Biomarkers for Enhanced Vaccine ImmunoSafety (BioVacSafe)

At a Glance
  • Status: Active Consortium
  • Year Launched: 2012
  • Initiating Organization: Innovative Medicines Initiative
  • Initiator Type: Government
  • No disease focus
  • Location: Europe


The five-year Biomarkers for Enhanced Vaccine ImmunoSafety (BioVacSafe) consortium is an Innovative Medicines Initiative (IMI) effort to improve and accelerate the testing and monitoring of vaccine safety. The consortium aims to accelerate the development of next-generation vaccines by providing tools to assess their safety and efficacy.


BioVacSafe’s goal is to improve the tools to assess the safety testing and monitoring of vaccines that are still being developed, as well as after approval and release into the market. By bringing together the various consortium members, BioVacSafe aims to improve vaccine development through the development of several tools. Its three specific objectives are as follows:

Consortium History

2012: The five-year BioVacSafe project officially started.
2013: BioVacSafe began clinical trials and began to analyze samples to measure inflammatory biomarkers. The project also initiated preclinical studies to define immune activation and inflammatory biomarkers in response to vaccination and infection. Results were expected at the BioVacSafe annual meeting in March 2014.

Structure & Governance

Governance and scientific oversight are provided by a three-tiered structure composed of a Consortium Assembly, External Advisory Board, and Steering Committee. Project management and administration are provided by the project coordinator and the European Federation of Pharmaceutical Industries and Associations (EFPIA) coordinator, the coordination team, and work package co-leaders. Each of the nine work package co-leaders oversees his/her work package, and its members execute project implementation.


The budget for the five-year project is €30.2 million (US$41.1 million). IMI contributed €17.4 million, EFPIA made in-kind contributions of €7.6 million, and other contributions accounted for an additional €5.2 million.

Intellectual Property

All IMI consortia, such as BioVacSafe, operate under the same umbrella intellectual property (IP) policy. Any IP discovered as a result of work in the collaboration is owned by the participating institution that made the discovery (or if the discovery was made jointly, there is joint ownership). Other participants have access rights to the generated IP during and after the project for research use, and participant owners have the right to license their IP and associated obligations to other parties, including to affiliated entities. Third parties may request access rights, which do not involve the ability to sublicense without receiving authorization from the IP-owning participant.

Data Sharing

In keeping with IMI policy, the BioVacSafe project has up to one year after conclusion of the project to disseminate IP and/or data created during the project.

Points of Contact

Project Coordinator & Managing Entity of EU funds
David Lewis
University of Surrey
phone.: +44 1483 689797

Sponsors & Partners

CDISC European Foundation

Chalmers University of Technology

Charité  Universitätsmedizin Berlin

Commissariat  à  l'énergie  atomique  et  aux  énergies  alternatives


GlaxoSmithKline Biologicals

Göteborgs universitet

Health Protection Agency, London


Imperial College London of Science, Technology and Medicine

Liverpool School of Tropical Medicine

Max-Planck-Gesellschaft zur Förderung der Wissenschaften

Novartis Vaccines and Diagnostics

Sanofi Pasteur

Statens Serum Institut

Università  degli  Studi  di  Siena

Universiteit Gent

Universiteit Utrecht

University of Surrey

Last Updated: 04/22/2016

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