This call is now closed.

CEPI opened a funding opportunity for vaccine development of platform technologies against SARS-CoV-2 and with the potential for use against other emerging infectious diseases (EIDs).

The ongoing COVID-19 pandemic is a public health crisis causing unprecedented disruption to human activity and costing huge numbers of lives. 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 loss of life and economic disruption.

CEPI is striving to accelerate vaccine development and to ensure that associated manufacturing capabilities and capacities will meet global demand as quickly as possible, and is supporting a portfolio of COVID-19 vaccine candidates already in clinical trials.

The primary objective of this Call for Proposals is to develop novel vaccine candidates against COVID-19 with scientific, technical or manufacturing differentiation from current COVID-19 vaccine candidates in advanced development, and additionally strive for platforms with potential for use against other EIDs (including Disease X).

CEPI is inviting submissions of Expressions of Interest (EOIs) for platform technologies that:

• enable rapid vaccine development and
• elicit robust induction of protective immunity against SARS-CoV-2 and
• offer scientific differentiation over existing approaches and
• are relevant for other potential outbreaks of known viruses as well as novel or previously unrecognised viruses, i.e. “Disease X”

These can be novel vaccine platforms or existing (proven) vaccine platforms where improvements can be made in terms of immune response, speed, costs and manufacturing scale-up, to respond mainly to the COVID-19 pandemic and potentially other known and unknown diseases.

This Call for Proposals was open from 6 November 2020 until 19 November 2020, 15.00CET. It is now closed.

Documents

• Call for Proposals text in English
• Call for Proposals text in Spanish
• Call for Proposals text in Chinese
• Application template (English only)

Applicant eligibility criteria

To be eligible, Applicants must have at least preclinical proof of concept data to support the platform and have preclinical data against SARS-CoV-2 indicating likelihood of improved or differentiated immune response from existing COVID-19 vaccine candidates. Detailed eligibility criteria are in the Call for Proposals text.

How to apply

This Call for Proposals is now closed.

Review process

Applications will be reviewed against the criteria set out in the Call for Proposals text. Responses to Applicants will be issued as soon as they are available, and preferably within one month from closing of the Call.

Questions

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

This call is now closed

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 

Please note that this call is now closed.

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

Please note that this call is now closed.

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].

CEPI, Gavi and the World Health Organization (WHO) are seeking representatives from civil society and community organisations (CSOs) to participate in COVAX – the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator – which aims to develop, manufacture and fairly allocate 2 billion doses of safe and effective COVID-19 vaccine by the end of 2021 to end the acute phase of the COVID-19 pandemic.

CSOs will play a vital role in the development and implementation of the COVAX initiative as well as the deployment of any successful vaccine through COVAX.

Specifically, we are looking for CSO representatives to participate in coordination meetings and a number of specific workstreams of COVAX:

• Technical review group
• Enabling Science SWAT
• Manufacturing SWAT
• Clinical development and operations SWAT
• Vaccine strategy, Access and allocation, and Country readiness and delivery coordination group and sub-groups.

We anticipate that the roles of CSOs will include fostering the necessary support at a political and community engagement level to ensure equitable access and delivery of future COVID-19 vaccine; providing in-depth subject matter expertise in one or more areas including vaccine R&D, manufacturing, delivery, demand, access and allocation, policy, governance; and, acting as an advocate for civil society and community perspectives as appropriate. We also seek representatives’ input in building public trust and capacity across healthcare systems for COVID-19 vaccination programmes.

For further details and information on each of the COVAX workstreams and how to apply, please see this application guidance document.

The deadline for applications has been extended to 14 September, 2020.

In order to supply several billions of doses of COVID-19 vaccines to the world, multi-dose Drug Product presentations or bags are being evaluated and advanced by CEPI, such as the MEDInstill 200-dose bag developed by INTACT Solutions. These bags are made from multi-layer film with good biological and chemical compatibility, and contain ports for sterile closed filling and dispensing, either via a multi-use syringe or via a luer lock port. Both contain a one-way anti-retro-contamination valve that ensures container-closure integrity and sterility are maintained during dispensing of the 200 doses.

To prove and validate the claim that container-closure integrity and sterility are maintained during dispensing of the 200 doses, we are seeking the support of a laboratory experienced in microbial challenge studies and sterility testing. We are looking for expertise and services specifically in the areas of controlled microbial challenge, sterility testing, mimicking administration procedures using devices, at a quality level acceptable for regulatory submissions. CEPI will work with the selected supplier to set up the studies.

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.

UPDATED deadline for submission of written proposals: Friday 7 August, 2020. 

Please send written proposals to [email protected]

If you have any questions, please contact: [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 call is currently closed. An updated call will be published in the coming weeks.

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]).

The ongoing COVID-19 pandemic is a public health crisis causing unprecedented disruption to human activity. As national and regional governments assess containment measures, only widely available safe and effective vaccines, used in conjunction with other public health measures, will allow a return to normal life and help stop further loss of life and its devastating social and economic impact.

In response to the global pandemic, CEPI is expanding and diversifying its COVID-19 vaccine portfolio to increase our chances of finding a successful vaccine which can be manufactured at scale. CEPI has opened this additional funding opportunity to accelerate the development of safe and effective vaccines by organisations who can rapidly deliver at scale and to ensure that the supply of vaccine doses is made available to meet the public health need on a worldwide basis during the pandemic.

Vaccine developers with end-to-end experience and capability for the global supply of COVID-19 vaccine doses in 12-18 months are encouraged to apply.

The new call will look more favourably on vaccine candidates that, based on field experience to date, have indications that their candidate vaccine is able to offer measurable protection after one dose.

This is an extension of CEPI’s second COVID-19 vaccine Call for Proposals launched in May 2020 (the first Call was issued in February 2020).

Documents: 

Call Text (English). The Call Text is also available in Japanese, Spanish (LatAm) and Chinese (zh-CN).

Application Template

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.

The extended Call is intended to target organisations which seek additional support to expand their COVID-19 vaccine global development plans, having already secured resources for a vaccine candidate for a given COVID-19 target indication or region. In particular, CEPI would like to engage vaccine developers with innovative COVID-19 vaccine technologies that have already or are soon to be proven, and with a track record of bringing vaccine candidates through development, including licensure and manufacturing.

To be eligible to submit a proposal the applicant or consortium should meet the requirements specified in the Call Text.

How to apply:

Before applying, please read the full Call Text, available in English, Japanese, Spanish (LatAm) and Chinese (zh-CN).. Please note. we only accept applications in English.

To respond to this Call for Proposals, entities must submit their application, using the application template, 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.

Review process:

This is a rolling call now open until at least September 28th, 2020 at 15.00CET. Applications will be rapidly reviewed in batches every three weeks. Proposals will be assessed against the review criteria outlined in the Call Text.

Questions:

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

To note: funding for this Call will be provided by CEPI with anticipated support towards the research and development aspects, including clinical trials, from the European Commission’s Horizon 2020 programme. Costs related to scale up/out of manufacturing will be financed exclusively by CEPI.

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 17 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.

Given the rapid increase in cases and spread of the novel coronavirus, 2019-nCoV, the world needs to act quickly and in unity to tackle this disease.

As part of our response, CEPI has opened a call for proposals to rapidly develop and manufacture a proven vaccine approach that can be used against 2019-nCoV – now named Coronavirus Disease-19 or COVID-19 . This call aims to complement CEPI’s COVID-19 vaccine candidate portfolio.

The deadline for applications is Friday 14 Feb (2020), 15:00 CET. 

The call is open worldwide to all types of non-profit research organisations, for-profit companies, international organisations and foundations, joint R&D ventures, government research organisations, and academic institutions ideally having a geographical footprint internationally.

Applicants should have large manufacturing capabilities for vaccine candidates against 2019-nCoV. In addition, the organisation must be willing to transfer their vaccine platform to a global network of large-scale manufacturing.

·         Call text (English)

·         Call text (Chinese zh-CN)

·         Application template

How to Apply and Review Process

Ahead of applying, please read our Call text, available above, for detailed information on:

• Objectives and the scope of this Call
• Applicant eligibility criteria
• Applicant guidelines and the review process
• Review criteria
• Award conditions
• Technical and administrative questions

To apply for this Call for Proposals, please complete the application template listed above.

Applicants must submit the completed 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 2019-nCoV vaccine). The application should be uploaded in a PDF format.

The review will be done on a rolling basis therefore incoming proposals will be reviewed immediately.

Proposals that have met the eligibility criteria will be further assessed against review criteria.

Questions?

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

Given the rapid increase in cases and spread of the novel coronavirus, 2019-nCoV, the world needs to act quickly and in unity to tackle this disease.

As part of our response, CEPI has opened a call for proposals to rapidly develop and manufacture a proven vaccine approach that can be used against 2019-nCoV – now named Coronavirus Disease-19 or COVID-19 . This call aims to complement CEPI’s COVID-19 vaccine candidate portfolio.

The deadline for applications is Friday 14 Feb (2020), 15:00 CET. 

The call is open worldwide to all types of non-profit research organisations, for-profit companies, international organisations and foundations, joint R&D ventures, government research organisations, and academic institutions ideally having a geographical footprint internationally.

Applicants should have large manufacturing capabilities for vaccine candidates against 2019-nCoV. In addition, the organisation must be willing to transfer their vaccine platform to a global network of large-scale manufacturing.

·         Call text (English)

·         Call text (Chinese zh-CN)

·         Application template

How to Apply and Review Process

Ahead of applying, please read our Call text, available above, for detailed information on:

• Objectives and the scope of this Call
• Applicant eligibility criteria
• Applicant guidelines and the review process
• Review criteria
• Award conditions
• Technical and administrative questions

To apply for this Call for Proposals, please complete the application template listed above.

Applicants must submit the completed 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 2019-nCoV vaccine). The application should be uploaded in a PDF format.

The review will be done on a rolling basis therefore incoming proposals will be reviewed immediately.

Proposals that have met the eligibility criteria will be further assessed against review criteria.

Questions?

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

CEPI is requesting information from entities able to serve as possible sponsors or to provide operational trial support (Clinical Research Organizations) for clinical trials involving vaccine candidates against COVID-19.

Please download our Expression of Interest (EOI) document here. This document describes the scope, requirements and process for submission of information.

This EOI has a deadline of Sunday 19^th April 2020, 15:00 CET. Information gathered through this EOI will be the basis for a procurement process to secure the services of one or more trial sponsors and CROs.

Please submit information in PDF format within max three pages, covering the questions above to [email protected] before 15:00 CET on Sunday 19^th April, 2020. Technical and administrative questions about this EOI should be directed to the CEPI Secretariat ([email protected]).

Comparing immune responses against different vaccine candidates intended for the prevention of the novel virus responsible for Coronavirus Disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is challenging given the global complexity in the number of institutions now focusing on developing SARS-CoV-2 vaccines. Biological variation and technical differences (how and where specimens are collected, transported, stored, and analysed) impacts the quality and usefulness of the data produced and makes comparisons between measurements in individual laboratories difficult.

In order to reduce some of this complexity, better compare the immunological profile of each vaccine candidate, and provide robust assays for regulatory purposes, CEPI is planning to measure the immune response elicited by different vaccine in preclinical studies as well as Phase I and II clinical studies in the same (centralized) laboratory, establishing a common protocol or providing the data package which allows formal bridging to a common protocol and information sharing.

To prepare for such studies CEPI is launching a Request for Proposals (RfP) to identify and select potential partners. Types of studies that pre-approved providers might be asked to perform could include, but are not limited to, ELISA assays, Wild type (BSL-3) and pseudo-virus neutralisation assays (BSL-2) and T-cells ELISPOT assays.

How to Apply:

The RfP is open to any laboratory worldwide that are able to perform one or more vaccine-relevant immunological assays for SARS-CoV-2 for preclinical and/or human samples under GLP/GCLP conditions. Applicants must have the assay(s) proposed already in place and be willing to run comparability studies with other laboratories in different geographical regions or able to fast tech transfer the assay(s) from other laboratories.

For more information, please read our Request for Proposals text. We request that all applicants use the CEPI template to provide the information requested in the Request for Proposals text.

Please submit your application in PDF format within max 10 pages to [email protected] before 15:00 CET on Sunday 10 May 2020.

CEPI will contact successful applicants once all submitted proposals have been reviewed, by Sunday 31 May 2020.

CEPI intends to implement framework agreements with successful applicants, to cover potential future provision of services as detailed in this request for proposals. Laboratories that are awardees or sub-awardees in consortia with pre-existing grants from CEPI to conduct a defined scope of work will not have that work affected by the new framework agreements.

Comparing immune responses against different vaccine candidates intended for the prevention of the novel virus responsible for Coronavirus Disease 2019 (COVID-19),  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is challenging given the global complexity in the number of institutions now focusing on developing SARS-CoV-2 vaccines. Biological variation and technical differences (how and where specimens are collected, transported, stored, and analysed) impacts the quality and usefulness of the data produced and makes comparisons between measurements in individual laboratories difficult.

In order to reduce some of this complexity, better compare the immunological profile of each vaccine candidate, and provide robust assays for regulatory purposes, CEPI has previously published a Request for Proposals (RfP) to select potential laboratory partners to test the immune response elicited by different vaccines in preclinical studies as well as Phase I and II clinical studies in the same (centralized) laboratory (RFP-CL-01-COVID).

CEPI is now extending the scope of the previously published RfP to include the testing of the immune response elicited by different vaccines in Phase III and beyond.

Types of studies that pre-approved providers might be asked to perform could include, but are not limited to, ELISA assays, Wild type (BSL-3) and pseudo-virus neutralisation assays (BSL-2) and T-cells ELISPOT assays.

The Request for Proposals is open to any laboratory worldwide that are able to perform one or more vaccine-relevant immunological assays for SARS-CoV-2 for preclinical and/or human samples under GLP/GCLP conditions. Applicants must have the assay(s) proposed already in place and be willing to run comparability studies with other laboratories in different geographical regions or able to fast tech transfer the assay(s) from other laboratories.

Application details:

New applicants must submit a full application using the CEPI template to provide the information in the Request for Proposals text.

Laboratories which have previously applied to the first Request for Proposals (RFP-CL-01-COVID) and would like to be considered for the scope extension are requested to submit an expression of interest for the extended scope, noting any relevant changes to their original application in the context of the scope extension.

Please submit your full application or the expression of interest in PDF format within max 10 pages to [email protected] before 15:00 CET on Sunday 4 October 2020.

CEPI will contact successful applicants once all submitted proposals have been reviewed, by Sunday 31 October 2020. CEPI intends to implement framework agreements with successful applicants, to cover potential future provision of services as detailed in this request for proposals.

Laboratories that are awardees or sub-awardees in consortia with pre-existing grants from CEPI to conduct a defined scope of work will not have that work affected by the new framework agreements.

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]

CEPI’s third call for proposals (CfP3i) was for the development of human vaccines against Rift Valley fever and Chikungunya diseases. Rift Valley fever disease is included among the WHO R&D Blueprint list of priority pathogens in 2018, while Chikungunya is deemed to present a major public health risk where further R&D is needed. The call for proposals closed on March 5, 2019, (15:00 CET).

For any queries related the submission system, access to proposal templates, or any other issues related to this call for proposals, please contact [email protected].

The following documents are available below for you to read and download:

• Overview of CfP3i
• Funding Agreement and Terms and Conditions
• CfP3i Team Charter Template

Calls for Proposals 3 (CfP3i)

The decision to fund the development of vaccines against Rift Valley fever and Chikungunya is based on the feasibility of vaccine development and the potential public health impact of vaccines against these diseases. While vaccines against both viruses appear to be technically feasible, the commercial prospects for vaccines against Rift Valley fever are non-existent and for Chikungunya , uncertain at best.

Funding will be provided by CEPI with anticipated support from the European Commission’s Horizon 2020 programme.

CfP3i invited vaccine developers to achieve the following objectives:

For Rift Valley fever vaccines: support accelerated clinical testing or activities enabling clinical testing of the most advanced Rift Valley fever vaccine candidates, including identification of correlates of protection and their validation.

For Chikungunya vaccines: support the rapid progression of the most advanced Chikungunya vaccine candidates through mid-stage and late-stage clinical development, and support activities enabling future phase III testing, including identification of correlates of protection and their validation.

During the proposed project period, we encourage vaccine developers to work towards the following timelines:

• Significant progress of the project should be made in the 12 to 15 months after the signing of a CEPI funding agreement
• Projects must be completed within 3 years from January 2019

A second open call (CfP3ii) is anticipated to open in 2020, which may advance work undertaken in CfP3i.

Budget

CfP3i presents a unique opportunity for CEPI and the European Commission to work in partnership to support the advancement and diversification of the current vaccine development pipeline against the Rift Valley fever and Chikungunya.

The budget of CfP3i is USD 48 million and it is expected to fund 1 to 8 projects. Funding for pre-award costs might be provided (conditions apply; see application documents). The budget for the second open call (CfP3ii) to open in 2020 is USD 100 million.

Our first call for proposals was open to all types of organisations able to advance vaccine candidates from the late pre-clinical stage through to Phase II for our priority diseases, Lassa, MERS and Nipah.

We worked with the Research Council of Norway to create an online application for interested organisations. The deadline for round 1 applications was 8 March 2017. Following our review process, we then invited a number of applicants to submit their full proposals. The deadline for round 2 applications was 12 July 2017. We have so far announced seven partnership agreements to develop vaccines against Lassa, MERS and Nipah.

On 1st September 2017, CEPI launched its Second call for proposals on vaccine platform technologies to promote the objective of developing development of real time response capabilities to novel emerging threats, and immunise at-risk populations against emerging infectious diseases, potentially resulting in great public health impact by rapidly limiting or ending outbreaks.

In response to this call for proposals, the Secretariat received over 35 applications, with a broad diversity displayed in the vaccine platform technologies being proposed, including both novel concepts and established technologies.

Applicants and their partners were from North America, South America, Europe, Africa, Asia and Australia, representing academic institutions, biotechs, large pharmaceutical companies and Product Development Partnerships.

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].

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. 

Please send applications to: [email protected]

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
• CEPI Budget Narrative

Questions

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

You can also access a list of Questions Submitted so far, and the corresponding answers. We are regularly updating this document.

Biological standards play a critical role in advancing vaccine development. International standards enable the harmonisation and standardisation of assay data, which in turn allows the evaluation and on-going quality control of a product throughout its life cycle. Proper standards and common assays allow comparison between different vaccines and enable different groups to provide comparable data about a given vaccine.

In September, 2018, CEPI asked for the submission of proposals for one or more of the following:

• Studies to obtain sera from Lassa-fever survivors, suitable for the development of serum standard and panels against Lassa fever
• Provision of recombinant antigens [Lassa virus (LASV) glycoprotein (GP) and nucleoprotein (NP)]
• Development of interim standard(s) through characterization, evaluation, and processing of antigens and serum
• Storage and provision of antigen(s) and serum to ensure long-term access by Lassa-vaccine developers

Early in 2017, CEPI and the Bill and Melinda Gates Foundation launched a request for information on rapid response vaccine and antibody technologies that could be used to address future emerging diseases.

We requested information on technologies related to production of both vaccines and antibody therapeutics. The request for information was used to inform of understanding of this landscape, as well as to influence the development of a call for proposals by CEPI for rapid-response platform technologies specifically for vaccine development.

CEPI has invested in the development of multiple vaccine candidates against Lassa virus, some of which will begin testing in phase 1 clinical trials at the beginning of 2019.

We recently announced plans to provide grants for epidemiological studies of Lassa virus that will inform future trial design, endpoints, and site selection for Lassa-vaccine development.

We invited research groups to express their interest in performing such studies. The expression of interest served as a prequalification to apply for funding through a subsequent “request for proposals” on epidemiological studies of Lassa virus. Applicants were informed of selection results in October 2018.

In November 2018 CEPI, FDA Ghana, and the Noguchi Memorial Institute for Medical Research organised a workshop, in Accra, Ghana, involving pre-qualified applicants, to discuss how we should prepare for Lassa vaccine trials with targeted epidemiology studies.

The objectives of this workshop included:

1. Identification data needs, objectives, case definition, study designs, laboratory confirmation and key harmonised elements of CEPI-funded studies to facilitate vaccine development for Lassa

2. Discuss options for enhanced collaboration and set up of governance of the targeted epidemiology studies to be funded by CEPI Researchers from across west Africa who are engaged in Lassa-virus research attended the workshop.

Attendees presented their expert insights and experiences of undertaking such epidemiological research and discussed what epidemiological research programs are needed in advance of potential phase 1, 2, or 3 vaccine trials.

The presentations from this workshop are available to below.

The 2014-15 Ebola outbreak in West Africa was a galvanizing event for the world, which led to the formation of CEPI. At the time of the outbreak a handful of vaccine candidates were in the pipeline, and while data on safety and effectiveness of the Merck VSV vaccine was gained from several clinical trials conducted in 2015-16, no Ebola vaccine is yet licensed.

Because the human response to vaccine is different than the response to natural infection, and the non-human primate model does not mirror the human response.

In 2018, CEPI issued a requested for proposals to further support animal-model developers, vaccine developers, and regulators to improve the scientific underpinning of Ebola vaccine development and help to better understand and collate information about the human immune response.