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FDA Approves New Type of Flu Vaccine
Date:1/16/2013

WEDNESDAY, Jan. 16 (HealthDay News) -- The U.S. Food and Drug Administration has approved a novel type of flu vaccine, the agency announced Wednesday.

Flublok, as the vaccine is called, does not use the traditional method of the influenza virus or eggs in its production. Instead, it is made using an "insect virus (baculovirus) expression system and recombinant DNA technology," the FDA said in a news release. This will allow vaccine maker Protein Sciences Corp., of Meriden, Conn., to produce Flublok in large quantities, the agency added.

The vaccine is approved for use in those aged 18 to 49.

"This approval represents a technological advance in the manufacturing of an influenza vaccine," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. "The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus."

While the technology is new to flu vaccine production, it has been employed in the making of vaccines that prevent other infectious diseases, the agency noted.

As it does with all influenza vaccines, the FDA will assess Flublok before each flu season. In research conducted at various sites in the United States, Flublok was about 45 percent effective against all circulating influenza strains, not just the strains that matched those in the vaccine. The most commonly reported adverse reactions included pain at the site of injection, headache, fatigue and muscle aches -- events also typical for conventional flu vaccines, the agency said.

The new flu vaccine could not have come at a better time, with the flu season well under way and sporadic shortages of both the traditional flu vaccine and the flu treatment Tamiflu.

"We have received reports that some consumers have found spot shortages of the vaccine," FDA Commissio
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