The FDA approved Novartis' ($NVS) novel flu vaccine produced using cultured animal cells instead of the traditional manufacturing process that uses fertilized chicken eggs.
Flucelvax is approved for use in people 18 and older, the FDA says. The virus strains for Novartis' newly approved vaccine are grown in mammal cells rather than in eggs. The technique is not new; cell-culture technology has been used for several decades to produce other U.S.-licensed vaccines, the regulator said.
Cell-culture technology proves advantageous because it allows the vaccine manufacturing process to be started more quickly in the event of a pandemic.
A clinical study of Flucelvax in the U.S. and Europe involved 7,700 people ages 18 to 49. The individuals received either a dose of the vaccine or a placebo. The study showed Flucelvax was 83.8% effective in preventing the flu compared with placebo.
"The approval of Flucelvax is an important milestone for our influenza franchise and brings an innovative vaccine to the U.S.," Andrin Oswald, head of Novartis Vaccines and Diagnostics, said in a statement. "Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way."
- see the FDA release
- here's more from Novartis
- get Reuters' take
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