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Expert Opinion on Rotavirus Vaccination in Infancy

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Expert Opinion on Rotavirus Vaccination in Infancy SCIENTIFIC ADVICE Expert opinion on rotavirus vaccination in infancy September 2017 www.ecdc.europa.eu ECDC SCIENTIFIC ADVICE Expert opinion on rotavirus vaccination in infancy This report of the European Centre for Disease Prevention and Control (ECDC) was coordinated by Kari Johansen. The production of this expert opinion was supported by an external ad hoc scientific panel of experts and ECDC internal experts. Acknowledgements The scientific panel included the following external experts (in alphabetical order): Gualtiero Grilli, MD, PhD, former Coordinator, Infectious Diseases Control and Vaccinations; Public Health Department; Marche Region, Italy. Daniel Levy-Bruhl, MD, PhD, Medical Epidemiologist, Head of the Vaccine Preventable Diseases Surveillance Unit at the Institut de Veille Sanitaire, Paris, France. Aurora Limia, MD, PhD, Public Health Officer, National Vaccination Program Coordination Area, Directorate General of Public Health, Ministry of Health, Social Services and Equality, Madrid, Spain. Paul McKeown, MD, MPH FFPHM(I), Consultant in Public Health Medicine, Head of Gastro-zoonotic Unit, Health Protection Surveillance Centre, Dublin, Ireland Miriam Wiese-Posselt, MD, MPH, Medical Epidemiologist, Department for Infectious Disease Epidemiology, Immunisation Unit, Robert Koch Institute, Berlin, Germany. The following internal disease experts from ECDC contributed to the literature reviews and assessment of articles: Tek-Ang Lim, Benedetto Simone and Pier Luigi Lopalco. The literature searches were conducted by Irene Munoz, ECDC Library. ECDC wishes to thank the EuroRotaNet strain surveillance network for supplying genotyping results of circulating rotavirus strains in the EU/EEA for the time period 2006 to 2016 and the Eudravigilance team at the European Medicines Agency for providing information on spontaneously reported intussusception cases retrieved from the Eudravigilance database. Suggested citation: European Centre for Disease Prevention and Control. ECDC Expert opinion on rotavirus vaccination in infancy. Stockholm: ECDC; 2017 Stockholm, September 2017 ISBN 978-92-9498-084-7 doi 10.2900/362947 TQ-02-17-947-EN-N © European Centre for Disease Prevention and Control, 2017 Reproduction is authorised, provided the source is acknowledged. ii SCIENTIFIC ADVICE Expert opinion on rotavirus vaccination in infancy Contents Abbreviations ................................................................................................................................................ v Executive summary ....................................................................................................................................... 1 Aim ......................................................................................................................................................... 1 Methods ................................................................................................................................................... 1 Results .................................................................................................................................................... 1 Conclusions and possible implications for public health practice and research ................................................. 3 1. Background .............................................................................................................................................. 4 Rotavirus disease ...................................................................................................................................... 5 Rotavirus vaccines available in EU/EEA countries ......................................................................................... 8 Rotavirus vaccines authorised in non-EU/EEA countries and vaccine candidates ............................................ 12 Overview of human rotaviruses ................................................................................................................ 14 Post-authorisation monitoring of circulating rotavirus strains in EU/EEA countries ......................................... 15 Rotavirus immunisation programmes in EU/EEA countries .......................................................................... 18 2. Methods .................................................................................................................................................. 22 Methodology used for evaluating burden of severe rotavirus disease in EU/EEA ............................................ 22 Methodology used for evaluating rotavirus vaccine efficacy ......................................................................... 22 Methodology used for evaluating rotavirus vaccine effectiveness ................................................................. 22 Methodology used for evaluating rotavirus vaccine-induced herd protection ................................................. 23 Methodology used for evaluating rotavirus vaccine safety ........................................................................... 23 Methodology used for evaluating rotavirus vaccine cost-effectiveness in the EU/EEA ..................................... 24 Methodology used for evaluating attitudes to rotavirus vaccination .............................................................. 24 Expert panel opinion ............................................................................................................................... 24 Updated expert opinion following ECDC Advisory Forum review and public consultation ................................ 24 3. Results .................................................................................................................................................... 25 Burden of rotavirus disease in EU/EEA countries ........................................................................................ 25 Rotavirus vaccine efficacy ........................................................................................................................ 29 Rotavirus vaccine effectiveness ................................................................................................................ 31 Herd protection provided by infant rotavirus vaccination ............................................................................. 33 Rotavirus vaccine safety .......................................................................................................................... 34 Rotavirus vaccine cost-effectiveness in EU/EEA countries ........................................................................... 45 Attitudes to rotavirus vaccination among parents and healthcare workers .................................................... 50 4. Options for monitoring and evaluating impact of rotavirus vaccination .......................................................... 51 Preparing for rotavirus vaccine introduction ............................................................................................... 51 Monitoring impact of rotavirus vaccine programmes ................................................................................... 51 5. Conclusions and possible implications for public health practice and research ................................................ 53 6. Strengths of methodology used in this expert opinion .................................................................................. 54 7. Limitations of methodology used in this expert opinion ................................................................................ 54 8. Next steps ............................................................................................................................................... 54 9. Expert opinion update .............................................................................................................................. 54 10. Annexes ................................................................................................................................................ 55 11. References ............................................................................................................................................ 64 Figures Figure 1. Number of rotavirus samples per age group submitted to16 EU/EEA countries’ rotavirus reference laboratories for genotyping 2006-2016............................................................................................................ 5 Figure 2. Rotavirus particle .......................................................................................................................... 14 Figure 3. Schematic overview of the rotavirus reassortment process when two sero/genotypes infect one enterocyte simultaneously ............................................................................................................................................ 15 Figure 4. Temporal distribution of rotavirus positive samples submitted to the EuroRotanet strain surveillance network database in consecutive seasons, 2006-2016 .................................................................................... 16 Figure 5. Overall distribution of rotavirus genotypes by EU/EEA country reported to the strain surveillance network, 2006-2016 ................................................................................................................................................. 17 Figure 6a. Rotavirus vaccine efficacy compared with placebo over a follow-up period of 2 years in randomised control trials reported
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