## 2.6 Description of the services LOT 5: Vaccine effectiveness against COVID- 19 and seasonal influenza among patients presenting to primary care physicians in EU/EEA 

## 2.6.1 Scope of the services in LOT 5 

The overall aim of this lot is to estimate vaccine effectiveness of COVID-19 and seasonal influenza vaccines among the subjects included in the target groups for vaccination and presenting to primary care with a syndrome compatible with influenza or COVID-19. A secondary aim is to provide preparedness for rapid implementation of such studies in other respiratory pandemics in the future. 

The assessment of the effectiveness of SARS-CoV-2 and influenza vaccines in preventing occurrence of disease in real-world settings will help to inform their benefit-risk profile, as vaccination will continue to be deployed and new vaccine formulation become licensed. The assessment needs to take into account also the variation in circulating strains or clades of the viruses. 

The results will serve to guide decision-making on vaccination strategies, also in light of emerging new variants of COVID-19 or strains of influenza. The results may also be used to support decision-making on vaccine composition and direct research and development of available vaccines, when relevant. 

For the purposes of achieving the overall aim a geographically representative network of study sites in EU/EEA will be established or enlarged. Such a network shall be capable of recruiting subjects for one or both of the clinical pictures, implement annual studies, ensure quality control and report on a timely basis to ECDC, other stakeholders and the general public. 

Study sites as defined in this lot can be represented by a country or a subnational administrative unit of a country, with a network of primary care units (sentinel or with national coverage). 

The studies 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. Previous relevant work and relevant documents will be shared by ECDC with the contractor. 

The contractor will be expected to obtain applicable approval for the conduct of the study, any subsequent additional analyses and study material (e.g. institutional review board approval, ethics committee approval where necessary, data protection body approval). 

## Specific objectives for the lot 

• To design and implement a study to estimate the effectiveness of a full-course of COVID-19 vaccine(s) against laboratory (polymerase chain reaction, PCR) confirmed COVID-19 infection in individuals presenting in primary care clinics (outpatients) aged > 18 years in the EU/EEA (primary study objective). Other secondary outcomes can be proposed. 

• To design and implement a study to estimate the effectiveness of seasonal influenza vaccine(s) against laboratory-confirmed (PCR) influenza infection in individuals presenting in primary care clinics (outpatients) aged > 18 years in the EU/EEA (primary study objective). Other secondary outcomes can be proposed. 

• To design and prepare for studies to estimate vaccine effectiveness during influenza, coronavirus and other respiratory pandemics. 

• Other study designs may be proposed by the contractor and shall be discussed with ECDC. 

