The FDA has just approved a bird flu vaccine made by Sanofi-Aventis. This will be used to combat the same H5N1 strain of the virus that keeps popping up in Asia and other countries.

“The licensure of the nation’s first vaccine is a significant milestone in pandemic preparedness,” says David Williams, ceo of Sanof-Pasteur, the drugmaker’s vaccine division. “We look forward to continuing to work with the U.S. government and others, to prepare for this crisis.”

The FDA approved the vaccine based on a clinical trial conducted by the National Institute of Allergy and Infectious Diseases, which evaluated the safety and ability to generate an immune response when administered in two 90 ug/ml doses in 103 healthy adults 18 through 64 years.
Approximately 300 healthy adults also received the vaccine at doses lower than 90 micrograms and a total of 48 who received a placebo injection.

The study, which was completed in 2005, showed the vaccine elicited an immune response against the virus among 45 percent of the participants, who reported mild side effects. “The timing and severity of an influenza pandemic is uncertain, but the danger remains very real,” says Jesse Goodman, who heads the FDA’s Center for Biologics Evaluation and Research.

The FDA statement;
World Health Organization fact sheet.[tags]Bird Flu, FDA, Sanofi-Aventis[/tags]