Comparison of national clinical practice guidelines and recommendations on vaccination of adult patients with autoimmune rheumatic diseases

Rheumatology International

Volumn 34, Issue 2, 2014, Pages 151-163

  Papadopoulou, Despoina ^a,b   Sipsas, Nikolaos V ^c  

^a UNIVERSITY OF ATHENS   (Greece)

^b Athens 2004 Olympic Games Organizing Committee   (Greece)

^c UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

Author keywords

Autoimmune rheumatic disease; Recommendations; Vaccination

Indexed keywords

ABATACEPT; DISEASE MODIFYING ANTIRHEUMATIC DRUG; HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; HEPATITIS B VACCINE; INACTIVATED VACCINE; INFLUENZA VACCINE; PNEUMOCOCCUS VACCINE; Q FEVER VACCINE; RITUXIMAB; TETANUS TOXOID; TOCILIZUMAB; TYPHOID VACCINE; VARICELLA ZOSTER VACCINE;

AUTOIMMUNE DISEASE; AUTOIMMUNE RHEUMATIC DISEASE; HAEMOPHILUS INFECTION; HEPATITIS B; HERPES ZOSTER; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFLUENZA; PNEUMOCOCCAL INFECTION; PRACTICE GUIDELINE; PRIORITY JOURNAL; Q FEVER; REVIEW; RHEUMATIC DISEASE; TETANUS; TYPHOID FEVER; VACCINATION;

ADULT; AUSTRALIA; AUTOIMMUNE DISEASES; EUROPE; HUMANS; IMMUNOCOMPROMISED HOST; IMMUNOSUPPRESSIVE AGENTS; NORTH AMERICA; OPPORTUNISTIC INFECTIONS; PHYSICIAN'S PRACTICE PATTERNS; PRACTICE GUIDELINES AS TOPIC; RHEUMATIC DISEASES; VACCINATION;

EID: 84895800417     PISSN: 01728172     EISSN: 1437160X     Source Type: Journal    
DOI: 10.1007/s00296-013-2907-9     Document Type: Review

References (92)

1. Rahier JF, Moutschen M, Van Gompel A, et al. (2010) Vaccinations in patients with immune-mediated inflammatory diseases. Rheumatology 49(10):1815-1827
2. Fessler BJ (2002) Infectious diseases in systemic lupus erythematosus: risk factors, management and prophylaxis. Best Pract Res Clin Rheumatol 16(2):281-291
3. Caporali R, Caprioli M, Bobbio-Pallavicini F, Montecucco C (2008) DMARDS and infections in rheumatoid arthritis. Autoimmun Rev 8(2):139-143
4. Swiss Society for Rheumatology (2010) Vaccination guidelines for patients with inflammatory rheumatic disease. Available from: http://www.rheuma-net.ch/ download/Content-attachments/FileBaseDoc/recommandations-vaccination-04-2010. pdf (cited 2013 July 10)
5. Goldacker S, Gause A, Warnatz K (2012). German Society for Rheumatology Pharmacotherapy Commission quality assurance for vaccination in adult patients with inflammatory rheumatic diseases. Available from: http://dgrh.de/fileadmin/ media/Praxis-Klinik/Therapie-Empfehlungen/impfung-qualitaetssicherung-final- 2012.pdf (cited 2013 July 10)
6. Standing Committee on Vaccination (STIKO) at the Robert Koch Institute (RKI) (2012) Recommendations of the Standing Committee on Vaccination (STIKO) at the Robert Koch Institute. Epidemiol Bull 30:283-310. Available from: http://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2012/Ausgaben/30-12.pdf? -blob=publicationFile (cited 2013 July 10)
7. Robert Koch Institute-German Federal Ministry of Health (2012) Vaccination recommendations by STIKO. Available from: http://www.rki.de/EN/ Content/Prevention/Vaccination/recommandations/recommendations-node.html (cited 2013 July 10)
8. Repo H, Peltomaa R, Finnish Rheumatology Association (2012) Vaccination of adults with inflammatory rheumatic diseases. Available from: http://www.reumatologinenyhdistys.fi/files/rokotus.pdf (cited 2013 July 10)
9. Department of Public Health England (2013) Immunisation against infectious disease: the green book. Available from: http://immunisation.dh.gov. uk/gb-complete-current-edition/ (cited 2013 July 10)
10. Swedish Rheumatology Association (2011) SRF vaccination recommendations in patients with inflammatory rheumatic diseases. Available from: http://www.svenskreumatologi.se/sites/default/files/8/images/ SRFs%20riktlinjer-vaccinationer-2011.pdf (cited 2013 July 10)
11. Dougados M (2010) Recommendations of the French Society for Rheumatology to detect or prevent diseases associated with chronic inflammatory rheumatism. Available from: http://www.rhumatologie.asso.fr/data/ModuleProgramme/PageSite/ 2010-1/Resume/6649.asp (cited 2013 July 10)
12. French Club of Rheumatism and Inflammation (2007) CRI factsheets. Available from: http://www.cri-net.com/recherche/fichesPratiques/ (cited 2013 July 10)
13. Pham T, Fautrel B, Gottenberg JE, et al. (2008) Rituximab (MabThera) therapy and safety management. Clinical tool guide. Joint Bone Spine 75(Suppl 1):S1-S99
14. Pham T, Bachelez H, Berthelot JM, et al. (2012) Abatacept therapy and safety management. Joint Bone Spine 79(Suppl 1):3-84
15. Pham T, Bachelez H, Berthelot JM, et al. (2011) TNF alpha antagonist therapy and safety monitoring. Joint Bone Spine 78(Suppl 1):15-185
16. Fautrel B, Pham T, Mouterde G, et al. (2007) Recommendations of the French Society for Rheumatology regarding TNFalpha antagonist therapy in patients with rheumatoid arthritis. Joint Bone Spine 74(6):627-637
17. Pham T, Fautrel B, Dernis E, et al. (2007) Recommendations of the French Society for Rheumatology regarding TNFalpha antagonist therapy in patients with ankylosing spondylitis or psoriatic arthritis: 2007 update. Joint Bone Spine 74:638-646
18. Pham T, Claudepierre P, Constantin A, et al. (2010) Tocilizumab: therapy and safety management. Joint Bone Spine. 77(Suppl 1):S3-S100
19. Singh JA, Furst DE, Bharat A,, et al. (2012). 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 64(5):625-639
20. Public Health Agency of Canada (2012) Immunization and vaccines. Available from: http://www.phac-aspc.gc.ca/im/index-eng.php (cited 2013 July 10)
21. Public Health Agency of Canada (2007) Recommended Immunizations. Immunization of immunocompromized persons. Canadian immunization guide. Part 3. Available from: http://www.phac-aspc.gc.ca/publicat/cig-gci/p03-07-eng.php (cited 2013 July 10)
22. Finnish National Institute for Health and Welfare (2013) Vaccination of immunocompromized patients. Available from: http://www.thl.fi/fi-FI/web/ rokottajankasikirja-fi/immuunipuutteiset (cited 2013 July 10)
23. Finnish National Institute for Health and Welfare (2013) Vaccination schedule. (http://www.thl.fi/fi-FI/web/fi/etusivu (cited 2013 July 10. Available from: http://www.ktl.fi/portal/suomi/terveyden-ammattilaisille/rokottaminen/ (cited 2013 July 10)
24. Austrian federal Ministry of health (2013) Austrian vaccination schedule 2013. Available from: http://bmg.gv.at/cms/home/attachments/3/3/6/CH1100/ CMS1327680589121/impfplan2013.pdf (cited 2013 July 10)
25. The British Society for Rheumatology (2011) BSR statement on vaccination in adult patients with rheumatic diseases. Available from: http://www. rheumatology.org.uk/includes/documents/cm-docs/2011/b/bsr-vaccination-statement- nov-2011.pdf (cited 2013 July 10)
26. The British Society for Rheumatology (2002) Vaccinations in the immunocompromised person. Guidelines for the patient taking immunosuppressants, steroids and biologics therapies Available from: http://www.rheumatology.org.uk/ resources/guidelines/archive-guidelines/default.aspx (cited 2013 July 21)
27. Dutch Society for Rheumatology (2011) Directive on responsible use of biologics. Available from: http://www.nvr.nl/uploads/Sk/A3/ SkA3YYPbz5IMt3e8kt5fFg/Richtlijn-biologicals-geautorisateerde-versie-januari- 2011.pdf (cited 2013 July 10)
28. Gómez Reino J, Loza E, Andreu JL, et al. (2011) Consensus statement of the Spanish Society of Rheumatology on risk management of biologic therapy in rheumatic patients. Reumatol Clin 7(5):284-298
29. Spanish Ministry of Health. Social Services and Equality (2004) Vaccination in adults-recommendations. Available from: http://www.msc.es/ ciudadanos/proteccionSalud/vacunaciones/docs/recoVacunasAdultos.pdf (cited 2013 July 10)
30. Vencovský J, The Committee of the Czech Society for Rheumatology (2009) Safety recommendations on biological treatment. Čes Revmatol 17(3):146-160
31. National Center for Immunization and Respiratory Diseases (2011) General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 60(2):1-64
32. Centers for Disease Control and Prevention. (2013) Vaccination of persons with primary and secondary immune deficiencies. Available from: http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/immuno-table. pdf (cited 2013 July 10)
33. Bombardier C, Hazlewood GS, Akhavan P, et al. (2012) Canadian Rheumatology Association recommendations for the pharmacological management of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs: part II safety. J Rheumatol 39(8):1583-1602
34. Australian Rheumatology Association (2011) Updated recommendations for the use of biologic agents for the treatment of rheumatic diseases. Available from: http://www.rheumatology.org.au/downloads/FINAL- BiologicalRecommendations060111-000.pdf (cited 2013 July 10)
35. Italian Society for Rheumatology (2009) New influenza A (H1N1) advice of the Italian Society for Rheumatology for patients suffering from chronic inflammatory rheumatic diseases treated with immunosuppressive drugs and biological. Available from: http://www.reumatologia.it/cmsx.asp?IDPg=114#alto (cited 2013 July 10)
36. Greek National Organization of Health Services (2012) New national vaccination program of children and adolescents 2011 and adult immunization program. Available from: http://www.eopyy.gov.gr/ 20-%20.pdf (cited 2013 July 10)
37. Swiss Federal Office of Public Health, Swiss Commission for Vaccinations (2013) Immunization: general recommendations. Swiss 2013 vaccinations plan. Available from: http://www.bag.admin.ch/themen/medizin/00682/00684/02535/index. html?lang=fr (cited 2013 July 10)
38. Spanish National Health System Library of clinical practice guidelines (2011) Update of the clinical practice guide for the management of rheumatoid arthritis in Spain. Available from: http://www.guiasalud.es/GPC/GPC-503-Guipcar- %28diciembre-2011%29.pdf (cited 2013 July 10)
39. Estonian Society for Rheumatology (2008) Rheumatoid arthritis-patient education material. (http://www.ers.ee/). Available from: http://www.ers.ee/ index.php?id=112 (cited 2013 July 10)
40. Australian Government, Department of Health and Ageing (2013) Groups with special vaccination requirements. The Australian immunisation handbook, 10th edn. Chap 3.3. Available from: http://www.health.gov.au/internet/immunise/ publishing.nsf/Content/handbook10-3-3 (cited 2013 July 10)
41. Australian Government, Department of Health and Ageing (2013) Vaccine preventable diseases. The Australian immunisation handbook, 10th edn. Part 4. Available from: http://www.health.gov.au/internet/immunise/publishing.nsf/ Content/handbook10part4 (cited 2013 July 10)
42. Rubbert A, Burmester G, The Pharmacotherapy Commission of the German Society for Rheumatology (2007) Recommendations for the use of rituximab in patients with rheumatoid arthritis. Available from: http://dgrh.de/fileadmin/ media/Praxis-Klinik/Therapie-Empfehlungen/rituximab-2013-final.pdf (cited 2013 July 10)
43. Bukhari M, Abernethy R, Deighton C, et al. (2011) BSR and BHPR guidelines on the use of rituximab in rheumatoid arthritis. Rheumatology (Oxford) 50(12):2311-2313
44. Krüger K, Gaubitz M, The Pharmacotherapy Commission of the German Society of Rheumatology (2008). Recommendations for the use of abatacept in patients with rheumatoid arthritis. Available from: http://dgrh.de/fileadmin/ media/Praxis-Klinik/Therapie-Empfehlungen/abatacept-final.pdf (cited 2013 July 10)
45. Favalli EG, Caporali R, Sinigaglia L, et al. (2011) Recommendations for the use of biologic therapy in rheumatoid arthritis: update from the Italian society for rheumatology II. Safety. Clin Exp Rheumatol 29(3 Suppl 66):S15-S27
46. Ding T, Ledingham J, Luqmani R, et al. (2010) BSR and BHPR rheumatoid arthritis guidelines on safety of anti-TNF therapies. Rheumatology (Oxford) 49(11):2217-2219
47. Dutch Society for Rheumatology. Gelre-IJssel Municipal Health Services (2008) Note on travel & vaccinations for patients on DMARDs & Biologics. Available from: http://www.nvr.nl/uploads/OK/pU/OKpULu4M6uy6R9GiuM9e4A/Notitie- reizen-en-vaccinaties.doc (cited 2013 July 10)
48. Belgian Royal Society for Rheumatology (2009) The Mexican Flu. Available from: http://www.srbr.be/fr/content/la-grippe-mexicaine (cited 2013 July 10)
49. Centers for Disease Control and Prevention (2013) Recommended adult immunization schedule. Available from: http://www.cdc.gov/vaccines/schedules/ downloads/adult/adult-schedule.pdf (cited 2013 July 10)
50. Australian Rheumatology Association (2013) Patient information. Medicine information sheets. Available from: http://www.rheumatology.org.au/community/ PatientMedicineInformation.asp (cited 2013 July 10)
51. Brezinschek H.P. and the Austrian Society for Rheumatology & Rehabilitation Working Group (2009) Opinion of the Austrian Society for Rheumatology on vaccination of patients with rheumatic diseases ('rheumatologic patients'). Available from: http://www.rheumatologie.at/pdf/OEGR-Stellungnahme- Impfen-16-Dez-2009.pdf (cited 2013 July 10)
52. Salvarani C, Pipitone N, Marchesoni A, et al. (2011) Recommendations for the use of biologic therapy in the treatment of psoriatic arthritis: update from the Italian Society for Rheumatology. Clin Exp Rheumatol 29(3 Suppl 66):S28-S41
53. Italian Ministry of Health (2012) Infectious disease and vaccination: national vaccine prevention plan. Available from: http://www.salute.gov.it/ malattieInfettive/paginaInternaMalattieInfettive.jsp?menu=pianovaccini&id= 651&lingua=italiano (cited 2013 July 10)
54. Manger B, Michels H, Nüsslein HG,, et al. (2006) Revision of the recommendations of the German society for rheumatology regarding therapy with tumor necrosis factor inhibitors in inflammatory rheumatic diseases. Available from: http://dgrh.de/fileadmin/media/Praxis-Klinik/Therapie-Empfehlungen/TNF- Blocker-06.pdf (cited 2013 July 10)
55. French Institute of Health (2010) The immunization schedule and vaccine recommendations in the opinion of the High Council of Public Health. BEH 14-15:121-172 Available from: www.invs.sante.fr/beh/2010/14-15/beh-14-15.pdf (cited 2013 July 10)
56. Statens Serum Institut- Danish Ministry of Health (2012) Free influenza vaccination. Available from: http://www.ssi.dk/English/News/EPI-NEWS/2012/ No%2039a%20-%202012.aspx (cited 2013 Aug 29)
57. Ireland Health Service Executive-National Immunisation Office (2013) Seasonal flu vaccine. Available from: http://www.immunisation.ie/en/ AdultImmunisation/FluVaccination/ (cited 2013 Aug 29)
58. National Institute of Public Health- Republic of Slovenia (2013). Recommendations for vaccination of adults and children aged 5 years and older against pneumococcal infections. Available from: http://img.ivz.si/janez/2230- 6991.doc (cited 2013 Aug 29)
59. Statens Serum Institut- Danish Ministry of Health (2012) Pneumococcal vaccination of persons at increased risk of invasive pneumococcal disease. Available from: http://www.ssi.dk/English/News/EPI-NEWS/2012/No%2051b%20- %202012.aspx (cited 2013 Aug 29)
60. Ireland Health Service Executive-National Immunisation Office (2013) Pneumococcal. Available from: http://www.immunisation.ie/en/AdultImmunisation/ Pneumococal/ (cited 2013 Aug 29)
61. National Institute of Public Health-Republic of Slovenia (2013) Vaccination against pneumococcal infection in adults and children. Available from: http://www.ivz.si/cepljenje/strokovna-javnost/navodila-in-priporocila?pi= 18&-18-view=item&-18-newsid=2230&pl=253-18.0 (cited 2013 July 29)
62. Czech National Institute of Health (2011) The vaccination schedule in the Czech Republic. Available from: http://www.szu.cz/tema/vakciny/ockovaci- kalendar-v-cr?highlightWords=O%C4%8Dkovac%C3%AD+kalend%C3%A1%C5%99+%C4%8CR (cited 2013 Aug 29)
63. Italian Society of Hygiene (2013) Vaccination Board of the Italian Society of Hygiene indications of pneumococcal vaccine in adults at risk. Available from: http://www.igienistionline.it/docs/2012/30pneumo.pdf (cited 2013 July 29)
64. Mitteilung der Ständigen Impfkommission (STIKO) am Robert Koch-Institut (2012) Stellungnahme zur Impfung Erwachsener gegen Pneumokokken. Epidemiologisches Bulletin 7:55-62. Available from: http://www.rki.de/DE/ Content/Infekt/EpidBull/Archiv/2012/Ausgaben/07-12.pdf?-blob=publicationFile (cited 2013 July 10)
65. Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (2010) Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP): MMWR Morb Mortal Wkly Rep 59(34):1102-1106
66. Community of Madrid-Expert Vaccine Advisory Committee (2012) Pneumococcal vaccination for adults in the community of Madrid. Available from: http://www.madrid.org/cs/Satellite?c=PTSA-Multimedia-FA&cid= 1142695928713&pagename=PortalSalud%2FPTSA-Multimedia-FA%2FPTSA- documentoWebeditpro (cited 2013 July 10)
67. Belgian Superior Health Board (2013). Vaccination of children and immunocompromised adults and chronically ill. Available from: http://www.cercles.be/base-cercle/fichiers-fiches/10536.pdf (cited 2013 July 29)
68. French High Council for Public Health (2013) Opinion on recommendations of vaccination for adults and children older than 2 years at risk of invasive pneumococcal disease. Available from: http://www.hcsp.fr/Explore.cgi/ Telecharger?NomFichier=hcspa20130425-infectionsinvasivespneumocoque.pdf (cited 2013 Aug 29)
69. Chakravarty K, McDonald H, Pullar T, et al. (2008) BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatologists. Rheumatology (Oxford) 47:924-925
70. Fonseca JE, Bernardes M, Canhão H, et al. (2011) Portuguese guidelines for the use of biological agents in rheumatoid arthritis - October 2011 update. Acta Reumatol Port 36:385-388
71. Šedová L, Štolfa J, Horák P, Pavelka K (2009) Czech Society for Rheumatology recommendations for monitoring the safety of the treatment of rheumatoid arthritis. Čes Revmatol 17(1):4-15
72. Harpaz R, Ortega-Sanchez IR, Seward JF, Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC) (2008) Prevention of Herpes Zoster. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 57(RR-5):1-30; quiz CE2-4
73. Watson JC, Hadler SC, Dykewicz CA, Reef S, Phillips L (1998) Measles, mumps, and rubella vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 47(RR-8):1-57
74. Chakravarty K, Mcdonald H, Pullar T, et al. (2008) BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatologists. Rheumatology (Oxford). doi: 10.1093/rheumatology/kel216b
75. No authors listed (1993). Recommendations of the Advisory Committee on Immunization Practices (ACIP): use of vaccines and immune globulins in persons with altered immunocompetence. MMWR Recomm Rep 42(RR-4):1-18
76. Public Health Agency of Canada (2007) Passive Immunization. Canadian Immunization Guide. Part. Available from: http://www.phac-aspc.gc.ca/publicat/ cig-gci/p05-01-eng.php (cited 2013 July 10)
77. Australian Government, Department of Health and Ageing (2013) Passive immunisation. The Australian immunisation handbook, 10th edn. Part 5 Available from: http://www.health.gov.au/internet/immunise/publishing.nsf/Content/ handbook10part5 (cited 2013 July 10)
78. Jong E, Freedman D (2012). Immunocompromised travelers. The yellow book. Chap 8. Centers for disease control and prevention. Available from: http://wwwnc.cdc.gov/travel/page/yellowbook-home-2012 (cited 2013 July 10)
79. Public Health Agency of Canada (2007) Recommended Immunizations. Immunization of travelers. Canadian Immunization Guide. Part 3. Available from: http://www.phac-aspc.gc.ca/publicat/cig-gci/p03-10-eng.php (cited 2013 July 10)
80. Australian Government, Department of Health and Ageing (2013) Vaccination for international travel. The Australian immunisation handbook, 10th edn. Chap 3.2 Available from: http://www.health.gov.au/internet/immunise/publishing.nsf/ Content/handbook10-3-2 (cited 2013 July 10)
81. van Assen S, Agmon-Levin N, Elkayam O, et al. (2011) EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 70(3):414-422
82. van Assen S, Elkayam O, Agmon-Levin N, et al. (2011) Vaccination in adult patients with auto-immune inflammatory rheumatic diseases: a systematic literature review for the European League Against Rheumatism evidence-based recommendations for vaccination in adult patients with auto-immune inflammatory rheumatic diseases. Autoimmun Rev 10(6):341-352
83. Styrt B (1990) Infection associated with asplenia: risks, mechanisms, and prevention. Am J Med 88(5N):33N-42N
84. Devey ME, Bleasdale K, Isenberg DA (1987) Antibody affinity and IgG subclass of responses to tetanus toxoid in patients with rheumatoid arthritis and systemic lupus erythematosus. Clin Exp Immunol 68(3):562-569
85. Kuruma KA, Borba EF, Lopes MH, de Carvalho JF, Bonfá E (2007) Safety and efficacy of hepatitis B vaccine in systemic lupus erythematosus. Lupus 16(5):350-354
86. Elkayam O, Yaron M, Caspi D (2002) Safety and efficacy of vaccination against hepatitis B in patients with rheumatoid arthritis. Ann Rheum Dis 61(7):623-625
87. Glück T, Müller-Ladner U (2008) Vaccination in patients with chronic rheumatic or autoimmune diseases. Clin Infect Dis 46(9):1459-1465
88. Oren S, Mandelboim M, Braun-Moscovici Y, et al. (2007) Vaccination against influenza in patients with rheumatoid arthritis: the effect of rituximab on the humoral response. Ann Rheum Dis 67(7):937-941
89. Bingham CO 3rd, Looney RJ, Deodhar A, et al. (2010) Immunization responses in rheumatoid arthritis patients treated with rituximab: results from a controlled clinical trial. Arthritis Rheum 62(1):64-74
90. European Medicines Agency (2011) Assessment report: Prevenar 13. Available from: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR- Assessment-Report-Variation/human/001104/WC500119784.pdf (cited 2013 July 29)
91. US Department of Health and Human Services. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee (VRBPAC) (2011) Adult indication briefing document: Prevnar 13. Available from: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/ bloodvaccinesandotherbiologics/ vaccinesandrelatedbiologicalproductsadvisorycommittee (cited 2013 July 29)
92. European Medicines Agency (2011). Prevenar 13. Summary of product characteristics. Available from: http://www.ema.europa.eu/docs/en-GB/document- library/EPAR-Product-Information/human/001104/WC500057247.pdf (cited 2013 July 29)