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Thanks to my friend ahrcanum for forwarding this information to me. H1N1 Swine Flu Vaccine Package Insert, Warnings

Posted Nov 04 2009 10:02pm

Thanks to my friend ahrcanum for forwarding this information to me.

DEB

================================================================================

H1N1 Swine Flu Vaccine Package Insert, Warnings

September 27, 2009 by ahrcanum

The U.S. Government has evaluated only these  vaccines that are licensed by the U.S. Food and Drug Administration. They are-

Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181975.ht

Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181973.ht

Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc)  http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181971.ht

Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181970.ht

Lot release information will be updated weekly.  Last update: 9/24/2009.  http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformatio

ManufacturerTotal Number of Lots Released by FDA
MedImmune LLC9
Novartis Vaccines and Diagnostics Limited3
Sanofi Pasteur, Inc.3

From the CSL package insert: Influenza A (H1N1) 2009 Monovalent Vaccine, Manufactured by CSL Limited, Suspension for Intramuscular Injection, Initial U.S. Approval: 2007 [sic- approved TWO YEARS AGO!)

From the CSL package insert -

Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals.

5.4 Limitations of Vaccine Effectiveness

N eurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported.

8.1 Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in nursing mothers. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman.

8.4 Pediatric Use

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in children. Safety and effectiveness in the pediatric population have not been established.

Similar warnings from the Novartis insert - http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UC

8.3 Nursing Mothers-It is not known whether FLUVIRIN or Influenza A (H1N1) 2009 Monovalent Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman

8.4 Pediatric UseSafety and effectiveness in pediatric subjects below the age of 4 years have not been established. [see ADVERSE REACTIONS (6) and CLINICAL STUDIES (14)]

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN. It is also not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

The government is starting an unprecedented system to track possible side effects as mass flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.

“Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone,” said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services. http://www.philly.com/philly/wires/ap/features/health/20090927_ap_swineflushotin

Just how did CSL Limited, Suspension for Intramuscular Injection get Initial U.S. Approval in 2007?????? TWO YEARS before the explosion of H1N1 around the world.  These patient inserts appear to be from the respective manufacturers of the seasonal flu vaccine, only adding the text for H1N1 with no large clinical studies.

US officials say the first swine flu vaccine will be available on Oct. 5. http://www.presstv.ir/detail.aspx?id=107252&sectionid=3510210 Women and children first please.

Thanks to my friend ahrcanum for forwarding this information to me.

DEB

================================================================================

H1N1 Swine Flu Vaccine Package Insert, Warnings

September 27, 2009 by ahrcanum

The U.S. Government has evaluated only these  vaccines that are licensed by the U.S. Food and Drug Administration. They are-

Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181975.ht

Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181973.ht

Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc)  http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181971.ht

Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181970.ht

Lot release information will be updated weekly.  Last update: 9/24/2009.  http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformatio

ManufacturerTotal Number of Lots Released by FDA
MedImmune LLC9
Novartis Vaccines and Diagnostics Limited3
Sanofi Pasteur, Inc.3

From the CSL package insert: Influenza A (H1N1) 2009 Monovalent Vaccine, Manufactured by CSL Limited, Suspension for Intramuscular Injection, Initial U.S. Approval: 2007 [sic- approved TWO YEARS AGO!)

From the CSL package insert -

Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals.

5.4 Limitations of Vaccine Effectiveness

N eurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported.

8.1 Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in nursing mothers. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman.

8.4 Pediatric Use

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in children. Safety and effectiveness in the pediatric population have not been established.

Similar warnings from the Novartis insert - http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UC

8.3 Nursing Mothers-It is not known whether FLUVIRIN or Influenza A (H1N1) 2009 Monovalent Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman

8.4 Pediatric UseSafety and effectiveness in pediatric subjects below the age of 4 years have not been established. [see ADVERSE REACTIONS (6) and CLINICAL STUDIES (14)]

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN. It is also not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

The government is starting an unprecedented system to track possible side effects as mass flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.

“Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone,” said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services. http://www.philly.com/philly/wires/ap/features/health/20090927_ap_swineflushotin

Just how did CSL Limited, Suspension for Intramuscular Injection get Initial U.S. Approval in 2007?????? TWO YEARS before the explosion of H1N1 around the world.  These patient inserts appear to be from the respective manufacturers of the seasonal flu vaccine, only adding the text for H1N1 with no large clinical studies.

US officials say the first swine flu vaccine will be available on Oct. 5. http://www.presstv.ir/detail.aspx?id=107252&sectionid=3510210 Women and children first please.

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