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FDA approves Flucelvax influenza vaccine

The FDA has approved the first seasonal influenza vaccine that was produced using cultured animal cells, instead of fertilized chicken eggs.

The vaccine, Flucelvax (Novartis) includes virus strains that are grown in mammalian animal cells, instead of in the egg. According to an FDA press release, this technology has been used for several decades to produce other vaccines that are licensed in the United States.

“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, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the press release.

Cell culture technology has several advantages, including the ability to maintain a supply of tested and characterized cells readily available to produce the vaccines. Also, they provide the potential for faster start-up of vaccine manufacturing in pandemics.

The vaccine was evaluated in a randomized trial that included 7,700 people aged 18 to 29 years in the United States in Europe. Flucelvax was 83.3% effective compared to placebo. In the safety evaluation, injction site reactions and other reactions were similar to those seen with current influenza vaccines, and included pain, redness and soreness at the injection site and headache and fatigue.