Biomarkers for Enhanced Vaccine Immunosafety
Unbiased biomarkers for the prediction of respiratory disease outcomes


Start Date
End Date
IMI1 - Call 3
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
17 408 770
EFPIA in kind
7 999 683
5 522 917
Total Cost
30 931 370


Since their discovery, vaccines have protected millions of people worldwide from a broad range of infectious diseases, making them one of the most effective public health interventions out. New and better vaccines are still urgently needed, yet their introduction is hampered by lengthy and expensive vaccine safety testing procedures. The aim of the IMI-funded BIOVACSAFE project is to develop cutting edge tools to speed up and improve the testing and monitoring of vaccine safety, both before and after release to the market. By bringing together Europe’s top industrial and academic teams for the first time, the project will ultimately usher in a new generation of safer, more effective vaccines.

Vaccines are widely acknowledged to be one of the cheapest and most efficient ways to combat infectious diseases in both developed and developing countries. With billions of doses of vaccines administered globally every year, vaccine safety is a top priority for pharmaceutical companies, regulators and the public alike. The problem is that testing and monitoring new vaccines for safety is a slow, cumbersome, and extremely expensive process; the development of a new vaccine costs millions of euros, and less than 1 vaccine in 10 makes it through clinical testing.

As companies add new components to vaccines to make them more effective, testing them for safety becomes even more challenging. And, while severe adverse reactions to vaccines are rare, predicting who is at risk of a severe reaction is extremely difficult; this problem will be further complicated by the ageing of the population and the growing burden of chronic conditions and diseases of the immune system.

A new approach to vaccine safety

The BIOVACSAFE project will draw on the latest life science research findings to profile, in great detail, how individuals respond to the different components of vaccines at the cellular, genetic and molecular level. This will allow the project team to develop tools that can rapidly and accurately identify warning signs that a potential vaccine may be reactogenic. The tools could be employed early on in vaccine development, before vast amounts of time and money have been spent. Meanwhile, the team will develop new ways to identify, classify and record adverse reactions to vaccines; this should also boost researchers’ ability to pick up on problems early in vaccine development. Finally, the team will probe how natural illnesses and infections, particularly diseases of the immune system, interact with vaccines. By identifying these interactions, the team hopes to find ways of preventing them occurring in the first place. Finally, the team will create databases that can be used to store information on and explore reactions to vaccines.

Towards the next generation of vaccines

By coming up with novel ways to identify and better understand the causes of adverse reactions to vaccines at all stages of development, BIOVACSAFE will accelerate the development and introduction of a new generation of safer, more effective vaccines to combat infectious diseases, cancer and chronic diseases. As well as speeding up vaccine development, the new, more accurate tools developed by BIOVACSAFE should help to boost public confidence in vaccine safety. Furthermore, because the project includes studies of populations in both developed and developing countries, its findings should be of global relevance.

An injection of health for Europe’s vaccine development sector

BIOVACSAFE brings together for the first time three of Europe’s leading vaccine development and manufacture companies as well as top experts from academic institutions and small and medium-sized enterprises (SMEs). By sharing their expertise as well as access to data and patient groups, all project partners will see their knowledge base and their competitiveness grow. Crucially, by pooling their expertise, the BIOVACSAFE partners have a unique opportunity to make progress in this important area.

Achievements & News

BIOVACSAFE clinical studies get underway
April 2013

The vaccine safety project BIOVACSAFE has started a series of clinical studies that will pave the way for novel tests to predict the safety of new vaccines.### Vaccine safety is of paramount importance; and although vaccines are widely recognised as one of the most effective public health interventions available, concerns about vaccine safety may lead some people to hesitate about having themselves and/or their children vaccinated. Vaccines are thought to work by triggering a mild and localised inflammatory response that will create the appropriate environment to establish immunity against the disease in question. However, excessive inflammation can result in serious complications. Currently, it is hard to predict when severe inflammation will occur, and this has led to some vaccines being withdrawn from the market. In BIOVACSAFE, researchers are using licensed vaccines to identify biological markers (biomarkers) that can predict beneficial and harmful responses to a vaccine. One study that is currently underway is a 'training' study, in which the licensed hepatitis B vaccine, Engerix B, is being evaluated. This vaccine was selected because it is a good representative of a particular class of vaccines and is used in a particular target group. In this study, participants receive two immunisations six months apart. For each immunisation, participants will have to spend a week at the study centre, during which physiological parameters (such as temperature, heart rate and blood pressure) and immunological parameters are investigated in detail. The data from this study will then be used to identify potential biomarkers. Ultimately, the objective is to develop novel tests using biomarkers identified in such studies. These tests can then be integrated into vaccine development programmes to identify new vaccine candidates with the best safety profiles.

Participants Show participants on map

EFPIA companies
  • Glaxosmithkline Biologicals SA, Rixensart, Belgium
  • Glaxosmithkline Vaccines SRL, Siena, Italy
  • Islensk Erfdagreining Ehf, Reykjavik, Iceland
  • Sanofi Pasteur SA, Lyon, France
Universities, research organisations, public bodies, non-profit groups
  • Cdisc Europe Foundation Fondation, Brussels, Belgium
  • Chalmers Tekniska Hoegskola AB, Goeteborg, Sweden
  • Commissariat A L Energie Atomique Et Aux Energies Alternatives, Paris, France
  • Department of Health, Leeds, United Kingdom
  • Goeteborgs Universitet, Gothenburg, Sweden
  • Imperial College Of Science Technology And Medicine, London, United Kingdom
  • Max-Planck-Gesellschaft Zur Forderung Der Wissenschaften Ev, Munich, Germany
  • St George'S Hospital Medical School, London, United Kingdom
  • Statens Serum Institut, Copenhagen S, Denmark
  • Universita Degli Studi Di Siena, Siena, Italy
  • Universiteit Gent, Gent, Belgium
  • Universiteit Utrecht, Utrecht, Netherlands
  • University Of Surrey, Guildford, United Kingdom
Small and medium-sized enterprises (SMEs)
  • ImmunArray Ltd, Rehovot, Israel
  • Vismederi SRL, Siena, Italy
Third parties
  • Universitair Ziekenhuis Gent, Gent, Belgium
Project coordinator
Giuseppe Del Giudice
GlaxoSmithKline Vaccines Srl
Managing entity
David Lewis
The University Of Surrey