The European Medicines Agency (EMEA) is planning to put in place a new fast-track procedure to ensure that vaccines against a potential flu pandemic strain can be made available to public health systems within a few days of an outbreak.
The approach would allow the EMEA to review the bulk of an application to market a flu vaccine - known as the core dossier - before the specific antigens that will be used in the vaccine are known. Once the strain causing the outbreak has been identified, the European Commission could approve a variation to this core dossier, containing only the quality data that is new and relevant to that strain, which should only take a few days to complete.
In a statement, the EMEA said the new measure would “increase pandemic influenza preparedness and help ensure that such vaccines are available to
EU citizens as soon as possible in the event of an outbreak.” A rapid approval process is necessary because flu vaccines can take several months to manufacture.
The move comes in the wake of outbreaks of bird flu in Romania and Turkey, which have prompted EU veterinary officers to hold an emergency meeting to discuss measures to prevent the disease spreading across Europe. Bird flu, and particularly the H5N1 strain of the virus, which is considered one of the most likely candidates to cause a global pandemic and has already caused 60 deaths in Asia since 2003.
Testing has not been completed to show whether the outbreaks in Romania and Turkey are caused by H5N1.
The pharmaceutical industry has been working hard on developing vaccines to protect against the H5N1 and other pandemic flu strains. At the forefront is the Sanofi Pasteur vaccine business of Sanofi-Aventis, which recently won a $100 million dollar contract for its H5N1 vaccine from the US Government [[16/09/05a]], as well as GlaxoSmithKline and Chiron. The USA has set itself the target of stockpiling 40 million doses of vaccine against H5N1.