Preparing for an Influenza Pandemic
Although the threat of avian influenza has only recently made major media headlines, Europe began developing its defences many years ago. In September 2001, a team of scientists from the UK, Italy and Norway collaborated with vaccine researchers from Sanofi Pasteur in France on the FLUPAN project. Funded through the Fifth Framework Programme, the project aimed to develop a candidate vaccine for human pandemic flu.
The partners decided to target the H7N1 avian influenza subtype which caused lethal outbreaks in Italian poultry in 1999. In 2003, 80 people in the Netherlands were infected with the related H7N7 subtype caught from poultry; one person died of the disease.
Although recent media attention has been devoted to the H5N1 subtype, researchers believe that H7 subtypes could also cause a pandemic. The deadly H7N1 strain is too dangerous for standard influenza vaccine production, so the FLUPAN scientists used a technique called reverse genetics to alter the H7 protein and make the virus safe. This process also modified the virus so that it could be grown in a mammalian cell line as well as the more usual poultry eggs. The use of a mammalian host for the virus makes large-scale production of a human vaccine easier and safer. The resulting vaccine will be the first influenza pandemic vaccine produced entirely in mammalian cells.
But the FLUPAN project has done more than produce a potential vaccine against H7 avian influenza. In other strands of this research, surveillance of avian influenza viruses in Italy has enabled the partners to build up a library of reagents which will be a valuable resource for pandemic vaccine development in the future; new tests to monitor antibodies induced by avian influenza viruses have been developed which should improve our ability to detect emergence of new pandemic viruses.[+] Read More
Status (January 2007):
A vaccine candidate against the H7N1 bird flu virus has been developed using reverse genetics technology and egg-free vaccine production technology. This new vaccine, called RD-3, went into pre-clinical immunogenicity studies in early 2006, and safety/efficacy Phase I clinical trial with 60 volunteers at the end of 2006. The protocols and techniques for monitoring human infections with avian influenza and carrying out clinical trials, which the FLUPAN consortium has developed will be important tools in pandemic preparedness and will provide methods that can be used to develop vaccines also against H5N1 in the event of a pandemic.
At the start of the FLUPAN project, we were ill-prepared to react to the emergence of highly pathogenic avian influenza viruses in man. Reverse genetics technology had never before been used to produce influenza vaccine viruses and there was little experience in producing and testing potential pandemic vaccines. It was vital to rehearse our pandemic preparedness by involving not only research scientists and vaccine specialists but also health and safety regulators and vaccine licensing agencies.
To diagnose more effectively, the emergence and spread of potential pandemic influenza viruses from animals to man and to be able to respond rapidly by producing safe, effective vaccines.
As the tools and techniques developed by FLUPAN can be adapted to develop new vaccines quickly and efficiently, for example against H5N1, the project has made an important contribution to Europe's pandemic preparedness. The experience gained in developing safe working practices for genetic modification of highly pathogenic influenza viruses and in devising a testing protocol for demonstrating safety of vaccine viruses derived by reverse genetics has been invaluable in producing WHO biosafety risk assessments for H5N1 vaccine development.