EU Clears Glaxo's Bird-Flu Vaccine
By ELENA BERTON
May 19, 2008; Page B7
LONDON -- GlaxoSmithKline PLC said its Prepandrix vaccine, which could provide protection against the H5N1 bird-flu virus in advance of a potential pandemic, was cleared for use in the European Union.
The European Commission's approval follows a recommendation by the European Medicines Agency in February, which made Glaxo the first pharmaceutical company to obtain a European license for a prepandemic vaccine.
Prepandrix offers some protection against several strains of the H5N1 virus, which has resulted in the deaths of several hundred people and the slaughter of millions of poultry.
In the event of a pandemic, Prepandrix would be given to people, especially health workers, to provide some form of immunity while drug makers develop a more precise vaccine that would directly target the virus responsible for the outbreak.
Due to vaccines' long manufacturing times, a vaccine using a specific strain would become available up to six months after an outbreak, leaving the population unprotected if a prepandemic vaccine weren't used in the meantime.
A number of European countries, including Switzerland and Finland, already have placed orders for the vaccine, while others are in talks with Glaxo, of the United Kingdom, with a view to building stockpiles.
The company has invested $2 billion over the past few years to boost production capacity at its vaccine plants and for its antiviral flu treatment Relenza.
The H5N1 bird-flu virus has been circulating for several years. While it is capable of spreading to people who have extensive physical contact with infected birds, there is no evidence of human-to-human transmission. But there are concerns it may mutate into a strain capable of spreading through humans.
French drug maker Sanofi-Aventis SA, Switzerland's Novartis AG and Baxter International Inc. of the U.S. also are developing pandemic vaccines.
online.wsj.com |
