# 675
Despite lackluster performance in stimulating an immune response during clinical trials, the U.S. government has approved Sanofi's bird flu vaccine for use.
In March of 2006, an interim analysis of this vaccine published in the New England Journal of Medicine (NEJM) indicated that it required two shots, of 90 ug of antigen each, to produce an acceptable immune response in 54% of the test subjects. That is roughly 12 x's the antigen required for a standard flu shot, and considerably less effective as well.
Last February, the FDA revealed that further study had reduced that number to only 45%.
Research is ongoing to see if an immune booster, an adjuvant, could be added to the vaccine to stretch the supplies.
Government OKs First Bird Flu Vaccine To Protect Against Spread Of Virus
Last updated: 4/17/2007 12:45:48 PM
By ANDREW BRIDGES
Associated Press Writer
WASHINGTON (AP) -- A bird flu vaccine won federal approval for the first time Tuesday as a stopgap measure against a potential pandemic until more effective vaccines can be developed.
The vaccine is the first to win Food and Drug Administration approval for use in protecting humans against the H5N1 influenza virus. It would be used if the strain mutated into a form that spread easily from person to person, sparking a pandemic.
The Sanofi Aventis SA vaccine already is being stockpiled for use in an outbreak of bird flu. It will not be commercially available. Approval came on the recommendation of FDA advisers, who in February said the vaccine would be better than nothing.
