GlaxoSmithKline says it had filed its flu vaccine, Fluarix, with the US Food and Drug Administration. The firm is clearly hoping to carve a niche for itself in the US flu vaccines market after the furore of last year, which was sparked by the UK’s drug regulator, the MHRA, pulling the plug on production of Chiron’s flu vaccine after contaminated lots were found at its plant in Liverpool – leaving the USA with just half its planned 100 million flu vaccine doses for the 2004/5 season [[06/10/04b]].
“Right now a limited number of companies supply injectable flu vaccine to the entire nation, making the system vulnerable when there are problems with supply as we saw last flu season,” said Christopher Viehbacher, president of GSK’s US pharmaceuticals division. ”We’re happy to be once again working closely with the Department of Health and Human Services and the FDA to help fill this void in public health, and with FDA approval, we’re committed to making Fluarix available before the next flu season,” he added.
If licensed, Fluarix, which is currently available in more than 75 countries around the world, would be the fourth vaccine available in the USA, alongside offerings from Sanofi-Aventis, MedImmune and Chiron.
Influenza is a highly contagious and potentially fatal virus that affects between 10% and 20% of the total US population during seasonal epidemics, resulting in approximately 36,000 deaths in the United States each year.
