Video: FDA approves swine flu vaccine

  1. Closed captioning of: FDA approves swine flu vaccine

    >>> now.

    >>> good evening, the message from the u.s. government and the news media has been that it's going to take at least two flu shots this season rk one for the regular or seasonal flu and the other for the swine flu that continues to spread. the question is, when will the swine flu shots be ready. tonight, the government gave us the answer. it is ready. we have details from our chief correspondent, robert bazell .

    >> reporter: the fda approved the swine flu vaccine. it should arrive in four weeks or sooner.

    >> i appreciate the opportunity to give you an update --

    >> reporter: kathleen sebelius gave us an update.

    >> just so i understand, this drug is not yet fda approved?

    >> it was today.

    >> reporter: they are buying it and distributing it to states. recommends certain the cdc@$% groups get it first, including pregnant women , health care workers and people 6 months to 24 years old. each state will decide how to allocate the vaccine. members of the target group may have trouble getting it.

    >> we have to keep working at making sure those who want the vaccine will get it. they may have to make two or three phone calls to get it. not every provider will have it the first day it's available.

    >> reporter: because of a problem in a 1976 vaccination campaign with a different swine flu that resulted in paralysis, sebelius heard about the safety of the vaccine.

    >> we are assured by the scientist that lots of steps have been taken along the way to make sure it will be a safe procedure.

    >> reporter: the swine flu vaccine can be a shot or inhaled nasal spray . people will be encouraged to get the swine flu vaccine and the really flu. experts are not sure how many will want the swine flu shot. the demand will depend og the risk.

    >> robert bazell in our new york studios, thanks.

    >>> now to politics in washington.

updated 9/15/2009 7:22:32 PM ET 2009-09-15T23:22:32

The Food and Drug Administration approved the new swine flu vaccine Tuesday, a long-anticipated step as the government works to get vaccinations under way next month.

Health and Human Services Secretary Kathleen Sebelius announced the vaccine's approval to Congress — and said she hopes to get the first limited supplies distributed early in October.

The bulk of vaccine will start arriving Oct. 15, and Sebelius said it should be available at 90,000 sites around the country.

"We will have enough vaccine available for everyone" eventually, Sebelius said — everyone who wants it, that is.

The government has ordered 195 million doses for now but may order more if needed, she said. Typically 100 million Americans seek flu vaccine every year.

But the vaccine, which protects against what doctors prefer to call the 2009 H1N1 flu strain, won't arrive all at once. About 45 million doses are expected by mid-October. That's why the government wants the people most likely to catch swine flu, and to suffer complications from it, to be first in line — including children and pregnant women.

FDA licensure means that the government has certified the vaccine is made properly and meets specific manufacturing and quality standards. Separately, the National Institutes of Health is studying the vaccine dosage and safety. Last week, the NIH announced that one dose appears to protect adults — and that that protection kicks in eight to 10 days after the shot.

Studies in children and pregnant women are continuing.

The vaccine approved Tuesday is made by CSL Ltd. of Australia; Switzerland's Novartis; Sanofi-Pasteur of France; and Maryland-based Medimmune, which makes the only nasal-spray flu vaccine.

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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