Cohorts united against COVID-19 variants of concern

This topic aims at supporting activities that are enabling or contributing to the development of large scale, COVID-19 cohorts and networks worldwide, including beyond Europe’s borders, forging links with European initiatives as a global response to the pandemic. To that end, proposals under this topic should aim at delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

• In the short-term, contribution to a better understanding of the global circulation of the current and emerging SARS-CoV-2 variants of concern and their characteristics, delivering recommendations on the best strategies to control viral spread, as well as on optimized clinical management and treatment of COVID-19 patients.

• In the short-term, contribution to the evaluation of the impact of the variants of concern on the different vaccines and vaccination strategies and information on best vaccine and treatment options.

• In the short/medium/long-term, monitoring the emergence of new variants of concern, elucidating the impact of different variants on transmissibility and severity of COVID-19 disease, including long-term post-infection sequelae (long COVID).

• In the long term, establishment of regional and internationally linked strategic cohorts that can be pivoted rapidly to research on emerging infectious diseases.

• In the long-term, contribution to regional and international pandemic preparedness networks to rapidly address pandemics in the future on a global scale.

Proposals submitted under this expression of interest are expected to build on existing large-scale, multi-centre, regional or international cohorts worldwide and/or establish new ones linked to those. These cohorts should aim to rapidly advance the knowledge on SARS-CoV-2 and its emerging variants of concern, with the aim of developing evidence-based strategic and robust recommendations for the effective control and prevention of COVID-19 infection. The regional or international cohort(s) should allow to rapidly and consistently provide estimations on the occurrence and spread of emerging variants of concern in different parts of the world. They should contribute to a better understanding of their transmissibility, virulence and pathogenicity.

Risk and protective factors to infection, and clinical manifestation including long-term post-infection sequelae (long COVID) should be investigated for different variants and different (risk) groups (e.g. children, elderly) to potentially identify biomarkers for vulnerable populations and inform treatment options.

The cohort(s) should also contribute to elucidating the effectiveness of the various first-generation vaccines and the risk of reinfection in previously infected individuals in the different cohort populations, including risk groups, to inform on optimal vaccine strategies. The effectiveness of second-generation or adjusted vaccines should be considered as soon as they become available.

Clinical studies, carried out within the cohort(s), might also help to inform best treatment options and vaccine strategies.

The cohort(s) should cover different regions of the world to capture the various variants and vaccine and treatment strategies.

To allow for harmonised, high-quality data collection, standardisation of clinical protocols facilitated data sharing and coordination across existing cohorts, a strong collaboration with the EU-funded projects ORCHESTRA and RECODID, as well as the EU COVID-19 data portal^[1] is expected. Applicants should describe their plans for such collaborations in the proposal^[2].

Applicant consortia are expected to collaborate with other relevant initiatives already existing or under development at national, regional, and international level, in order to maximise synergy and complementarity and avoid duplication of the research efforts. Coordination across cohorts and established clinical trial networks on COVID-19 treatment and vaccines is encouraged to improve research outcomes.

Strong collaboration with regional public health and regulatory authorities is strongly encouraged.

Proposals should include a plan on maintaining the established cohort(s) to strengthen regional or international research preparedness for a future epidemic or pandemic.

If more than one proposal is successful, proposals should collaborate and this should be foreseen in the proposal.

Gender-related issues are an important crosscutting priority of this Expression of Interest. All data should be sex- and gender-disaggregated, and attention should be paid to critical social factors intersecting with sex/gender, such as age, social origin, ethnicity/migration, and disability.

This action seeks to address the challenges linked to the COVID-19 variants. As such, the granting authority has activated the public emergency provisions included in the General Annexes, meaning that beneficiaries must comply with the public emergency related provisions listed in the General Annexes of the Work Programme 2021 (part G - Legal and financial set-up of the grant agreements) and in the Model Grant Agreement concerning the project implementation under Intellectual Property Rights (IPR), background and results, access rights and rights of use (article 16 and Annex 5) for the duration of the pandemic; and under Communication, dissemination, open science and visibility (article 17 and Annex 5) during the entire duration of the action and for four years after the end of the action.

It is expected that quality-controlled data are shared in accordance with the FAIR^[3] principles. The use of harmonised protocols in collaboration with other actors is recommended for this purpose.

For the selection of proposals for funding, the Commission will take the geographical distribution of activities into account.

The Commission considers that proposals requesting a contribution from the EU of between EUR 7 and 10 million would allow these specific challenges to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. Please note that expenditures can be covered from the date of submission of the proposal, but at the applicant’s own risk.

Proposals can be concise and should focus on the essential information to facilitate an appropriate evaluation.

[1] https://www.covid19dataportal.org

[2] Applicants should not contact these projects before they submit the proposal as this would lead to work overload for the applicants as well as the mentioned projects. Applicants should indicate in their proposal which networks/projects would be relevant for their proposed work. If their application is successful, the Commission will facilitate the connection between the coordinator/project and the relevant network/project(s) at the time the grant preparation will start.

[3] FAIR data are data, which meet principles of findability, accessibility, interoperability, and reusability. https://www.openaire.eu/how-to-make-your-data-fair