HORIZON EUROPE
Europeo
Scope:Specific challenge
In view of the current epidemic, the WHO has identified the progression of vaccine candidates currently in development as an urgent public health need. Because Ebola vaccines are recombinant adenovirus or other viral-based vaccines and need to be produced in facilities meeting an appropriate biosafety level, manufacturing the quantity of vaccine doses necessary for large-scale clinical testing and that can be thereafter urgently deployed represents a major challenge.
Scope
The project(s) will work on scaling up the currently available production techniques to the necessary scale and will be fully compliant with good manufacturing practices (GMP) and biological safety level requirements.
a. Costs and milestones are requested for manufacturing activities at volumes in the range of:
100,000 – 250,000 vaccine courses 250,000 – 2M vaccine courses 2M – 20M vaccine coursesConsideration to Drug Substance manufacture (formulated vaccine bulk) and finished Drug Product (vialed vaccine doses) should be given. Alternative manufacturing platforms...
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Scope:Specific challenge
In view of the current epidemic, the WHO has identified the progression of vaccine candidates currently in development as an urgent public health need. Because Ebola vaccines are recombinant adenovirus or other viral-based vaccines and need to be produced in facilities meeting an appropriate biosafety level, manufacturing the quantity of vaccine doses necessary for large-scale clinical testing and that can be thereafter urgently deployed represents a major challenge.
Scope
The project(s) will work on scaling up the currently available production techniques to the necessary scale and will be fully compliant with good manufacturing practices (GMP) and biological safety level requirements.
a. Costs and milestones are requested for manufacturing activities at volumes in the range of:
100,000 – 250,000 vaccine courses 250,000 – 2M vaccine courses 2M – 20M vaccine coursesConsideration to Drug Substance manufacture (formulated vaccine bulk) and finished Drug Product (vialed vaccine doses) should be given. Alternative manufacturing platforms to those currently utilised, or process improvement activities to increase vaccine manufacturing yields, may also be proposed.
b. Production and release of finished Drug Product is currently foreseen as a key bottleneck. Based on current regulatory requirements, non-replicating viral vaccine vectors need to be filled in BSL-2 compliant manufacturing facilities. This limits the number of manufacturers (CMOs and pharmaceutical companies) that are able to offer their services for fill and finish of an Ebola vaccine. Proposals are sought to generate additional data to help provide the necessary scientific, technical and regulatory justifications to seek a reclassification of such vectors such that they require BSL-1 containment, thereby opening up the potential for more manufacturers to assist in responding to the current outbreak.
It is considered that an IMI2 JU financial contribution of 10-20 million and an EFPIA in-kind contribution of EUR 70-110 million would allow this specific challenge to be addressed appropriately. Nevertheless, this does not preclude submission and selection of proposals requesting other amounts.
Expected impact
The project will deliver a manufacturing platform to provide the capacity for producing the required number of vaccine doses in GMP quality. Getting this type of production capacity online will have impact more generally for European competitiveness in the area of biological production under appropriate biological safety level conditions.
Special informationSince the implementation of Phase I, II, and III clinical trials is linked to manufacturing capability, projects funded under Topics 1 and 2 of this Call are expected to work in collaboration to ensure maximal impact.
Cross-cutting Priorities:International cooperation
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Características del consorcio
:
La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
Please note that submitting proposals for this call can only be done through the IMI SOFIA software tool.
Please read carefully all provisions below before the preparation of your application.
List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation (EU) N° 622/2014 of 14 February 2014
Evaluation
For a guide to the submission and evaluation process including evaluation criteria and procedure, scoring and threshold: please see the IMI2 Manual for submission, evaluation and grant award.
See also the IMI2 RIA Proposal Template and IMI2 RIA Evaluation Form in section 6, below.
Proposal page limits and layout: Please refer to IMI2 RIA Proposal Template in section 6, below.
Indicative timetable for evaluation and grant agreement:
Information on the outcome of one-stage evaluation: maximum 2 months from the final date for submission.
Signature of grant agreements: maximum 1 month from the date of informing successful applicants.
Provisions, proposal templates and evaluation forms for... Please read the IMI2 2nd Call Topic Text for full details of this topic.
Please note that submitting proposals for this call can only be done through the IMI SOFIA software tool.
Please read carefully all provisions below before the preparation of your application.
List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation (EU) N° 622/2014 of 14 February 2014
Evaluation
For a guide to the submission and evaluation process including evaluation criteria and procedure, scoring and threshold: please see the IMI2 Manual for submission, evaluation and grant award.
See also the IMI2 RIA Proposal Template and IMI2 RIA Evaluation Form in section 6, below.
Proposal page limits and layout: Please refer to IMI2 RIA Proposal Template in section 6, below.
Indicative timetable for evaluation and grant agreement:
Information on the outcome of one-stage evaluation: maximum 2 months from the final date for submission.
Signature of grant agreements: maximum 1 month from the date of informing successful applicants.
Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Summary of the most relevant provisions for participating in IMI2 actions
IMI2 RIA Proposal Template
IMI2 RIA Evaluation Form
IMI2 Model Grant Agreement
Información adicional de la convocatoria
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