Reuters: Regulatory News: UPDATE 1-FDA approves novel Novartis seasonal flu vaccine

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UPDATE 1-FDA approves novel Novartis seasonal flu vaccine Nov 20th 2012, 23:13 Tue Nov 20, 2012 6:13pm EST * First U.S. approved flu vaccine using animal cell cultures * Process is faster than growing virus in chicken eggs * Novartis will produce vaccine in new North Carolina plant Nov 20 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it approved a seasonal flu vaccine produced by Novartis using animal cell culture rather than the traditional manufacturing using chicken eggs - a speedier process that could help build stockpiles in the event of a pandemic. The vaccine, to be sold by the Swiss drugmaker under the brand name Flucelvax, is approved to prevent season influenza in people aged 18 and over, the agency said. To produce Flucelvax, virus strains for the vaccine are grown in animal cell cultures derived from mammals instead of in chicken eggs. Similar cell culture technology has long been used to produce other types of vaccines, FDA said. "Today's approval represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process," Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. Using cell cultures rather than chicken eggs allows for a faster start-up of the vaccine manufacturing process in the event of a health crisis, such as a flu pandemic. Traditional flu vaccine production requires a tremendous number of fertilized chicken eggs to grow virus strains and often takes several months before it is ready to be delivered to physicians or pharmacies. The cell-based process also enables manufacturers to maintain a supply of readily available, previously tested cells for use in vaccine production. "Modern cell-culture technology will likely become the new standard for influenza vaccine production," predicted Andrin Oswald, head of Novartis' vaccines and diagnostics division. Flucelvax will eventually be manufactured at a new U.S. plant in Holly Springs, North Carolina, once that facility is ready for full-scale commercial production, Novartis said. The production takes place in a sterile, controlled environment, which significantly reduces the risk of potential impurities, the company said. In clinical trials, Flucelvax was 83.8 percent effective in preventing flu when compared with a placebo. A limited supply of the new vaccine will be available for this year's flu season, Novartis spokeswoman Liz Power said. Novartis supplies the United States with about 30 million doses of flu vaccine annually, she said. Link this Share this Digg this Email Reprints

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