Clinical Trial Readiness through the Establishment of a Pilot Filovirus Investigational Vaccine Reserve

Who can apply:Organisations capable of supplying, storing, managing and rapidly deploying investigational vaccine doses under contract (economic operators/tenderers able to meet procurement and security requirements).

Deadline note:the published closing date is 2 September 2026. Early documents and invitation were published on 3 June 2026.

Application essentials:follow the tender specifications and submit required forms (Invitation to Tender, Declaration on Honour, Financial offer form, draft contract and annexes). See procurement documents for security, storage and rapid-deployment obligations 1.

Official link:Tender page

Tender type and contracting authority:This is a tender / procurement procedure managed by the Health and Digital Executive Agency (HaDEA), HaDEA - Health and Digital Executive Agency, acting as the Contracting Authority. The procedure type is a services procurement with estimated overall contract value €16,000,000 and planned duration 48 months.

Deadlines and publication data:initial publication date 3 June 2026. Two deadline timestamps are associated in the metadata: 1 January 2026 14:00:59Z (listed among Deadlines) and the formal closing date for submissions 2 September 2026 at 16:00:59 Europe/Brussels time (UTC+02:00). Submission method required is electronic submission via the EU Funding & Tenders Portal (eSubmission). The tender documents and templates were published on 3 June 2026 and include invitation letter, tender specifications, draft contract and annexes, declaration on honour and financial offer form among others.

Eligible applicant types:This is a public procurement for services. Typical eligible tenderers include commercial entities (pharmaceutical companies, vaccine developers, contract development and manufacturing organisations CDMOs), research organisations with operational manufacturing and regulatory capability, consortia of organisations capable of meeting the requirements, and other legal entities able to sign a direct service contract with the European Commission/HaDEA. The procurement metadata indicates SME suitability is false, so the tender is not limited to or specially targeted at SMEs.

Geographic eligibility and beneficiary scope:The procurement is EU-level and aims to establish an EU-based investigational vaccine reserve. Tenderers must be able to operate under EU contractual and regulatory frameworks and deliver services/stockpiles based in or accessible from the EU. Eligible participants are therefore expected to be established legal entities able to contract with HaDEA under EU law and to comply with security requirements and export/transfer rules if relevant.

Scope overview:the contractor will establish, pilot and maintain an investigational reserve of Filovirus candidate vaccines against SUDV, BDBV and/or MARV. Activities include but are not limited to procurement or provision of investigational doses, secure storage and inventory management, maintenance of product quality and cold chain, rapid release procedures for deployment under defined triggers, logistic arrangements for international deployment where needed, regulatory and quality documentation, and cooperation arrangements supporting embedding of doses into outbreak-associated clinical trials. The contractor must ensure ability for rapid deployment of investigational doses subject to outbreak occurrence and Contracting Authority consent.

Procedure details:The procurement is run as a tender with documents published on the Funding & Tenders Portal. Award criteria are quality weighted 80% and price weighted 20% as indicated in the lot awarding terms. Tender validity period indicated is six months. An open tender event is scheduled for 4 September 2026 at 10:00 (likely clarifications/contract opening). Additional information request period ends 25 August 2026. The procurement uses eSubmission and standard Funding & Tenders eForms and templates.

Award weighting:Quality 80 and Price 20. Tenderers should consult the detailed tender specifications for the full breakdown of quality sub-criteria and scoring mechanisms 1.

Estimated total procedure value and contract amount:€16,000,000 (estimated overall contract amount). The contract type is services; the draft direct service contract and draft annexes (security requirements) are published with the tender documents. The tender includes a financial offer form template (xlsx).

Application structure and templates:bidders will complete the eForms and attach the requested supporting documents. Tender specifications will indicate required technical dossiers, evidence of manufacturing and quality systems, storage and logistics capabilities, personnel qualifications, regulatory compliance records, insurance and security measures, and references for similar contracts. The financial offer form must present the proposed price and any cost breakdowns required by the tender specification. Bidders must sign the Declaration on honour and adhere to the draft contract terms.

Selection and exclusion:standard procurement selection criteria apply. Bidders must provide evidence of legal status, financial capacity, technical and professional capacity. The tendering terms reference specific tenderer qualification requests and selection criteria provided in the procurement documents (tender specifications and eForms). Security requirements are included for handling investigational biological material.

Target sectors:health, vaccines, infectious diseases, biotech/biopharma, clinical trial logistics, cold chain and pharmaceutical supply chain, regulatory affairs and quality assurance. Organisations with experience in investigational product manufacturing, storage and release for clinical trials, or in providing large-scale clinical trial supplies, are directly relevant.

Expected project stage:the procurement targets readiness and later-stage clinical development support. This includes validation and demonstration of capacity to hold investigational vaccines ready for rapid deployment into outbreak-associated clinical trials. The reserve supports advancing candidate vaccines into later-stage development during outbreaks, so projects must be able to work at development/clinical trial readiness and deployment stages.

Application type:open public tender via the EU Funding & Tenders Portal (eSubmission). Submission and evaluation is a procurement award process. Typical stages for this procurement are: submission (single-stage bid submission), administrative and eligibility check, selection (confirmation of capacity and absence of exclusions), evaluation of technical quality and price, potential clarification or interview stage, and award/contract signature. The tender documents schedule an open tender event on 4 September 2026 and an information request cut-off of 25 August 2026.

Number of application stages:Practically 1 major submission stage followed by evaluation and award actions (so applicants pass through a single submission stage and then up to two evaluation/clarification stages in the award process).

Success rates:the tender documentation does not publish historical success rates. As a competitive procurement with one large estimated contract and 80% quality weighting, success will depend heavily on technical compliance, quality and readiness rather than price alone. No explicit quota or multiple-award framework is indicated (single lot).

Co-funding requirement:the call is a direct service contract; there is no explicit co-funding requirement set out in the published metadata. The contractor will be remunerated under the contract terms; tenderers must propose prices via the financial offer form. Any requirements for performance guarantees, bank guarantees, or advance payments will be governed by the draft contract annexes in the procurement documents.

Focus on the quality criteria (80% weighting):prepare detailed technical proposals demonstrating capacity to procure, store and maintain investigational vaccine doses; GMP/GCP-compliant processes; cold chain and logistics; rapid release procedures and fast response deployment; regulatory and legal readiness for transfers and clinical trial integration; personnel qualifications and governance; risk management and security measures; and experience in similar contracts or large-scale clinical supply deployments. Complete the financial offer form accurately and ensure all mandatory declarations and templates are signed and uploaded. Consult the draft contract and security annex to verify contractual obligations before submission.

In short:the opportunity is a single-lot EU procurement to build clinical trial readiness for high-consequence Filoviruses by creating and maintaining a pilot reserve of investigational vaccine doses in the EU. It targets organisations able to manage investigational vaccine supply chains and compliance pathways, with evaluation focused on technical quality and capability, and award governed by the draft contract terms in the tender package 1.

Core Obligations:Tenderers must ensure the rapid deployment of investigational doses subject to outbreak occurrence and expressed consent from the Contracting Authority 1.