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FDA approves H1N1 swine flu vaccines

swine flu vaccine approved fdaThe U.S. Food and Drug Administration approved the long-awaited vaccines for the H1N1 "swine" flu virus this afternoon. It is expected to be available in a month at about 90,000 locations nationwide, the Associated Press reported

"We will have enough vaccine available for everyone," Kathleen Sebelius, Health and Human Services Secretary, said in an address to Congress today, the AP reports. The government, which does not expect everyone to get the vaccine, has an order out for 195 million doses, but only about 45 million are expected to be available by mid-October. The announcement from the National Institutes of Health (NIH) last week that one dose is sufficient to protect against the virus means supplies will be more robust than they might otherwise have been. Nevertheless, the government is prepared to order more if necessary.

The vaccines, which have been in clinical studies in the U.S. since June, are made by four different firms.

"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," Jesse Goodman, acting chief scientist at the FDA, said in a prepared statement.

Given the initially limited availability of the vaccine, the government still recommends that those who are most likely to have complications from the flu, including children and pregnant women, should be the first in line for the shots.

At least one million people in the U.S. have likely been infected with the virus since April, according to the Centers for Disease Control (CDC), and 593 people have died, including about 40 children. The seasonal flu infects from 5 to 20 percent of the U.S. population every year and kills about 36,000, according to the CDC. Unlike the seasonal flu, the H1N1 swine flu virus has been found to be contagious for about a week after symptoms have receded. Researchers are recommending people with the flu stay home for several days even after they start feeling better.

Image courtesy of iStockphoto/VCTStyle

Tags: swine flu, H1N1, vaccine
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  1. 1. hellblade 08:32 PM 9/15/09

    i don't get it. millions of people die of heart disease and cancer, and a lot die of regular seasonal influenza, yet these "animal flus" that are quite benign in comparison are constantly pushed as the world's prime health concern.

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  2. 2. Beth 10:31 PM 9/15/09

    Hellblade, perhaps this can help you understand why the entire world led by the medical profession is focused on H1N1. It is because it has never been introduced into the human population before and therefore is "pandemic" which means it will infect more than 50% of the population everywhere in the world. There is no present immunity. There is concern that the health system will be overloaded by huge numbers of sick people and even that the basic services will not function properly.
    Further, without previous immunity in the population, you see a large number of deaths in the younger population rather than the older. The outcomes of a new organism on the population are not the same as the outcomes of a previously existing one.

    Also, when a pathogenic organism jumps from one species to another, it is cause for concern. Trans-special infections are not natural and create...guess what....a pandemic such as what we are facing now.

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  3. 3. Beth 10:33 PM 9/15/09

    @hellblade.....PS....are you sure you were at the right site
    here. Did you take a wrong turn from Sports Illustrated and landed here by mistake?

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  4. 4. Shemlock 11:22 PM 9/15/09

    Beth,

    There's no reason to get upset. Hellblade was asking a legitimate question, which you effectively answered. These comments and sciam is about freely sharing information. Once you start infusing emotional jabs you inhibit others from sharing info and run the risk of having your innate bias overpower your reasoning and ability to learn.

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  5. 5. Catgotmytounge 12:41 AM 9/16/09

    Food for thought...Doing some math, take these #'s for whatever they mean to you. P.S. Beth, there was a prev. H1N1 pandemic in the late 19teen's, and there is likely (thankfully) improved immunity developed by those folks who were exposed (and are still around with us) at that point in time.

    1 million infected in US (at least), 593 deaths = 1/20th of 1% of those infected die of H1N1.

    Of other influenza "A" and "B" strains that typically infect the US, there is 5% to 20% (15 million to 60 million using pop. of 300 million in US) infectious rate with ~36,000 deaths. These other viral strains produce higher (1/4 of 1% to 1/16 of 1%, respectively) mortality rates than does this H1N1.

    Simply putting the #'s out there, basically my thoughts that this is just another flu virus, and not a need to be a huge concern. Educate yourselves on what the signs and symptoms are, take precautions to prevent transmission to yourself (some may think that means vaccination, and if you want to do that, go for it; others may think that means taking extra precautions to stay clean and prevent airborne transmission), and if you are infected let those around you know and keep yourself away from those who are not infected. The world will continue to turn, don't panic and turn a mole hill into a mountain.

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  6. 6. Catgotmytounge 01:06 AM 9/16/09

    My apologies. 19teen's H1N1 was a human virus, not swine. I stand corrected.

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  7. 7. sicily726 01:41 AM 9/16/09

    Thank you, catgotmytounge. In light of your analysis, the 1976 government promoted swine flu scare and vaccine travesty that followed, there is no way I'm succumbing to this latest government sponsored swine flu scare nor the push to get a vaccine approved by a fatally flawed FDA. Fool me once, shame on you. Fool me twice, shame on me:

    Check out the 1979 CBS 60 Minutes program about the 1976 Swine Flu scare and the lives ruined by the vaccine they had back then:

    http://www.youtube.com/watch?v=JD6UyEP3qEg

    http://www.youtube.com/watch?v=pUZfAaXok3E

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  8. 8. til 07:17 AM 9/16/09

    @Catgot mytongue:
    I thought the present "swine flu" is also at least partially a "human" virus. I guess that doesn't really matter so much anyway, I should think some of the older flus would be a combination with some animal virus as well, and actually some of the real swine flus would be coming from human flus as well.

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  9. 9. Spiff 02:41 PM 9/16/09

    As long as the CDC lingers under a political party administration appointee , there will always be doubt about the sincerity of its data...

    Reply | Report Abuse | Link to this
  10. 10. huyidian in reply to hellblade 09:43 AM 9/17/09

    ok~

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  11. 11. jh443 01:57 PM 9/17/09

    Actually Beth, H1N1 has been around before. There is presently an immunity to it... you just had to be exposed to it in the 70's to get it.

    This is why the younger people are catching it in disproportionate numbers. It didn't become a pandemic in the 70's, and it's not going to become one today. Despite the scary name due to its protein shell, it just doesn't have what it takes. It's not that communicable, nor is it very fatal to those who do get it.

    I'm all in favor of a vaccine. I consider most of the reports of adverse effects of the last swine flu vaccine to be blown way out of proportion. But we don't need to get all bent out of shape until it arrives.

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  12. 12. Beth 06:03 PM 9/17/09

    I was sarcastic because of frustration. So much factual information has been painstakingly disseminated across all
    communication lines in this country. Yet, without considering any available information, people review an article and make comments such as "Why are they making such a big deal?" Yes, it's a legitimate question, but all the answers can be broken down to their basic levels anywhere on line or in mainstream media. There are suggested basic preparatory actions CDC and the govt are asking people to do, such as having a months' worth of food, water and medications per person on hand as well as hygiene protocols. When people at this late point in time don't even seek out answers, they will likely become part of the population that creates the burden on the system and resources. Since I am one of those who will be somewhere carrying the load of such people in the medical profession, I get tired of grown people failing to take personal responsibility.The medical profession through the media has made a painstaking effort to inform and advise. It is tiring and frustrating when, at this point, some people still seem in a fog. I was just surprised to find this on Scientific American. Sorry if it offended anyone.

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  13. 13. Beth 06:14 PM 9/17/09

    @JH443:

    It remains to be seen how the virus' potential to attach and thereby infect will be. People are universally susceptible at this point although it is true that one component out of four has in a prior form infected the world's population, thereby creating a transferable immunity, which is believe not to protect one, but to lessen the infection. However, no one living through that season knows if they were exposed to that strain or not.
    This virus viciously attacks the lungs themselves unlike most other similar viruses. People who die, die of respiratory failure quite often. Part of the reason young people die is found in the
    strength of their biological defense responses, which are so strong it contributes to a negative outcome.
    I saw those who came down with Gillian-Barre Syndrome and was involved in their care and treatment at that time. They did have one bad year of the progression and then the remission of the condition, but they lived. It was scary for them to have ascending and then descending paralysis and they required mechanical ventilation when it progressed to their respiratory muscles, which was brief, but as I said, they lived.
    I am going to take the vaccine as my personal choice when available. There will be some untoward effects, as with all vaccines, but that is the way it is with all broad medical interventions.

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  14. 14. janrossny 10:12 PM 9/17/09

    It's very scary what the FDA approves. The last swine flu vaccine in the 70's caused 500 cases of Guillaine-Barre (a paralyzing neuromuscular disease) and had to be pulled. And the pandemic that they were so afraid of, never happened. Just recently (out of nowhere) New York State passed a law mandating healthcare workers to get not only the H1N1 vaccine, but also the seasonal flu vaccine. I am a healthcare worker and I have worked in hospitals for many years. I have never had the flu, nor have I ever had the flu. I am in excellent health -- I work out, eat right, don't smoke, etc. -- Now I am forced to take these vaccines and have to worry about their side effects. This is ridiculous, especially since the high risk group for H1N1 is young people who were never exposed to the H1N1 in the 70's.

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  15. 15. janrossny 11:00 PM 9/17/09

    Correction to following comment: I've never had the flu or a flu vaccination.

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  16. 16. vedavyas 02:30 AM 9/20/09

    a new theory in virology.IMPULSE THEORY BY VEDAVYAS PLEASE CALL 9440788713 FOR INFORMATION ON THIS THEORY

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  17. 17. happiness&loveguru 08:42 PM 9/21/09

    i think that the vaccine might improve some people but make it worse for others... they should test it out on different people. Good Luck to those that have the swine flu and stay healthy to those who do not yet have it.

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  18. 18. Lou_40 10:49 AM 9/25/09

    Have a online test for H1N1 : H1N1 - I Have to be inoculated..??
    http://apps.facebook.com/hfnz---do-i-n-bdacaf/

    Reply | Report Abuse | Link to this
  19. 19. Lou_40 10:55 AM 9/25/09

    Have a online test H1N1 : H1N1 - I Have to be inoculated..??
    http://apps.facebook.com/hfnz---do-i-n-bdacaf/

    Reply | Report Abuse | Link to this
  20. 20. Lou_40 10:56 AM 9/25/09

    Have a online test H1N1 : H1N1 - I Have to be inoculated..??
    http://apps.facebook.com/hfnz---do-i-n-bdacaf/

    Reply | Report Abuse | Link to this
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