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FDA Approves Vaccines for the 2012-2013 Influenza Season

Darrell Hulisz, RPh, PhamD
Amanda Scharf,

December 14, 2012

Flucelvax is the first seasonal flu vaccine to be approved by the U.S. Food and Drug Administration using a manufacturing method called cell culture technology, the agency said.

Other flu vaccines are produced inside eggs. But that process takes longer than the newer method and could be harmful to people with egg allergies, the FDA explained. In cell culture technology, virus strains are grown inside mammalian animal cells.

This technology has been used for decades to produce other vaccines, the agency said, and since it is quicker, it can be used more efficiently to develop flu vaccines rapidly in the event of a pandemic.

Flucelvax was evaluated in clinical studies in the United States and Europe involving some 7,700 people ages 18 to 49. Common side effects included pain, redness, injection-site soreness, headache and fatigue; reactions typically seen in people given egg; based flu vaccines, the FDA said

The U.S. Centers for Disease Control and Prevention recommends the annual flu shot for anyone 6 months and older.

Flucelvax is produced by Novartis Vaccines and Diagnostics, based in Marburg, Germany.

Source: Drugs.com FDA Approves Vaccines for the 2012-2013 Influenza Season