FDA Approves New Flu Vaccine by Novartis

Novartis AG, the Swiss drug maker, won approval on Wednesday for a flu vaccine that is the first of its kind from the U.S. Food and Drug Administration. The vaccine uses cell cultures from animals and not eggs.

The Vaccines and Diagnostics division of the company is headquartered in Cambridge, Massachusetts and a clinical program and toxicology work were coordinated there with the government of the U.S., said Elizabeth Power a spokeswoman for Novartis.

The new vaccine, Flucelvax, gained approval to treat individuals 18 and older. The cell culture technology by Novartis uses mammalian cell lines instead of chicken eggs for growing strains of flu virus, which then are inactivated to be used in the vaccine. Flucelvax has no antibiotics or preservatives, said the drug maker.

Other vaccines use the method of manufacturing which speeds up the production of the vaccine. This means it takes only weeks to produce instead of the months that are needed for the method that uses chicken eggs.

Novartis said that the approval of the new vaccine is a milestone for the company’s influenza sector and introduces an innovative new vaccine into the U.S. Over $1 billion was invested in developing the new vaccine technology by a partnership that was public and private between Novartis and the U.S. Department of Health.

Part of that cost was to construct a special facility in the North Carolina city of Holly Springs, which will be used to produce the vaccine.

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