Changes to the recommended use of pneumococcal vaccines
Australian Technical Advisory Group on ImmunisationPublic consultation on changes to the recommended use of pneumococcal vaccinesThe Australian Technical Advisory Group on Immunisation (ATAGI) is consulting with stakeholders on proposed changes to the pneumococcal vaccination recommendations for inclusion in The Australian Immunisation Handbook, with an intention to submit the recommendations to the National Health and Medical Research Council (NHMRC) for its approval under section 14A of the National Health and Medical Research Council Act 1992.This draft includes new recommendations and the rationale for the proposed changes. You are invited to make a submission on the draft recommendations by 1 March 2020. In particular, ATAGI is seeking comments on the following:Are there additional potential benefits, harms or unintended consequences which could arise from the proposed changes to the use of pneumococcal vaccines, not already outlined, and how likely are they to occur?Are there additional clinical or implementation considerations which need to be outlined?Should you require additional information please contact ATAGI Secretariat on atagi.secretariat@.au.Changes to the recommended use of pneumococcal vaccines TOC \o "1-1" \h \z \u Plain-language summary PAGEREF _Toc31192126 \h 2Summary of revised recommendations PAGEREF _Toc31192127 \h 3Background PAGEREF _Toc31192128 \h 5Rationale PAGEREF _Toc31192129 \h 5New recommendations for people with risk conditions PAGEREF _Toc31192130 \h 8New recommendations for Aboriginal and Torres Strait Islander people PAGEREF _Toc31192131 \h 21New recommendation for healthy non-Indigenous adults PAGEREF _Toc31192132 \h 24Additional information to be included in the Australian Immunisation Handbook – catch-up vaccination PAGEREF _Toc31192133 \h 26Future review of pneumococcal vaccine recommendations PAGEREF _Toc31192134 \h 28Benefits of new recommendations PAGEREF _Toc31192135 \h 28Potential risks of new recommendations PAGEREF _Toc31192136 \h 28Preferences and values PAGEREF _Toc31192137 \h 29Glossary PAGEREF _Toc31192138 \h 29References PAGEREF _Toc31192139 \h 29Plain-language summaryPneumococcal disease is a very serious bacterial infection. It can cause:infection of the lungs (pneumonia)infection of the middle ear (otitis media)swelling and infection of the brain (meningitis)infection of the blood (septicaemia)comadeathInvasive pneumococcal disease (IPD) is when the bacteria are found in the blood, spinal fluid or another part of the body that would normally be sterile. IPD mainly affects:young childrenolder peopleAboriginal and Torres Strait Islander peoplepeople with certain long-term diseasespeople with weakened immune systemsVaccination is the best protection against pneumococcal disease. There are 2 types of pneumococcal vaccine, called 13vPCV and 23vPPV.The recommendations for pneumococcal vaccines are changing. This will make pneumococcal vaccines more readily available and give extra protection to people who are most at risk of disease. The changes will also make it easier to understand:who should get pneumococcal vaccineswhich vaccine they should getwhen they should get itThere are no changes to the routine infant schedule. All children are recommended to receive 3 doses of 13vPCV at ages 2, 4 and 12 months.Broadly, the new recommendations are:Anyone with an increased risk of pneumococcal disease is recommended to receive 1?extra dose of 13vPCV and 2 doses of 23vPPV. This includes:people with certain risk conditions at any ageAboriginal and Torres Strait Islander people aged 50?years.Aboriginal and Torres Strait Islander children in certain states and territories are already recommended to receive an extra dose of 13vPCV. They should also receive 2 doses of 23vPPV.Otherwise healthy people of all ages with no risk factors for pneumococcal disease are no longer recommended to receive 23vPPV. Infants should receive 3 doses of 13vPCV in the routine schedule, and older Australians a single dose of 13vPCV at age 70 years.Summary of revised recommendationsPeople with medical risk factorsChildren diagnosed with certain risk conditions at 12 months of age are recommended to receive 4 doses of 13vPCV and 2 doses of 23vPPVChildren and adolescents aged >12 months to <18 years with newly identified risk conditions are recommended to receive 1?dose of 13vPCV and 2 doses of 23vPPVAdults of any age 18 years with newly identified risk conditions are recommended to receive 1?dose of 13vPCV and 2 doses of 23vPPV Aboriginal and Torres Strait Islander peopleAboriginal and Torres Strait Islander children aged 5 years living in certain states and territories are recommended to receive 4 doses of 13vPCV and 2 doses of 23vPPVAboriginal and Torres Strait Islander adults aged 50 years without conditions associated with an increased risk of pneumococcal disease are recommended to receive 1 dose of 13vPCV and 2?doses of 23vPPVHealthy non-Indigenous adultsNon-Indigenous adults aged 70 years without conditions associated with an increased risk of pneumococcal disease are recommended to receive 1 dose of 13vPCVFigure 1 also shows a summary of the revised recommendations.Figure 1Summary of revised recommendations for pneumococcal vaccinationBackgroundThe Australian Technical Advisory Group on Immunisation (ATAGI) advises the Australian Government on clinical recommendations for vaccinations. ATAGI is proposing changes to the recommendations for the use of pneumococcal vaccines.The proposed changes reflect the current best clinical practice to prevent pneumococcal disease in adults and in people with conditions that increase their risk of disease. The revised recommendations will be published online in the Australian Immunisation Handbook.In general, invasive pneumococcal disease (IPD) incidence is highest in very young people and older people. Pneumococcal disease surveillance shows there is a high disease burden in certain populations in Australia. Aboriginal and Torres Strait Islander people, and people with certain medical or lifestyle conditions continue to be at greatest risk of IPD.2 vaccines are used to prevent pneumococcal disease:13-valent pneumococcal conjugate vaccine (13vPCV), which protects against serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F23-valent pneumococcal polysaccharide vaccine (23vPPV), which protects against serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33FPneumococcal vaccination is recommended as part of the routine infant and adult schedules. It is also recommended for specific populations with an increased risk of pneumococcal disease.RationaleATAGI has proposed new recommendations for people with an increased risk of pneumococcal disease to: optimise protection against the diseasesimplify vaccination adviceensure equitable access for those most at risk of diseaseThe current recommendations for people with an increased risk of pneumococcal disease are complex, and vary depending on: the person’s agewhether they have a risk condition and when the condition was diagnosedtheir Aboriginal and Torres Strait Islander statustheir vaccination historyThe changes to the recommended vaccines and the list of risk conditions will help to simplify this advice.Note there are no proposed changes to the routine infant schedule. All children are recommended to receive 3 doses of 13vPCV at ages 2, 4 and 12 months.Children and adults with risk conditionsPneumococcal disease incidence is higher in children and adults with risk conditions than in healthy children and adults.A range of medical and behavioural conditions can increase the risk of IPD. ATAGI has reviewed the evidence and revised the list of conditions to ensure that people with the highest risk of disease are protected through vaccination.The burden of IPD caused by serotypes that are included in 23vPPV but not included in 13vPCV (known as 23v-non-13v serotypes) is higher in non-Indigenous adults with risk conditions than those without risk conditions. To address this issue, ATAGI is recommending that people with specific risk conditions receive both 13vPCV and 23vPPV to maximise protection against disease.Aboriginal and Torres Strait Islander peopleCompared with non-Indigenous adults, in Aboriginal and Torres Strait Islander adults:IPD incidence starts to increase at a younger age the prevalence of risk conditions for pneumococcal disease is higher at younger ages the burden of IPD caused by 23v-non-13v serotypes is higher To address these issues, ATAGI is recommending that all Aboriginal and Torres Strait Islander adults continue to receive pneumococcal vaccines from age 50, and that they receive both 13vPCV and 23vPPV to maximise protection against the serotypes that commonly cause disease in this group. Aboriginal and Torres Strait Islander adults <50 years with risk conditions should receive pneumococcal vaccines according to the recommendations for people with risk conditions. Aboriginal and Torres Strait Islander adults <50 years without risk conditions do not need additional pneumococcal vaccines.Aboriginal and Torres Strait Islander children aged 5 years living in certain states and territories (Queensland, Western Australia, South Australia and the Northern Territory) already receive 4 doses of 13vPCV as part of their routine schedule (at 2, 4, 6 and 12?months). ATAGI is also recommending 2?doses of 23vPPV in addition to these 4 doses of 13vPCV.Older adults without conditions associated with an increased risk of pneumococcal diseaseIn older adults, community-acquired pneumonia (CAP) is the most common form of pneumococcal disease. The current pneumococcal vaccination program for older adults uses 23vPPV, but 23vPPV is expected to have limited benefit against non-invasive pneumococcal CAP. A large randomised controlled trial in adults aged ≥65 years in the Netherlands (the CAPiTA trial) showed that a dose of 13vPCV was effective against invasive as well as non-invasive pneumococcal CAP caused by vaccine serotypes. Informed by this evidence, ATAGI proposes that the dose of 23vPPV currently given to all non-Indigenous adults at age ≥65?years is replaced with a dose of 13vPCV. This dose will also be moved to age ≥70 because pneumococcal disease is much more common in people over 70 years of age than in people aged 65–69 years. The incidence rate of IPD caused by 13vPCV serotypes in adults from 70 years of age is about 2-fold higher than that in people aged 65–69 years (unpublished estimates from National Notifiable Diseases Surveillance System notification data). Because the effectiveness of pneumococcal vaccines reduces over time, moving this dose to age 70?years will ensure protection as people move into older age groups with increasing IPD risk.23vPPV includes 11 extra serotypes that are not included in 13vPCV. In healthy non-Indigenous older adults, the incidence of IPD caused by 23v-non-13v serotypes is too low to support the continued use of 23vPPV following 13vPCV in this group. New recommendations for people with risk conditionsNew list of risk conditionsThe following list of conditions associated with an increased risk of invasive pneumococcal disease applies to all recommendations that are based on these risk factors.List. Risk conditions for invasive pneumococcal diseaseChildren and adults with these risk conditions may be at increased risk of pneumococcal disease and may benefit from additional doses of pneumococcal vaccine.Many children and adults with these risk conditions are eligible for funded doses of 13vPCV (13valent pneumococcal conjugate vaccine) and 23vPPV (23-valent pneumococcal polysaccharide vaccine) under the National Immunisation Program (NIP). However, some groups are not eligible to receive funded vaccine doses because the incidence of disease is not sufficient to meet cost-effectiveness thresholds. Vaccine doses for people with the risk conditions in this list are funded under the NIP unless otherwise noted.Previous episode of invasive pneumococcal diseaseFunctional or anatomical asplenia, including– sickle cell disease or other haemoglobinopathies– congenital or acquired asplenia (for example, splenectomy) or hypospleniaImmunocompromising conditions, including– congenital or acquired immune deficiency, including symptomatic IgG subclass or isolated IgA deficiency– haematological malignancies– solid organ transplant– haematopoietic stem cell transplant– HIV infection– immunosuppressive therapy, where sufficient immune reconstitution for vaccine response is expected; this includes those with underlying conditions requiring but not yet receiving immunosuppressive therapya– non-haematological malignancies receiving chemotherapy or radiotherapy (currently or anticipated)aProven or presumptive cerebrospinal fluid (CSF) leak, including– cochlear implants– intracranial shuntsChronic respiratory disease, including– suppurative lung disease, bronchiectasis and cystic fibrosis– chronic lung disease in preterm infantsChronic renal disease – relapsing or persistent nephrotic syndrome– chronic renal impairment – eGFR <30 mL/min (stage 4 disease)bCardiac disease, including– congenital heart diseasec– coronary artery diseasec– heart failurecChildren born less than 28 weeks gestationcTrisomy 21cChronic liver disease, including – chronic hepatitisa– cirrhosisa– biliary atresiaaDiabetesaSmoking (current or in the immediate past)aHarmful use of alcoholaa Not funded under the NIPb Funded under the NIP for eGFR <15?mL/min only (including patients on dialysis)c Funded under the NIP for children <5 years onlyCurrent list of risk conditionsATAGI currently recommends a similar list that is split into Category A (highest increased risk) and Category B (increased risk). Vaccination recommendations differ depending on the risk category.Key differencesThe revised list includes all the risk conditions listed in the current Handbook, but consolidates the previous Category A and Category B conditions into a single list. It includes ‘previous episode of invasive pneumococcal disease’ in adults as well as children. The specific increase in risk of pneumococcal disease varies widely with each risk condition (see Table?1). This revised list aims to simplify the current complex recommendations for people with risk conditions to improve compliance and reduce disease burden.New recommendationChildren diagnosed with certain risk conditions at 12 months of age are recommended to receive 4 doses of 13vPCV and 2 doses of 23vPPVIn addition to the 3 doses for all children 5 years of age, children 12 months of age with conditions that increase their risk of invasive pneumococcal disease (see List. Risk conditions for invasive pneumococcal disease) are recommended to receive:a dose of 13vPCV at 6 months of agea dose of 23vPPV at 4–5 years of agea 2nd dose of 23vPPV 5–10 years after the 1st dose of 23vPPVThis is because of the higher disease burden and the possibility of lower antibody responses in these children.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LbHVnbWFuPC9BdXRob3I+PFllYXI+MjAxODwvWWVhcj48
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ZT4A
ADDIN EN.CITE.DATA 1-3Aboriginal and Torres Strait Islander children diagnosed with risk conditions at 12 months of age who live in the NT, Qld, SA or WA already receive these extra doses as part of their routine schedule.Any child from 6 to 11 months with a?newly identified?medical condition who has not received an additional dose of?13vPCV?at 6 months of age, should receive this at diagnosis. The exception is children who have received a haematopoietic stem cell transplant — these children are recommended to receive 3 doses of?13vPCV?after transplantation. See?Table. Recommendations for revaccination after haematopoietic stem cell transplant in children and adults.See?Catch-up vaccination?for more details, including minimum intervals between doses.See?Table. Recommended ages for pneumococcal vaccination in children aged ≤5 years.Current recommendationATAGI currently recommends the following:Children aged 5 years with certain medical conditions are recommended to receive 4 doses of 13vPCV and 1 dose of 23vPPVChildren and adolescents aged 5 years to <18 years with pre-existing medical conditions in Category A who have previously received 4 doses of 13vPCV and a dose of 23vPPV at 4–5?years of age are recommended to receive further doses of 23vPPVChildren and adolescents aged 5 years to <18 years with pre-existing conditions in Category?B who have previously received 4 doses of 13vPCV and a dose of 23vPPV at 4–5?years of age are recommended to receive another dose of 23vPPVKey differencesATAGI proposes that children with conditions that increase their risk of pneumococcal disease receive an additional dose of 13vPCV and 2 doses of 23vPPV, and no further doses of 23vPPV during their lifetime.New recommendationChildren and adolescents aged >12 months to <18 years with newly identified risk conditions are recommended to receive 1?dose of 13vPCV and 2 doses of 23vPPVAll children and adolescents with newly identified risk conditions (see List. Risk conditions for invasive pneumococcal disease) (except Aboriginal and Torres Strait Islander children <5?years of age living in the NT, Qld, SA or WA) are recommended to receive: 1 dose of 13vPCV at diagnosis (at least 2 months after any previous doses of 13vPCV)1 dose of 23vPPV 12 months after 13vPCV (2–12 months later is acceptable), or at 4 years of age, whichever is latera 2nd dose of 23vPPV 5–10 years laterAboriginal and Torres Strait Islander children <5?years of age with risk conditions who live in the NT, Qld, SA or WA already receive these doses as part of their routine schedule. The exception is people who have received a haematopoietic stem cell transplant — these people are recommended to receive 3 doses of?13vPCV?after transplantation. See?Table. Recommendations for revaccination after haematopoietic stem cell transplant in children and adults.A?minimum interval?of 2 months between the last dose of?13vPCV?and?23vPPV?is recommended. This is based on a small number of studies in children of different ages with underlying conditions. These studies have shown that?23vPPV?is more immunogenic if given approximately 2 months after a?7vPCV?dose.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BYnp1ZzwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 4-7See?Table. Recommended ages for pneumococcal vaccination in children aged ≤5 years.Current recommendationOverall, for people with risk conditions, the current recommendation is for 3 lifetime doses of 23vPPV. This includes the following:Children and adolescents aged 5 years to <18 years with newly identified medical conditions in Category A who have never received 13vPCV are recommended to receive 1 dose of 13vPCV at diagnosis and doses of 23vPPVChildren and adolescents aged 5 years to <18 years with newly identified conditions in Category B are recommended to receive doses of 23vPPVChildren and adolescents aged 5 years to <18 years with pre-existing conditions in Category?A who received 23vPPV at 4–5 years of age but have never received 13vPCV are recommended to receive 1 dose of 13vPCV and further doses of 23vPPVKey differencesATAGI proposes to simplify the current recommendations by:consolidating Category A and Category B conditions into a single list of conditions that increase the risk of pneumococcal diseaserecommending the same vaccines and number of doses – 1 dose of 13vPCV and 2 doses of 23vPPV – for all people >12 months of age, regardless of their age at diagnosislimiting the number of lifetime doses of 23vPPV to 2 doses New recommendationAdults of any age 18 years with newly identified risk conditions are recommended to receive 1?dose of 13vPCV and 2 doses of 23vPPVAll adults of any age with newly identified risk conditions (see List. Risk conditions for invasive pneumococcal disease) are recommended to receive: 1 dose of 13vPCV at diagnosis (at least 2 months after any previous doses of 13vPCV)1 dose of 23vPPV 12 months after 13vPCV (2–12 months later is acceptable)a 2nd dose of 23vPPV 5–10 years laterAboriginal and Torres Strait Islander adults aged 50 years already receive these doses, and they do not need to be repeated.The exception is people who have received a haematopoietic stem cell transplant — these people are recommended to receive 3 doses of?13vPCV?after transplantation. See?Table. Recommendations for revaccination after haematopoietic stem cell transplant in children and adults.A?minimum interval?of 2 months between the last dose of?13vPCV?and?23vPPV?is recommended. This is based on a small number of studies in children of different ages with underlying conditions. These studies have shown that?23vPPV?is more immunogenic if given approximately 2 months after a?7vPCV?dose.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BYnp1ZzwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 4-7Current recommendationOverall, for people with risk conditions, the current recommendation is for 3 lifetime doses of 23vPPV. This includes the following:Adults with newly identified medical conditions in Category A are recommended to receive 1?lifetime dose of 13vPCV and 3 doses of 23vPPVAdults with newly identified conditions in Category B are recommended to receive 3 doses of 23vPPVAdults with pre-existing medical conditions in Category?A who have previously received 23vPPV are recommended to receive 1 dose of 13vPCV and 2 doses of 23vPPVAdults with pre-existing medical conditions in Category?A who have previously received 13vPCV are recommended to receive 3 doses of 23vPPVAdults with pre-existing conditions in Category?B are recommended to receive 3 lifetime doses of 23vPPVKey differencesATAGI proposes to simplify the current recommendations by:consolidating Category A and Category B conditions into a single list of conditions that increase the risk of pneumococcal diseaserecommending the same vaccines and number of doses – 1 dose of 13vPCV and 2 doses of 23vPPV – for all people >12 months of age, regardless of their age at diagnosislimiting the number of lifetime doses of 23vPPV to 2 doses Evidence for the new recommendationsHigher burden of disease in people with risk conditionsOverall, the burden of pneumococcal disease has decreased significantly, driven mainly by the indirect protective effects of the 13vPCV schedule in infants. However, some population subgroups have an increased risk of pneumococcal disease due to underlying medical conditions and behavioural factors (Table 1). In these groups, the burden of disease remains substantial and involves a broad range of pneumococcal serotypes. People in these risk groups are likely to benefit from a pneumococcal schedule that uses both 13vPCV and 23vPPV. Risk conditions are present across all age groupsThere are no Australian-specific estimates for the prevalence of risk factors associated with an increased risk of IPD that specifically match the new list of pneumococcal risk conditions. However, data from 2 international studiesPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LeWF3PC9BdXRob3I+PFllYXI+MjAwNTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 8,9 and the Australian Bureau of Statistics national population health surveys show that conditions associated with an increased risk of IPD occur across all age groups.13vPCV is likely to be effective in people with risk conditionsThere is a lack of data on the efficacy and effectiveness of 13vPCV in people with risk conditions. However, immunogenicity data are available for several risk conditions, and these data indicate that the vaccine induces a protective response. Studies in people with risk conditions showed no major safety concerns after vaccination.Immunogenicity and safety data are available for 13vPCV in people with HIV infection, people with chronic kidney disease, people who have had a haematopoietic stem cell transplant, people who have had a kidney transplant and people who are receiving immunosuppressive therapy for cancers.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CaG9yYXQ8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 18 assessed the efficacy of 13vPCV in people with certain risk conditions, including: heart diseaselung diseaseasthmadiabetesliver diseasesmokingsplenectomyIn these people, the efficacy of 13vPCV against vaccine-type IPD was 77.3%, and 40.3% against vaccine-type CAP.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdWF5YTwvQXV0aG9yPjxZZWFyPjIwMTg8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 19,20 In people with chronic conditions who are not immunocompromised, vaccine effectiveness against IPD is estimated to be 50–60%.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGFwaXJvPC9BdXRob3I+PFllYXI+MTk5MTwvWWVhcj48
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ADDIN EN.CITE.DATA 19,21 Sequential administration of 13vPCV and 23vPPV in people with risk conditions is therefore likely to protect these people against 23v-non-13v serotypes. This is supported by immunogenicity studies that compared sequential administration of 7vPCV or 13vPCV and 23vPPV in varying combinations and dose intervals (2, 6, 12 months or 3–4 years) in adults from 50 years of age.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HcmVlbmJlcmc8L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFy
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ADDIN EN.CITE.DATA 22-28 In these studies, antibody levels were generally higher when PCV was given as the first dose.The recommended interval between 13vPCV and 23vPPV of 2–12 months aims to harness the extended protection against 23v-non-13v serotypes in a short period of time.Immunogenicity data support 1 repeat dose of 23vPPV 3–5 years later, but there is no substantial benefit in further doses of 23vPPV beyond this.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYXlhPC9BdXRob3I+PFllYXI+MjAxNTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 30-32 It is unclear whether additional doses of 23vPPV may lead to immune hyporesponsiveness. Because of these factors, ATAGI recommends a total of 2 doses of 23vPPV for people with risk conditions. The current schedule and funding for pneumococcal vaccines in people with risk conditions is complex and challenging for patients, providers and programs. By using the same recommendation for all those at risk and providing funded doses to large number of Australians with risk factors, the new recommended schedule is expected to simplify the recommendations and improve compliance.Table 1Summary of incidence rates of IPD and rate ratios in people with underlying risk conditions (compared with healthy people) from selected studies, in descending order of incidence or relative riskImmunosuppressive conditionsConditionAge groupRate per 100,000Rate ratio (95% CI)Notes and referencesStem cell transplant recipients≥18 years2250naClinically recommended to receive 3 doses of 13vPCV. Torda et al ADDIN EN.CITE <EndNote><Cite><Author>Torda</Author><Year>2014</Year><RecNum>1290</RecNum><DisplayText><style face="superscript">33</style></DisplayText><record><rec-number>1290</rec-number><foreign-keys><key app="EN" db-id="e05e9rx03fdvrze5a555trdqz25tsfdstdpd" timestamp="1574315108">1290</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Torda, A</author><author>Chong, Q</author><author>Lee, A</author><author>Chen, S</author><author>Dodds, A</author><author>Greenwood, M</author><author>Larsen, S</author><author>Gilroy, N</author></authors></contributors><titles><title>Invasive pneumococcal disease following adult allogeneic hematopoietic stem cell transplantation</title><secondary-title>Transplant Infectious Disease</secondary-title></titles><periodical><full-title>Transplant Infectious Disease</full-title></periodical><pages>751-759</pages><volume>16</volume><number>5</number><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>33Solid organ transplant recipients – any solid organ≥18 years 146naKumar et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LdW1hcjwvQXV0aG9yPjxZZWFyPjIwMDc8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 34Solid organ transplant recipients – liver transplant≥18 years354naKumar et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LdW1hcjwvQXV0aG9yPjxZZWFyPjIwMDc8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 34Asplenia, functional or anatomical5–17 years107.9101.5 (60.1-171.5)Pelton et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZWx0b248L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 36Haematological malignancy – all malignanciesAll age groups50naLee et al ADDIN EN.CITE <EndNote><Cite><Author>Lee</Author><Year>2018</Year><RecNum>1291</RecNum><DisplayText><style face="superscript">37</style></DisplayText><record><rec-number>1291</rec-number><foreign-keys><key app="EN" db-id="e05e9rx03fdvrze5a555trdqz25tsfdstdpd" timestamp="1574315354">1291</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lee, YJ</author><author>Huang, YT</author><author>Kim, SJ</author><author>Kerpelev, M</author><author>Gonzalez, V</author><author>Kaltsas, A</author><author>Papanicolaou, G</author></authors></contributors><titles><title>Trends in invasive pneumococcal disease in cancer patients after the introduction of 7-valent pneumococcal conjugate vaccine: a 20-year longitudinal study at a major urban cancer center</title><secondary-title>Clinical Infectious Diseases</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>244-253</pages><volume>66</volume><number>2</number><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>37Haematological malignancy – leukaemiaAll age groups52naLee et al ADDIN EN.CITE <EndNote><Cite><Author>Lee</Author><Year>2018</Year><RecNum>1291</RecNum><DisplayText><style face="superscript">37</style></DisplayText><record><rec-number>1291</rec-number><foreign-keys><key app="EN" db-id="e05e9rx03fdvrze5a555trdqz25tsfdstdpd" timestamp="1574315354">1291</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lee, YJ</author><author>Huang, YT</author><author>Kim, SJ</author><author>Kerpelev, M</author><author>Gonzalez, V</author><author>Kaltsas, A</author><author>Papanicolaou, G</author></authors></contributors><titles><title>Trends in invasive pneumococcal disease in cancer patients after the introduction of 7-valent pneumococcal conjugate vaccine: a 20-year longitudinal study at a major urban cancer center</title><secondary-title>Clinical Infectious Diseases</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>244-253</pages><volume>66</volume><number>2</number><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>37Haematological malignancy – lymphomaAll age groups28naLee et al ADDIN EN.CITE <EndNote><Cite><Author>Lee</Author><Year>2018</Year><RecNum>1291</RecNum><DisplayText><style face="superscript">37</style></DisplayText><record><rec-number>1291</rec-number><foreign-keys><key app="EN" db-id="e05e9rx03fdvrze5a555trdqz25tsfdstdpd" timestamp="1574315354">1291</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lee, YJ</author><author>Huang, YT</author><author>Kim, SJ</author><author>Kerpelev, M</author><author>Gonzalez, V</author><author>Kaltsas, A</author><author>Papanicolaou, G</author></authors></contributors><titles><title>Trends in invasive pneumococcal disease in cancer patients after the introduction of 7-valent pneumococcal conjugate vaccine: a 20-year longitudinal study at a major urban cancer center</title><secondary-title>Clinical Infectious Diseases</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>244-253</pages><volume>66</volume><number>2</number><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>37Haematological malignancy – myelomaAll age groups139naLee et al ADDIN EN.CITE <EndNote><Cite><Author>Lee</Author><Year>2018</Year><RecNum>1291</RecNum><DisplayText><style face="superscript">37</style></DisplayText><record><rec-number>1291</rec-number><foreign-keys><key app="EN" db-id="e05e9rx03fdvrze5a555trdqz25tsfdstdpd" timestamp="1574315354">1291</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lee, YJ</author><author>Huang, YT</author><author>Kim, SJ</author><author>Kerpelev, M</author><author>Gonzalez, V</author><author>Kaltsas, A</author><author>Papanicolaou, G</author></authors></contributors><titles><title>Trends in invasive pneumococcal disease in cancer patients after the introduction of 7-valent pneumococcal conjugate vaccine: a 20-year longitudinal study at a major urban cancer center</title><secondary-title>Clinical Infectious Diseases</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. 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ADDIN EN.CITE.DATA 36Solid tumour malignancyAll age groups11naLee et al ADDIN EN.CITE <EndNote><Cite><Author>Lee</Author><Year>2018</Year><RecNum>1291</RecNum><DisplayText><style face="superscript">37</style></DisplayText><record><rec-number>1291</rec-number><foreign-keys><key app="EN" db-id="e05e9rx03fdvrze5a555trdqz25tsfdstdpd" timestamp="1574315354">1291</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lee, YJ</author><author>Huang, YT</author><author>Kim, SJ</author><author>Kerpelev, M</author><author>Gonzalez, V</author><author>Kaltsas, A</author><author>Papanicolaou, G</author></authors></contributors><titles><title>Trends in invasive pneumococcal disease in cancer patients after the introduction of 7-valent pneumococcal conjugate vaccine: a 20-year longitudinal study at a major urban cancer center</title><secondary-title>Clinical Infectious Diseases</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>244-253</pages><volume>66</volume><number>2</number><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>37Chronic kidney diseaseConditionAge groupRate per 100,000Rate ratio (95% CI)Notes and referencesChronic renal failure, including end-stage renal failure, glomerulonephritis, nephrotic syndrome and dialysis5–17 years74.169.7 (37.0–131.6)Pelton et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZWx0b248L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 36Chronic renal failure, including end-stage renal failure, glomerulonephritis, nephrotic syndrome and dialysis50–64 years57.913.0 (10.8‐15.6)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Chronic renal failure, including end-stage renal failure, glomerulonephritis, nephrotic syndrome and dialysis≥65 years506.0 (5.0‐7.2)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 38Previous invasive pneumococcal diseaseConditionAge groupRate per 100,000Rate ratio (95% CI)Notes and referencesPrevious IPD5–17 years90naJ?Malo and S?Lambert, Queensland Health, personal communication to ATAGI, January 2017Previous IPD≥18 years377naJ?Malo and S?Lambert, Queensland Health, personal communication to ATAGI, January 2017Blood–brain barrier dysfunctionConditionAge groupRate per 100,000Rate ratio (95% CI)Notes and referencesCochlear implant5–17 years50naWeycker et al ADDIN EN.CITE <EndNote><Cite><Author>Weycker</Author><Year>2016</Year><RecNum>1271</RecNum><DisplayText><style face="superscript">39</style></DisplayText><record><rec-number>1271</rec-number><foreign-keys><key app="EN" db-id="e05e9rx03fdvrze5a555trdqz25tsfdstdpd" timestamp="1503449581">1271</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Weycker, Derek</author><author>Farkouh, Raymond A.</author><author>Strutton, David R.</author><author>Edelsberg, John</author><author>Shea, Kimberly M.</author><author>Pelton, Stephen I.</author></authors></contributors><titles><title>Rates and costs of invasive pneumococcal disease and pneumonia in persons with underlying medical conditions</title><secondary-title>BMC Health Services Research</secondary-title></titles><periodical><full-title>BMC Health Services Research</full-title></periodical><pages>182</pages><volume>16</volume><number>1</number><dates><year>2016</year><pub-dates><date>2016//</date></pub-dates></dates><isbn>1472-6963</isbn><label>PDF</label><urls><related-urls><url> NCIRS</modified-date></record></Cite></EndNote>39Cochlear implant≥65 years87.410.5 (1.5–74.8)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Chronic respiratory disease (not asthma)50–64 years34.47.7 (6.8‐8.8) §Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 35Asthma (excluding severe asthma)18–49 years4.52.5 (1.9‐3.2)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Asthma (excluding severe asthma)50–64 years16.73.8 (3.2‐4.5)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Asthma (excluding severe asthma)≥65 years34.24.1 (3.4‐5.0)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Fibrotic lung disease/ pneumoconiosis50–64 yearsna1.3 (0.2-10.0)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Chronic liver diseaseConditionAge groupRate per 100,000Rate ratio (95% CI)Notes and referencesChronic liver disease18–49 years18.710.2 (6.7‐15.6)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Chronic liver disease50–64 years28.56.4 (4.8‐8.5)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Chronic liver disease≥65 years53.46.4 (4.4‐9.5)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Chronic hepatitis18–49 years2.03.5 (3.0- 4.1)Wotton et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Xb3R0b248L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 9Down syndromeConditionAge groupRate per 100,000Rate ratio (95% CI)Notes and referencesDown syndrome5–17 years14.613.7 (3.4–55.2)Pelton et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZWx0b248L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 35Chronic heart diseaseConditionAge groupRate per 100,000Rate ratio (95% CI)Notes and referencesChronic heart disease5–17 years10.69.9 (4.7–21.1)Pelton et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZWx0b248L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 35Chronic heart disease18–49 years7.23.9 (3.0‐5.1)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Chronic heart disease50–64 years132.9 (2.6‐3.3)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Chronic heart disease≥65 years26.63.2 (2.8‐3.6)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Severe heart failure50–64 years55.2 (3.8-7.1)Incidence rate calculated by taking the incidence of IPD in people with no recorded risk factors (from enhanced IPD surveillance data for 2014–16) and multiplying by the relative risk from Jackson et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5KYWNrc29uPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48
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ADDIN EN.CITE.DATA 43Ischaemic heart disease50–64 years32.9 (1.3-6.2)Incidence rate calculated by taking the incidence of IPD in people with no recorded risk factors (from enhanced IPD surveillance data for 2014–16) and multiplying by the relative risk from Watt et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYXR0PC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Behavioural risk factorsConditionAge groupRate per 100,000Rate ratio (95% CI)Notes and referencesSmoking18–49 years6.53.6 (2.8‐4.5)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Smoking50–64 years19.24.3 (3.7‐5.0)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Harmful use of alcohol18–49 years14.17.7 (5.3‐11.2)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Harmful use of alcohol50–64 years29.66.6 (4.8‐9.1)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Harmful use of alcohol≥65 years41.85.0 (2.7‐9.4)Shea et alPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVhPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36New recommendations for Aboriginal and Torres Strait Islander peopleNew recommendationAboriginal and Torres Strait Islander children aged 5 years living in certain states and territories are recommended to receive 4 doses of 13vPCV and 2 doses of 23vPPVIn addition to the 3 doses for all children ≤5 years of age, Aboriginal and Torres Strait Islander children living in the following states and territories are recommended to receive an additional dose of 13vPCV at 6 months of age: Northern TerritoryQueenslandSouth Australia Western Australia This is because of the higher disease burden and the possibility of lower antibody responses in these children. ADDIN EN.CITE <EndNote><Cite><Author>Naidu</Author><Year>2013</Year><RecNum>849</RecNum><DisplayText><style face="superscript">45</style></DisplayText><record><rec-number>849</rec-number><foreign-keys><key app="EN" db-id="e05e9rx03fdvrze5a555trdqz25tsfdstdpd" timestamp="1411605851">849</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Naidu, L.</author><author>Chiu, C.</author><author>Habig, A.</author><author>Lowbridge, C.</author><author>Jayasinghe, S.</author><author>Wang, H.</author><author>McIntyre, P.</author><author>Menzies, R.</author></authors></contributors><titles><title>Vaccine preventable diseases and vaccination coverage in Aboriginal and Torres Strait Islander people, Australia 2006–2010</title><secondary-title>Communicable Diseases Intelligence</secondary-title></titles><periodical><full-title>Communicable Diseases Intelligence</full-title><abbr-1>Commun. Dis. Intell.</abbr-1><abbr-2>Commun Dis Intell</abbr-2></periodical><pages>S1-95</pages><volume>37 Suppl</volume><dates><year>2013</year></dates><urls></urls></record></Cite></EndNote>45These children are also recommended to receive 2 doses of 23vPPV:1 dose at 4–5 years of agea 2nd dose 5–10 years laterThis is because a considerable proportion of invasive pneumococcal disease in these children is caused by serotypes that are present in 23vPPV but not in 13vPCV.Current recommendationATAGI currently recommends the following:Aboriginal and Torres Strait Islander children aged 5 years living in certain states and territories are recommended to receive 4 doses of 13vPCVKey differencesAll Aboriginal and Torres Strait Islander children living in the NT, Qld, SA or WA are currently recommended to receive 4?doses of 13vPCV (3+1 schedule) due to their overall higher burden of pneumococcal disease. ATAGI proposes to add 2 doses of 23vPPV to the schedule for these children.Evidence for the new recommendationA considerable proportion of IPD in Aboriginal and Torres Strait Islander children living in the NT, Qld, SA or WA is caused by 23v-non-13v serotypes (Table 2). ATAGI therefore considers that a schedule that includes both 13vPCV and 23vPPV will maximise protection for these children. This schedule also aligns with the schedule for children with medical risk factors.Table 2Proportion of IPD caused by different vaccine serotype groups in Aboriginal and Torres Strait Islander children in NT, Qld, SA and WA, 2015–2017Age group (years)Serotype group 13vPCV, % (n)Serotype group 23v-non-13v, % (n)Serotype group other, % (n)Total, % (n)<519.7 (15)27.6 (21)52.6 (40)100 (76)5–1426.5 (9)35.3 (12)38.2 (13)100 (34)Data source: National Notifiable Diseases Surveillance SystemNew recommendationAboriginal and Torres Strait Islander adults aged 50 years are recommended to receive 1 dose of 13vPCV and 2?doses of 23vPPVAboriginal and Torres Strait Islander adults without conditions that are associated with an increased risk of invasive pneumococcal disease are recommended to receive:a dose of 13vPCV at age 50 yearsa dose of 23vPPV 12 months latera 2nd dose of 23vPPV 5–10 years laterThis is based on: the increased risk of invasive pneumococcal disease in Aboriginal and Torres Strait Islander adults compared with non-Indigenous adultsthe high prevalence of conditions associated with an increased risk of invasive pneumococcal disease (including tobacco smoking) in Aboriginal and Torres Strait Islander adults after 50 years of age compared with younger agesAboriginal and Torres Strait Islander adults who have previously received a dose of 23vPPV are recommended to receive:1 dose of 13vPCV 12 months after their 23vPPV dose1 dose of 23vPPV 12 months after their 13vPCV dose, or 5 years after their previous 23vPPV dose, whichever is laterAboriginal and Torres Strait Islander adults who have previously received doses of 23vPPV are recommended to receive the dose of 13vPCV 12 months after their last 23vPPV dose. If they have already received at least 2 doses of 23vPPV, no further 23vPPV doses are recommended. In all these scenarios, the interval between doses of 13vPCV and 23vPPV should be 12 months, but 2–12 months is acceptable. The interval between doses of 23vPPV should be 5 years.Aboriginal and Torres Strait Islander adults with conditions that are associated with an increased risk of invasive pneumococcal disease are recommended to receive 1?dose of 13vPCV at diagnosis followed by 2 doses of 23vPPV (see recommendations for people with risk conditions).Current recommendationATAGI currently recommends the following:Aboriginal and Torres Strait Islander adults aged 50 years without conditions associated with an increased risk of pneumococcal disease are recommended to receive 2 doses of 23vPPVKey differencesATAGI proposes to add a dose of 13vPCV for Aboriginal and Torres Strait Islander adults aged 50 years.Evidence for the new recommendationHigher burden of disease in Aboriginal and Torres Strait Islander adultsThe incidence of IPD among Aboriginal and Torres Strait Islander people is higher than that among non-Indigenous Australians for all age groups (Table 3). The incidence of IPD has continued to increase in Aboriginal and Torres Strait Islander adults, despite the high coverage of 13vPCV vaccination in infants and children. This is in contrast to the incidence of IPD in non-Indigenous adults, which has decreased. This widens the gap in disease burden between Aboriginal and Torres Strait Islander people and non-Indigenous people.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Jb2FubmlkZXM8L0F1dGhvcj48WWVhcj4yMDE5PC9ZZWFy
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ADDIN EN.CITE.DATA 46 Table 3Notification rates (per 100,000) of invasive pneumococcal disease by age group in Aboriginal and Torres Strait Islander and non-Indigenous populations, and rate ratios, 2011–2014Population group0–4 years5–14 years15–24 years25–34 years35–49years50–64 years≥65 yearsAboriginal and Torres Strait Islander (rate)51.622.716.035.864.380.398.9Non-Indigenous (rate)13.02.61.52.74.87.616.8Aboriginal and Torres Strait Islander:non-Indigenous (rate ratio)4.08.610.413.313.410.65.9Data source: National Notifiable Diseases Surveillance SystemAlong with this higher disease burden, 26% of IPD cases in Aboriginal and Torres Strait Islander adults aged ≥50 years are due to 23v-non-13v types (Table 4). Table 4Proportion of IPD caused by different vaccine serotype groups in Aboriginal and Torres Strait Islander adults aged ≥25 years, 2011–2014Age groupSerotype group 13vPCV, % (n)Serotype group 23v-non-13v, % (n)Serotype group non-vaccine type, % (n)Serotype group not typed, % (n)Total, % (n)25–4936.7% (138)30.1% (113)31.9% (120)1.3% (5)100% (376)50–6433.7% (58)28.5% (49)34.3% (59)3.5% (6)100% (172)≥6538.1% (24)19.0% (12)34.9% (3)7.9% (5)100% (63)Total36% (220)28.5% (174)32.9% (201)2.6% (16)100% (611)Data source: National Notifiable Diseases Surveillance SystemThis epidemiology indicates that a schedule that includes both 13vPCV and 23vPPV will optimise protection for Aboriginal and Torres Strait Islander adults.New recommendation for healthy non-Indigenous adultsNew recommendationNon-Indigenous adults aged 70 years without conditions associated with an increased risk of pneumococcal disease are recommended to receive 1 dose of 13vPCVA single dose of 13vPCV is recommended for all non-Indigenous adults at 70?years of age.Non-Indigenous adults aged 70?years who have previously received a dose of 23vPPV are recommended to receive a dose of 13vPCV at least 12 months after their 23vPPV dose.Adults aged 70 years with conditions associated with an increased risk of pneumococcal disease are recommended to receive 13vPCV followed by additional doses of 23vPPV, as per the schedule for people with risk conditions.Current recommendationATAGI currently recommends the following:Non-Indigenous adults aged 65 years without conditions associated with an increased risk of pneumococcal disease are recommended to receive 1 dose of 23vPPVKey differencesATAGI proposes to:change the vaccine given to healthy non-Indigenous adults from 23vPPV to 13vPCVchange the age of vaccination from 65 years to 70 yearsEvidence for the new recommendation13vPCV has higher efficacy than 23vPPV against common serotypesThe largest disease burden caused by pneumococcus in adults aged ≥65 years is non-bacteraemic CAP. The CAPiTA trial in adults aged ≥65 years showed that efficacy of 13vPCV was:PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb250ZW48L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 4745.6% (95% CI 21.8–62.4%) against a first episode of CAP (invasive or non-invasive) due to 13vPCV serotypes75.0% (95% CI 41.4–90.8%) against a first episode of IPD due to 13vPCV serotypes51.8% (95% CI 22.4–70.7%) against a first episode of IPD (vaccine type or non-vaccine type)In contrast, estimates of efficacy and effectiveness for 23vPPV are lower and also vary, particularly against CAP outcomes:Vaccine effectiveness against vaccine-type IPD is estimated at 61.1% (95% CI 55.1–66.9%), based on data from an Australian observational study, national notification data and adult health surveys ADDIN EN.CITE <EndNote><Cite><Author>Menzies</Author><Year>2014</Year><RecNum>850</RecNum><DisplayText><style face="superscript">48</style></DisplayText><record><rec-number>850</rec-number><foreign-keys><key app="EN" db-id="e05e9rx03fdvrze5a555trdqz25tsfdstdpd" timestamp="1411605995">850</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Menzies, R. I.</author><author>Jayasinghe, S. H.</author><author>Krause, V. L.</author><author>Chiu, C. K.</author><author>McIntyre, P. B.</author></authors></contributors><titles><title>Impact of pneumococcal polysaccharide vaccine in people aged 65 years or older</title><secondary-title>Med J Aust</secondary-title></titles><periodical><full-title>Medical Journal of Australia</full-title><abbr-1>Med. J. Aust.</abbr-1><abbr-2>Med J Aust</abbr-2></periodical><pages>112-115</pages><volume>200</volume><number>2</number><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>48 Vaccine effectiveness against CAP outcomes ranges from 27% (95% CI 3–46%) to 51% (95% CI 16–71%) from observational studiesPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PY2hvYS1Hb25kYXI8L0F1dGhvcj48WWVhcj4yMDE0PC9Z
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ADDIN EN.CITE.DATA 49,50Vaccine efficacy against CAP outcomes from randomised controlled trials was not statistically significant in a pooled analysis undertaken by ATAGI (unpublished data)IPD incidence is higher in people aged ≥70 years than in those aged 65–69 yearsIn pooled notification data for 2016 and 2017, the incidence of IPD due to 13vPCV serotypes was almost 2-fold higher among non-Indigenous adults aged ≥70 years (6.2?per 100,000) than in those aged 65–69 years (3.4 per 100,000). This substantially greater burden in adults from age 70 years and expected waning of pneumococcal protection with increasing age supports the recommendation of 13vPCV for all adults aged 70?years and above. Of all IPD notifications in non-Indigenous adults ≥65 years of age, around 4% occurred in those without risk conditions as identified in notification data. Of those cases, only 20% were due to 23v-non-13v serotypes. ATAGI therefore considers that the potential additional benefit of 23vPPV in all older adults without risk conditions is not substantial enough to recommend 13vPCV followed by 23vPPV.In contrast, in Aboriginal and Torres Strait Islander people and people with risk conditions, it is justifiable to use 23vPPV as well as 13vPCV. This is because there is a higher burden of disease in these groups, including disease caused by 23v-non-13v serotypes.Additional information to be included in the Australian Immunisation Handbook – catch-up vaccinationCatch-up vaccination for infants and children <5 years of ageChildren living in ACT, NSW, Tas or Vic, and non-Indigenous children living in the NT, Qld, SA or WA, who have no underlying risk conditions and have not received 3 doses of 13vPCV are recommended to receive further doses of 13vPCV. The number of doses required depends on age at presentation (Table 5).The recommended minimum interval between primary doses given at <12 months of age for catch-up is 4 weeks. For doses given at ≥12 months, the recommended minimum interval is 2?months.Table 5Catch-up schedule for 13vPCV for Aboriginal and Torres Strait Islander children living in ACT, NSW, Tas or Vic, and all children who do not have condition(s) associated with an increased risk of invasive pneumococcal disease, aged <5?yearsNumber of doses received previouslyAge at presentationAge at 1st?dose of PCVAge at 2nd?dose of PCVAge at 3rd?dose of PCVNumber of further primary doses neededNumber of booster doses needed at age ≥12 monthsNone<12?monthsnanana2112–59?monthsnananaNone11<12?months<12?monthsnana1112–59?months<12?monthsnanaNone112–59?months≥12?monthsnanaNoneNone2<12?months<12?months<12?monthsnaNone112–59?months<12?months<12?monthsnaNone112–59?months<12?months≥12?monthsnaNoneNone3<12?months<12?months<12?months<12?monthsNone112–59?months<12?months<12?months<12?monthsNoneNone (not routinely recommended but may be given to maximise individual protection)na = not applicableChildren with pre-existing medical conditions and Aboriginal and Torres Strait Islander children living in the NT, Qld, SA or WA who have not received 4 doses of 13vPCV are recommended to receive further doses of 13vPCV and 2 doses of 23vPPV. The number of 13vPCV doses required depends on age at presentation (Table 6).The recommended minimum interval between primary doses given at <12 months of age for catch-up is 4 weeks. For doses given at ≥12 months, the recommended minimum interval is 2?months.Table 6Catch-up schedule for pneumococcal vaccines for Aboriginal and Torres Strait Islander children living in NT, Qld, SA or WA ONLY, and all children with any condition(s) associated with an increased risk of invasive pneumococcal disease, aged <5?years These children are also recommended to receive 2 doses of 23vPPV:1 dose at 4–5 years of age and a minimum of 2 months after a 13vPCV dosea 2nd dose 5–10 years after the first 23vPPV doseNumber of 13vPCV doses received previouslyAge at presentationAge at 1st?dose of PCVAge at 2nd?dose of PCVAge at 3rd?dose of PCVNumber of further primary PCV dose(s) neededNumber of PCV booster doses needed at age ≥12?monthsNone <12?monthsnanana3112–59 monthsnanana111<12?monthsAny agenana2112–59 months<12?monthsnana1112–59 months≥12?monthsnanaNone12<12?monthsAny ageAny agena1112–59 months<12?months<12?monthsna1112–59 months<12?months≥12?monthsnaNone112–59 months≥12?months≥12?monthsnaNoneNone3<12?monthsAny ageAny ageAny ageNone112–59 months<12?months<12?monthsAny ageNone112–59 months<12?months≥12?months≥12?monthsNoneNonena = not applicableCatch-up vaccination for children 5 years of age and adultsAll people with pre-existing medical conditions are recommended to receive 1 dose of 13vPCV (in addition to any doses received at <5 years of age) and 2 doses of 23vPPV. The recommended intervals between subsequent doses of pneumococcal vaccines are:12 months between a dose of 23vPPV and a subsequent dose of 13vPCV12 months between 13vPCV and the first subsequent dose of 23vPPV (2–12 months is acceptable) 5–10 years between any 2 doses of 23vPPVFuture review of pneumococcal vaccine recommendationsThe epidemiology of pneumococcal disease in Australia will continue to change. In July 2018, the National Immunisation Program (NIP) schedule for pneumococcal vaccines changed from a 3+0 schedule in infants (at 2, 4 and 6 months) to a 2+1 schedule (at 2, 4 and 12 months). This change is expected to further reduce the burden of pneumococcal disease in all age groups due to direct and indirect effects.The successful vaccination program will reduce 13v serotypes, and there is potential for serotype replacement. This means the proportion of disease caused by non-13v serotypes may increase over time. New pneumococcal vaccines that protect against more and different serotypes are in the pipeline. Implementing these vaccines will also affect pneumococcal epidemiology in ways that are not yet clear.Because of these factors, ATAGI proposes that these recommendations for pneumococcal vaccination are reviewed within the next 5 years.Benefits of new recommendationsThere are 5 key benefits from the new pneumococcal recommendations:Simplifying the recommendations will reduce confusion for vaccine providers and vaccine recipients, particularly by creating a single list of risk conditions.Including a dose of 13vPCV for all adults is likely to improve protection against CAP. For people with risk conditions, a schedule that combines 13vPCV and 23vPPV will provide the greatest clinical benefits against both CAP and IPD.Including both 13vPCV and 23vPPV for Aboriginal and Torres Strait Islander children and adults is likely to improve protection against pneumococcal disease. This will help reduce the disproportionately higher burden of disease in Aboriginal and Torres Strait Islander people.Moving the recommended age for vaccination in older non-Indigenous people from 65?years to 70 years aligns with the age recommendation for zoster vaccine. This may help simplify communication messages about adult vaccinations.Simplifying the vaccines recommended to individuals (particularly those with risk conditions) and increasing the number of Australians who can access funded doses of both 13vPCV and 23vPPV is expected to improve compliance.Potential risks of new recommendationsThe potential risks that may arise from the new recommendations include the following:Changing the vaccine recommendations for people with risk conditions means that some people may be improperly vaccinated due to an unclear medical history.A person may present to an immunisation provider with pre-existing risk conditions but their medical and vaccination history are unclear. In these scenarios, the person is recommended to receive no more than 2 doses of 23vPPV after 13vPCV. This is the same as the recommendation for people who have never received a pneumococcal vaccine. The benefit of taking the opportunity to give a dose of 23vPPV outweighs the uncertain risk of harm of receiving a possible extra dose. This may lead to inadvertent administration of more doses of 23vPPV than currently recommended, but this situation is likely to be rare. This scenario also highlights the importance of immunisation providers recording all doses of vaccines given in the Australian Immunisation Register, so that vaccine histories are captured accurately.There is a lack of high-quality efficacy data to inform the recommendation for 13vPCV in people with risk conditions.There is little evidence for 13vPCV vaccine efficacy in people who are immunocompromised. Similarly, there are no Australian-specific estimates available for the prevalence of risk conditions associated with an increased risk of IPD that exactly match the new list of pneumococcal risk conditions. These recommendations have been based on extrapolation of the best available evidence.Preferences and valuesThe proposed changes to the use of pneumococcal vaccines are in line with best clinical advice. It is expected that the changes will result in additional protection for individuals most at risk of disease, and the wider community, including those who are not vaccinated. This is consistent with societal expectations of the best use of vaccines in Australia, including under the NIP.These recommendations align with best clinical practice. Some of these recommendations are not funded under the NIP. 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