Periodic Reporting for period 1 - TRANSVAC-DS (DESIGN STUDY FOR A EUROPEAN VACCINE INFRASTRUCTURE) Reporting period: 2020-06-01 to 2021-11-30 Summary of the context and overall objectives of the project The EC-funded projects TRANSVAC1 and TRANSVAC2 formed the basis of a trans-European vaccine infrastructure, offering qualified candidates a range of services across the various stages of the vaccine development pipeline. The TRANSVAC-DS project seeks to solidify the successes of these efforts by transitioning the TRANSVAC initiatives into self-sustaining model.This transition relies upon the experience gained during the course of the previous TRANSVAC projects. The TRANSVAC-DS partners will work together to provide state-of-the-art services for vaccine developers and training courses in highly-demanded vaccinology subjects through a sustainable business model. A wide range of technologies and proficiencies are required to develop a novel vaccine, posing a significant barrier to small- and mid-size enterprise (SME) biotechnology/pharmaceutical companies and academic groups. These users are expected to be major beneficiaries of the final consortium. Additionally, society at-large will be provided a robust European vaccine development network and access to additional vaccines to address existing gaps and deficiencies in the human and veterinary prophylactic/therapeutic vaccine arsenal and to better prepare for emerging diseases. The TRANSVAC-DS project will provide a report detailing the conceptual design of the permanent vaccine infrastructure. This includes a five-year business plan and implementation plan. Together, these documents will provide a framework under which partners will join to establish the final sustainable European vaccine infrastructure. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Significant progress was made towards establishing the framework for a self-sustaining TRANSVAC infrastructure during the first reporting period. The highlights of the completed work are summarized below.o The project kick-off and first annual meetings were successfully held to introduce members of the project, coordinate strategies, and update all parties on the project statuses. o Ethical guidelines for the project were written, a communication policy established, and a website created as a hub for sharing of materials within the consortium and dissemination with outside groups. o A gaps and needs analysis was performed through extensive background research, surveys, focus group meetings, and interviews with experts to identify market sectors favorable towards the new entity. o Potential stakeholders were identified and contacted to provide feedback and a basis of support for the initiative. The results of the ground-laying works efforts were compiled in a manuscript for publication. The findings informed the comparison of potential business models for the permanent infrastructure, resulting in the choice of a combination of bio-holding/contract development partnership. This business model was then elaborated on with a planned governance structure, and the drafting of a business plan and financing plan was begun. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) In the proceeding reporting periods, the TRANSVAC-DS consortium will continue preparations for a permanent European infrastructure. The choice of a combination bio-holding/contract development partnership is expected to ensure that the infrastructure is not just a provider of research services but of expertise and scientific/business guidance for users, and that the consortium is invested in the final outcome and impact of the vaccines. The gaps/needs analysis ensures that the initiative will target real needs of users and the broader marketplace.The ongoing COVID-19 pandemic has created unforeseen obstacles due to a combination of the demands of new fast-tracked COVID-19-associated projects planning and the disruption of planned meetings. A 6-month extension to the project will be requested to ensure completion of all stated aims. These include the final business and implementation plans, a dissemination/exploitation plan, a finalized stakeholder registry, and socio-economic impact report. These efforts will be informed by the extensive background research and planning conducted in the first periodic report and will ensure that the final infrastructure is aligned with the goals of partners, other stakeholder organizations, and society at-large. Additionally, discussions are underway regarding the precise legal nature of the final consortium, including country and format of incorporation. These discussions have produced positive initial feedback and it is expected that this process, combined with the previously mentioned reports, will result in a legal framework which partners can join to ensure the provision of high-quality, self-sustained services and training for vaccine development into the future.