Pneumococcal conjugate vaccine failure in children: A systematic review of the literature |
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| Affiliation: | 1. Paediatric Infectious Disease Research Group, St. George’s University of London, United Kingdom;2. Immunisation, Hepatitis, and Blood Safety Department, Public Health of England, United Kingdom;1. Sage Analytica, Bethesda, MD, USA;2. Department of Global Health, School of Public Health and Health Services, George Washington University, Washington DC, USA;3. Rollins School of Public Health, Atlanta, GA, USA;1. Pfizer Vaccines Research, 401 North Middletown Road, Pearl River, NY, USA;2. Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA;3. Pfizer Vaccines Research, Pfizer Pharma GmbH, Linkstrasse 10, 10785, Berlin, Germany;4. Pfizer France, Paris, France;1. Neisseria and Streptococcus Reference Laboratory, Department of Microbiology and Infection Control, Statens Serum Institut, Copenhagen, Denmark;2. Department of Infectious Diseases, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark;3. Department of Infectious Disease Epidemiology, Statens Serum Institut, Copenhagen, Denmark;1. Epidemiology Department, EpiConcept, Paris, France;2. Centre for Epidemiology and Microbiology, National Institute of Public Health, Prague, Czech Republic;3. Infectious Disease Department, French National Agency for Public Health, Saint-Maurice, France;4. Vaccine Preventable Disease Department, Health Protection Surveillance Centre, Dublin, Ireland;5. Department of Vaccine Preventable Diseases, Norwegian Institute of Public Health, Oslo, Norway;6. General Sub-Directorate for Surveillance and Public Health Emergency Response, Public Health Agency of Catalunya, Barcelona, Spain;7. Sub-Directorate of Health Promotion and Prevention, Madrid, Spain;8. Public Health Institute of Navarra—IdiSNA, Pamplona, Spain;9. CIBER Epidemiología y Salud Pública, Madrid, Spain;10. Health Protection Scotland, National Services Scotland, Glasgow, UK;11. Department of Microbiology, Public Health Agency of Sweden, Solna, Sweden;12. National Centre for Pneumococci, European Hospital George Pompidou, Paris, France;13. Molecular Microbiology Department, Hospital Sant Joan de Déu, Barcelona, Spain;14. International University of Catalunya, Barcelona, Spain;15. Scottish Haemophilus, Legionella, Meningococcus and Pneumococcus Reference Laboratory, Glasgow, UK;p. Department of Microbiology, Tumour and Cell Biology, Karolinska Institute, Stockholm, Sweden;q. Department of Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden;r. Office of Chief Scientist Unit, European Centre for Disease Prevention and Control, Stockholm, Sweden;1. Faculdade de Medicina da Universidade Metropolitana de Santos, São Paulo, Brazil;2. Faculdade de Ciências Médicas da Santa Casa de São Paulo, São Paulo, Brazil;3. Hospital Nacional de Niños Dr. Carlos Sáenz Herrera, San José, Costa Rica;4. Facultad de Medicina, Universidad de la República, Uruguay;5. Hospital de Niños Ricardo Gutierrez, Ciudad Autónoma de Buenos Aires, Argentina;6. Secretaría de Salud del Estado de Morelos, Mexico;7. Centro Medico Universidad Central Del Este, Santo Domingo, Dominican Republic;8. Universidad Militar Nueva Granada, Bogotá, Colombia;1. Children’s Faculty Hospital Košice, Department of Pediatric Infectious Diseases, Košice, Slovakia;2. Charles University, Faculty of Medicine in Hradec Kralove, Department of Social Medicine, Hradec Kralove, Czech Republic;3. Great Ormond Street Institute of Child Health, University College London, London, United Kingdom;4. Biovomed, Hradec Kralove, Czech Republic;5. University Hospital, Department of Infectious Diseases, Hradec Kralove, Czech Republic |
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| Abstract: | BackgroundPneumococcal conjugate vaccines (PCVs) are highly effective in preventing pneumococcal invasive disease (IPD) due to serotypes included in the vaccines. The risk of vaccine-type IPD in immunised children (i.e. vaccine failure) has not been systematically assessed in countries with established PCV programmes.MethodsWe undertook a systematic review of the English literature published from January 2000 to April 2016 to evaluate the vaccine schedule, risk factors, serotype distribution, clinical presentation and outcomes of vaccine failure in children vaccinated with the 7-valent (PCV7), 10-valent (PCV10), and 13-valent (PCV13) vaccines. Data sources included MEDLINE, EMBASE, Cochrane library, and references within identified articles.ResultsWe identified 1742 potential studies and included 20 publications involving 7584 participants in children aged ⩽5 year-olds: 5202 received 2 doses followed by a booster in 10 studies, (68.6%), 64 (0.8%) received 3 doses without a booster in 2 studies, and 2318 received a 3 + 1 schedule (30.6%) in 8 studies. A total of 159 vaccine failure cases were identified, representing 2.1% [95% CI: 1.8–2.4%] of the reported IPD cases. Most studies did not report clinical characteristics or outcomes. Among eight studies reporting comorbidities, 33/77 patients (42.9%) had an underlying condition. The main serotypes associated with vaccine failure were 19F (51/128 cases with known serotype; 39.8%), 6B (33/128; 25.8%), and 4 (10/128; 7.8%). Only five studies reported patient outcomes, with a crude case fatality rate of 2.4% (2/85; 95%CI: 0.3–8.5%).ConclusionPneumococcal conjugate vaccines have been implemented in national immunisation programmes for more than a decade, yet there are only a few studies reporting vaccine failure. PCV failure is rare, irrespective of vaccine or schedule. Co-morbidity prevalence was high amongst vaccine failure cases but case fatality rate was relatively low. There is a need for more systematic reporting vaccine failure cases in countries with established pneumococcal vaccination programmes. |
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| Keywords: | Conjugate pneumococcal vaccine Pneumococcal invasive disease Vaccine failure Children Systematic review |
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