FDA Approves New Flu Vaccine Produced Without Eggs

from fiercebiotech.com

The FDA approved Novartis' novel flu vaccine produced using cultured animal cells instead of the traditional manufacturing process that uses fertilized chicken eggs. Novartis will use a process to manufacture its seasonal flu vaccine at its new plant in Holly Springs, NC, that is based on animal cell cultures and so will cut weeks off production times.

The FDA approved the approach for Novartis Flucelvax a few days ago, saying it provides "the potential for a faster startup of the vaccine manufacturing process in the event of a pandemic." The method is used to make other kinds of vaccines. Novartis has received about $500 million in support from the U.S. government for the Holly Springs plant as part of a program that gives the government say over production in the event of a pandemic. Novartis says the joint investment in the technology and plant is about $1 billion.

The Swiss company will use a cell-culture system derived from the kidney of a dog, The Wall Street Journal said. Using mammal cells will shave about four weeks off the process compared with using eggs and eliminates the need to keep a stock of eggs. Novartis uses the same process at a plant in Germany. Novartis says the North Carolina plant will be the first of its kind in the U.S.

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