Caterina Bonetto1, Francesco Trotta2, Patrizia Felicetti2, Graciela S Alarcón3, Carmela Santuccio2, Novilia Sjafri Bachtiar4, Yolanda Brauchli Pernus5, Rebecca Chandler6, Giampiero Girolomoni7, Robert D M Hadden8, Merita Kucuku9, Seza Ozen10, Barbara Pahud11, Karina Top12, Frederick Varricchio13, Robert P Wise14, Giovanna Zanoni15, Saša Živković16, Jan Bonhoeffer17. 1. Italian Medicines Agency (AIFA), Rome, Italy. Electronic address: contact@brightoncollaboration.org. 2. Italian Medicines Agency (AIFA), Rome, Italy. 3. The University of Alabama at Birmingham, USA. 4. Bio Farma Vaccine Institute, Bandung, West Java, Indonesia. 5. Brighton Collaboration Foundation, Basel, Switzerland. 6. Uppsala Monitoring Centre, Uppsala, Sweden. 7. Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy. 8. King's College Hospital, London, United Kingdom. 9. Department of Vaccines Control, National Agency for Medicines and Medical Devices, Tirana, Albania. 10. Department of Pediatric Rheumatology, Hacettepe University, Ankara, Turkey. 11. Children's Mercy Hospital, Kansas City, MO, USA. 12. Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. 13. Independent Consultant Vaccinologist, Wakefield, RI, USA. 14. MedImmune/AstraZeneca, Gaithersburg, MD, USA. 15. Immunology Unit, Policlinico G.B. Rossi, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy. 16. University of Pittsburgh Medical Center, Pittsburgh, USA. 17. Brighton Collaboration Foundation, Basel, Switzerland; University of Basel Children's Hospital, Basel, Switzerland.
Abstract
BACKGROUND: Several types of vasculitis have been observed and reported in temporal association with the administration of various vaccines. A systematic review of current evidence is lacking. OBJECTIVE: This systematic literature review aimed to assess available evidence and current reporting practice of vasculitides as adverse events following immunization (AEFI). METHODS: We reviewed the literature from 1st January 1994 to 30th June 2014. This review comprises randomized controlled trials, observational studies, case series, case reports, reviews and comments regardless of vaccine and target population. RESULTS: The initial search resulted in the identification of 6656 articles. Of these, 157 articles were assessed for eligibility and 75 studies were considered for analysis, including 6 retrospective/observational studies, 2 randomized controlled trials, 7 reviews, 11 case series, 46 case reports and 3 comments. Most of the larger, higher quality studies found no causal association between vaccination and subsequent development of vasculitis, including several studies on Kawasaki disease and Henoch-Schönlein purpura (IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines against influenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis. CONCLUSIONS: Existing literature does not allow establishing a causative link between vaccination and vasculitides. Further investigations were strengthened by the use of standardized case definitions and methods for data collection, analysis and presentation to improve data comparability and interpretation of vasculitis cases following immunization. Published by Elsevier Ltd.
BACKGROUND: Several types of vasculitis have been observed and reported in temporal association with the administration of various vaccines. A systematic review of current evidence is lacking. OBJECTIVE: This systematic literature review aimed to assess available evidence and current reporting practice of vasculitides as adverse events following immunization (AEFI). METHODS: We reviewed the literature from 1st January 1994 to 30th June 2014. This review comprises randomized controlled trials, observational studies, case series, case reports, reviews and comments regardless of vaccine and target population. RESULTS: The initial search resulted in the identification of 6656 articles. Of these, 157 articles were assessed for eligibility and 75 studies were considered for analysis, including 6 retrospective/observational studies, 2 randomized controlled trials, 7 reviews, 11 case series, 46 case reports and 3 comments. Most of the larger, higher quality studies found no causal association between vaccination and subsequent development of vasculitis, including several studies on Kawasaki disease and Henoch-Schönlein purpura (IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines against influenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis. CONCLUSIONS: Existing literature does not allow establishing a causative link between vaccination and vasculitides. Further investigations were strengthened by the use of standardized case definitions and methods for data collection, analysis and presentation to improve data comparability and interpretation of vasculitis cases following immunization. Published by Elsevier Ltd.
Entities:
Keywords:
Adverse event following immunization (AEFI); Case definition; Immunization; Systematic review; Vaccine; Vasculitis