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Influenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDC

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DRIVE Annual Forum
17th -18th September 2018, Rome

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Influenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDC

  1. 1. Influenza vaccine effectiveness studies in Europe – current landscape Pasi Penttinen, ECDC Office of Chief Scientist DRIVE at ISS, Rome, 17 September 2018 European Centre for Disease Prevention and Control
  2. 2. ECDC’s Strategic Work Areas
  3. 3. Influenza & Respiratory Viruses DP Strategic Objectives 1. Improve the information available for guiding public health action against influenza 2. Promote, strengthen and evaluate immunisation against influenza, and other respiratory viruses as appropriate 3. Strengthen preparedness and promote consistent and proportionate responses to influenza and other respiratory virus threats with pandemic potential
  4. 4. ECDC’s Strategic Work Areas Improve the information available for guiding public health action against influenza Promote, strengthen and evaluate immunisation against influenza, and other respiratory viruses as appropriate Strengthen preparedness and promote consistent and proportionate responses to influenza and other respiratory virus threats with pandemic potential
  5. 5. ECDC Director’s Priorities 2019 - 20 •Tackle antimicrobial resistance; •Improve vaccine coverage in the EU; •Support the European Commission and the Member States in addressing the Sustainable Development Goals in the area of HIV, TB and hepatitis; •Further support the European Commission and the Member States in strengthening the preparedness for cross- border health threats; •Focus on strategic partnerships to create synergy and avoid duplication of work; •Further enhance ECDC’s performance and monitoring. •Gradually assess and integrate innovative technological and scientific advances
  6. 6. ECDC Director’s Priorities 2019 - 20 •Tackle antimicrobial resistance; •Improve vaccine coverage in the EU; •Support the European Commission and the Member States in addressing the Sustainable Development Goals in the area of HIV, TB and hepatitis; •Further support the European Commission and the Member States in strengthening the preparedness for cross- border health threats; •Focus on strategic partnerships to create synergy and avoid duplication of work; •Further enhance ECDC’s performance and monitoring. •Gradually assess and integrate innovative technological and scientific advances
  7. 7. Strategy to mitigate the impact of influenza and other respiratory viruses in the EU TRANSFORM FLU SURVEILLANCE Epidemiology, virology, mortality INFLUENZA VACCINATIONS Promote, strengthen, evaluate VE, coverage, impact Integration and modelling PREPAREDNESS Develop, test and monitor plan RSV surveillance
  8. 8. IRV Priorities for 2019 1) Transform the European surveillance of influenza and other respiratory viruses. 2) Enable early detection, monitoring, and scientific advice for zoonotic and other emerging respiratory viruses 3) Strengthen laboratory and surveillance capacity in the network through training and External Quality Assessment. 4) Support Member State vaccination programmes by monitoring vaccination coverage, vaccine effectiveness and safety signals, as well as communication campaigns. 5) Support tackling antimicrobial resistance, by enhancing the understanding of the impact of seasonal influenza vaccination on decreasing antimicrobial consumption, and the potential resultant effect on antimicrobial resistance. 6) Monitor and strengthen pandemic preparedness in the EU by supporting the EC, EU MS, and the Global Health Security Initiative 7) Support EU/EEA Member States in establishing surveillance of respiratory syncytial virus (RSV).
  9. 9. IRV Priorities for 2019 1) Transform the European surveillance of influenza and other respiratory viruses. 2) Enable early detection, monitoring, and scientific advice for zoonotic and other emerging respiratory viruses 3) Strengthen laboratory and surveillance capacity in the network through training and External Quality Assessment. 4) Support Member State vaccination programmes by monitoring vaccination coverage, vaccine effectiveness and safety signals, as well as communication campaigns. 5) Support tackling antimicrobial resistance, by enhancing the understanding of the impact of seasonal influenza vaccination on decreasing antimicrobial consumption, and the potential resultant effect on antimicrobial resistance. 6) Monitor and strengthen pandemic preparedness in the EU by supporting the EC, EU MS, and the Global Health Security Initiative 7) Support EU/EEA Member States in establishing surveillance of respiratory syncytial virus (RSV).
  10. 10. ECDC Influenza Outputs/Activities 2019 ECDC SPD 2019-2021 -Update of influenza surveillance protocol -Feasibility study on forecasting of yearly seasonal influenza epidemic (modelling) -Weekly surveillance reports on FluNewsEurope.org during the season -External Quality Assessment (EQA) for influenza laboratory specimens -Timely vaccine effectiveness estimates and vaccine coverage data available to stakeholders. -Expert meeting in support of Member States planning cost/benefit analysis of influenza vaccination programmes -Analysis of the association between seasonal influenza vaccination coverage, antimicrobial consumption, and resistance. -Continued monitoring of influenza antiviral resistance -Assessment of preparedness through e.g. case studies, country visits, simulation exercises -Regional pandemic preparedness workshop/exercise
  11. 11. ECDC Influenza Outputs/Activities 2019 ECDC SPD 2019-2021 -Update of influenza surveillance protocol -Feasibility study on forecasting of yearly seasonal influenza epidemic (modelling) -Weekly surveillance reports on FluNewsEurope.org during the season -External Quality Assessment (EQA) for influenza laboratory specimens -Timely vaccine effectiveness estimates and vaccine coverage data available to stakeholders. -Expert meeting in support of Member States planning cost/benefit analysis of influenza vaccination programmes -Analysis of the association between seasonal influenza vaccination coverage, antimicrobial consumption, and resistance. -Continued monitoring of influenza antiviral resistance -Assessment of preparedness through e.g. case studies, country visits, simulation exercises -Regional pandemic preparedness workshop/exercise
  12. 12. Key Influenza Outputs 12
  13. 13. Budget and Staff Resources 2018 •690,000 EUR •6.60 FTE 2019 •900,000 EUR •6.00 FTE
  14. 14. Determinants of vaccine hesitancy in Europe ECDC. Rapid literature review on motivating hesitant population groups in Europe to vaccinate. Stockholm: ECDC; 2015
  15. 15. Seasonal influenza vaccination coverage in older population in 26 EU/EEA MSs EU target 75%
  16. 16. 2018 Commission communication and Council recommendation on vaccinations https://ec.europa.eu/health/sites/health/file s/vaccination/docs/com2018_2452_en.pdf https://ec.europa.eu/health/sites/health/file s/vaccination/docs/com2018_2442_en.pdf
  17. 17. Commission communication 245/2 (2018) “ …There is value in better EU coordinated efforts and pooling of joint EU technical expertise to assess the evidence in the pre- and post-licensing phase of a vaccine. In the pre-licensing phase, EU collaborative approaches can improve the qualitative and quantitative efficiency of the decision-making process while maintaining a strong and coordinated network of national vaccine experts. Post-authorisation passive and active monitoring and specifically designed studies are also needed to provide further real- life robust evidence on the safety, effectiveness, and impact of vaccines after use, and overcome current fragmented efforts at EU level…” pp 5-6
  18. 18. Council recommendation (for consultation) 244/2 (2018) “ The commission’s intention to take the following actions: … … 11. With the support of the European Medicine Agency, continuously monitor the benefits and risks of vaccines, at EU level. 12. Work towards developing common methodologies and strengthen the capacities to assess the relative effectiveness of vaccines and vaccination programmes, including as part of the European cooperation on health technology assessment…” pp 15
  19. 19. Joint Action on vaccination • The European Commission is reinforcing its support to national vaccination efforts to increase coverage, including through the preparation of a Joint Action on vaccination co-funded by the Health Programme (€3.55 million). • Launching in 2018, the Joint Action will address vaccine hesitancy and seek to increase vaccination coverage in the EU. It is coordinated by INSERM (France) and involves 24 countries (among them 21 EU countries) are partners. • It will also work towards strengthening cooperation of national immunisation advisory groups (NITAGs) with a view to increasing transparency and trust in the decision-making process regarding the introduction of new vaccines.
  20. 20. ECDC VE framework with I-Move consortium allows in-depth analyses with enlarged sample sizes VE Real-time monitoring? Age- specific Seroepi? Clade- specific Integration into TESSy? Target group Progr specific Pandemic response?
  21. 21. Key stakeholders in VE monitoring/studies •IMI •Vaccines Europe •Individual manufacturers •Vaccinology •Immunology •Epidemiology •Virology •Nat’l regulatory •EMA •Nat’l PHI •ECDC •WHO VCM •Third parties Public health institutes Regulatory agencies Vaccine industry Academia
  22. 22. Emerging scientific questions •Discrepancy between annual HAI results and VE – how can these be reconciled? •More data available on virus sequences – predicting VE? •VE against B-viruses during season with mismatched lineage in vaccine – Cross-protection or residual protection? Role of NA? Role of cell- mediated immunity? •Impact of first virus/ vaccine exposure in childhood? •Impact of repeated vaccinations?
  23. 23. 23 Acknowledgements • ECDC IRV DP • VENICE (J.Mereckiene, S.Cotter)

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