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.htm

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

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

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

Lot release information will be updated weekly. Last update: 9/24/2009. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm181956.htm

Manufacturer Total Number of Lots Released by FDA
MedImmune LLC 9
Novartis Vaccines and Diagnostics Limited 3
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

Neurological 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/UCM182242.pdf

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.