Transcript ECDC Guidance for the Introduction of HPV Vaccines in

ECDC Guidance for the Introduction of HPV
Vaccines in EU countries
European Cervical Cancer Summit Meeting
Brussels, 22 January 2008
Professor Johan Giesecke
Chief Scientist, ECDC
ecdc.europa.eu
Introduction
• ECDC is today publishing Guidance for the
Introduction of HPV vaccines in EU countries.
• The purpose of the Guidance is to lay down the
scientific basis to help the EU Member States
make policy choices.
• The Guidance has been developed by panel of
independent experts set up and coordinated by
ECDC.
• Target audiences for the Guidance are:
– national immunisation programme managers;
– policy makers at EU-level and national level;
– experts involved in advising on introduction of HPV
vaccines.
What is ECDC ?
“An independent agency, named the European
Centre for Disease Prevention and Control’”
(Regulation 851/2004)
A European Union Agency which :
• Is a member of the European Union (EU)
family.
• Covers EU 27, EEA/EFTA countries and
gradually integrating accession and
candidate countries.
• Within neighbourhood policy and DG
Relex, outreach to others countries
beyond the EU 27.
• Supports and promotes global health
security (role in International Health
Regulations).
• Is financed by the EU budget.
What is the role of ECDC?
Identify, assess & communicate current & emerging
health threats to human health from communicable
diseases
• EU level disease surveillance
• Scientific opinions and studies
• Early Warning system and response
• Technical assistance and training
• Epidemic intelligence
• Communication to scientific
community
• Communication to the public
ECDC works in partnership
• EU institutions: European Parliament, Commission,
Council, EU agencies.
• WHO: HQ and EURO and other public health
institutions.
• Member States: ECDC builds on networks,
infrastructure and expertise of the Member States.
• ECDC has no institutions, research centres or
laboratories of its own – “networks the networks”
to ensure synergy and consistency between
European and national levels.
Scientific Panel on HPV
Chair, Prof Patricia Clayes
University of Ghent, Belgium
Dr Daniel Lévy-Bruhl
Institut de veille sanitaire,
France
Prof Paolo Bonani
Dr Ahti Anttila
University of Florence, Italy
Finnish Cancer Registry, Finland
Dr Kate Soldan
Health Protection Agency,
UK
Prof Adam Finn
Institut of Child Life and Health,
UK
Guidance outline
The Guidance evaluates scientific evidence on:
• Cervical cancer and HPV infections in the EU
• The HPV vaccine
• HPV vaccines and cervical cancer screening
programmes
• Target populations
• Strategy options for HPV vaccine delivery in EU
countries
• Modelling costs and outcomes of HPV
vaccination
• Monitoring and evaluation
Cervical cancer and
HPV infections in the EU
• Cervical cancer is second most
common cancer after breast
cancer affecting women aged
15-44 in the EU.
• Each year there are around
33 000 cases of cervical cancer
and 15 000 deaths in the EU.
• The primary cause of cervical
cancer is persistent infection of
the genital tract by high-risk HPV
types.
The HPV Vaccine
• Two prophylactic HPV vaccines have been
licensed in the EU.
• Both vaccines protect against the high-risk HPV
types 16 and 18, responsible for an estimated
73% of cervical cancer cases in Europe.
• In large phase III trials both vaccines have been
shown to prevent more than 90% of
precancerous lesions associated with HPV types
16 and 18 among HPV-naïve women.
HPV vaccines and
cervical cancer screening
• Well organised cervical cancer screening
programmes are proven to reduce cervical
cancer incidence by over 80%.
• HPV vaccine offers a complementary tool to
improve the control of cervical cancer…
• …But does not eliminate need for cervical
cancer screening even for vaccinated women.
• National authorities should continue efforts to
organise and improve screening programmes
independent of vaccine introduction.
HPV vaccines and
cervical cancer screening
(cont’d)
• HPV vaccines will have an impact on efficacy of
existing screening programmes, which will need
close monitoring.
• Women need to be informed and motivated to
attend screening programmes, even if they are
vaccinated.
• One of the most important challenges will be to
achieve synergy between vaccination and
screening in a cost-effective way with the
maximum benefit for women.
Target populations
• The primary target group for routine vaccination
should be young adolescent girls before they become
sexually active.
• Targeting older girls and young women with catch-up
vaccination could increase vaccination benefits in the
short term.
• Country-specific factors are important to determine
the exact age for routine vaccination, and the ages for
any catch-up vaccination.
Strategy options for HPV vaccine
delivery in EU countries
• School based immunisation is likely to be the
lowest cost option for delivery of HPV vaccines to
young adolescent girls.
• Clinic or practice-based immunisation is a
universally available additional or alternative option
for HPV vaccine delivery.
• Sexual and reproductive health and other medical
clinics provided specifically for women may be
important sites for immunisation, mainly for catchup programmes.
Modelling costs and outcomes
of HPV vaccination
• HPV vaccination should be evaluated not only for
its efficacy, but also from an economic viewpoint.
• Economic evaluations are not entirely exportable,
due to the variability of costs and healthcare
systems in different countries.
• Efforts should be made by each country to perform
such evaluation (taking into account the kind of
cervical screening in place) before deciding on the
best strategy to prevent cervical cancer.
• Studies undertaken in a number of countries
indicate that HPV vaccination of young adolescent
girls has a favourable cost-effectiveness profile.
Monitoring and evaluation
• Post-licensure evaluation of the HPV vaccines needs to
determine:
– Vaccine long-term efficacy and effectiveness;
– Vaccination uptake and compliance;
– Safety;
– Integration of vaccination with other strategies such
as organised screening.
• The minimum set of information to monitor HPV
vaccination should include data on: vaccine coverage;
adverse events; and sentinel surveillance of impact on
pre-cancer lesions.
• Coordination between vaccine monitoring and cancer
control programmes will be critical.
Final comments
• There are only five-year data available on the
HPV vaccines and many questions still need
to be answered.
• ECDC’s Guidance is made on the basis of
current knowledge and will need to be reevaluated in 6-12 months.
Thank you!
www.ecdc.europa.eu | [email protected]