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FDA gives green light to cell-based flu vaccine

NEWS IN BRIEF — Posted Dec. 10, 2012

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The Food and Drug Administration has approved a seasonal influenza vaccine produced using cultured animal cells instead of chicken eggs.

Flucelvax was OK’d for adults 18 and older on Nov. 20. The manufacturing process is described to be similar to other flu vaccines, but the virus strains in the vaccine are grown in animal cells from mammals, the FDA said. Flucelvax is manufactured by Novartis Vaccines and Diagnostics GmbH in Germany.

Using cells for manufacturing has the advantage of maintaining adequate supply and the potential for faster production in the event of a pandemic, the FDA said.

“Today’s approval represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/12/10/gvbf1210.htm.

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