FDA Approves First U.S. Plant to Make Cell-Based Flu Vaccine


The Food and Drug Administration has licensed a first-of-its-kind facility in the United States to manufacture cell-based flu vaccines. The plant is located in Holly Springs, North Carolina is owned by pharmaceutical company Novartis.

The vaccine, Flucelvax, will now be produced in the U.S. for the first time. It’s the first FDA-approved seasonal influenza vaccine manufactured without chicken eggs; it does not contain any antibiotics or preservatives.

Flucelvax is made with flu viruses grown in mammalian cell cultures. The cells can be banked, and since there’s no need for an egg supply, Novartis said production is faster and more flexible.

Government health officials invested $487 million in constructing and certifying the plant as a place that would be able to quickly manufacture vaccines in the case of a flu pandemic. The facility is a public-private partnership between Novartis and the Biomedical Advanced Research and Development Authority, a division of the U.S. Department of Health and Human Services.

The facility opened in 2011 and has produced pre-pandemic H5N1 vaccines. This plant gives the FDA more control over the quality and supply of flu vaccines, since currently much of the U.S. supply is made in other countries.

With the same technology used to make Flucelvax, Novartis has developed a vaccine candidate for the H7N9 avian influenza virus that has infected people in China. The company said it has supplied the U.S. government with a stockpile of that vaccine.

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