I-MOVE studies
Objectives
Having annual influenza VE estimates at European level as soon as possible after the start of a seasonal influenza epidemic or a pandemic and monitoring it along the course of the epidemic/pandemic is essential to:
- decide on recommendations for the use of the vaccine,
- target complementary or alternative public health measures (e.g. antivirals) for population sub-groups in which vaccine is less effective,
- allow more precise estimates of the impact of current vaccination strategies on the burden of disease to support vaccination campaigns,
- trigger further investigations on seasonal and pandemic vaccines (improve composition, use of adjuvants, need for booster doses),
- better manage and respond to expected reports of vaccine failures (especially during a pandemic),
- counter-balance reports of adverse events following immunisation by providing elements for an adequate risk management and cost-effectiveness analysis.
Project phases
The phase I of the project included:
- A review of the literature
- An expert meeting held in Paris
- Development of generic protocols for influenza VE measurements in EU
- Adaptation of protocols by countries
The phase II included conducting pilot studies in EU Member States During the influenza season 2008-2009, 6 EU member states developed and conducted a total of 8 studies to measure flu VE including 6 case control studies and 2 cohort studies. Measurements were conducted early and late in the season.
The phase III of the project corresponded to the pandemic 2009-10 season and included:
- A meeting with EU partners, ECDC and external experts
- Lessons learnt during this first two phases of the project were discussed during the I-MOVE annual meeting organised in June 2009 in Lisbon, Portugal. Lessons learnt were incorporated into the protocols approved for the 2009-10 influenza season.
- Conducting 11 studies in EU MS financed by ECDC.
- Annaul I-MOVE meeting organised in 2010 in Budapest
Studies conducted in Phase III
- Case control studies using a common protocol with test-negative design in France, Hungary, Ireland, Italy, Portugal, Romania and Spain.
- Cohort studies in England & Wales, the Navarra region of Spain, Scotland and The Netherlands.
- Studies using the screening method in Italy, Spain and Portugal.
- Impact of the pandemic vaccination campaign in Jersey
The phase IV of the project corresponds to the season 2010-11 and 2011-12 and includes
-
Case control studies using a common protocol with test-negative design in
France, Hungary, Ireland, Italy, Poland, Portugal, Romania and Spain.
- Cohort studies in England & Wales, the Navarra region of Spain, Scotland .
- Studies using the screening method in Italy, Spain, Scotland, England and Portugal.
Background
EpiConcept and the European Federation of Pharmaceutical European Industries and Associations (EFPIA) / European Vaccine Manufacturers (EVM) during the 2009 influenza pandemic signed a Collaboration Agreement to conduct post-marketing observational studies to measure vaccine effectiveness (VE) of the 2009 pandemic vaccines licensed in Europe and administered in countries where the studies were conducted (Denmark, France, Italy, Spain).
Study funded by EFPIA/EVM in 2009-10
- Measuring real-time influenza vaccine effectiveness in a cohort: the Moli-Sani Study (Italy)
- Hospital based incidence density sampling case control study, Valencia (Spain)
- Assessment of the Field Effectiveness of the Pandemic Influenza Vaccines using the Screening Method: The EffiVAC study (France)
- Effectiveness of vaccination against pandemic influenza A (H1N1)v in the Danish population. A registry based study (Denmark).
|
Ċ ď Esther Kissling, 18 Mar 2009 07:14
|
