FDA outlines pandemic flu vaccine plans

FDA said on Thursday that it is proceeding on two parallel tracks for licensing vaccines for swine influenza A (H1N1), one for products based on currently licensed vaccines and another for novel vaccines. In the best-case scenario, 160 million doses of pandemic H1N1 vaccine could be available for use in the U.S. by October, Robin Robinson, director of HHS's Biomedical Advanced Research and Development Authority (BARDA), told FDA's Vaccines and Related Biological Products Advisory Committee.

Manufacturers with approved seasonal influenza vaccines can obtain approval for a monovalent H1N1 pandemic vaccine without clinical data under the same procedures used to approve strain changes in seasonal trivalent influenza vaccines based on nonclinical CMC data, FDA said. Approval will be contingent on having trials ongoing. CSL Ltd. (ASX:CSL), Novartis AG (NYSE:NVS; SIX:NOVN), MedImmune Inc., GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY) outlined plans to develop pandemic H1N1 vaccines as strain changes. ...