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Swine Flu Vaccine Approved: 9/15/09 Press Release
Swine Flu Vaccine Approved by the FDA on 9/15/09
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
I, too, was wondering on the thermisol as well as trying to get labeling for latex .. my oldest is anaphylactic and some stoppes contain latex in some vaccines, so far no luck.
Yes. That is useful information. Just would like to know, as my mother asked, if someone who hasn't gotten the standard flu shot yet if they have to get both seperatedly or they could get them at once though I would think only a doctor would be able to answer that. Also for my own information I am just curious why they make it with and without Thimerosol. Since there are concerns about the potential side effects of that preservative if there are ways to make the vaccines without it why not do so in all cases?
GOT IT ha Ha had to hit join again it got erased ...LOL alls well
1 shot >10
2 shots > 10
I think that is how I interpet it too?
Currently available data suggest that children 6 months to 9 years of age have little or no evidence of protective antibodies to the pandemic (H1N1) 2009 virus (MMWR 2009; 58(19) 521-524, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a1.htm). Based on these data, children 9 years of age and younger should be administered 2 doses of the monovalent pandemic (H1N1) 2009 virus vaccine. Adults should be administered 1 dose, as should children and adolescents 10 years of age and older, as we expect that they will respond similarly to adults.
2 shots > 10
I think that is how I interpet it too?
Currently available data suggest that children 6 months to 9 years of age have little or no evidence of protective antibodies to the pandemic (H1N1) 2009 virus (MMWR 2009; 58(19) 521-524, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a1.htm). Based on these data, children 9 years of age and younger should be administered 2 doses of the monovalent pandemic (H1N1) 2009 virus vaccine. Adults should be administered 1 dose, as should children and adolescents 10 years of age and older, as we expect that they will respond similarly to adults.
Yes, I found it on the FDA FAQ's .. I think this is the answer and you are correct as I understand it:
Does FDA know at this time how many doses individuals should receive?
Currently available data suggest that children 6 months to 9 years of age have little or no evidence of protective antibodies to the pandemic (H1N1) 2009 virus (MMWR 2009; 58(19) 521-524, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a1.htm). Based on these data, children 9 years of age and younger should be administered 2 doses of the monovalent pandemic (H1N1) 2009 virus vaccine. Adults should be administered 1 dose, as should children and adolescents 10 years of age and older, as we expect that they will respond similarly to adults. Clinical studies are underway and will provide additional information about the optimal number of doses.
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm
Does FDA know at this time how many doses individuals should receive?
Currently available data suggest that children 6 months to 9 years of age have little or no evidence of protective antibodies to the pandemic (H1N1) 2009 virus (MMWR 2009; 58(19) 521-524, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a1.htm). Based on these data, children 9 years of age and younger should be administered 2 doses of the monovalent pandemic (H1N1) 2009 virus vaccine. Adults should be administered 1 dose, as should children and adolescents 10 years of age and older, as we expect that they will respond similarly to adults. Clinical studies are underway and will provide additional information about the optimal number of doses.
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm
I heard this moring that it is only one shot for 10- adult age can you verify this anyone 2 shots for younger kids ..
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