Home Science Health FDA approves new flu vaccine

The U.S. Food and Drug Administration (FDA) has approved the new influenza (flu) vaccine Flucelvax from the Swiss drug comppany Novartis AG.

Novartis AG is a drug company from Switzerland. On Tuesday, November 20, 2012, the company was approved to provide a new flu vaccine that uses – for the first time – animal (mammalian) cells instead of chicken eggs, as is used in the other flu vaccines.

The Novartis AG division called Vaccines and Diagnostics is located in Cambridge, Massachusetts. It spearheaded the development of the new vaccine Flucelvax.

Flucelvax has been approved by the FDA to treat people with seasonal influenza who are 18 years of age and older. Novartis AG states that its flu vaccine contains no preservatives or antibiotics. The company makes the vaccine from its facility in Holly Springs, North Carolina.

The November 20, 2012 FDA news release FDA approves first seasonal influenza vaccine manufactured using cell culture technology tells the story of its approval of Flucelvax.

Karen Midthun, the director of the FDA’s Center for Biologics Evaluation and Research made the following statement on the FDA’s new approval of Flucelvax: “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.”

The FDA press release also stated, “Flucelvax was evaluated in a randomized controlled clinical study conducted in the United States and Europe that involved about 7,700 people ages 18 to 49 years who received either Flucelvax or a placebo.”

And, “The study showed that Flucelvax was 83.8 percent effective in preventing influenza when compared to placebo.”

In conclusion, “The use of Flucelvax in people older than 49 is supported by antibody responses in about 1,700 adults which showed it to be comparable to Agriflu, an egg-based seasonal influenza vaccine approved by FDA for use in people 18 years and older.”

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William Atkins

William Atkins completed educational degrees in science (bachelor’s in physics and mathematics) from Illinois State University (Normal, United States) and business (master’s in entrepreneurship and bachelor’s in industrial relations) from Western Illinois University

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