The Coalition for Epidemic Preparedness Innovations (CEPI) is inviting applications for the Broadly Protective Vaccine Against New Emerging Variants and Variants of Concern of SARS-CoV-2 Virus (BPCoV2) to prevent disease caused by circulating SARSCOV-2 variants of concern and emergent variants of interest (in aggregate referred to as ‘variants’ herein).
The main objective of the first part of this call for applications is to support the research and development of broadly protective SARS-CoV-2 vaccines (BPCoV2) to meet the need for protection against variants. Emphasis is again on antigen design to elicit durable, potent and broad protection against variants. Both novel Spike antigens and other relevant viral antigens will be considered.
The TPP for a BPCoV2 vaccine should aim for the following indication(s): active immunization of at-risk individuals who remain susceptible to moderate-to-severe disease and mortality caused by variants, regardless of prior SARS-CoV-2 vaccination status; used in a primary vaccination series, or as a booster following primary vaccination against ancestral strains of SARS-CoV-2, to prevent disease and mortality, and ideally to prevent infection and viral transmission. Such vaccines may also be used as a booster following clinical recovery from disease due to ancestral SARS-CoV-2 in high-risk individuals, based on specific risk factors. In the long term: active immunization of at-risk persons to prevent disease and infection.
The main focus of the call is:
- Immunogen design and selection, based on Spike protein, and other relevant immunogens where applicable to induce a broader protective immune response against variants.
- Design that considers existing VOC, emergent variants of interest and potentially future variants predicted computational or experimentally.
- Safe and already proven, rapid response vaccine technology platforms; well suited to use and distribution in LMICs.
- Technology platforms that can be accelerated through development, drive the breadth of responses and offer large volume production potential for equitable access to vulnerable populations.
To be eligible the applicants need to fulfil the following criteria:
- Applicants must be legal entities, or consortia comprised of legal entities.
- At least one of the partners in the applicant organisations or consortia of partnering organisations should have experience in human vaccine development and have a track record of bringing vaccine candidates through to human clinical trials in the past 5 years.
- Have a Target Product Profile (TPP) clearly stipulating the intended indication that drives subsequent immunogen design and R&D plans. Accompanying the TPP, have rationale that justifies the desired breadth of protection being sought.
- Have access to an established or licensed vaccine technology platform that needs to have mid-stage clinical data on safety and immunity and has ideally rapid response attributes, as well as parameters suitable for LMICs
- Scientific and operational plans for the design and selection of antigen(s) aiming to provide a sufficient breadth of protection against variants.
- Definition for a successful preclinical and clinical POC.
- Have plans for preclinical immunogenicity, safety and toxicology studies in relevant small animal models and NHPs.
- Clinical and development plans that align with CEPI’s targets timelines for this part of the call.
- Present plans to produce Good Manufacturing Practice (GMP) batch for clinical trial materials and subsequent full-scale production.
- A regulatory strategy articulated that includes the pathway to licensure of a BPCoV2 vaccine.
- Present plans to integrate Phase I immunological testing which would utilize CEPI’s available Centralised Laboratory network, and apply for sample testing, by completing and submitting the Sample Analysis Request Form.
- Indicate willingness for data sharing, use of common assays and particularly the use of international reagent standards that must be utilized.
- Indicate willingness to commit to CEPI’s Equitable Access principles including the supply of vaccine doses through the COVAX Facility.