FDA Approves H1N1 Vaccine

(CBS/AP)  Updated 6:35 p.m. EDT.

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.

"There's no doubt we're in a race - .the virus versus the vaccine," Dr. William Schaffner of the Vanderbilt University Medical Center told CBS News medical correspondent Dr. Jon LaPook. "So the sooner we can get the vaccine and get it into people, the more likely we are to truncate this epidemic."

Swine flu information on the Web

CBSNews.com H1N1 section
Flu.gov
CDC Flu advice
CDC Flu Questions and Answers

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.

The FDA said that in clinical studies, a single does has proven effective for adults, who achieve full protection eight to 10 days after the dose is administered. The agency said that dosing for children is still being studied and that all dosing information is subject to change as clinical studies continue

The vaccine approval is timely. The CDC has found that flu activity is increasing around the country and has been found in all 50 states. For the week ending Sept. 4, nearly 5,000 new cases surfaced on college campuses, LaPook reports. The Southeast (2,414 cases) and Mid-Atlantic (515 cases) were hardest hit.

And new studies indicate the H1N1 virus lingers longer than previously thought. One study found 40 percent of patients may still be contagious seven days after symptoms began.

"I think we're learning that this virus is the seasonal virus, a little bit on steroids." Schaffner said. "It seems to be spread for a more prolonged period of time after people get completely well."

That's another reason why the government is promoting prevention, through a lighthearted public service announcement contest on YouTube, featuring entries such as this one.

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.

[jac5167]

My mother-in-law who is a doctor recently took the H1N1 vaccine. That very day she began to have stroke-like symptoms. Tests showed that it wasn't a stroke, and that her symptoms were from the vaccine. This was last week. Currently her entire left arm and side are paralyzed.

[adt090876]

My parent is a physician who received the vaccine. That evening, he had stroke like symptoms (couldn't walk, fell down). He suspected it may be from the vaccine before going to ER, tests at hospital could not confirm stroke. Scary.

[DrRiskie]

It's wonderful that vaccines have been created before this virus really becomes out of control. Yes, the <a href="http://www.pediatricsupersite.com/view.aspx?rid=43763">FDA approves vaccines for influenza A</a>. So which drug companies will be reaping the benefits from this?

[wdh3007]

Do you need a public option for this vaccine or or does private insurance cover it? Did the Government create N1H1? The FDA sure came up with a vaccine really quick!

[mollydtt]

I've never had my insurance cover the cost. The cost is 100 per cent the cost of the vaccine, administered by a nurse. Lately, though, I've been able to get a flu shot through a public reduced-cost program, so I've only had to pay 10 dollars. It's nice that the government has decided which groups should get the vaccine first, but they will probably have to pay full price, even with insurance.

[maxcoffee-2009]

If the President comes out and tells America that Americans should get the Vaccince, do you think that Repbulicans will protest it. Like the School speech... 'Don't tell my kid to get the vaccine!' 'little Billy isn't going to have a vaccine because the President thinks its a good idea."
Something like that...
It could happen...

[G-I_Jesus]

Horror Movies Never Finish Well!

You are not out of the woods yet. Here comes the H2N2 virus!

[hologram5]

Yes, just released from a lab near you!

[mollydtt]

LOL! I think you are onto something there!

[mollydtt]

The Spanish flu back in 1918 was a type of H1N1 flu. Healthy people got sick and many died within 24 hours. There was so little natural immunity in people that their immune reactions were activated to the point that even healthy cells were killed off. I am planning on getting an H1N1 flu shot when it is available, but I also feel that having lived long enough to have some natural immunity to some of the past flu strains is a definite advantage. I worry most about those that are 25 years old and younger.

[baileyccc]

The "Snake Oil" of western medicine is for sale. The dismal history of vaccine makes this a shot for the truly uninformed. You can rest assure that a large majority of health care professional won't be taking this shot. Posted by Baileyccc

[mason_man112]

So the end begins. They are obviously rushing this vaccine. It's about to get real ugly.

[woeisme1]

You'll feel like a terribly sick fool if you catch this illness won't you?

[hologram5]

ALready had it so no, I don't feel like a fool. You?

[hologram5]

Again I say, "You first"!!

[hologram5]

So I don't have any fools replying saying I'll be sorry, I have already had it and got over it in less than 5 days. It wasn't that bad at all.

[momnextdoor-2009]

They have done R&D and testing--I know because I was a volunteer in the testing. Yes, it's 'rushed' to market--just like every single seasonal flu vaccine because of the nature of the flu viruses. And lobbyists had nothing to do with it. It's also dangerous to tell people "I had the flu, it wasn't bad". While it has been milder for most people, there are many people at risk, especially young adults, children and certain at-risk groups; encouraging someone not to get the vaccine who really needs it could be endangering their lives. Do you really want to be the one to tell a grieving parent of a dead college student hat you helped influence their child not to get the shot? And finally 'the history of vaccines' has been absolutely stellar--billions of lives saved world-wide. In fact most of you wouldn't be here to post if it weren't for the vaccines you got as children. I read these comments and am amazed how many people in this country don't have critical thinking skills.