Outside panel approves Sanofi Aventis's bird flu vaccine
FDA likely to accept recommendation despite disappointing trial results; 50 percent immune seen as better than none; stockpiling continues as GlaxoSmithKline Plc and Novartis SA continue developing competing vaccines
With bird flu continuing to spread, federal health officials have decided to stop waiting for a magic bullet vaccine. Instead, an outside panel has approved both the safety and effectiveness of Paris-based Sanofi Aventis’s experimental vaccine — one that is known to be of limited utility but is also the first to be submitted to the Food and Drug Administration (FDA) for approval. “I am of the view that anything is better than nothing,” said panel member Dr. Robert Couch. In recent tests, only half of those receiving the vaccine developed an immune response, lower than the 70 percent response desired by the FDA. Nevertheless, the vaccine is already being stockpiled in anticipation of FDA approval — the agency typically accepts the views of the outside panel — and would be used until other vaccines are approved. Other companies working on pandemic flu vaccines include GlaxoSmithKline Plc and Novartis SA.
-read more in this AP report
