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FDA OKs US cell-based flu vaccine facility as govt prepares for pandemic

Published: June 17, 2014
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Source: CIDRAP

The US Food and Drug Administration (FDA) has approved the first US facility that can make cell-culture influenza vaccines, a Novartis plant in Holly Springs, N.C., that has been part of federal government efforts to prepare for a pandemic and to sidestep some limits of egg-based flu vaccine technology.

Novartis said in a press release today that the approval clears the way for commercial production to begin at the site and for Flucelvax, its seasonal flu vaccine, to be made in the United States for the first time. The vaccine, approved in November 2012, was the first cell-based flu vaccine to receive FDA clearance, and the first doses—made in the company's German production facility—entered the US market during the 2013-14 flu season.

Flucelvax, an inactivated trivalent vaccine approved for use in adults, contains flu viruses grown in mammalian cell cultures. Though cell-culture methods have been used to make other US-licensed vaccines, Flucelvax is the first US flu vaccine to be made with the process. The technology is designed to make production faster and more flexible, because the cells can be banked and there is no need for an egg supply.

Development of the vaccine, underway since 2006, and construction of the Holly Springs facility have been a public-private partnership between Novartis and the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS). HHS invested $487 million toward constructing and certifying the Holly Springs facility. Federal officials have said the plant is designed to make 150 million doses of monovalent vaccine within 6 months of the start of a pandemic.

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