## 2.5 Description of the services LOT 4: Vaccine effectiveness and impact of COVID- 19 vaccines through routinely collected exposure and outcome data using health registries 

## 2.5.1 Scope of the services in LOT 4 

The objective of this lot is to build knowledge on the impact of COVID-19 vaccination programmes and COVID-19 vaccine effectiveness through the implementation of observational studies. yesThese studies will be conducted relying on exposure and outcome data using established health data registries across several study sites in the EU/EEA. This lot will entail the identification of suitable health registries and their feasibility to be used for study purposes, the identification of the minimal necessary data to support study objectives and the set-up of a routine system to monitor the effectiveness of COVID-19 vaccines when used in real-conditions of life. The studies will be conducted across several study sites in the EU/EEA and may include the pooling of data from several study sites to meet study objectives. This lot will include the set-up of a system with established procedures, the training and capacity building of study sites to allow an investigation of COVID-19 vaccines effectiveness and impact on a continuous basis. 

Within the built-in system, a set of studies will be implemented studying various endpoints of interest in light of the potential evolution of COVID-19 vaccination programmes in the EU/EEA. This will be decided at study onset based on the latest knowledge of the COVID-19 pandemic (e.g. specific brand VE, VE against specific virus variants, new population targeted by vaccination programmes, impact in specific population groups). 

For the purpose of this lot, study sites are defined as any public entity (e.g. national institute of public health, Ministry of Health, university) at national or subnational level in the EU/EEA that is governing and has the ability to access individual-based health outcome databases including electronic immunisation registries, hospital registries, primary care registries or laboratory registries. 

The activities described in this lot should be performed in collaboration with the national competent public authority of the concerned EU Member States; the ECDC will facilitate these interactions if needed. In addition, the contractor is expected to perform the activities in close collaboration with ECDC, taking into account the joint work performed by ECDC and WHO, as well as work performed by other stakeholders, such as the EMA and the European Commission on these topics. 

## 2.5.2 Place of performance and number of meetings of LOT 4 

All tasks are expected to be performed at the contractor’s premises and on the study sites. It is estimated that only two meetings (see table with deliverables) could be held either at ECDC or in a location in EU/EEA. 

## 2.5.3 Summary table of tasks, deliverables, quality requirements and timelines in LOT 4 

See the Table Lot 4 / Technical annex D summarising the type of tasks and the related deliverables envisaged under the lot during the duration of the framework contract including estimated timelines and quality requirements. 

