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FDA Approves Flucelvax, First Cell-Culture Flu Vaccine in U.S.

Cell-culture technology allows faster start-up in event of pandemic (Nov. 20)

The FDA has approved Flucelvax (Novartis), the first U.S.-licensed seasonal influenza vaccine produced using cultured animal cells instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in adults aged 18 years and older.

The manufacturing process for Flucelvax is similar to the egg-based production method, but a significant difference is that the virus strains included in the vaccine are grown in animal cells of mammalian origin instead of in eggs. Cell-culture technology (CCT) has been in use for several decades to produce other U.S.-licensed vaccines.

CCT is another manufacturing alternative to conventional egg-based influenza vaccine production. The advantages of CCT include the ability to maintain an adequate supply of readily available, previously tested and characterized cells for use in vaccine production and the potential for a faster start-up of the vaccine manufacturing process in the event of a pandemic.

Flucelvax was evaluated in a randomized controlled clinical study conducted in the U.S. and Europe that involved approximately 7,700 adults aged 18 to 49 years who received either Flucelvax or placebo. The study showed that Flucelvax was 83.8% effective in preventing influenza compared with placebo. The use of Flucelvax in individuals older than 49 years is supported by antibody responses in approximately 1,700 adults, which showed that Flucelvax was comparable with Agriflu (Novartis), an egg-based seasonal influenza vaccine approved by the FDA for use in adults aged 18 years and older.

The safety evaluation included approximately 6,700 individuals who received Flucelvax in controlled clinical studies. Injection-site and general reactions to Flucelvax were typical of those seen with current influenza vaccines. Pain, redness, and soreness at the injection site, headache, and fatigue were the most common adverse reactions.

Source: FDA; November 20, 2012.

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