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