FLUCOP

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.