Recently, the Coalition for Epidemic Preparedness Innovations (CEPI) published a call for proposals that is open from 28 JAN 2021 to 28 MAY 2021 and can be found here [CEPICfPCallText.pdf]. Trials that expand access in low and middle income countries is strongly encouraged. The objective is to expand access to vaccines that are already in clinical trials and produce data that can be used for label expansion, dosing flexibility, or effectiveness against new variants of the COVID-19 virus. It also discusses safety and efficacy in special populations such as pregnant, pediatric, and immunocompromised. The solicitation specifically states that trials that enable initial Emergency Use Authorization (EUA) approval, initial Phase 1 trials, and pivotal Phase 2/3 trials are not within the scope of the solicitation. However trials that are amendments or expansions of ongoing studies are acceptable. More information about specific objectives that are within the scope of the solicitation and eligibility criteria are available in the document. It also includes links to other pages at the CEPI website that provide instructions and guidance for the letter of interest and explain the review criteria. Awards will be made depending on the availability of funds and may total 140M USD. The scope is limited to expansion of ongoing trials to address access and special populations, not preclinical development of next generation candidates that may offer advantages in manufacturability or logistics (shipping/storage).
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EverGlade Consulting is a national consulting firm that helps clients navigate the federal landscape. We are inspired by technology-driven companies whose focus is to secure non-dilutive funding through the federal government. We offer services ranging from proposal support through the implementation of systems to comply with federal regulations at agencies including BARDA, the DOD, HHS, NIAID, and DTRA.