Posted: Mon May 19, 2008 1:06 am Post subject: Brussels gives green light to Glaxo's bird flu vaccine
Preparations to protect humans against a possible future bird flu pandemic will receive a boost today after GlaxoSmith-Kline became the first drug manufacturer to be granted marketing approval for its pre-pandemic influenza vaccine. The world's second-biggest drugs group said the European commission had approved its vaccine, called Prepandrix, in all 27 EU member states.
GSK said its vaccine had the advantage of allowing governments to begin to inoculate their population before a pandemic. The vaccine uses the current H5N1 influenza virus, which scientists believe could jump from birds to humans in a form that is highly infectious, triggering a flu pandemic that could kill tens of millions of people.
The company said its vaccine was flexible and would be effective if the virus mutated slightly. Most other flu vaccines under development would need to be altered after a new strain of the virus emerges, which could take four to six months.
Health officials have warned that the risk of a human influenza pandemic is probably growing as the H5N1 virus becomes more entrenched in poultry in Asia, Africa and parts of Europe. There have been 382 human cases of bird flu worldwide since 2003, 241 of them fatal, according to the World Health Organisation, an agency of the United Nations.
GSK is betting that the next pandemic flu virus will be a variant of the H5N1 virus. If a future flu pandemic has mutated too far away from the H5N1 virus into a totally new form, then GSK's vaccine will not be effective and a new vaccine will have to be made.
Jean-Pierre Garnier, GSK's chief executive, who retires on Wednesday, said: "For the first time the authorities are approving a pre-pandemic vaccine. We have demonstrated that even if the H5N1 virus drifts to a different strain it is still effective."
He said that if governments primed the population by giving them a pandemic vaccine, it would boost their immune system. "It's like training for the Olympics - it doesn't mean you're going to win the gold medal but if you train you'll be a much better system. [Our vaccine] can make you more resistant to the pandemic."
The company hopes that governments will start vaccinating sections of their populations now with Prepandrix, combining it with seasonal flu jabs to prepare people's immune systems to fight off a possible future pandemic.
GSK has donated 50m doses of its influenza vaccine to the World Health Organisation and sold versions of it to the governments of the US, Switzerland and Finland. The UK government has reserved the right to buy up to 122m doses of pandemic flu vaccines from a number of suppliers, including GSK, if there is an outbreak.
GSK's bird flu vaccine, which has completed clinical trials, blends small doses of existing H5N1 strains from Vietnam and Indonesia to teach the human immune system to recognise the virus and help it fight off mutations. Garnier said other governments wanted more assurances of Prepandrix's effectiveness from regulators. He added that its flu pandemic vaccine would be offered at a "much reduced" price to all developing nations. He declined to be drawn on the potential profits from the vaccine.
Bird flu vaccine to hit the shelves (headline Nature.com , but no mention whether it will actually be
available to privates or only sold outside the shelves)
GlaxoSmithKline supports governments health-agencies, interested companies
worldwide in their pandemic preparations
Florian Martius, Director Corporate Communications , Telefon: 089/360 44-8329(Germany)
Fax: 089/360 44-8066 , E-Mail: Florian.Martius@gsk.com
The first orders for Prepandrix were placed last year by Finland and Switzerland, before it
had been approved by the Europea Commission. In 2007, sales for Prepandrix totalled
US$284 million worldwide.
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