrative verification and record‑keeping burdens on providers."},"kimi_summary":{"_metrics":{"completionTokens":794},"content_quality":"ok","complexity_score":8,"scope_assessment":{"changed":true,"description":"The original 2014 Determination has expanded significantly through 27 amendment instruments. Major scope expansions include: addition of new vaccine types (RSV, 9-valent HPV, 20-valent pneumococcal, meningococcal B, shingles for immunocompromised adults); broadened eligibility for influenza vaccines (multiple new age and risk categories); new catch-up provisions for refugees and humanitarian entrants; and expanded medical risk categories for pneumococcal and meningococcal vaccines. The document has grown from a basic childhood schedule to a comprehensive program covering all life stages and specific high-risk medical conditions."},"complexity_factors":["Extensive cross-referencing between section 7 and Schedule 1 items","Multiple nested conditions for eligibility (age + medical condition + geography + Indigenous status)","Precise technical specifications for vaccine formulations and dosages","27 separate amendment instruments since 2014, creating layered modifications","Detailed definitions of 'member of a medical risk group' with 14 specific sub-conditions","Age-based dosing schedules with multiple breakpoints (6 weeks, 6 months, 12 months, 18 months, 4 years, 5 years, etc.)","Brand-specific approvals rather than generic vaccine categories","Temporal limitations on some provisions (e.g., item 202A with expiry conditions)","Visa subclass references for refugee/humanitarian catch-up eligibility","Multiple influenza vaccine items (205-210E) with slightly different eligibility criteria"],"plain_english_summary":"The Determination names which vaccines the Australian government funds under the National Immunisation Program and the circumstances for free administration. It covers routine childhood, adolescent, pregnancy, older adult, Indigenous, medically at‑risk, occupational, and refugee catch‑up immunisations.\n\nClinicians use it to confirm Medicare‑funded eligibility, timing, doses and approved brands—so it determines who gets free vaccines and when, ensuring targeted public‑health protection."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-immunisation-program-designated-vaccines-determination-2014-no-1","history":"/api/acts/national-health-immunisation-program-designated-vaccines-determination-2014-no-1/history","analysis":"/api/acts/national-health-immunisation-program-designated-vaccines-determination-2014-no-1/analysis","conflicts":"/api/acts/national-health-immunisation-program-designated-vaccines-determination-2014-no-1/conflicts","importantCases":"/api/acts/national-health-immunisation-program-designated-vaccines-determination-2014-no-1/important-cases","documents":"/api/acts/national-health-immunisation-program-designated-vaccines-determination-2014-no-1/documents"}}