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

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. ECDC’s Strategic Work Areas

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. 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. 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. 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. 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. 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. 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. 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. 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. Key Influenza Outputs
12

13. Budget and Staff Resources
2018
•690,000 EUR
•6.60 FTE
2019
•900,000 EUR
•6.00 FTE

14. Determinants of vaccine hesitancy in Europe
ECDC. Rapid literature review on motivating hesitant population groups in Europe to vaccinate. Stockholm: ECDC; 2015

15. Seasonal influenza vaccination coverage
in older population in 26 EU/EEA MSs
EU target 75%

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. 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. 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. 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. 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. 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. 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
Acknowledgements
• ECDC IRV DP
• VENICE (J.Mereckiene, S.Cotter)