Pharmaceutical

FDA approves first flu shot using animal cell technology

fda logo FDA approves first flu shot using animal cell technologyThe first seasonal flu vaccine using animal cell technology instead of the 50-year-old egg method has been approved by the Food and Drug Administration (FDA). The new flu shot, Flucelvax, is made by Novartis and is approved for people 18 years and older.

The newly approved vaccine is desirable because it takes less time to produce than the egg method, which medical experts say is ideal in the event of a pandemic.

The older flu shots are made from virus samples that are injected into specialized chicken eggs. The eggs are incubated and, after some time, the egg fluids are harvested, concentrated and purified to make the vaccine.

The new method uses small amounts of virus that are put into fermenting tanks with nutrients and mammal cells. The virus is inactivated, purified, and then put into vials.

Tests on the vaccine compared to placebo were conducted during the 2007-2008 flu season in the United States, Finland, and Poland. The flu shot had an 83.3 percent efficacy in preventing the infection, about the same as vaccines made with the egg method. Side effects with the new shot were also similar in type and frequency to the older treatment.

Novartis says it is partnering with the government to build a $1 billion manufacturing plant in North Carolina. Until that facility is complete, the drug company it is not ready for full-scale production of the new vaccine.

Source: MedPage Today