European approval for GSK’s bird flu vaccine
pharmafile | May 20, 2008 | News story | Sales and Marketing |Â Â Â
GlaxoSmithKline has won approval from European regulators for the first ever pre-pandemic vaccine.
Prepandrix is based on the currently circulating H5N1 strain of avian influenza virus and has a licence to treat adults aged 18-60.
The vaccine is manufactured before a pandemic is declared and meant for use either before or right at the start of a flu outbreak, as opposed to rival immunisations that have longer lead times because they can only be produced after a pandemic breaks out.
GSK believes Prepandrix will provide faster aid to people at risk, and could save those victims who might suffer in the first wave of a pandemic.
The company's out-going chief executive Jean-Pierre Garnier said it marked a significant step in the world's ability to cope with an influenza pandemic, and hoped the new licence would encourage European governments to stockpile the vaccine.
He added: "It is testament to GSK scientists who have pioneered the approach to pre-pandemic vaccination, demonstrating our commitment to doing everything we can to help prevent the devastating effects of a pandemic and play our part in averting this potential public health crisis."
Since the discovery of the H5N1 influenza strain in south-east Asia in 1997 cases have been reported in birds in at least half of the European Union's countries, including France, Germany, Italy, Greece and the UK.
The main risk to humans is for those in close contact with poultry and figures released last month by the World Health Organisation (WHO) showed that of the 382 people who had so far contracted bird flu, 241 had died.
GSK has previously announced its intention to donate 50 million doses of the vaccine to the WHO, in support of the organisation's plans to stockpile doses for the world's poorest countries.
The company has already signed contracts with the US and several European countries, such as Switzerland and Finland, and in 2007 sold £146 million of its pre-pandemic vaccine and bulk antigen.
