GSS EU Science Funding Gateway

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. Furthermore, 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. Additionally, 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.

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. Also, they are expected to engage early on with the European Medicines Agency (EMA) to ensure adequacy of the proposals from a regulatory point of view as well as to collaborate with existing European research infrastructures, linking and sharing relevant data to the COVID-19 data portal and also collaborate with one of the large European trial networks VACCELERATE, RECOVER or EU-RESPONSE projects. Moreover, it is expected that quality- controlled data are shared in accordance with the FAIR principles.