Standardization and development of assays for assessment of influenza vaccines correlates of protection


Start Date
End Date
IMI1 - Call 10
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
6 100 000
EFPIA in kind
6 100 208
1 632 913
Total Cost
13 833 121


Every year, pharmaceutical companies develop vaccines designed specifically to combat the strains of flu that are most likely to be in circulation the following winter. Vaccines are also developed in response to emerging pandemics. However, accurately predicting how much protection a new vaccine would actually offer against emerging virus types is far from easy. The FLUCOP project’s goal is to deliver a standardised toolbox to evaluate the ability of new vaccines to stimulate the immune system and compare results from different laboratories, so as to pave the way for future research into which tests will be predictive of vaccine efficacy. Ultimately, the toolbox will improve vaccines research and development globally.

Flu epidemics are common in the winter, and while most people infected will recover without medical intervention, certain groups are at greater risk of suffering complications that may result in hospitalisation and even death. At-risk groups include the elderly, the very young, pregnant women, and people with other underlying health problems such as lung or heart problems or a weakened immune system.

According to the World Health Organization (WHO), these seasonal epidemics cause 3-5 million cases of severe illness and up to 500 000 deaths worldwide. Furthermore, flu epidemics place immense strain on health systems, and can affect economic productivity due to sick leave.

Vaccines – key to flu prevention

The influenza virus is spread easily and can be transmitted through coughing and by contaminating surfaces. Basic infection control measures (coughing into a tissue, regular handwashing) are important in slowing the spread of the disease. However, the WHO recommends vaccination as the most effective way to prevent the disease, especially in vulnerable people and those who care for them.

Today’s flu vaccines do not provide protection against all strains of the virus because of  the ability of the influenza virus to change continuously as it circulates amongst human and animal populations. Therefore, every year the WHO Global Influenza Surveillance and Response System closely monitors the strains in circulation and provides advice on the emerging strains likely to be in circulation the following winter. Subsequently, in a race against time, pharmaceutical companies develop, in a matter of months, vaccines designed specifically to protect individuals from infection by those emerging strains.

The challenge of checking vaccines

A major challenge in flu vaccine development is the need for standardised tests, ideally blood-tests, that rapidly and reliably indicate the level of actual protection that might be expected from a new vaccine against a given emerging strain of the virus. Public research institutions, vaccine manufacturers and other stakeholders currently use tests to measure the immune response that the vaccine generates to the virus in people. However, those tests, which have been locally developed, can vary widely from laboratory to laboratory. This prevents potentially useful comparisons, and limits their value as predictive tools – something that all stakeholders would like to increase.

A toolbox for the entire flu vaccine community

FLUCOP represents an unprecedented collaboration between European vaccine manufacturers, academic institutions, regulatory bodies, and public health agencies to improve the toolbox available to evaluate the ability of new influenza vaccines to stimulate the immune system in humans.The collaboration  seeks to improve current tests, develop new tests and, very importantly, to harmonise how those test are performed in different laboratories.

In the short term, the toolbox will ensure that results of clinical studies of flu vaccines will be comparable, even if they are carried out at different times and in different laboratories in different parts of the world. In the longer term, it will likely have an impact on the way medicines regulators approve new flu vaccines, and will improve best practice in the way flu vaccines are developed worldwide.

Achievements & News

FLUCOP project gets underway
FLUCOP, IMI’s new project on seasonal flu vaccines, has got underway. The focus of the project is on ‘correlates of protection’ of flu vaccines – markers that indicate the level of protection offered by a vaccine. FLUCOP will provide ###the seasonal influenza vaccine community with improved or new tools to evaluate the vaccine’s ability to raise an immune response, allowing the comparability of clinical data across laboratories, and paving the way for establishing improved and/or novel correlates of protection. The harmonisation of laboratory tests will ultimately contribute to increase the transparency of the results and therefore the public trust in seasonal flu vaccination programmes. FLUCOP has 22 partners, including vaccine manufacturers, small and medium sized enterprises, major academic institutions, public health governmental institutions, and non-governmental organisations. 

Participants Show participants on map

EFPIA companies
  • Abbott Biologicals BV, Weesp, Netherlands
  • Astrazeneca AB, Södertälje, Sweden
  • Glaxosmithkline Biologicals SA, Rixensart, Belgium
  • Janssen Vaccines & Prevention BV, Leiden, Netherlands
  • Sanofi Pasteur SA, Lyon, France
  • Seqirus S.r.l., Siena, Italy
Universities, research organisations, public bodies, non-profit groups
  • Bundesinstitut Fur Impfstoffe Und Biomedizinische Arzneimittel, Langen, Germany
  • Department of Health, Leeds, United Kingdom
  • Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
  • European Vaccine Initiative - EEIG, Heidelberg, Germany
  • Sclavo Vaccines Association, Siena, Italy
  • Stichting Biomedical Primate Research Center, Rijswijk, Netherlands
  • The European Medicines Agency, Canary Wharf, London, United Kingdom
  • Universita Degli Studi Di Parma, Parma, Italy
  • Universita Degli Studi Di Siena, Siena, Italy
  • Universiteit Gent, Gent, Belgium
  • Universitetet I Bergen, P.O. Box 7800, Bergen, Norway
  • University Of Surrey, Guildford, United Kingdom
  • University of Oxford, Oxford, United Kingdom
Small and medium-sized enterprises (SMEs)
  • Artemis Bio-Support B.V., Utrecht, Netherlands
  • Quinten, Paris, France
Non EFPIA companies
  • Istituto Superiore Di Sanita, Roma, Italy
Project coordinator
Patricia Londono-Hayes
Sanofi Pasteur
Managing entity
Donata Medaglini
Sclavo Vaccines Association
Scientific coordinator
Emanuele Montomoli
University of Siena