FDA approved first seasonal influenza vaccine manufactured using cell culture technology

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On Nov. 20, 2012, the U.S. Food and Drug Administration (FDA) announced it had approved first seasonal influenza vaccine named Flucelvax manufactured using cell culture technology by Novartis.

The vaccine was produced using cultured animal cells rather than fertilized chicken eggs. Although mammalian cell culture has long been used for production of other vaccines. In a randomized, placebo-controlled trial involving 7,700 people aged 18 to 49, Flucelvax was 84% effective in preventing influenza. In a separate study involving about 1,700 individuals aged >49, immunogenicity was similar to that of an egg-based vaccine.

This technology was expected to reduce the start-up time for developing vaccines based on assessment of annual antigenic drift, thus potentially improving the match between vaccines and circulating influenza virus strains.

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Source: New England Journal of Medicine
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