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.
(1C) For item 111B of Schedule 1, the circumstances are that a designated vaccine referred to in that item may be provided to:
(a) a child who is about 6 months old and is an Aboriginal person or Torres Strait Islander; or
(b) a child who is about 6 months old and has one or more of the following medical risk conditions:
(i) functional or anatomical asplenia, including sickle cell disease, other haemoglobinopathies, congenital or acquired asplenia (e.g. splenectomy) or hyposplenia; or
(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
(iv) chronic respiratory disease, including suppurative lung disease, bronchiectasis and cystic fibrosis or chronic lung disease of prematurity; or
(v) chronic renal disease, including end stage renal disease (eGFR <15mL/min) or relapsing or persistent nephrotic syndrome; or
(vi) proven or presumptive cerebrospinal fluid leak; or
(vii) cochlear implants; or
(viii) intracranial shunts; or
(ix) previous episode of invasive pneumococcal disease; or
(x) born less than 28 weeks gestation; or
(xi) trisomy 21; or
(xii) chronic heart disease including cyanotic heart disease and heart failure; or
(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
(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).
(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:
(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 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
(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
(e) a woman who 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:
(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 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:
(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
(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:
(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
(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.
(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:
(aa) a child who is at least 6 months of age but less than 5 years of age; or
(a) an Aboriginal or Torres Strait Islander who is at least 6 months of age but less than 65 years of age;
(b) a person who is at least 6 months of age but less than 65 years of age 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;
(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;
(d) a woman who is pregnant.
(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.
(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:
(a) has an underlying condition, including any of the following:
(i) acute haematological malignancies such as acute leukaemia or aggressive lymphomas;
(ii) chronic haematological malignancies, such as:
(A) myelodysplastic syndromes;
(B) chronic myeloproliferative disorders;
(C) lymphoproliferative malignancies;
(D) plasma cell dyscrasias which includes myeloproliferative neoplasms, chronic lymphocytic leukaemia, indolent non‑Hodgkin lymphoma or multiple myeloma;
(iii) human immunodeficiency virus infection with CD4+ cell count < 200/µL;
(iv) inborn errors of immunity with ongoing functional deficits including:
(A) humoral e.g., X‑linked agammaglobulinemia;
(B) combined defects, including severe combined immunodeficiency;
(C) phagocytic disorders, including chronic granulomatous disease; or
(D) other inborn errors of immunity except complement disorders, hereditary angioedema and IgA deficiency;
(v) stage 5 kidney disease or on dialysis;
(b) malignancy, autoimmune or inflammatory conditions receiving immunomodulatory or immunosuppressive treatments, including any of the following:
(i) cellular therapies, whether received currently or within the previous 24 months, including:
(A) autologous haematopoietic stem cell transplant;
(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
(C) chimeric antigen receptor T‑cell therapy;
(ii) B and T‑cell targeted monoclonal antibody therapies, whether received currently or within the last 6 months, including any of the following:
(A) anti‑CD20;
(B) anti B‑cell activating factor;
(C) anti‑CD52;
(D) anti‑thymocyte globulin;
(iii) conventional chemotherapy for:
(A) treatment of haematological malignancy; or
(B) solid organ tumours, currently or within the last 6 months;
(iv) immunosuppressive therapy to prevent organ rejection prior to or following solid organ transplantation, currently or within the last 6 months;
(v) conventional immunosuppressive agents, currently or within the last 6 months, including any of the following:
(A) high dose methotrexate ≥20mg per week (oral and subcutaneous);
(B) azathioprine ≥3.0mg/kg/day;
(C) 6‑mercaptopurine ≥1.5mg/kg/day;
(D) mycophenolate ≥1g/day;
(E) cyclophosphamide;
(F) systemic calcineurin inhibitors such as tacrolimus or cyclosporin;
(G) mTOR inhibitors;
(H) purine analogues such as cladribine;
(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:
(A) tumour necrosis factor inhibitors;
(B) T‑cell co‑stimulation modulators such as Abatacept);
(C) soluble TNF receptors;
(D) type I interferon receptor inhibitors;
(E) proteasome inhibitors;
(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;
(vii) immunomodulatory drugs including sphingosine‑1‑phosphate receptor modulators within the last 6 months;
(viii) oral small molecule targeted therapies, received currently or within the last 6 months including any of the following:
(A) bruton’s tyrosine kinase inhibitors;
(B) janus kinase inhibitors;
(C) BCR‑ABL inhibitors.