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

This tender (HADEA/2026/OP/0019) by the Health and Digital Executive Agency (HaDEA) seeks to establish, pilot and maintain an EU-based investigational vaccine reserve targeting Ebola Sudan (SUDV), Ebola Bundibugyo (BDBV) and Marburg (MARV) to enable rapid deployment into outbreak-associated clinical trials. Indicative contract value is €16,000,000 with an indicative duration of 48 months and electronic submission via the EU Funding & Tenders Portal by 2 September 2026 at 16:00:59 Brussels time. The contract requires GMP/GCP-compliant supply, secure storage and inventory management, rapid release and logistics for conditional deployment, and regulatory and security compliance to support embedding doses in Phase 2+ outbreak trials. Eligible tenderers include pharmaceutical companies, biotech firms, CDMOs or consortia with demonstrated manufacturing, quality, cold-chain and regulatory capacity.

What it funds

Scope summary

Establishment, piloting and maintenance of an EU-based investigational reserve of candidate vaccines for filoviruses (Ebola Sudan SUDV, Ebola Bundibugyo BDBV and/or Marburg MARV) to enable rapid deployment into outbreak-associated clinical trials and support later-stage development.

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).

1. 1Key tasks: establish stock reserve, pilot its use, maintain supply and logistics, ensure rapid conditional deployment, and support legal/international frameworks for outbreak use.
2. 2Procurement type: direct service contract (tender) managed by HaDEA (Health and Digital Executive Agency).
3. 3Selection/award: quality weighted heavily (80 quality 20 price) — see procurement documents.

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

Footnotes

1. 1Procurement documents published 3 June 2026 include: 1. Invitation to Tender, 2. Draft direct service contract and annexes, 3. Tender specifications Filoviridae viruses, 4. Declaration on Honour, 5. Financial offer form. Access via the tender page above.

Opportunity summary

What the tender is for

This is a public procurement tender (Call identifier HADEA/2026/OP/0019) launched by the Health and Digital Executive Agency (HaDEA) to establish, pilot and maintain an EU-based investigational vaccine reserve for Filoviruses. The reserve will cover candidate vaccines for Ebola Sudan (SUDV), Ebola Bundibugyo (BDBV) and/or Marburg virus (MARV). The purpose is to ensure clinical trial preparedness for future Filovirus outbreaks by allowing rapid deployment of investigational doses to embed into outbreak-associated clinical trials and thereby accelerate later-stage development of candidate vaccines. Deployment of investigational doses will be subject to specific conditions such as occurrence of an outbreak and the expressed consent of the Contracting Authority.

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.

Key administrative facts

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.

1. 1Call identifier: HADEA/2026/OP/0019
2. 2Publication date: 3 June 2026
3. 3Submission deadline (closing date): 2 September 2026, 16:00:59 Europe/Brussels
4. 4Submission method: eSubmission via Funding & Tenders Portal
5. 5Estimated overall contract value: €16,000,000
6. 6Planned contract duration: 48 months (planned period)
7. 7Lot structure: single lot (LOT-0001) for the described services

Eligibility and applicant profile

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.

What the contract requires (technical and operational scope)

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.

1. 1Establish and pilot an EU-based investigational vaccine stock/reserve for SUDV, BDBV and/or MARV candidate vaccines
2. 2Maintain reserve with appropriate storage, quality control, labeling and documentation
3. 3Ensure legal, regulatory and security compliance for investigational vaccine holding and transfer
4. 4Enable rapid release and logistic deployment mechanisms contingent on outbreak triggers and Contracting Authority instructions
5. 5Coordinate with international agreements and frameworks to facilitate use of investigational doses in outbreak-associated clinical trials
6. 6Provide reporting, traceability and audit transparency to the Contracting Authority

Procurement, evaluation and award

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.

Financial and contractual details

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 process and required documents

Submission is electronic via the Funding & Tenders Portal eSubmission/Forms tool. Tenderers must use the published templates and complete the required forms. A number of tender documents are explicitly published and must be used to prepare the bid package.

1. 11. Invitation to Tender (document 1) — central call text and instructions
2. 22. Draft direct service contract (document 2) — contains contractual terms and obligations
3. 33. Appendix 1 Security requirements - Direct Service Contract (document 2a) — specific security rules for handling sensitive materials and information
4. 44. Tender specifications Filoviridae viruses (document 3) — detailed technical/operational specifications, deliverables, timetables and quality criteria
5. 55. Declaration on honour (tender) (document 4) — mandatory compliance declaration template
6. 66. Financial offer form (document 5, xlsx) — price and cost proposal template

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.

Eligibility, selection and award criteria details

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.

Who should apply and target sectors

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.

1. 1Pharmaceutical and vaccine manufacturers (including CDMOs)
2. 2Clinical supply and logistics providers with GMP-compliant storage and release capability
3. 3Biomedical organisations and research institutes with regulatory and clinical trial supply expertise
4. 4Public-private consortia able to meet security, legal and logistic requirements

Project maturity and expectations

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 rounds, stages and success rates

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, financial obligations and payments

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.

Security, regulatory and legal considerations

The tender includes an Appendix 1 Security requirements annex to the draft contract. Handling, storage, transfer and deployment of investigational biological materials raise regulatory, biosafety and legal obligations. Bidders must demonstrate compliance with applicable EU and national regulations for investigational medicinal products, GMP storage and distribution, import/export controls and any relevant public health emergency mechanisms. The contractor must also be able to cooperate with international frameworks that facilitate the use of investigational doses in outbreak trials.

Mentioned countries and geographic scope in documents

The tender text is EU-focused and does not list specific beneficiary countries beyond the EU-level scope. The reserve is to be EU-based and managed under EU contractual frameworks. Therefore the primary geographic scope is the European Union and entities able to contract under EU law. No third countries are explicitly specified in the published summary.

How to prepare a competitive bid

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.

1. 1Read the Invitation to Tender and Tender Specifications in full
2. 2Review the Draft Direct Service Contract and Appendix 1 Security requirements
3. 3Prepare technical dossier demonstrating capacity and compliance (GMP, regulatory, QA/QC, logistics)
4. 4Complete Declaration on Honour and Financial Offer form
5. 5Submit bid via eSubmission by 2 September 2026, 16:00:59 Europe/Brussels

Templates and application forms (structure)

Published templates and forms (available in the procurement package) that must be completed or referenced in the submission include: Invitation to Tender (guidance and requirements), Tender Specifications (technical and operational requirements, deliverables and evaluation criteria), Draft Direct Service Contract (full contract terms), Appendix 1 Security requirements (security handling and personnel rules), Declaration on Honour (compliance and exclusion declarations), Financial Offer Form (xlsx) with required cost breakdown. The tender specifications will also specify the eForm sections to be completed in the Funding & Tenders Portal.

1. 1Declaration on honour: legal and exclusion declarations to be signed by the legal representative
2. 2Financial offer form: structured excel workbook to report price, cost categories, and any unit prices requested
3. 3Technical offer: narrative and evidence structured according to the quality sub-criteria in the tender specifications (e.g., technical capacity, logistics, quality management, staffing, past performance)
4. 4Supporting attachments: certificates, references, GMP licenses, CVs, audit reports, insurance certificates, regulatory approvals or correspondence, and any security clearances required

Risks, constraints and important considerations

Key constraints include legal/regulatory complexity for investigational vaccine handling, international transfer rules during outbreaks, potential export restrictions, biosecurity and storage requirements, sensitivity of investigational material, and contractual obligations under the draft direct service contract. Tenderers should carefully review the security annex and ensure they can meet rapid deployment conditions and the Contracting Authority's consent procedures. The tender is not marked as SME targeted and requires robust organizational capability.

Mentioned timelines and events

Success rates and selection probability

The procurement notice and documents do not provide historical success rates. As a single large-value service contract with quality heavily weighted, selection will be competitive and determined primarily by compliance with technical/quality criteria and the robustness of the operational plan rather than price alone.

Final summary and recommendation

This tender seeks a contractor to establish and maintain an EU-based investigational vaccine reserve for Filoviruses (SUDV, BDBV and/or MARV) to enable rapid deployment of investigational doses into outbreak-associated clinical trials. It is a procurement contract valued at an estimated €16,000,000 over a 48-month period, managed by HaDEA. The call prioritises technical quality (80% weighting) and requires robust experience in vaccine supply, GMP/GCP compliance, cold-chain logistics, regulatory readiness and security. Submissions must be made electronically via the Funding & Tenders Portal by 2 September 2026 and must use the published templates including the invitation to tender, tender specifications, draft contract and financial offer form. Tenderers should thoroughly review the draft contract and security annex, prepare detailed quality documentation and ensure they can fulfil rapid deployment and international coordination obligations.

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.

Footnotes

1. 1Tenderers must consult the full procurement documents published on the Funding & Tenders Portal for the complete award criteria, quality sub-criteria, contractual clauses and security requirements: Clinical Trial Readiness through the Establishment of a Pilot Filovirus Investigational Vaccine Reserve (HADEA/2026/OP/0019) available via the EU Funding & Tenders Portal Funding & Tenders Portal - opportunity details.

Opportunity Overview

This is an EU4Health call for tenders (HADEA/2026/OP/0019) aimed at ensuring clinical trial preparedness for Filovirus outbreaks by establishing an EU-based reserve of investigational vaccines against Ebola Sudan (SUDV), Ebola Bundibugyo (BDBV), and Marburg (MARV) ¹.

The primary objective is to establish, pilot, and maintain a reserve of candidate vaccines that can be rapidly deployed in outbreak-associated clinical trials to advance their development, as no authorized vaccines currently exist for these specific pathogens ².

Key Details

Who Should Apply

Tenderers must be capable entities with the technical and operational capacity to establish, pilot, and maintain an investigational vaccine reserve and ensure rapid deployment under specific outbreak conditions ¹.

Potential applicants include pharmaceutical companies, biotech firms, and specialized vaccine manufacturers with experience in filovirus vaccine development and clinical trial dose production ³.

Eligibility and Requirements

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

1. 1Establish and maintain a reserve of investigational vaccines for SUDV, BDBV, and/or MARV
2. 2Embed vaccines in outbreak-associated clinical trials to advance development (Phase 2 onwards)
3. 3Facilitate international agreements and frameworks for outbreak preparedness
4. 4Ensure compliance with security requirements as detailed in Appendix 1 of the draft contract ¹

Strategic Context

This action supports the policy priority to enhance the availability and accessibility of medical countermeasures and critical medicines, enhancing preparedness for future health emergencies in synergy with Horizon Europe ¹.

It implements the EU4Health Programme’s general objective of improving the availability, accessibility, and affordability of medicinal products and crisis-relevant products ².

Application Process

Interested parties must consult the EU Funding and Tenders Portal for the publication of the contract notice and tender documents, including the Invitation to Tender, Tender Specifications, and Draft Contract ¹.

Tenders must be submitted electronically via the EU Funding and Tenders Portal before the deadline of September 2, 2026 ².

Footnotes

1. 1Official call details: HaDEA Call for Tenders
2. 2Prior Information Notice: HaDEA PIN HADEA/2026/OP/0019
3. 3BARDA investment context for filovirus vaccines: Developing Vaccines to Improve Preparedness for Filovirus Outbreaks