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FDA Approves New Flu Vaccine
Date:9/28/2007

That should ensure adequate supply for coming influenza season, officials say

FRIDAY, Sept. 28 (HealthDay News) -- With flu season fast approaching, U.S. health officials announced Friday the approval of a new vaccine intended for people 18 and older.

The vaccine, called Afluria, is designed to protect adults from influenza viruses type A and type B.

"Today's action is important, because it brings to six the number of companies licensed to supply flu vaccine in the United States," Dr. Jesse L. Goodman, director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, said during an afternoon teleconference.

Goodman noted that in 2000, there were only three manufacturers of flu vaccine for the United States. In 2004, one manufacturer had problems with the sterility of its British production facility, which caused a severe shortage of vaccine in the United States.

Since then, the FDA has been looking for other vaccine manufacturers to fill the gap and ensure that even if there were a problem with one manufacturer, there would still be an adequate supply, Goodman said.

Afluria was approved using the FDA's accelerated approval process, said Norman Baylor, director of FDA's office of vaccines research and review.

"This process allows the agency to approve products for serious or life-threatening diseases based on early evidence of the product's effectiveness," Baylor said at the teleconference. "This accelerated approval process can reduce the time for needed medical product to become available to the public."

Afluria is made by CSL Limited of Parkville, Australia. The company is expected to supply about 2 million doses of the vaccine to the United States market this year.

The approval means there will be an estimated 132 million doses of flu vaccine for the 2007-2008 influenza season. That's 10 million doses more than last year, officials said.

The Afluria vaccine is made with inactivated influenza viruses grown in chicken eggs. Those allergic to eggs or any other component of the vaccine should not receive the vaccine, officials said.

The most common side effects are tenderness, pain, redness and swelling at the injection site, and headache, fatigue and muscle aches.

Flu season in the United States can start in October and last until May. More than 200,000 people are hospitalized with influenza each year in the country, and about 36,000 people die annually from complications from the disease, according to the U.S. Centers for Disease Control and Prevention.

The CDC recommends that people should get their flu shot starting in September, but it's worthwhile to get a shot as late as January.

The CDC says anyone looking to avoid the flu should get vaccinated. But those at high risk for complications from the flu should get a shot. Those people include: children aged 6 months to 5 years old; pregnant women; people 50 years of age and older; people of any age with certain chronic medical conditions; and people who live in nursing homes and other long-term care facilities.

Also urged to get vaccinated are people who live with or care for those at high risk for complications from flu, including health-care workers.

More information

To learn more about the flu, visit the CDC.



SOURCES: Sept. 28, 2007, teleconference with Jesse L. Goodman, M.D., M.P.H., director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.; Norman Baylor, Ph.D., director, office of vaccines research and review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration


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