Advisory Committee recommends approval of Sinofi Aventis bird flu vaccine

Tuesday: a federal advisory committee recommended approval of a vaccine produced by the French drug company Sanofi Aventis. This is the first bird flu vaccine for humans and the recommendation comes despite concerns about its safety and evidence that the shots won't protect most people.
The panel recognised that the vaccine had significant shortcomings but concluded it was safe and effective for use during a pandemic or in high-risk situations, such as military deployment to regions facing an outbreak. The vaccine will not be commercially available.

The US government plans to stockpile vaccine doses for 20 million people, including health-care workers and emergency personnel.Panel member Robert Webster, chairman of the department of virology and molecular biology at St. Jude Children's Research Hospital in Memphis, Tenn., said the vaccine would be better than nothing."We need this pre-pandemic stockpile," he said. "It worries me that if we don't license this vaccine, what are the consequences?"

Norman Baylor, director of the FDA's vaccine office, told the panel that "There are numerous vaccines under development that are potentially better than this one," but felt that the Sanofi Aventis vaccine would be useful as a stop gap measure.

The Food and Drug Administration is not required to follow the advice of its outside experts but typically does.
The US Department of Health and Human Services has funded research of more than 30 potential bird flu vaccines.
In clinical trials, two-shot doses of Sanofi vaccine provided protection in 45% of adults who had the highest dose, according to an FDA analysis. The New England Journal of Medicine last year published an interim analysis showing the vaccine protected 54% of adults.This is below the level provided by other approved vaccines.
The seasonal flu vaccine protects 70% to 90% of people. The FDA usually looks for antibody response in at least 70% of vaccine recipients. Although no serious side effects were detected among the 450 healthy adults in a clinical test some panel members were concerned that the trial was too small to show rare side effects. There have also been concerns possible allergic reactions to the vaccine because it needs 12 times the dose of the seasonal vaccination.