U.S. cell-based flu vaccine plant gets FDA approval


The Food and Drug Administration on June 17 approved the first U.S. facility to make seasonal influenza vaccine using cultured-cell–based technology, giving another layer of approval to the vaccine-making capabilities of a North Carolina plant that opened in January 2012.

The plant, in Holly Springs, N.C., resulted from a partnership of the Novartis Corp., which owns it, and the federal Biomedical Advanced Research and Development Authority, a branch of the Department of Health and Human Services.

Dr. Michael T. Osterholm

The HHS goal was to boost capabilities for U.S.-based production of influenza vaccine, specifically cell-based vaccine production using cultured canine kidney cells. The facility, which would produce as much as 200 million doses of influenza vaccine for a pandemic, would receive FDA approval for a pandemic vaccine on a case by case basis as its production began to scale up.

The FDA’s action in June licensed the seasonal influenza vaccine made by the cell-culture process. The facility can produce at least 50 million doses of seasonal influenza vaccine each season, according to the announcement.

The Holly Springs cell-culture facility was seen by experts as an important way to broaden the scope of U.S. influenza vaccine production while also hastening the availability of significant amounts of vaccine for a pandemic, cutting the lag to vaccine appearance by perhaps as much as 1 month. But one expert criticized the facility as being inevitably archaic by producing a conventional, hemagglutinin-based vaccine that is "inadequate for providing the kind of immunologic protection we need," Michael T. Osterholm, Ph.D., said when the facility first opened.

"Just because you can make more of this [vaccine] faster, what does that mean? It’s better than nothing, absolutely, but that doesn’t mean it will be the answer for a very serious pandemic," said Dr. Osterholm, director of the center for infectious disease research and policy at the University of Minnesota in Minneapolis.

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