Novartis Flu-Vaccine gets FDA approval: Report

on Wednesday, 21 November 2012. Posted in News, Products and Guidelines Written By: HealthTzars News Group

Novartis Flu-Vaccine gets FDA approval: Report

The Food and Drug Administration in the US recently announced its approval for a seasonal flu vaccine produced by the leading drug manufacturer, Novartis. 

This vaccine is said to use animal cell culture in place of the traditional method of manufacturing using chicken eggs. The new procedure is claimed to be helpful in building stockpiles owing to the speedier process involved in case of an outbreak of a pandemic.

The vaccine will be sold by Novartis under the brand-name of 'Flucelvax' and will prevent seasonal influenza or flu in people aged 18 years and above. In order to produce this vaccine; virus-strains from the vaccine are grown in animal cell cultures derived from mammals in place of egg-based process.

Traditional flu vaccine production in chicken eggs requires a large number of fertilized eggs in order to grow the virus strains which take several months to become ready for delivery to physicians or pharmacies. FDA said that similar cell culture technology has already been used for a while to produce other types of vaccines.

The cell-based production of the vaccine would enable manufacturers to maintain a steady supply of readily available cells which are previously tested which can be put into use for the production of the vaccine. Andrin Oswald who heads the Vaccine and Diagnostic division in Novartis said that cell-culture technology could well become the new standard fort production of vaccine against influenza.

Sources from Novartis said that this new vaccine will be manufactured at a new plant at Holly Springs located at North Carolina after the facility is made ready for full-sale production. The facility is expected to have a sterile and controlled environment which will reduce the risk of potential impurities.

During clinical trials, the new vaccine was found to be effective in 83.8 percent cases in preventing the flu as compared to a placebo. According to Liz Power who is the spokesperson for Novartis, a limited supply of the vaccine will be made available for the flu-season this year. 

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