FDA Approves Swine Flu Vaccine 9/15/09 Press Release...

Sep 16, 2009 - 26 comments
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Swine Flu Vaccine Approved by the FDA


http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm


FDA NEWS RELEASE
For Immediate Release: Sept. 15, 2009
Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-***@****; Peper Long, 301-796-4671, mary.***@****
Consumer Inquiries: 1-888-INFO-FDA
FDA Approves Vaccines for 2009 H1N1 Influenza Virus
Approval Provides Important Tool to Fight Pandemic


The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

“Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.

”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.

Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.  

Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.
As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.  

People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and -- in children 2 to 6 years old -- fever.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.
Vaccines against three seasonal virus strains are already available and should be used (see information on the seasonal flu). However, they do not protect against the 2009 H1N1 virus (see information on H1N1 flu).


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FDA Vaccine Questions & Answers:

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm


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168348_tn?1379360675
by ChitChatNine, Sep 16, 2009
FDA Vaccine Questions & Answers:

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm



C~

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by margypops, Sep 16, 2009
I have heard there isnt enough to go round ...will we draw straws ??

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by ChitChatNine, Sep 16, 2009
I read there's nasal, injection, thermisol and non-thermisol that'll be available .... interesting, eh?

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by ChitChatNine, Sep 16, 2009
I called my Pediatrician to get on the "list" and was told there is no list - it's a gov't vaccine and we all need to just keep watching for where to go for the vaccine such as schools, etc.   The regular flu shot has a "list" @ the Pediatrician's office.

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by margypops, Sep 16, 2009
oh I like the Nasl , I hate shots .. so no list means there is plenty to go around,that is good news.

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by ChitChatNine, Sep 16, 2009
Am trying to find out about nasal vs. vaccine for athmatics -- posted out on asthma community if anybody has found out about nasal vs. vaccine for the swine flu ... with regular flu I believe asthmatics should not take nasal -- I have two kids who have asthma.  The FAQ didn't mention the protocol .. unless I missed it ?

C~

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by ChitChatNine, Sep 16, 2009
oops .. cannot type this morning (too early) .. should be "asthmatics" ....

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by aly79, Sep 16, 2009
i am still at a toss up about this one i am 26 weeks and 4 days pregnant so we are at the top of the list to get vaccinated but still leary about it i mean i get the regular flu shot ever yr but this is a new strand and im scared what it may do to me and my child  

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by jenstam, Sep 16, 2009
I will not be getting this vaccine. No way, no how. I am 31 weeks on Friday. Not worth the risk. Either is the H1N1 but I am willing to take my chances.

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by zodiacqueen, Sep 16, 2009
This vaccine was "thrown together" and approved much too quickly.  That freaks me out, so I won't be getting this vaccine!

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by Melissa0116, Sep 16, 2009
I will not be getting the vaccine either.  As I am 21 weeks pregnant and as Zodiacqueen said that threw this vacccine together way too quickly.  

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by jenstam, Sep 16, 2009
I do not think there will be many expectant moms getting this vaccine. There are not many mothers who are willing to take the risk, even if the risk is small. It's one of those things that they could say "Oops, we didn't know this would happen" years down the road when children of expectant mothers at the time are having problems or adverse reactions. I'm sorry, call me paranoid but I am not willing to put my unborn son at risk of the unknown. Scary stuff. Any pregnant women who do plan to get the vaccine?

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by ChitChatNine, Sep 16, 2009
Yeah, I agree .. this is scary stuff .. all of it .. the pro's and con's and the not knowing ....

C~

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by teko, Sep 16, 2009
77 people have died in Florida alone from this virus. Today I heard a 40something year old woman was found dead. A few days ago it was a very healthy 20something year old guy.  I will take my chances with the vaccine. From what I understand they are concerned that this thing will merge in with another and develop into a superbug of sorts. This would be very very bad!

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by jenstam, Sep 16, 2009
Yes, but if it merged with another to make a superbug then the current vaccine wouldn't protect against it anyhow, correct? I would take my chances with the vaccine if I was not pregnant maybe this year.

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by houseofgirls, Sep 16, 2009
I will be getting both flu shots this year, which is a first for me.  Even the seasonal flu shot that people get every year is new each year.  They change it each year depending on what scientists guess will be the strains going around each year.  So I don't feel that the swine flu shot is any more thrown together than the seasonal flu shot.  I'm getting it because my baby is under 6 months old, so her ped recommended our entire family get them to protect her.  I'm not so worried about myself getting the flu, but it could be a disaster for my little one to get it.  My oldest is in preschool, so there is a chance she will be exposed at some point.

At Washington State University, I think about 50 people had the swine flu at the start of the school year.  Within 1-2 weeks, 2000 people had it.  I the risks of getting it are much higher than the risks of getting the shot.  I'm not sure what I would do though if I was pregnant.  

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by akl_cdl, Sep 16, 2009
I am due December 2nd and have been reading up on the swine flu. I am worried about catching anything being pregnant, not just H1N1. Everyone has there own opinion and I think they should do whatever they feel comfortable doing. I will be getting the seasonal flu vaccine and the H1N1 vaccine. I feel it's the best decision for me and my family.

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by ginger899, Sep 16, 2009
Masks which protect against viruses, such as H1N1, and alcohol hand-sanitizer, in handy purse-size dispensers -are available easily online, or at pharmacies and don't cost the earth. I don't know why everyone isn't using them? (well, people who have to go into crowded busy places, shop in stores, ride buses and trains, etc.) I know it looks weird to wear a mask, and would have to be taken off to eat and drink, but it's easy to talk and be heard with one on. And maybe it's time people should wear them everywhere??

Regular dust-masks which are normally used for DIY jobs, etc, won't do. So the best thing is to enquire if the mask is effective protection against Swine flu virus. Some are, some aren't. Some are single-use, which could become very expensive, and some are re-usable. But there is a protocol to using them properly, and removing them, etc.

The alcohol hand-sanitizer would be hard to remember to use, at first, but could easily become a routine.

These solutions might help to protect pregnant women, or anyone who either cannot, or doesn't wish to receive the vaccine.  

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by Tammy2009, Sep 17, 2009
If you are worried about superbugs I wouldn't use hand santizer .....

IF at any point, the hand santizer is not used properly and some virus particles are harmed but not killed, then it sets up resistance and will make any treatment that much harder.  I still advocate plain old washing your hands (with non anti-bacterial soap), you aren't killing the viruses/bacteria but instead lowering the amount you have on your hands, which will not allow them to become resistant, but still help yourself and those around you from getting the flu.  

They already is a case (or more?) of drug resistant H1N1 so yes there is the potential to become like MRSA (although very small).  

For the superbug and mixing with the avian flu, scientists have been worried about this for many years and with every new pandemic virus, not just H1N1.  Any time the virus mutates (which is constantly), the vaccine will not be effective (or only mildly) so giving the vaccine doesn't mean **** if it turns into something horrible and scary.  The vaccine will only help your body increase its reaction to the flu in which it was made for, the mild H1N1 that is going around now (or a couple months ago, depending when they took their sample of the virus).

For a fourth year biological science student majoring in cellular, molecular and microbial biology, I wouldn't worry yourself scared about H1N1, there are much scarier things out there (even other strains of the flu that are much more severe).  Try preventative in the way of eating good food (lower fat, higher fibre, veggies, blah blah blah), excerising and trying to keep pollution down (use organic, natural products as much as possible, and don't overclean your house, overmedicate, fill yourself full of overprocessed products) .  

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by teko, Sep 17, 2009
Tammy makes sense, however for me being someone with copd, any flu can be deadly and I will take whatever precautions necessary to prevent getting sick because getting sick can literally kill me.  I do agree about hand sanitizers and the like. Being germ free counteracts being well.  Exposing ones families to germs to a degree is what builds the immunity and in this day and age, I think that is part of the problem. To say not to be too concerned to me is too little too late for those who have died.

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by ChitChatNine, Sep 17, 2009
I think it comes down to the risk/benefit thing for many .....  that may help some of us make up our mind.




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by PlateletGal, Sep 17, 2009

Interesting that Dr. Joseph Mercola has been VERY outspoken on this vaccination :

http://products.mercola.com/multivitamin-vital-minerals/?source=nl


http://articles.mercola.com/sites/articles/archive/2009/09/17/Many-Health-Workers-Wont-Take-Swine-Flu-Vaccine.aspx



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by cjruz, Sep 17, 2009
dont get it.wait until they force it upon you at gunpoint

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by PlateletGal, Sep 17, 2009

They shouldn't force flu vaccinations on everyone. Of course cases such as smallpox are exceptions to the rule.

Anyhow.. for those people who are concerned about this, the 4th International Public Conference on Vaccinations is scheduled on October 2 - October 4th at the Hyatt Regency in Reston, Virginia. Guest speakers are:


George Annas, JD, MPH - Bioethics
David Ayoub, M.D. - Vaccine Adjuvants
Cindy Bevington - Moderator
Sue Blevins, MPH - Tagging & Tracking
Twila Brase, PHN - DNA Banking
Jane Bryant - Freedom of Press (UK)
Shiv Chopra, BVSc, PhD - Corporate Influence
Vicky Debold, PhD, RN - Vaccinated vs. Unvaccinated
Peter Doshi - Global Vaccine Policies
Bonnie Dunbar, PhD - Out of Africa
Jonathan Emord, JD - Law & Liberty
Barbara Loe Fisher - Vaccine Freedom
Colin Forbes, MD - Child Health in Africa
Louise Habakus, HHP, ASDP - Smart Vaccine Questions
Diane Harper, MD, MPH - Gardasil Vaccine
Tom Jefferson, MD - Influenza Vaccine
Christopher Kent, DC, JD - Health Law Post 9- 11
Eleanor Kibrick, MSc - Effective Activism
Robert Krakow, JD - Vaccine Injury Law
Walter Kyle, JD - Vaccine Contamination
Amy Lansky, PhD - Homeopathy Heals
Gary Matsumoto - Squalene Adjuvants
Matthew McCoy, DC, MPH - A Chiropractic Perspective
Joe Mercola, DO - Healthy Options
Nancy Massotto, PhD - Holistic Moms
Stephen Marini, PhD, DC - Immune Dysfunction
Jim Moody, JD - Moderator
Meryl Nass, MD - Anthrax Vaccine
Gary Null, PhD - Nutrition First
Jeanne Ohm, DC - Pregnancy & Birth
Dan Olmsted - Activist Journalism
Peggy O'Mara - Freedom of Press
Lawrence Palevsky, MD - What is Health?
Richard Pitcairn, DVM, PhD - Holistic Pet Health Shelley Reynolds - Educating Legislators
Dawn Richardson - Vaccine Exemptions
Rick Rollens - Effective Lobbying
Steve Rubin, PhD - Moderator
Bob Sears, MD - Vaccine Schedules
Alan Sherr, DC - Paradigm Shift
Kim Stagliano - Blog & Twitter
Andrew Wakefield, MD - Vaccine Inflammation
Mark Zaid, JD - Experimenting on Soldiers


To register for the conference or for more information, visit: http://www.nvic.org/Events/overview.aspx

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by ginger899, Sep 17, 2009
To Tammy.......I didn't know that there was a danger to using the alcohol hand-sanitizer! Well I know now, I can see what you mean. I ALWAYS wash my hands (just instinctively feel I have to and always have) -after going to town, or to places where there are lots of people, and I've been touching door handles, etc
Yes, all we need is a resistant strain! I don't think!

But....although of course a healthy lifestyle raises the immune system...Last winter I suddenly came down with an awful flu bug (not H1N1, too early for that I believe, but nasty nevertheless ) I am extremely fit and well, eat really well, healthy food, plenty of fruit and vegetables (lots! every day) fiber, water, take a multivit/mineral supplement daily, (mainly because I don't eat red meat, and don't eat any meat very often) I am in the fresh air, exercising for hours every day, can run like the wind, don't live in a polluted atmosphere....etc Yet I was suddenly hit by this bug and it was very bad indeed, and took about12 days to recover. I have a good immune system, don't often 'come down' with things, but was knocked for six with that bug.
So what I'm saying is even an exemplary lifestyle and a fit and healthy body can't necessarily protect anyone from catching this or any other flu. All you need is for someone to sneeze near you, or wipe their nose then touch a door handle....
I actually remember how I caught my flu. I was in a pharmacy buying lavender oil. A woman (obviously suffering, and coughing) happened to be in the queue behind me, and there was nothing I could do to get away from her. Three days later, I got it.As easy as that.

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by Tammy2009, Sep 18, 2009
Very true ginger, I've been sick with a couple of things every so often.  It was more of a post because all I hear is swine flu this H1N1 that.  Most people don't put it into context with everything else.  

I totally understand for people will want to get the vaccine if being sick could be dangerous for them or for young kids around.  I have got all vaccines that you get in school, plus keeping tetanus up to date but there is something about the flu vaccine that I balk at and I'm not sure exactly what.  

Up until this June I have never got the flu, and had 4 days of intense body aches (still worked 8 hour shift and 2 hour walk/runs with the puppy I was watching but it did suck and I ended up losing 8 pounds because I wasn't eating and being only 90 pounds to begin with...).  I think it has something to do with having a 800mcg dose of inhaled steriods now for my stupid reactive airways (lol), I'm currently looking into other treatments because I think some of the mild issues (muscle weakness/pain, menstral spotting for a month solid, headaches and increased facial hair/acne) are all due to the steriods, however if I don't take my full dose I can't  breathe so it's taking the lesser of the two evils.  

I hate it when the media blows something out of propotion and basically makes everyone scared stiff of this "horrible" flu.  There are worse flus than H1N1 that will also be going around!!  For an influenza virus, H1N1 is mild and very low death rate.  I wish the media would cover other stories with the same determination, such as how crappy our water/air supply is with all the pollution and how unhealthy everyone is with the current diet/lack of excerise.

I'm sorry if anyone got offended by my other post, it was right after my medical anthropology  class that the teacher was talking about H1N1 and knows almost no science so his answers weren't correct and it bugged me.  

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