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FLUCOP: a toolbox for the evaluation of new flu vaccines


Seasonal influenza is a major public health threat: between 10 and 35 % of Europe‘s population is infected every year, mostly between November and April, when the sickness spreads throughout the northern hemisphere. Influenza virus infections are vaccine-preventable, but unpredictable changes in circulating strains require annual modifications of the vaccines. In order to improve new anti-influenza vaccines, IMI’s FLUCOP project is working to deliver a standardised toolbox to evaluate the ability of new vaccines to stimulate the immune system.

‘FLUCOP is a project with the main aim to improve and standardise the existing immunological assays applicable for the definition of correlates of protection in future efficacy trials and, whenever feasible, to develop new assays to better evaluate influenza vaccine immunogenicity,’ says Emanuele Montomoli, professor of Public Health in the Department of Molecular Medicine at the University of Siena, and the scientific coordinator of the project. ‘The ultimate goals of FLUCOP will be achieved through three intermediate objectives.’

Three goals

FLUCOP is a public-private consortium of 22 partners involving experts from 6 vaccine manufacturers from Europe, small and medium-sized enterprises, major academic institutions, European public health governmental institutions, and European non-governmental organisations. It is a unique pan-European effort to pave the way for the easier development of new anti-influenza vaccines.

Expectations are high when it comes to the new vaccines: they have to provide long-lasting immunity and be able to protect against possible pandemic influenza. To develop a successful new vaccine, it is important to gather all relevant information about previous ones, and those results should be comparable and standardised.

The primary goal of FLUCOP is to achieve the standardisation of HAI (haemagglutination inhibition) and VN (virus neutralisation) assays. Since previous studies have shown that both assays are highly variable between laboratories, and the results obtained in different laboratories are not always comparable, standardised immunological assays will have a huge impact on the global research and development process. Moreover, standardised assays will facilitate any future investigation and definition of correlates of protection for the anti-influenza vaccines.

The second goal is to advance the understanding and application of CMI (cell-mediated immunity) and NA (neuraminidase) assays as tools for evaluating influenza vaccine performance. CMI analyses provide supportive information for the evaluation of vaccine immunogenicity, but there is a need to optimise and standardise the different procedures and assays involved. NA plays an important role in the late phase of the infection cycle, but at present, the relevance of NA antibodies and their contribution to vaccine-induced immunity is largely unclear.

FLUCOP’s third goal is to consider new technologies that could be applied to investigate correlates of protection and population-based evaluations of influenza vaccines, so the researchers are developing novel methods and assays that could supplement existing technologies in future influenza vaccination studies.

Significant economic and social consequences

‘Once we will have the assays harmonised among laboratories, it will be easier to follow the antigenic drift and the stray change in the vaccine formulation,’ expects Prof. Montomoli, adding that the important topic considered in the FLUCOP project is the evaluation of different sources of antigens to use in the vaccine assessment assays. Prof Montomoli also explained that once the assays are harmonised, the regulatory agencies will have more robust results for influenza vaccine approvals.

As an acute viral infection that spreads easily from person to person and can cause serious complications, influenza has significant economic and social consequences. According to the World Health Organisation (WHO), 3–5 million cases of severe influenza illness occur every year, resulting in between 290 000 and 645 000 deaths. In Europe, the death toll related to influenza is between 5 000 and 17 000 people, and the vaccination level is low, especially among the older population.  Influenza vaccines have been available for 80 years, and they can provide protection even when the vaccine does not exactly match the circulating viruses. European Centre for Disease Prevention and Control (ECDC) data show that in a good year, a flu vaccination reduces the risk of illness by 60 %.  In order to promote vaccination as the most effective weapon against communicable diseases, the WHO has established an annual Immunisation Week every April. The main goal of the 2019 campaign is to raise awareness about the critical importance of full immunisation throughout people’s lives, with the WHO aiming to show how routine immunisation (as for influenza) is the foundation for strong, resilient health systems and universal health coverage.

About World Immunisation Week

The WHO marks World Immunisation Week annually during the last week of April; in 2019, it runs from 24-30 April. Information on activities in Europe can be found on the websites of WHO Europe and the ECDC. To mark World Immunisation Week 2019, IMI is publishing a short series of articles on the results and activities of our vaccine projects.

Find out more about the FLUCOP project