## 1.12 Public access to documents 

In the general implementation of its activities and for the processing of tendering procedures in particular, ECDC observes Council Regulation (EC) No. 1049/2001 of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. 

## 2 TECHNICAL SPECIFICATIONS 

This part of the tender specifications will provide information regarding the topic of the tender. It will describe with the nature of the services and the required results. It will also describe the minimum requirements which must be met by the tender during the execution of the contract otherwise it’s compliance will be questioned. 

General information is applicable to all the lots. Lots specific information will appear under the heading of that lot. 

## COVID-19 

The COVID pandemic has caused significant harm worldwide with over 109 million cases (of those 21,113,083 in the EU/EEA) and 2.4 million deaths (of those 515,519 in the EU/EEA) as of 18 February 2021. 

In an analysis performed by the ISARIC (International Severe Acute Respiratory and Emerging Infections Consortium) COVID-19 database, 18% of hospitalised patients were admitted to an ICU or high dependency unit 2 . As of 4 March 2021, several EU/EEA countries are still experiencing widespread community transmission partly due to SARS-Cov-2 emerging variants of concern and in some countries the healthcare system is under considerable strain. 

Several vaccines against COVID-19 have been developed and currently four have received conditional marketing authorisation for the European Union by the European Medicines Agency (EMA). These vaccines (Comirnaty, an mRNA vaccine developed by Pfizer/BioNTech; COVID-19 Vaccine Moderna, an mRNA vaccine from Moderna Inc.; COVID-19 Vaccine Vaxzevria, a viral vector vaccine from Astra Zeneca/Oxford University; COVID-19 Vaccine Janssen, a viral vector vaccine from by Janssen-Cilag International N.V.). 

Other vaccines still under development that could reach the EU market in 2021, use different manufacturing technologies and have different benefit-risk profiles. 

## 2.1 Introduction to tender specifications 

## 2.1.1 General background 

In 2018, the Council recommendation on Strengthened Cooperation against Vaccine-preventable Diseases (2018/C 466/01) called on the European Commission to work with the Member States and with the support and cooperation with the European Medicines Agency (EMA) and ECDC in order to “continuously monitor the benefits and risks of vaccines and vaccinations at EU level including through post-marketing authorisation studies”. In the Communication from the Commission Preparedness for COVID-19 vaccination strategies and vaccine deployment from 15 October 2020 established that “The European Centre for Disease Prevention and Control and European Medicines Agency, in close collaboration with the Commission, Member States, European and international partners are establishing enhanced vaccine 

