Vaccines & therapeutic clinical trials to boost COVID-19 prevention and treatment

This topic aims at supporting activities that enable the conduct of vaccine & therapeutic trials to boost prevention and further inform public health policy and clinical management. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to two of the three expected outcomes listed below:

• Enrichment of the current portfolio of SARS-CoV-2 /COVID-19 prophylactics and therapeutics with clinical testing of promising candidates.

• Further development of new, or adjustment of existing, vaccine candidates to be effective against the current SARS-CoV-2 variants and potentially protect against new emerging ones.

• Development of new effective therapies against SARS-CoV-2 for the clinical management of COVID-19 disease, including for the prevention of disease progression to severe illness and hospitalisation.

Proposals submitted under this expression of interest should aim to further develop promising therapeutic or prophylactic candidates against SARS-CoV-2/COVID-19. The vaccine/treatment candidates should have completed preclinical development, including animal studies, and be ready to enter clinical evaluation in Phase I or II studies. Applicants should have addressed the current viral variants of concern in their pre-clinical work, and/or anticipated the emergence of new variants. Proposals should include a summary of results obtained in the concluded studies (pre-clinical and/or Phase I). Proposals are also expected to include assurances on sufficient and timely access to GMP production of the compound(s) to be trialled (the costs of which can be included in the proposal). In addition, options to upscale production for subsequent development beyond the activities for which funding is requested, should be indicated as appropriate.

The proposed interventions should address, and be assessed for, different age population groups, including children and pregnant women, and target specific groups of interest such as immunocompromised, patients with co-morbidities or other groups with higher risk to develop severe disease, and patients suffering from long-term health consequences of COVID-19.

The therapeutic interventions to be developed should aim at treating mild to moderate illness (e.g. antivirals, antibodies, immunomodulators). Therapeutic interventions targeting severe to critical illness resulting from the infection are excluded.

Thermostability, innovative delivery systems, affordability and the flexibility of the platforms to speedily adjust the candidates to emerging variants, should be also considered when possible.

Successful applicants are expected to engage early on with the European Medicines Agency (EMA) to ensure adequacy of the actions from a regulatory point of view.

Collaboration with one of the large European trial networks VACCELERATE, RECOVER or EU-RESPONSE projects is expected and applicants are encouraged to describe their plans for such collaboration in the proposal^[1].

Proposals should envisage an appropriate level of collaboration with existing European research infrastructures, and should link to the COVID-19 data portal^[2] for the timely sharing of relevant data.

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.

The Commission expects to select at least one proposal on a vaccine and one on a therapeutic candidate for funding.

The Commission considers that proposals requesting a contribution from the EU of between EUR 3 and 10 million would allow these specific challenges to be addressed appropriately, with phase I trials expected to be at the lower end of this spectrum. 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] 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

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

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