Giuseppe
Emeritus
Brussels gives green light to Glaxo's bird flu vaccine
? Drug will let inoculations begin before a pandemic
? Product would be effective if H5N1 virus alters slightly
Nick Huber - The Guardian, Monday May 19 2008
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.
Jeremy Batstone-Carr, head of private client research at Charles Stanley, said vaccines had relatively low profit margins and therefore needed to be produced in bulk to be cost effective for the manufacturer. "The attraction for GSK lies in flogging the product to as many governments as possible," he said.
Explainer: Avian influenza
Avian influenza, known as bird flu, is a contagious viral disease in animals caused by a virus loosely related to human influenza. Domestic poultry flocks are especially vulnerable to infection, which can rapidly result in epidemics among their populations. The H5N1 form of bird flu is the most dangerous.
Most of the human deaths have been in Asia in communities in which people live close to poultry. In Britain, there have been cases of HN51 among swans on a nature reserve in Dorset and among turkeys at a Bernard Matthews farm in Suffolk.
The most severe flu pandemic occurred in 1918-19, and is estimated to have killed an estimated 50 million people across the world.
The Department of Health's national framework for pandemic flu has predicted that up to 750,000 extra deaths could be expected in Britain within 15 weeks of a flu pandemic. A quarter to half of the population could be infected and up to 2.5% of those could die.
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http://www.guardian.co.uk/business/2008/may/19/glaxosmithklinebusiness.pharmaceuticals
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? Drug will let inoculations begin before a pandemic
? Product would be effective if H5N1 virus alters slightly
Nick Huber - The Guardian, Monday May 19 2008
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.
Jeremy Batstone-Carr, head of private client research at Charles Stanley, said vaccines had relatively low profit margins and therefore needed to be produced in bulk to be cost effective for the manufacturer. "The attraction for GSK lies in flogging the product to as many governments as possible," he said.
Explainer: Avian influenza
Avian influenza, known as bird flu, is a contagious viral disease in animals caused by a virus loosely related to human influenza. Domestic poultry flocks are especially vulnerable to infection, which can rapidly result in epidemics among their populations. The H5N1 form of bird flu is the most dangerous.
Most of the human deaths have been in Asia in communities in which people live close to poultry. In Britain, there have been cases of HN51 among swans on a nature reserve in Dorset and among turkeys at a Bernard Matthews farm in Suffolk.
The most severe flu pandemic occurred in 1918-19, and is estimated to have killed an estimated 50 million people across the world.
The Department of Health's national framework for pandemic flu has predicted that up to 750,000 extra deaths could be expected in Britain within 15 weeks of a flu pandemic. A quarter to half of the population could be infected and up to 2.5% of those could die.
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http://www.guardian.co.uk/business/2008/may/19/glaxosmithklinebusiness.pharmaceuticals
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