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FDA Approves Swine Flu Vaccine (also avail in Nasal .. see press release ....)
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).
______________
FDA Vaccine Questions & Answers:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm
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).
______________
FDA Vaccine Questions & Answers:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm
bah! I don't want to listen to them. -acts subborn- I don't care if I have asthma, I still don't want the flu shot. -pouts-
If I get sick this year then yes I'll get it next year, since I also know the stupid inhaled steriods affect my immune system negatively.
Tired and cranky today .... ignore my random posts.
If I get sick this year then yes I'll get it next year, since I also know the stupid inhaled steriods affect my immune system negatively.
Tired and cranky today .... ignore my random posts.
I googled this for your question as I too had the same thought but didn't know.
Asthma Information for Patients and Parents of Patients
September 15, 2009, 5:00 PM ET
* Anyone with asthma is at higher risk for flu-related complications, such as pneumonia. Along with everyone else, if you have asthma you should:
o wash your hands often with soap and water, especially after coughing or sneezing;
o cover your nose and mouth with a tissue when coughing or sneezing and throw the tissue away. If you do not have a tissue, cough or sneeze into your elbow or shoulder not your bare hands;
o avoid touching your eyes, nose, or mouth (germs are spread that way); and
o stay home when you are sick, except to get medical care.
* If you have asthma, you should follow an updated, written Asthma Action Plan developed with your doctor. Follow this plan for daily treatment and for controlling your asthma symptoms.
* If your child has asthma, make sure that his or her updated, written Asthma Action Plan is on file at school or at the daycare center. Be sure that the plan and medication(s) are easy to get to when needed.
* Everyone with asthma who is older than 6 months should get a shot every year to protect against the seasonal flu. Children aged 6 months to 8 years who never have had a seasonal flu shot will need two doses the first time. Children who have had a seasonal flu shot in the past only need one shot. Persons with asthma should not use the inhaled "FluMist®" vaccine.
* Everyone with asthma who is aged 6 months to 64 years should get the 2009 H1N1 flu shot when it becomes available. The 2009 H1N1 flu shot is not the same as the shot for seasonal flu. If the H1N1 flu vaccine is in short supply, some persons may not be able to get the shot right away.
* Certain antiviral drugs are prescription medicines that fight the flu virus by stopping it from growing in your body. They make you feel better faster and may prevent serious flu problems. The antiviral drug Tamiflu (also known as oseltamivir) is recommended for treating 2009 H1N1 virus infection and may be prescribed for persons with asthma. Flu treatments work best if they start within two days of when you get flu-like illness.
* Persons with flu infections might also get bacterial infections. These persons will also need to take antibiotics to fight the bacterial infection. Some signs of bacterial infection are severe or prolonged illness, or illness that seems to get better but then gets worse.
* Do not give aspirin (acetylsalicylic acid) to children or teenagers who have the flu. This can cause a rare but serious illness called Reye’s syndrome.
* To learn more about these recommendations and for updates, visit www.cdc.gov/flu/ on the Web or call CDC at 1-800-CDC-INFO.
Asthma Information for Patients and Parents of Patients
September 15, 2009, 5:00 PM ET
* Anyone with asthma is at higher risk for flu-related complications, such as pneumonia. Along with everyone else, if you have asthma you should:
o wash your hands often with soap and water, especially after coughing or sneezing;
o cover your nose and mouth with a tissue when coughing or sneezing and throw the tissue away. If you do not have a tissue, cough or sneeze into your elbow or shoulder not your bare hands;
o avoid touching your eyes, nose, or mouth (germs are spread that way); and
o stay home when you are sick, except to get medical care.
* If you have asthma, you should follow an updated, written Asthma Action Plan developed with your doctor. Follow this plan for daily treatment and for controlling your asthma symptoms.
* If your child has asthma, make sure that his or her updated, written Asthma Action Plan is on file at school or at the daycare center. Be sure that the plan and medication(s) are easy to get to when needed.
* Everyone with asthma who is older than 6 months should get a shot every year to protect against the seasonal flu. Children aged 6 months to 8 years who never have had a seasonal flu shot will need two doses the first time. Children who have had a seasonal flu shot in the past only need one shot. Persons with asthma should not use the inhaled "FluMist®" vaccine.
* Everyone with asthma who is aged 6 months to 64 years should get the 2009 H1N1 flu shot when it becomes available. The 2009 H1N1 flu shot is not the same as the shot for seasonal flu. If the H1N1 flu vaccine is in short supply, some persons may not be able to get the shot right away.
* Certain antiviral drugs are prescription medicines that fight the flu virus by stopping it from growing in your body. They make you feel better faster and may prevent serious flu problems. The antiviral drug Tamiflu (also known as oseltamivir) is recommended for treating 2009 H1N1 virus infection and may be prescribed for persons with asthma. Flu treatments work best if they start within two days of when you get flu-like illness.
* Persons with flu infections might also get bacterial infections. These persons will also need to take antibiotics to fight the bacterial infection. Some signs of bacterial infection are severe or prolonged illness, or illness that seems to get better but then gets worse.
* Do not give aspirin (acetylsalicylic acid) to children or teenagers who have the flu. This can cause a rare but serious illness called Reye’s syndrome.
* To learn more about these recommendations and for updates, visit www.cdc.gov/flu/ on the Web or call CDC at 1-800-CDC-INFO.
I'm supposed to get the flu shot, as I get very bad asthma exacerbations with viruses and my specialist said it was too risky to go without. So I guess I will be getting one this year, as I've been slacking off with getting the shot these past few years. I get the flu so seldom, that I forget how bad it can go.. And seeing that this has been a bad asthma year for me, I don't see the need to take more risks then necessary.
Not a big importance to me .... I have had the flu once in my life and never got a flu shot. Plus H1N1 is NOT any where near a severe flu.
The only reason I got the flu is that I was working very closely with the one girl and even shared a pop (I know, very stupid) the day before she got sick. She ended up in the hosiptal for 4 days (not H1N1 though) and I still worked through the couple days of intense body aches.
Not worried about the flu at all, more worried about being at my Aunt's house since it is bugging my lungs quite a bit from all the dust.
The only reason I got the flu is that I was working very closely with the one girl and even shared a pop (I know, very stupid) the day before she got sick. She ended up in the hosiptal for 4 days (not H1N1 though) and I still worked through the couple days of intense body aches.
Not worried about the flu at all, more worried about being at my Aunt's house since it is bugging my lungs quite a bit from all the dust.
Also - noted in the press release is that it contains Chicken & Egg .. for those with severe allergies.
----> I am assuming asthmatics should NOT take the intra-nasal and be offered the vaccine -- similar to protocol with regular flu-season shots? Anybody know ? I didn't see it on the FDA Q & A section {{{ yet }}}} that is.
C~
----> I am assuming asthmatics should NOT take the intra-nasal and be offered the vaccine -- similar to protocol with regular flu-season shots? Anybody know ? I didn't see it on the FDA Q & A section {{{ yet }}}} that is.
C~
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