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EU grants bird flu vaccine licence

EU medical regulators grant bird flu vaccine licence to Glaxo
19 May 2008 09:21am

European medical regulators have granted the first licence for the marketing of a vaccine to be used in preparation for a pandemic of bird flu, it has been revealed.

The ruling from the European Medicines Agency allows British pharmaceutical giant GlaxoSmithkline to sell Prepandrix, which targets the H5N1 virus, in all 27 European Union member states.

Glaxo, which has spent £1 billion developing the vaccine, has orders for 8 million doses for Switzerland - enough to cover the whole population - and 27.5 million for the US. The company says that several EU countries, including Finland, have also placed orders.

Flu viruses mutate swiftly and it is generally understood that to provide full protection a vaccine must be tailored to the particular strain involved in any outbreak.

But Glaxo chief executive Jean-Pierre Garnier said Prepandrix, which was based on the Vietnam strain of bird flu, had been shown also to have effectiveness against the lethal Indonesian strain.

When the alert is sounded for a potential outbreak, millions of people can be inoculated with the pre-pandemic vaccine, providing them with protection for the four to six months required to identify and deal with the new strain. Individuals could then be given a booster jab designed specifically for this strain.

Mr Garnier told the BBC Radio 4 Today programme: "If the virus that is responsible for a pandemic alert is a cousin of H5N1, there will be a recognition in your immune system. Therefore you have a stronger immune system and resist better than if you had not been vaccinated."

He added: "The way this will be used is to boost the immune system of the entire population at risk. Once we are in an alert for a pandemic, it is essentially preparing people for the worst.

"If the worst does occur, then at least they have been protected against the virus and they are highly likely to resist much better the infection than otherwise."

Experts believe H5N1, which has killed at least 241 people worldwide, is the most likely candidate to cross from birds to human populations and mutate into a pandemic virus. The virus has been circulating in Asia, Europe and Africa since late 2003 and several distinct H5N1 strains have been identified.