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This Article is From Sep 16, 2009

US approves new H1N1 vaccine

US approves new H1N1 vaccine
Washington: The US Food and Drug Administration (FDA) approved the new swine flu vaccine on Tuesday, a long-anticipated step as the US government works to get vaccinations underway next month.

Health and Human Services Secretary Kathleen Sebelius told lawmakers on Tuesday that limited supplies should start trickling out the first week of October - about a week earlier than expected.

Then, about 45 (m) million doses should arrive around October 15, followed by more shipments each week.

Testifying before a House committee, Sebelius said the FDA had "approved applications for vaccines from four of the manufacturers of the US-licensed seasonal influenza vaccines."

"The vaccines for this virus are being produced under careful FDA oversight using the same license manufacturing processes and facilities used for seasonal flu vaccines," she added.

Sebelius said the vaccine will be available at up to 90,000 sites across the US, including schools and clinics that state health departments have deemed best to get the shots out fast.

She said the government had already ordered 195 (m) million doses, but may order more if there was enough demand.

Contradicting earlier reports that the swine flu - or H1N1 - vaccine would be in short supply, Sebelius said eventually, there will be "enough vaccine available for everyone. There is enough on order."

But she said the government's initial concern was  getting the vaccine "to the priority populations as quickly as possible," such as children and pregnant women - who were most likely to catch swine flu, and to suffer complications from it.

Sebelius announced the FDA's approval of vaccine made by four of the expected five manufacturers: CSL Ltd. of Australia, Switzerland's Novartis Vaccines, Sanofi Pasteur of France - which produces flu shots at its Swiftwater, Pennsylvania factory - and Maryland-based MedImmune LLC, which makes the only nasal-spray flu vaccine.
London-based GlaxoSmithKline was also expected to supply vaccine.

Sebelius said only that a fifth manufacturer's vaccine was expected to be approved soon, pending some final steps.

Getting licensing from the FDA means that the vaccine is made properly and meets specific manufacturing and quality standards.

The H1N1 vaccine seems just as safe as the long-used regular flu vaccine, the FDA said, not a surprise as it's made the same way.

Side effects include soreness or redness at the injection site and some fever.

Swine flu figures

According to World Health Organisation figures from four days ago, the total number of swine flu cases reported across the globe was 2,77,607 and the number of deaths reported was 3,205

WHO though warned that given that countries are no longer required to test and report individual cases, the number of cases reported actually understated the real number of cases.

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