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CEPI объявляет конкурс на разработку вакцин против нового коронавируса

 

CEPI has opened a call for proposals to rapidly develop and manufacture a proven vaccine approach that can be used against novel coronavirus, 2019-nCoV.

The rapid global spread and unique epidemiological characteristics of 2019-nCoV virus is deeply concerning.

In coordination with WHO, as it leads the development of a coordinated international response, CEPI is promoting the development of new vaccines against the emerging threat of 2019-nCoV virus.

The objective of this Call for Proposals is to rapidly develop and manufacture a proven vaccine approach that can be used against the 2019-nCoV. This call aims to complement CEPI’s 2019-nCoV portfolio and candidates should have large-scale manufacturing capabilities for 2019-nCoV. The organization must be willing to transfer their vaccine technology to a global network of large-scale manufacturing.

The suggested vaccine-technology performance will be considered towards the following guidelines:

        Speed from sequence of pathogen availability to clinical-trial testing

        Number of doses needed – to gain clinical benefit

        Scale of manufacturing

        In the current situation CEPI will be aiming for a capacity of production of millions of doses

Supporting the development of vaccines that can prevent or stop an outbreak is a key part of CEPI’s mission. An equally critical part of the mission is to ensure that the vaccine is available and equally accessible to those who need them. Thus, in addition to the criteria of speed and versatility the vaccine technology must be able to be delivered to individuals easily in an outbreak setting and to be at a cost of goods that does not preclude broad access.

Eligibility Criteria

        The funding opportunity through this 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 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 10 years.

        The applicant should also have a manufacturer with a track record of vaccine production identified within the consortium.

        To be eligible to submit a proposal the applicant should:

        Hold a vaccine technology that has already been proven

        Licensed product based on the same technology or

        Relevant data from clinical trials of a vaccine candidate based on the same technology

        Propose only one 2019-nCoV vaccine candidate per application

        Include plans and costs for preclinical studies (toxicology / PoC / challenge / immunotoxicology)

        Include plans and costs to conduct Phase I studies

        Include parallel plans and costs to generate GMP grade material for Phase II

        Indicate final scale-up and include plans, costs, and timelines to generate final manufacturing scale material

        Propose how you would accelerate the pathway to licensure of your vaccine candidate

        Have the capacity to start vaccine manufacturing in at short notice

        Be an organization that must be willing to transfer their vaccine technology to a global network of large-scale manufacturers and ideally has its own large-scale manufacturing capabilities.

Deadline: 14 February 2020 For more information, visithttps://cepi.net/news_cepi/cepi-launches-new-call-for-proposals-to-develop-vaccines-against-novel-coronavirus-2019-ncov/