Issue Date: May 7, 2007
Novartis has taken a major step toward launching the first flu vaccine to be produced in mammalian cells rather than in chicken eggs. A European advisory committee has recommended approval for Optaflu, and the European Commission is expected to make a final ruling on the vaccine in two to three months.
Making a flu vaccine in mammalian cells would represent a major manufacturing breakthrough that experts say could make the supply of flu vaccines more reliable. Manufacturing flu vaccines in chicken eggs has a host of disadvantages, says Hedwid Kresse, infectious disease analyst at Datamonitor. A firm using eggs needs six months of lead time to supply the market in time for flu season, and the number of doses manufactured is essentially fixed to the egg supply. Also, production of egg-based vaccines requires antibiotics, and they cannot be used by anyone allergic to egg-based products.
After a shortage of flu vaccine during the 2004-05 season, the Department of Health & Human Services provided financial incentives for pharma companies to develop alternatives to egg-based production. Sanofi and GlaxoSmithKline were awarded major contracts to support their cell-culture-based vaccine programs. However, Kresse points out that Novartis' competitors are still years away from launching their vaccines.
Novartis plans to apply for FDA approval for its vaccine next year.
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