Glaxo Wins U.S. Approval for Bird Flu Vaccine

[xchrom]

http://www.bloomberg.com/news/2013-11-22/glaxo-wins-u-s-approval-for-bird-flu-vaccine.html

GlaxoSmithKline Plc (GSK) won approval for the first vaccine to prevent bird flu that allows for a higher number of doses to be made available during a pandemic, U.S. regulators said.

The Food and Drug Administration cleared the vaccine for H5N1 influenza for use in people 18 years of age and older at increased risk of exposure to the virus, the agency said yesterday in a statement. Bird flu has caused serious illness and death outside of the U.S. mainly among people who come in close contact with infected and ill poultry, the FDA said.

The vaccine from London-based Glaxo isn’t for commercial use, rather will be kept in the U.S. national stockpile, the agency said. About 60 percent of people who become infected die from bird flu. ID Biomedical Corp., a Glaxo subsidiary based in Quebec City, makes the vaccine with an adjuvant of oil-in-water emulsion to enhance the immune response of patients, allowing the vaccine to stretch further, the FDA said.

“This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the globe,” Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.