And it's approved-H1N1

[bbrandonsmom]

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

I have a question-do they include people with underlying medical conditions in thier trials or only healthy people?

[3monkeys]

FDA NEWS RELEASE

For Immediate Release: Sept. 15, 2009
Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov; Peper Long, 301-796-4671, mary.long@fda.hhs.gov
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 (http://www.flu.gov/seasonalflu/index.html)). However, they do not protect against the 2009 H1N1 virus (see information on H1N1 flu (http://www.cdc.gov/h1n1flu/)).

#

Additional Information
Influenza A (H1N1) 2009 Monovalent (http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm)
RSS Feed for FDA News Releases (http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/PressReleases/rss.xml) [what is RSS? (http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/ucm144575.htm)]

[3monkeys]

There is so much that is wrong with that ^^^ that I just sit here shaking my head in disbeleif. Mostly if that was rigorous testing then I would love to see what non rigorous testing is. Crazy that after such a short time its been approved. But of course its for the good of the people. Its going to save people from serious illness and death from influenza......

Gosh I can't help but be cynical.

There is absolutely no way on Gods green earth that that vaccine is coming near me or mine........

[Momtezuma Tuatara]

Nor me. ..............................

[Sarah]

What makes me want to laugh, or simply shake my head in frustration is the side effects from the vaccine are the same as if you were a healthy person who got the flu anyway !!!!

[Momtezuma Tuatara]

Here is the FDA url (http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm) for product approval:

[ema-adama]

Whoop di wooo. :mad:

And this is being pushed for pregnant women. With absolutely no studies done on the effects on the fetus. But it is classified as a pregnancy C drug - as in some harm is done to the fetus when this drug is used. But no studies have been done, so how they can know what harm is beyond me.

[bbrandonsmom]

They can't, and you know that won't make it's way to the news and made known to the public either :(

[gilima]

not coming near me or mine .......:mad:

makes me sad to think of all the people who will run to get this...and I am concerned about how many people will suffer who knows what from it:(

[bbrandonsmom]

That's how I feel gilima. My aunt asked just about a week or so ago if I was getting the kids the vax, if we were etc, and that her dr said she should get it. I told her the trials were too short and we don't know the long term effects of it. It was like talking to, I don't know..myself.

[oloph]

Just read a bunch of stuff from MT's link and oh. my goodness. None of these "approved" vaccines have even done any real testing. All of them are using data from the regular influenza vaccines for adverse events and safety. They say that they "make them the same way" so that magically means they only have the same problems even though it's a completely different vaccine. :eyeroll:

And the only dead vaccine approved for the under 4 crowd is citing safety data (from the regular vaccine, not the h1n1 vaccine) from a whopping 31 kids.

And my dad is pleading with us to get this for our kids because the disease is so scary. :eyeroll:

[magical1]

I only went through the first one but it didn't have any safety data for children at all... I wonder if they will tell the parents that?

[oloph]

That first one on the list, the CSL one, is only approved for 18 and over so it wouldn't have any pediatric info on it. Not sure if that is the one you read or not.

At any rate, you know they are going to tell parents that these vaccines are perfectly safe.

[bbrandonsmom]

Of course they will. On the news they are still saying it's for seniors, preg women and children first.
What would happen if everyone we knew who cared emailed in the insert info for preg/ped to the news, or sent in a comment about it etc? Would it even make a difference and get reported?

[bbrandonsmom]

http://www.reuters.com/article/newsOne/idUSTRE58H4EP20090918

Is to be nasal spray first according to the cdc today.

[Barefoot]

http://www.reuters.com/article/newsOne/idUSTRE58H4EP20090918

Is to be nasal spray first according to the cdc today.

That should spread the virus around nicely.

[MinorityView]

Yeah, I think they are afraid of not having much of an epidemic, so measures are being taken.

[bbrandonsmom]

Oh Barefoot and Mv-you guys are bad lol. That was my first thought too-let's get everyone sick. You know there will be something printed about the likely of it spreading via the nasal will be low, but hey, it's still a live virus. I wonder how many people got sick from the nasal vax last year for that seasonal flu?
Did anyone see the funny video about the home made h1n1 vax? It's hilarious.

[MinorityView]

No, I haven't see that video. There is another funny video on making flu vaccine that has been around for a year or two.

[Barefoot]

From a personal point of view, if i was forced to take a vaccine i would rather have the nasal spray as i can simply spray hydrogen peroxide into my nasal passages both before and after the vaccine.
Followed by some more neti.

[Momtezuma Tuatara]

I agree. Walk straight out, and then blow your nose really carefully into a tissue and dispose in ziplock bag. then HP or saline. But be careful. Anything that strips the nose of it's mucus coating actualy opens up the cells to infection if anything remains. I think I'd pre-coat my inside of the nose with something slimy or mucusy to give a substrate to "blow" out. :alien:

[cartersmom]

I agree. Walk straight out, and then blow your nose really carefully into a tissue and dispose in ziplock bag. then HP or saline. But be careful. Anything that strips the nose of it's mucus coating actualy opens up the cells to infection if anything remains. I think I'd pre-coat my inside of the nose with something slimy or mucusy to give a substrate to "blow" out. :alien:
This is interesting because I have resigned that if we are indeed forced here in the US that I will only agree to the mist. So if one were to Netti afterwards would you put the HP in the Netti water or put straight HP in the nose with a dropper?? Also what would you coat the nose with beforehand?? Something like aquaphor??

[cartersmom]

I agree. Walk straight out, and then blow your nose really carefully into a tissue and dispose in ziplock bag. then HP or saline. But be careful. Anything that strips the nose of it's mucus coating actualy opens up the cells to infection if anything remains. I think I'd pre-coat my inside of the nose with something slimy or mucusy to give a substrate to "blow" out. :alien:
Double post opps

[Barefoot]

This is interesting because I have resigned that if we are indeed forced here in the US that I will only agree to the mist. So if one were to Netti afterwards would you put the HP in the Netti water or put straight HP in the nose with a dropper?? Also what would you coat the nose with beforehand?? Something like aquaphor??
I too would insist on the mist but i don;t think were getting that in the UK unless its offered privately to pay for.
You could buy a cheap nasal inhaler from the drug store empty it out and add 3% HP or use 3% in a netti pot. It would need to be in spray form to inhale deep into the sinus passages
Perhaps plant mucilage such as slippery elm would be a good lining for the sinus passages which would best applied by a netti pot before hand.
Anyone else have any thoughts on this?