Context

In December 2019 a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China, resulting in a rapidly spreading outbreak of coronavirus disease (COVID-19).

On Jan 30, 2020, the World Health Organization (WHO) declared COVID-19 a public health emergency of international concern (PHEIC), and by 12 March 2020, due to its rapid global spread, the outbreak was declared a pandemic.

The need for a vaccine has become more pressing than ever, as the prospect of containment with non-pharmaceutical interventions has become less feasible given their high economic and social costs.

The ACT Accelerator refers to the global initiative aimed at developing and accelerating access to COVID-19 diagnostics, therapeutics and vaccines. It includes three partnerships each of which is focused on one of the three tools. The COVAX Pillar is the partnership driving forward the work on vaccines. With the COVAX Pillar, the COVID-19 Global Vaccine Access Facility (COVAX Facility) will pool investments from participating countries to secure large volumes of vaccine to be allocated globally.

Vaccine development is moving at an unprecedented speed and scale and as promising candidate vaccines advance, practical realities will require a process that independently validates the most promising candidates to inform procurement decisions of the COVAX Facility.

Objectives

The Independent Product Group will be set up with the aim of establishing an independent process to advise the COVAX Facility and the COVAX Pillar more broadly on the candidates likelihood of meeting threshold criteria for purchase by the Facility, and subsequently,  whether those criteria are met.  Meeting those criteria would inform the criteria for purchase, along with e.g. price.

The working group is established with a program of work to:

1. Review the data and information on all candidate vaccines proposed for procurement by the COVAX Facility, using the a priori defined attributes and criteria including agreed target product profiles, and review manufacturing data for scalability and quality;
2. Provide individual scores for each candidate vaccine and a recommendation on the pertinence of prioritizing one or more given candidates for procurement including if there are vaccines more appropriate for some populations or use in some settings;
3. Provide continuous review (monthly) of the potential timing and numbers of doses meeting threshold criteria that might become available
4. Support COVAX Facility portfolio management and advise whether pivots to incorporate additional vaccines are required to ensure all high potential products are covered and that enough doses will be available in the desired time frames.

The Independent Product Group will work effectively with the COVAX portfolio governance structure under the Development and Manufacturing workstream, which is tasked with R&D and manufacturing investment decision making for the COVAX portfolio of vaccine candidates and enabling sciences activities.

The COVAX Facility will consider the recommendations of this independent group and consult with other pertinent advisory bodies to inform their opinion.

Expertise required

The Working Group will be composed by 5-7 experts. Independent expertise in the following areas is sought:

• Coronavirus vaccines and/or COVID-19 vaccines
• Animal models and assays for vaccine evaluation
• Clinical evaluation of vaccines including vaccine evaluation in large randomised clinical trials
• Regulatory expertise in vaccine evaluation
• Vaccine manufacturing and GMP issues
• Epidemiology/public health expertise
• Expertise in immunization programmes and service delivery
• Vaccine safety evaluation and monitoring

Timeline for submission of nominations

Proposals for nominations should be sent by email to [email protected] with a Curriculum Vitae, indicating area of expertise, years of experience and current involvement, if any, in COVID vaccines development and evaluation. Deadline for submission is 10 July 2020.

Evidence Review Process

There will be a standardized process for requesting information from developers, reviewing the evidence, decision-making, reporting and communicating the outcomes from the group. WHO TPPs, SAGE recommendations, and EUL/PQ processes will serve the roles of providing WHO’s normative review of the evidence. Understanding that these are appropriately streamlined in the context of the pandemic, Gavi will aim to support procurement of candidates that are recommended by WHO as for other GAVI-supported vaccines. Gavi may further prioritize amongst vaccines that are supported by WHO recommendations following Gavi’s governance processes.

CEPI is pleased to announce a new funding opportunity for the sourcing of sera from recovered patients with securely diagnosed Rift Valley Fever (RVF) disease.  The sourced material will be used to develop a RVF antibody standard to support and accelerate the development of vaccines against RVF.  

The call seeks to facilitate CEPI’s strategic objective on vaccine development for RVF, one of the CEPI prioritized diseases with epidemic potential. The ultimate purpose of this call is that it will lead to the development of WHO/ECBS-endorsed International Antibody Standard for RVF.  

Applicants may submit their proposals as a single actor or as a consortium. CEPI may request multiple applicants to collaborate towards the end deliverables of this call. We seek applicants with already established activities in connection to diagnosis, treatment and care of RVF patients. Groups or organizations with the flexibility and capacity to set up their RVF-activity and do the sourcing of sera in connection to new and different outbreak–sites will be particularly appreciated. 

How to apply 

For further information on the call, please see the full Request for Proposals. In order to be eligible for funding, all required templates must be completed as requested and submitted by the deadline of midnight GMT on 31st August 2020. 

Documents 

 The open call consists of the following documents: 

• Full Request for Proposals document regarding Sourcing of Serum from Recovered Patients for Development of a Rift Valley fever (RVF) International Antibody Standard 
• Annex 1: CEPI’s Product Profile for Sourcing of Serum from Recovered Patients after RVF Disease
• Annex 2: Request for Proposals Form; CEPI (RFP-ES-RVF-01)
• Annex 3: CEPI Budget Template 

Questions 

Any questions about this call should be directed to Johan Holst ([email protected]). 

CEPI has opened an additional funding opportunity for the rapid development of vaccines against COVID-19.

The ongoing COVID-19 pandemic is a public health crisis causing unprecedented disruption to human activity. As national and regional governments assess containment measures, it is thought that only widely available safe and effective vaccines in conjunction with other public health measures will allow a return to normal life and help prevent further sickness and deaths.

CEPI is striving to accelerate vaccine development and to ensure that associated manufacturing capabilities and capacities will meet global demand as quickly as possible. This Call for Proposals will support the rapid development of vaccines striving for licensure/emergency authorization in 12-18 months or less and, to ensure the availability of sufficient doses for wide-spread global deployment as soon as possible in 2021.

This is a rolling call open now until at least June 30th, 2020. Applications will be rapidly reviewed in batches every two weeks. The call may be extended if needed.

Documents

• Call for Proposals text – available in English, Chinese (zh-CN), Japanese and Spanish
• Application template (Please note. we only accept applications in English)

Applicant eligibility criteria

The funding opportunity through this rolling Call is open worldwide, to all types of organisation: for-profit 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, ideally 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.

Detailed information is in our Call for Proposals text – available in English, Chinese (zh-CN), Japanese and Spanish

How to apply

Before applying, please read the full Call for Proposals text – available in English, Chinese (zh-CN), Japanese and Spanish.

Please note. we only accept applications in English.

To respond to this Call for Proposals, entities must submit their application to CEPI via a secure portal. Please send an email to [email protected] to be provided with a secure link to upload your application to the secure portal (in the Subject field indicate: Application for COVID-19 vaccine). The application should be uploaded in a PDF format

Proposals that have met the eligibility criteria will be further assessed against review criteria detailed in the Call for Proposals text – available in English, Chinese (zh-CN), Japanese and Spanish.

Review process

This is a rolling call now open until at least June 30th, 2020. Applications will be rapidly reviewed in batches every two weeks.

Questions

Technical and administrative questions about this Call should be directed to the CEPI Secretariat ([email protected]).

CEPI has funded several COVID-19 vaccine development programmes and intends to support their manufacturing as well as the procurement of primary packaging components (e.g. vials, stoppers and aluminium flip-offs) that are fungible across CEPI’s COVID-19 portfolio.

For this reason, CEPI is launching a Request for Proposals to identify rubber stopper manufacturers and suppliers with the capacity and willingness to support delivery of COVID-19 vaccines. The objective of this Request for Proposals is to secure access to elastomeric closures and aluminium flip-offs to be used for the manufacture of COVID-19 vaccines.

We are seeking to engage with suppliers that have: infrastructure and expertise to serve the pharmaceutical industry and high quality and technologically advanced manufacturing processes.

Proposals are sought independently for elastomeric closures and aluminium flip-offs.

CEPI will work with the selected manufacturer/s to establish contractual arrangements that best meet the objectives of this solicitation.

For further information on the scope of tender, including information on bidder qualification, tentative time plans and applications details please see our Request for Proposals.

Tentative deadline for submission of written proposals: Monday 15 June, 2020

If you have any questions: please contact  [email protected]

Pausing our Call for Proposals 2 Rolling (CfP2R) – Platform technologies to rapidly respond to Disease X

Given the rapid increase in cases and spread of COVID-19, CEPI is currently focusing its resources on our COVID-19 vaccine development efforts and our current vaccine portfolio. As a result, we have collectively taken the decision to temporarily pause our Call for Proposals inviting applications for the development of innovative platform technologies that can be used to develop vaccines and other immunoprophylactics to rapidly respond to future outbreaks of Disease X.

The CEPI Secretariat will review all Expressions of Interest sent in up until Sunday 15 March. If you have been specifically invited to apply to the call, we will review your proposal if you submit your Expression of Interest before Wednesday 1 April. Any proposals sent in after these dates will not be assessed for the time being.

We will still be running our CEPI TechTalks

While our submission and review process for our Call for Proposals is temporarily on pause, you can still get a broader understanding of the call and see if your idea meets our suitability and eligibility requirements, through arranging a CEPI TechTalk with the Secretariat. Our CEPI TechTalks run as video conferences whereby you are invited to present your technology to the Team. CEPI TechTalks typically take place on Thursdays and Fridays from 1200 CET. Further information is available below.

Should you have any questions, please email [email protected]

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About the call 

This call for proposals invites applications for the development of innovative platform technologies that can be used to develop vaccines and other immunoprophylactics to rapidly respond to future outbreaks of emerging infectious diseases and unknown pathogens, known as “Disease X”.

Our ultimate goal is to develop the tools required to rapidly immunise at-risk populations against emerging infectious diseases, potentially resulting in public-health benefits by quickly limiting or ending outbreaks. This call builds on the original call for platform technologies launched in September, 2017.

Aims

CEPI aims to advance development of vaccine and other immunoprophylactic platform technologies that enable a rapid response to protect at-risk populations against emerging infectious diseases, including “Disease X”. CEPI plans to invest in platform technologies that can improve timelines from identification of a pathogen sequence to the development of a vaccine candidate or immunoprophylactic product. Platform technologies should enable rapid product development, rapid scale-up, and rapid induction of immunity or immunoprophylactic benefit for use in outbreaks. These can be novel platforms or existing (proven) platforms where improvements can be made in terms of increased speed, reduced costs, and manufacturing scale-up to respond to both known and unknown threat situations.

During the proposed project period, CEPI encourages vaccine developers to work towards the following aspirational targets for their platforms:

• 16 weeks from antigen identification to product release for clinical trials
• 6 weeks from administration of first dose to achieving an immune response likely to result in a clinical benefit
• 8 weeks to manufacture 100,000—from a “go” decision to production, fill, finish, and release.

Our Call Text  provides further information on our call for proposals.

Information for applicants 

Given the rapid increase in cases and spread of COVID-19, CEPI is currently focusing its resources on our COVID-19 vaccine development efforts and our current vaccine portfolio. As a result, we have collectively taken the decision to temporarily pause our Call for Proposals inviting applications for the development of innovative platform technologies that can be used to develop vaccines and other immunoprophylactics to rapidly respond to future outbreaks of Disease X.

Please download our  Call Text  which provides further information on the call.

Pre-Submission – CEPI TechTalks

If you would like to get a broader understanding of the call and see if your idea meets our suitability and eligibility requirements, you can arrange an optional CEPI TechTalk with the CEPI Secretariat.

Our CEPI TechTalks are video conference or face to face meetings (if located near one of our offices) up to 60 minutes in length. During the first half of the meeting, you are invited to present your technology. Feedback is provided in the second half of the meeting.

CEPI TechTalks typically take place on Thursdays and Fridays from 1200 CET.

If you would like to organise a CEPI TechTalk, please email [email protected], with the subject line ‘CEPI Tech Talk: *Name* and *Organisation*’. Please provide us with an overview of the idea you would like to discuss within the body of the email. The CEPI Secretariat will prioritise ideas that we perceive to best meet our suitability and eligibility requirements.

In advance of the meeting please provide:

• A brief description of the technology
• Information about the pathogens you have tested your platform on
• Current developmental stage
• Ideas of the pathogens you would suggest within your proposal
• Your tentative timeline for developing the technology through Phase I
• A rough estimate of the potential costs related to this development
• Any additional questions ie legal, technical, criteria relating to the call

CEPI TechTalks are optional and will not affect Expression of Interest.

Submission

The process for submitting your proposal is divided into two stages:

Stage 1: Applicants submit an “Expression of Interest” form. These forms can be submitted at any time and will be reviewed on a rolling basis.

Stage 2: If an “Expression of Interest” is accepted, applicants are then invited to submit a full proposal for funding.

How to apply

Step 1:

Download and complete the “Expression of Interest” form, which must include essential evidence outlined in the template, meet the presented timeline requirements for completion, and contain sufficient detail for review of the proposed product development process. Any claims made within the proposal must be supported by evidence.

Step 2:

Expression of Interest forms must be submitted via a secure portal. When ready, please email [email protected] to request a secure link to upload your completed form to the secure portal. Forms should be uploaded in PDF format. No additional documents should be submitted.

Submissions that fail to meet the eligibility criteria outlined in the “Expression of Interest” form template or that exceed the specified page limit (10 pages) will not be considered for further review.

Step 3:

Selected applicants will be invited to submit full proposals. Instructions for submission of full proposals will be sent directly to the applicants.

Review process

CEPI reviews and evaluates proposals on their merits and in the context of stated eligibility criteria and CEPI’s overall project portfolio. Regardless of eligibility at any stage of a funding call, CEPI reserves the right to consider and to decline proposals. Personal data included in proposals will be handled according to CEPI’s Privacy Notice on www.cepi.net/terms.

Enquiries

For questions related to this call for proposal or to arrange a CEPI TechTalk meeting, please contact [email protected].

Deadline for applications: Extended to Thursday 7 May 2020

Background 
Vaccines have contributed enormously to the successful control and elimination of many diseases, but few vaccines have so far been developed for the prevention and control of emerging infectious diseases. Lassa virus (LASV) has been added to the WHO R&D Blueprint list of diseases for which there is an urgent need for accelerated research and development, considering the disease’s potential to cause a public health emergency, and given the absence of efficacious drugs and/or vaccines. In the coming years, several candidate vaccines against LASV will enter clinical development and there is an urgent need to fast track their development. The aim is to facilitate the development of promising vaccines and the preparation of investigational sites in affected countries to be ready to perform proof of concept and/or pivotal efficacy trials.

Scope
The purpose of this call for proposals is to support distinct strategic actions (clinical research activities) which are part of efforts to prepare and conduct a large-scale clinical trial that has the potential to achieve proof of concept and/or the demonstration of pivotal efficacy of novel candidate vaccines against LASV.

Applications are invited for large-scale collaborative projects which include one or more clinical trials (phase II to III) aiming to accelerate the clinical development of Lassa candidate vaccines. Applications must include a minimum of one clinical trial to be conducted in affected countries in sub-Saharan Africa to test the safety, immunogenicity and/or efficacy of a candidate vaccine. Proposals that include phase III trials are particularly encouraged.

Projects should incorporate activities to enhance the capacity of existing trial sites and/or develop new trial sites in affected countries in sub-Saharan Africa for the conduct of vaccine trials. These activities could include observational (site set-up) studies, retrospective evaluation of available epidemiological data and prospective cohort studies to define incidence and case definitions for subsequent efficacy trials. Strengthening of laboratory testing capacity for case ascertainment and product evaluation is considered in scope when necessary for supporting the proposed clinical trial(s). This could include the evaluation of newly developed or newly standardized diagnostic assays for LASV and immunological read-outs for vaccine performance as well as the setup or strengthening of regional or in-country biobanks for sample storage and archiving.

These activities would ideally build on and leverage existing or developing networks of excellence or ongoing capacity development of researchers, institutions, and sites, including existing national or regional biobanking facilities, in sub-Saharan Africa, to conduct clinical trials and related research, including observational studies. The inclusion of plans to involve public health authorities in disease-endemic countries is also encouraged.

Supporting information on the composition and scale, as well as on the management structures and procedures of the large-scale clinical trial must be presented to enable assessment of their appropriateness.

The EDCTP Association and CEPI consider that proposals for actions of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately. When the EDCTP Association and CEPI deem participation of the entity essential for carrying out the action, legal entities from anywhere in the world will be eligible for funding through this call for proposals.

Expected impact
Actions supported under this call for proposal should advance the development of promising LASV candidate vaccines moving towards regulatory licensure. The actions should also contribute towards a better understanding of the mechanisms of the reactogenicity (safety), immunogenicity and efficacy profile of the LASV candidate vaccine(s) and build capacity for the evaluation of vaccines against LASV and other EIDs in sub-Saharan Africa.

Capacity-enhancing activities should contribute to strengthening regional, national, institutional and individual capacities to conduct clinical trials for product evaluation according to ICH-GCP standards and generate data to inform trial design and appropriate endpoints.

Eligibility
A proposal/application will only be considered eligible if:

1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
2. it complies with the eligibility conditions for participation set out below, depending on the type of action:
   • At least three legal entities. Two of the legal entities shall be established in two different Participating States (European Partner States)* and one of the legal entities must be established in a sub-Saharan African** country. All three legal entities must be independent of each other.
   • ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.

Notes

*The Participating States (European Partner States) are Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.

**The following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic People’s Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, Equatorial Guinea, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.

• For information and details on how to apply, please visit the EDCTP website.
• For Frequently Asked Questions specific to the EDCTP-CEPI Lassa Virus Call, please click here.
• For the CEPI template side letter, mentioned within the FAQs, please click here.
• For specific questions related to this call for proposals, please contact Jean Marie Habarugira at [email protected].