Speed up the access to and uptake of an Mpox vaccine

The objective of this call for tender is to strengthen the scientific evidence on the immune response provided by the Modified Vaccinia Ankara virus-Bavarian Nordic (MVA-BN) vaccine, with particular emphasis on the need and optimal timing of booster doses. Therefore, the purpose of this call for tenders is to purchase …

CPV: 73000000 Servicios de investigación y desarrollo y servicios de consultoría conexos, 73300000 Diseño y ejecución en materia de investigación y desarrollo
Plazo:
21 de abril de 2025 a las 16:00
Tipo de plazo:
Presentación de una oferta
Lugar de ejecución:
Speed up the access to and uptake of an Mpox vaccine
Organismo adjudicador:
Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Número de premio:
HADEA/2025/OP/0013

1. Buyer

1.1 Buyer

Official name : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Legal type of the buyer : EU institution, body or agency
Activity of the contracting authority : General public services

2. Procedure

2.1 Procedure

Title : Speed up the access to and uptake of an Mpox vaccine
Description : The objective of this call for tender is to strengthen the scientific evidence on the immune response provided by the Modified Vaccinia Ankara virus-Bavarian Nordic (MVA-BN) vaccine, with particular emphasis on the need and optimal timing of booster doses. Therefore, the purpose of this call for tenders is to purchase clinical services for clinical research and/or other equivalent scientific activities to evaluate and compare the immunogenicity of a booster dose of MVA-BN vaccine considering different routes of administration, namely intradermal and subcutaneous injection, and the appropriate timing of the booster dose. The activities under this call are expected to include a Phase II and/or Phase III clinical trial(s). The results of the clinical trial(s) should be able to contribute to the development and refinement of vaccination strategies to be adopted by public health authorities, as well as, provide further evidence for the European Commission and EU Member States to consider when developing relevant policies, e.g. on stockpiling initiatives, and/or the feasibility of dose-sparing strategies for Mpox vaccination during shortages
Procedure identifier : 6f497612-8ee1-4d01-83c4-5341cb1c9aeb
Internal identifier : HADEA/2025/OP/0013
Type of procedure : Open
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services

2.1.3 Value

Estimated value excluding VAT : 4 900 000 Euro

2.1.4 General information

Additional information : In case of unavailability or disruptions in the functioning of the electronic means of communication provided in Section 5.1.11 in the last 5 calendar days before the time limit for receipt indicated in Section 5.1.12, the contracting authority reserves the right to extend this time limit and publish the extension at the Internet address provided in Section 5.1.11, without a preceding publication of a corrigendum to this notice. Economic operators interested in this procurement are invited to subscribe to the call for tenders at the address in Section 5.1.11 in order to get notified when new information or documents are published.
Legal basis :
Regulation (EU, Euratom) 2018/1046

2.1.6 Grounds for exclusion

Bankruptcy : For the full list of exclusion grounds please consult the procurement documents.

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Speed up the access to and uptake of an Mpox vaccine
Description : The objective of this call for tender is to strengthen the scientific evidence on the immune response provided by the Modified Vaccinia Ankara virus-Bavarian Nordic (MVA-BN) vaccine, with particular emphasis on the need and optimal timing of booster doses. Therefore, the purpose of this call for tenders is to purchase clinical services for clinical research and/or other equivalent scientific activities to evaluate and compare the immunogenicity of a booster dose of MVA-BN vaccine considering different routes of administration, namely intradermal and subcutaneous injection, and the appropriate timing of the booster dose. The activities under this call are expected to include a Phase II and/or Phase III clinical trial(s). The results of the clinical trial(s) should be able to contribute to the development and refinement of vaccination strategies to be adopted by public health authorities, as well as, provide further evidence for the European Commission and EU Member States to consider when developing relevant policies, e.g. on stockpiling initiatives, and/or the feasibility of dose-sparing strategies for Mpox vaccination during shortages
Internal identifier : HADEA/2025/OP/0013

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73300000 Design and execution of research and development

5.1.3 Estimated duration

Duration : 36 Month

5.1.5 Value

Estimated value excluding VAT : 4 900 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : EU4Health Programme (2021/2027)
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 109791-2025

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 80
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 20
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 21/04/2025 16:00 +02:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 22/04/2025 11:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

8. Organisations

8.1 ORG-0001

Official name : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Registration number : HADEA
Department : HADEA - Directorate of HaDEA,HADEA.A - Health and Food,HADEA.A.2 - EU4Health/SMP Food
Postal address : COV2, Place Charles Rogier 16
Town : Brussels
Postcode : B-1210
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Internet address : https://hadea.ec.europa.eu
Roles of this organisation :
Buyer

8.1 ORG-0002

Official name : Court of Justice of the European Union
Registration number : CURIA
Postal address : Rue du Fort Niedergrünewald
Town : Luxembourg
Postcode : L-2925
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 4303-1
Internet address : http://curia.europa.eu
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : European Commission
Registration number : EUCOM
Postal address : Mondrian (CDMA), Rue du Champ de Mars 21
Town : Brussels
Postcode : B-1050
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Roles of this organisation :
TED eSender
Notice information
Notice identifier/version : 127377ec-a4a5-4362-b95c-3fe58d0bfee6 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 12/03/2025 09:20 +01:00
Languages in which this notice is officially available : English
Notice publication number : 00163055-2025
OJ S issue number : 51/2025
Publication date : 13/03/2025