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FDA Approves Swine Flu Vaccine
From: Campbell Rebecca
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Sent: Tuesday, September 15, 2009 8:03 PM
Subject: FDA Approves Swine Flu Vaccine
Sebelius says FDA has approved swine flu vaccine
New Mexico Business Weekly
The U.S. Food and Drug Administration has OK’d the H1N1/swine flu vaccine, opening the door to its use as soon as manufacturers are ready to deliver supplies.
The department’s approval was announced Tuesday morning to Congress by Kathleen Sebelius, secretary of Health and Human Services.
Separately the FDA said it has approved vaccines made by four manufacturers against the 2009 version of the H1N1 influenza virus, which should be distributed nationally within four weeks. "The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines," said Jesse Goodman, M.D., FDA acting chief scientist.
Late last week, the National Institute of Allergy and Infectious Diseases said the swine flu vaccine had been tested, was safe, and could provide immunity from the disease with just one dose.
The federal government has ordered enough vaccine for an estimated 195 million doses, and approximately 45 million doses should be ready by mid-October for individuals in high-risk categories, including doctors, nurses, other health care workers, pregnant women, people who come into contact with children, older adults, children between six months and 24 years of age, and other targeted groups. Cumulatively, that includes an estimated 160 million Americans.
Manufacturers working on the now-approved vaccine include Australia’s CSL Ltd., Switzerland’s Novartis, France’s Sanofi-Pasteur and Maryland-based MedImmune, which makes an inhalable version.
Some supplies may be available by early next month, officials said, and ultimately should be delivered to some 90,000 sites nationwide, according to Sebelius.
Chris Rauber of the San Francisco Business Times, an affiliated publication, compiled this report.
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