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Cell-Based Flu Vaccines

Questions & Answers

On November 20, 2012, the U.S. Food and Drug Administration (FDA) approved the use of Flucelvax,  the first U.S.-licensed (trivalent inactivated) influenza vaccine manufactured using cell culture technology for use in people 18 years and older. In May 2016, FDA approved a quadrivalent (four component) inactivated formulation of Flucelvax [193 KB, 19 pages], approved for use in people 4 years and older.

What are cell-based flu vaccines?

‘Cell-based’ refers to how the flu vaccine is made. Cell-based flu vaccines are made by growing viruses in animal cells. Cell-based flu vaccines are developed through a different manufacturing process than the traditional egg-based manufacturing process that is used to develop flu vaccines. Cell-based influenza vaccines are similar to the egg-based influenza vaccines, but a significant difference is that the influenza A and B viruses included in the cell-based vaccine are grown in cultured cells of mammalian origin instead of in hens’ eggs.

How is the cell-based vaccine manufacturing process different than the traditional egg-based manufacturing process?

In place of fertilized chicken eggs, the cell-based vaccine manufacturing process for Flucelvax uses animal cells (Madin-Darby Canine Kidney, or MDCK) in liquid culture as a host for the growing influenza virus.

Why are cell-based flu vaccines being developed?

Cell-based flu vaccines are being developed as an alternative to the egg-based manufacturing process. Cell culture technology is potentially more flexible than the traditional technology, which relies upon adequate supply of eggs.

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What are the possible benefits of using cell-based influenza vaccines?

A major advantage of cell culture technology includes the potential for a faster start-up of the vaccine manufacturing process in the event of a pandemic. The cells used to manufacture Flucelvax are kept frozen and “banked.” Cell banking assures an adequate supply of cells is readily available for vaccine production. Growing the influenza viruses in cell culture for the manufacture of Flucelvax is not dependent on an egg supply.

What were the results of the clinical trials using cell-based technology?

Clinical studies demonstrate that Flucelvax is safe and effective for use in individuals 4 years of age and older. General reactions to Flucelvax were typical of those seen with current influenza vaccines. Pain, redness and soreness at the injection site and headache and fatigue were the most common reactions.

Has cell-based technology been used before?

Cell culture technology has already been used to produce other U.S.-licensed vaccines, including vaccines for the following diseases: rotavirus, polio, smallpox, hepatitis, rubella and chickenpox.

Cell-based flu vaccines have been approved for use in multiple European countries.

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