Multiple Sourcing Framework Contracts to Speed up the Development of and Access to Innovative Medical Countermeasures: Next-Generation Influenza Vaccines

The Health and Digital Executive Agency (HaDEA) is initiating a call for tenders focused on the development of next-generation influenza vaccines. This procurement opportunity, identified with the procedure number HADEA/2025/CPN/0008-PIN, aims to establish multiple sourcing framework contracts to enhance the accessibility and development of innovative medical countermeasures. The estimated total budget for this call is approximately EUR 147,951,410, indicating a significant investment in this initiative.

Eligible applicants include organizations capable of conducting research and development in vaccine innovation, such as larger biotech and pharmaceutical companies. The tender specifically indicates that small and medium-sized enterprises (SMEs) are not suitable, implying a preference for larger entities with the necessary resources.

The funding mechanism for this opportunity is a procurement framework under the Pre-Commercial Procurement model, which allows for the purchase of research and development services from selected tenderers. The project stages will incorporate competitive phases, focusing on research, development, and validation of vaccines beyond the initial research phase but not yet reaching commercialization.

The target sectors for this tender include healthcare, specifically biotech and medtech, with an emphasis on developing vaccines that utilize novel administration methods and scalable manufacturing platforms. Desired qualities of the vaccines include the ability to confer mucosal immunity, adaptability to emerging pandemic threats, and low reliance on adjuvants for immunogenicity.

The call for tenders is open for submissions, with the estimated publication date of the contract notice set for April 7, 2025. Organizations involved in vaccine research and development are encouraged to apply, and feedback from stakeholders was gathered through a public consultation prior to this announcement.

This initiative responds to the pressing need for innovative influenza vaccines that can be rapidly produced and effectively protect against various influenza strains. The framework contract model is designed to facilitate multiple contracts, permitting flexibility in sourcing solutions from engaged entities while encouraging collaboration in advancing vaccine technology.

The Health and Digital Executive Agency (HaDEA) is launching a planned call for tenders with procedure identifier HADEA/2025/CPN/0008-PIN for multiple sourcing framework contracts to speed up the development of and access to innovative medical countermeasures, specifically next-generation influenza vaccines. This is an open for submission procedure.

The call for tenders aims to accelerate the development of next-generation influenza vaccines. These vaccines should be producible in rapidly scalable manufacturing platforms, such as nucleic acid approaches, eukaryotic or bacterial cell culture, plants, or in vitro transcription. The desired vaccines should also support novel administration routes like nasal, oral, or microneedle patches, confer mucosal immunity, target potentially pandemic influenza A viruses, be rapidly adaptable to pandemic influenza A viruses, be protective across influenza subtypes or alpha-influenza viruses, and/or possess intrinsic immunogenicity without adjuvants. The call will be implemented via a competitive development in phases as foreseen under Pre-Commercial Procurement (PCP).

The estimated total value of the call is 147,951,410 EUR. The contract is a framework agreement, partly without reopening and partly with reopening of competition. The TED publication date was 06/02/2025, and the estimated date of publication of a contract notice is 07/04/2025, linked to contract notice HADEA/2025/CPN/0008. The lead contracting authority is the Health and Digital Executive Agency (HaDEA). The main classification (CPV) code is 73000000, which refers to research and development services and related consultancy services. The nature of the contract is for services.

A public consultation was launched to gather feedback from stakeholders. The deadline for the public consultation was extended until 10 March 2025, 23:00 CET. The survey is available at https://ec.europa.eu/eusurvey/runner/Next_Generation_Influenza_Vaccine_Development. The survey has officially closed as of 12/03/2025 16:13.

The contracting authority envisages signing at least 3 framework contracts, each with the same ceiling mentioned in the PIN.

Requirements for applying to the call for tenders are available at the recently published call for tender link: https://ec.europa.eu/info/funding-tenders/opportunities/portal/scr.

CMC activities linked to the manufacturing of vaccine products should be included in the budget proposals for such tender.

The planned call for tenders announces the intention of the contracting authority to publish a future call for tenders. No other information or documents other than those published here are available.

In summary, this opportunity is a pre-commercial procurement (PCP) call for tenders by the Health and Digital Executive Agency (HaDEA) to develop next-generation influenza vaccines. The goal is to fund research and development that leads to innovative vaccine technologies, manufacturing platforms, and administration methods for better protection against pandemic influenza. The call encourages solutions that offer broad protection, rapid scalability, and enhanced immunogenicity. The total estimated budget is substantial, and the initiative involves a phased, competitive development process. The call aims to establish multiple framework contracts with selected entities to drive innovation in influenza vaccine development.

Eligible Applicant Types: The eligible applicant types are not explicitly stated, but given the nature of the call for tenders, it is likely that eligible applicants include entities capable of conducting research and development in the field of vaccine development. This could include research institutes, universities, biotech companies (SMEs and large enterprises), and other organizations with relevant expertise.

Funding Type: The primary financial mechanism is a procurement, specifically a Pre-Commercial Procurement (PCP) framework contract. This implies a service contract where the procurer (HaDEA) buys R&D services from tenderers.

Consortium Requirement: The information does not explicitly state whether a single applicant or a consortium is required. However, given the complexity and scale of vaccine development, consortia are likely to be competitive, although single applicants with sufficient capacity might also be eligible. The framework agreement is a multiple sourcing framework contract.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility is not explicitly mentioned, but since it is an EU call for tenders, it is highly likely that entities from EU member states and possibly associated countries are eligible. The specific eligibility criteria will be detailed in the official call documentation.

Target Sector: The target sector is health, specifically vaccine development, biotech/medtech, and research and development services.

Mentioned Countries: No specific countries are mentioned. The opportunity is at the EU level.

Project Stage: The project stage is focused on development, specifically speeding up the development of next-generation influenza vaccines. The call will be implemented via a competitive development in phases as foreseen under Pre-Commercial Procurement. It appears to target projects that are beyond the initial research phase but not yet at the commercialization stage. The scope includes activities from early-stage development through clinical trials (Phase 1, 2, and 3).

Funding Amount: The estimated total value of the call for tenders is 147,951,410 EUR. The ceiling mentioned in the PIN corresponds to the ceiling of each Framework Contract (FWC) that will be signed. The contracting authority envisages signing at least 3 FWCs, each with the same ceiling.

Application Type: The application type is a planned call for tenders with OJ S publication. This indicates a formal tendering process following EU procurement rules.

Nature of Support: The beneficiaries will receive money in exchange for research and development services related to the development of next-generation influenza vaccines.

Application Stages: The call will be implemented via a competitive development in phases as foreseen under Pre-Commercial Procurement. This suggests multiple stages, likely involving proposal submission, evaluation, contract negotiation, and phased execution of the R&D activities.

Success Rates: The success rates are not mentioned in the provided text. However, given that the contracting authority envisages signing at least 3 framework contracts, the success rate is likely to be higher than if only one contract was to be awarded.

Co-funding Requirement: The information does not explicitly state whether co-funding is required. This detail will likely be specified in the official call documentation.

Summary:

This is a planned call for tenders by the Health and Digital Executive Agency (HaDEA) to accelerate the development of next-generation influenza vaccines. The call, titled "Multiple Sourcing Framework Contracts to Speed up the Development of and Access to Innovative Medical Countermeasures: Next-Generation Influenza Vaccines," aims to foster the creation of vaccines that are rapidly scalable, utilize novel administration routes, confer mucosal immunity, target potentially pandemic influenza A viruses, are protective across influenza subtypes, and/or possess intrinsic immunogenicity without adjuvants. The call will be implemented through a Pre-Commercial Procurement (PCP) approach, involving competitive development in phases. The estimated total value of the call is 147,951,410 EUR, and the contracting authority plans to sign at least three framework contracts. The tender is open for submission, and the estimated date of publication of a contract notice is April 7, 2025. The call targets organizations involved in vaccine research and development, including research institutes, universities, and biotech companies. The initiative also involves a public consultation to gather feedback from stakeholders, which closed on March 12, 2025, after an extension. The call seeks to address the need for innovative influenza vaccines that can be rapidly adapted to emerging pandemic threats and offer improved protection compared to existing vaccines. The tender documents, including the specific requirements for applying, are available at the recently published call for tender link: https://ec.europa.eu/info/funding-tenders/opportunities/portal/scr.... The call encourages the inclusion of CMC (Chemistry, Manufacturing, and Controls) activities linked to the manufacturing of vaccine products in the budget proposals. The contracting authority envisages signing at least 3 framework contracts, each of them with the same ceiling.