Effectiveness of a 3 + 0 pneumococcal conjugate vaccine schedule against invasive pneumococcal disease among a birth cohort of 1.4 million children in Australia |
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| Institution: | 1. School of Public Health and Community Medicine, UNSW Medicine, The University of New South Wales, Sydney, NSW, Australia;2. National Centre for Immunisation Research and Surveillance, Westmead, NSW, Australia;3. Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, The University of Western Australia, Perth, WA, Australia;4. Department of Infectious Diseases, Princess Margaret Hospital, Perth, WA, Australia;5. Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;6. School of Public Health, Curtin University, Perth, WA, Australia;7. School of Medicine, University of Western Australia, Perth, WA, Australia;8. Department of Microbiology, PathWest Laboratory Medicine WA, Princess Margaret Hospital, Perth, WA, Australia;9. Discipline of Child and Adolescent Health, Medical School, University of Sydney, Sydney, Australia;10. Communicable Disease Control Directorate, Department of Health Western Australia, Perth, WA, Australia;11. School of Public Health, Medical School, University of Sydney, Sydney, Australia;12. National Centre for Epidemiology and Population Health, Australian National University, Canberra, Australian Capital Territory, Australia;1. National Research Institute of Aquaculture, Fisheries Research and Education Agency, Research Center for Fish Diseases, Minami-Ise, Mie 516-0193, Japan;2. National Research Institute of Fisheries Science, Fisheries Research and Education Agency, Research Center for Bioinformatics and Biosciences, Yokohama, Kanagawa 236-8648, Japan;3. Seikai National Fisheries Research Institute, Fisheries Research and Education Agency, National Center for Stock Enhancement, Goto, Nagasaki 853-0508, Japan;4. National Research Institute of Aquaculture, Fisheries Research and Education Agency, Research Center for Aquatic Breeding, Saeki, Ooita 879-2602, Japan;1. Department of Microbiology and Immunology, Yong Loo Lin School of Medicine, National University Health System, National University of Singapore, Singapore;2. Saw Swee Hock School of Public Health, National University Health System, National University of Singapore, Singapore;1. Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, The University of Western Australia, PO Box 855, West Perth, WA 6872, Australia;2. School of Public Health and Community Medicine, UNSW Medicine, The University of New South Wales, Samuels Avenue, Kensington, NSW 2033, Australia;3. National Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, Locked Bay 4001, Westmead, NSW 2145, Australia;4. Communicable Diseases Branch, NSW Health, Locked Mail Bay 961, North Sydney, NSW 2059, Australia;5. Communicable Diseases Control Directorate, WA Department of Health, PO Box 8172, Perth, WA 6849, Australia;6. Princess Margaret Hospital for Children, Roberts Rd, Subiaco, WA 6008, Australia;7. Curtin University, School of Public Health, GPO Box U1987, Perth 6845, Australia;8. Menzies School of Health Research and Charles Darwin University, PO Box 41096, Casuarina, NT 0811, Australia;9. Department of Medicine, The University of Western Australia, Roberts Rd, Perth, WA 6008, Australia;10. PathWest Laboratory Medicine WA, QEII Medical Centre, Hospital Ave, Nedlands, WA 6009, Australia;1. The Pediatric Infectious Disease Unit, Soroka University Medical Center, Beer-Sheva, Israel;2. Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel;1. School of Population and Global Health, University of Western Australia, 35 Stirling Highway, Perth Western Australia 6009, Australia;2. Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, The University of Western Australia, PO Box 855, West Perth, Western Australia 6872, Australia;3. Department of Infectious Diseases, Perth Children′s Hospital, Locked Bag 2010, Nedlands, Western Australia 6909, Australia;4. Menzies School of Health Research and Charles Darwin University, PO Box 41096, Casuarina, NT 0811, Australia;5. School of Public Health, Curtin University, GPO Box U1987, Perth 6845, Australia;6. Communicable Disease Control Directorate, Department of Health, PO Box 8172 Perth Business Centre Western Australia 6849, Australia;1. Epidemiology, Worldwide Safety and Regulatory, Pfizer Inc, New York, NY, USA;2. Statistical Research and Consultation Center, Pfizer Inc, New York, NY, USA;3. Biostatistician Consultant, Pittsboro, NC, USA;4. Vaccine Clinical Research and Development, Pfizer Inc, Collegeville, PA, USA |
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| Abstract: | BackgroundMost studies use indirect cohort or case-control methods to estimate vaccine effectiveness (VE) of 7- and 13-valent pneumococcal conjugate vaccines (PCV7 and PCV13) against invasive pneumococcal disease (IPD). Neither method can measure the benefit vaccination programs afford the unvaccinated and many studies were unable to estimate dose-specific VE. We linked Australia’s national immunisation register with health data from two states to calculate IPD incidence by vaccination status and VE for a 3 + 0 PCV schedule (doses at 2, 4, 6 months, no booster) among a cohort of 1.4 million births.MethodsBirths records for 2001–2012 were probabilistically linked to IPD notifications, hospitalisations, deaths, and vaccination history (available until December 2013). IPD rates in vaccinated and unvaccinated children <2 years old were compared using Cox proportional hazards models (adjusting for potential confounders), with VE = (1 ? adjusted hazard ratio) × 100. Separate models were performed for all-cause, PCV7, PCV13 and PCV13-non-PCV7 serotype-specific IPD, and for Aboriginal and non-Aboriginal children.ResultsFollowing introduction of universal PCV7 in 2005, rates of PCV7 serotype and all-cause IPD in unvaccinated children declined 89.5% and 61.4%, respectively, to be similar to rates in vaccinated children. Among non-Aboriginal children, VEs for 3 doses were 94.2% (95%CI: 81.9–98.1) for PCV7 serotype-specific IPD, 85.6% (95%CI: 60.5–94.8) for PCV13-non-PCV7 serotype-specific IPD and 80.1% (95%CI: 59.4–90.3) for all-cause IPD. There were no statistically significant differences between the VEs for 3 doses and for 1 or 2 doses against PCV13 and PCV13-non-PCV7 serotype-specific IPD, or between Aboriginal and non-Aboriginal children.ConclusionOur population-based cohort study demonstrates that >90% coverage in the first year of a universal 3 + 0 PCV program provided high population-level protection, predominantly attributable to strong herd effects. The size of the cohort enabled calculation of robust dose-specific VE estimates for important population sub-groups relevant to vaccination policies internationally. |
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| Keywords: | Pneumococcal conjugate vaccine Vaccine effectiveness Invasive pneumococcal disease Data linkage |
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