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Published on 3 October 2007

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FDA approves new seasonal flu jab

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The FDA has approved the seasonal influenza vaccine Afluria® for adults in the USA.

The approval of Afluria, manufactured by CSL Ltd in Australia, brings the number of flu jabs licensed for the US market to six.

The FDA’s Centers for Disease Control and Prevention estimates that the six manufacturers will supply a record 132 million doses of vaccines for the 2007-8 flu season.

Dr Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, said: “Routine immunisation is the most effective way to prevent influenza and decrease influenza-related complications which can include serious illness and death.

“The licensure of this additional manufacturer contributes to having an adequate supply of seasonal influenza vaccine for Americans, one of FDA’s highest priorities.”

In the USA, more than 200,000 people are admitted to hospital with flu symptoms every year, and some 36,000 people die from its complications.

Afluria got the green light after the FDA used its accelerated approval process for serious or life-threatening diseases, which reduces the time required before medical products can become available to the public.

The vaccine is available in both a single-dose, preservative-free, prefilled syringe, and a multidose vial with thimerosal, a mercury derivative, as a preservative.

Copyright © PA Business 2007

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