The funding opportunity through this rolling Call is open worldwide, to all types of organisation: forprofit companies; non-profit organisations; international institutions and foundations; joint R&D ventures; government research organisations; and other vaccine developers.
Applicants must be independent legal entities, or consortia comprised of legal entities. The main applicant, or for a consortium at least one of the members, must have experience in human vaccine development and have a track record of bringing vaccine candidates through development, including licensure and manufacturing.
The applicant should either be a manufacturer or have a manufacturer with a track record of vaccine production identified within the consortium.
To be eligible to submit a proposal the applicant or consortium should meet the following
1. Apply for one lead COVID-19 vaccine candidate
2. Have rights to a vaccine technology that has already been proven, or soon will be
3. Have preliminary preclinical efficacy data
4. Have clinical data Q1 2021 justifying start of Phase IIB/Phase III
5. Have experience in conducting/sponsoring international clinical trials
6. Have a proven track record in vaccine licensure and commercialisation
7. Be able to scale up/out in 2021 to more than 500 million doses (two dose regimens) or 250 million (single dose) annually. Single-dose vaccines will be more favourably reviewed.
8. Have a well characterised vaccine delivery system
9. Propose a full development plan with the following component(s):
a. Comprehensive and sufficient detailed clinical development plan to licensure and costs to conduct clinical trials. From the application it should be clear how these trials contribute to the overall Clinical Development Plan (CDP) that constitutes pivotal trials for licensure and / or supports the expansion of the desired product label for multiple geographical regions or specific populations
b. Parallel plans and costs to generate GMP grade materials for clinical studies
c. Scale-up and/or scale-out plans, including costs and timelines to generate final manufacturing scale material presented in suitable containers
d. Plans that support the ideal storage requirements for final product
e. Plans to specifically accelerate the pathway to licensure and market readiness
Note: CEPI might fund a full development plan or some of its components.
10. Be an organisation that has or a consortium that includes its own large-scale manufacturing capabilities and a mature supply chain or is able to expand upon its existing infrastructure/footprint
11. Be in a position for market readiness within the next 12-18 months or less