EU licenses first pre-pandemic bird flu vaccine

By Ben Hirschler

LONDON (Reuters) - European authorities have approved the first pre-pandemic bird flu vaccine, Prepandrix, from GlaxoSmithKline Plc, its maker said on Monday.

Europe's biggest drugmaker hopes the move will spur fresh stockpile orders from governments around the world.

Prepandrix is intended for use before or in the early stages of a flu pandemic. It triggers an immune response to the H5N1 strain of bird flu, which experts fear may trigger a widespread human flu outbreak threatening millions of people.

The official license from the European Commission puts Glaxo ahead of rivals in the vaccine race. The green light had been expected, following a positive recommendation from experts at the European Medicines Agency in February.

So far, Glaxo has received orders for Prepandrix from a handful of governments, including the United States, Switzerland and Finland. In 2007, it sold 146 million pounds ($284 million) of its pre-pandemic vaccine and bulk antigen.

Now Glaxo's flu vaccine head Emmanuel Hanon expects more buyers to follow, justifying the $2 billion his company has invested in increasing flu capacity.

"It's clear that some governments are more proactive than others ... the policy is evolving and I'm looking for some kind of alignment in terms of what governments are going to do," he told reporters.

"Governments are concerned by the real medical and economic threat of a pandemic."

MASS IMMUNISATION

Glaxo sees governments, rather than the private sector, as the prime market for its new vaccine because of the need to coordinate mass immunization programs.

It has previously announced plans to donate 50 million doses of the pre-pandemic vaccine to the World Health Organisation.

Other drugmakers including Sanofi-Aventis and Novartis AG are also working on bird flu vaccines and industry analysts say such products may represent a $1 billion-plus sales opportunity for such companies.

Glaxo's vaccine should give a degree of protection until a more precisely tailored pandemic vaccine can be produced -- a process likely to take four to six months from the time any pandemic strain is identified.

Tests have shown that Prepandrix protects against H5N1 variants currently circulating in Asia, Europe and Africa.

The new vaccine contains a special additive, or adjuvant, which allows a very low dose of active ingredient to be used in each shot.

A key challenge in producing a vaccine for millions of people around the world is how to make the maximum number of shots from the minimum amount of antigen, or active ingredient.

While H5N1 remains mainly a virus affecting birds, scientists say it is the most likely source of the next global flu pandemic in humans, since it may soon mutate into a form that is easily transmitted from person to person.

So far, most human cases can be traced to direct or indirect contact with infected birds. The H5N1 virus has killed around 240 people since 2003.

(Editing by Jason Neely)