| May
19, 2008
EU clears first human vaccine for bird flu
European medical regulators have approved the first human vaccine against bird flu intended for use before or in the early stages of a pandemic, GlaxoSmithKline, its maker, said Monday.
The vaccine, Prepandrix, activates an immune response to the H5N1 strain of bird flu, which experts fear may lead to a widespread human flu outbreak threatening millions of people.
GlaxoSmithKline, the biggest drug maker in Europe, has spent about $2 billion developing the vaccine and hopes that the approval will prompt fresh orders of Prepandrix from governments around the world looking to build stockpiles.
The official license comes from the European Commission, the executive arm of the European Union, and puts Glaxo ahead of its rivals in the race for a vaccine for bird flu.
The approval had been expected after a positive recommendation from experts at the European Medicines Agency in February.
Glaxo has received orders for Prepandrix from several governments, including those of the United States, Switzerland and Finland. In 2007, the company sold £146 million, or about $284 million, of its prepandemic vaccine and bulk antigen.
Switzerland has ordered eight million doses, or enough to cover its entire population, and the U.S. Department of Health and Human Services has ordered 27.5 million doses.
Emmanuel Hanon, vice president of the Influenza Vaccine Franchise at Glaxo, said Finland and several other European countries, which did not want to be identified, had also placed orders.
"It's clear that some governments are more proactive than others," Hanon said. "The policy is evolving, and I'm looking for some kind of alignment in terms of what governments are going to do. Governments are concerned by the real medical and economic threat of a pandemic."
Glaxo considered governments, rather than the private sector, as the prime market for Prepandrix because of the need to coordinate mass immunization programs.
The company has previously announced plans to donate 50 million doses of the prepandemic vaccine to the World Health Organization.
Other drug makers, including Sanofi-Aventis and Novartis, are also working on bird flu vaccines. Industry analysts say such products could represent potential sales of more than $1 billion for the companies.
Source: www.iht.com
Comments:
While the Asian countries are fighting to curb a potential bird flu epidemic, pharmaceutical companies are prepared to fight—and cash in on— the pandemic with a new brand of vaccines. No wonder other drug makers, including Sanofi-Aventis and Novartis, are also working on bird flu vaccines, which could represent potential sales of more than $1 billion for such companies. It is well known that a flu virus mutates very frequently . H5N1 is no exception to that and since it is a bird specific strain, it has to undergo a specific mutation to infect humans. Scientists don't yet know how much of an immune response - the creation of infection-fighting antibodies - a vaccine must prompt to protect people against bird flu. Besides, there is also a lack of information regarding the long-term effects of this vaccine. This article clearly states that Glaxo’s vaccine should give a degree of protection until a pandemic strain is identified and a more precise vaccine is formulated. Until that time, GSK will continue to profit from sales of existing vaccines, which could provide a false sense of protection from bird flu. Novartis has already been awarded a contract worth $40.95 million to boost the United States' bird flu vaccine stockpile.
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