Details about U.S. Approved Swine Flu Injections
Package Insert Information for Each H1N1 Vaccine by Manufacturer
Oct 26, 2009
The United States Department of Health and Human Services provides extensive information on the Novel Influenza A (H1N1) 2009 Monovalent vaccines that are being made available here in the U.S., including which formulations are approved for different segments of the population, and how many doses are appropriate for individual formulations. Differences in manufacturing processes and packaging also result in different safety information for each vaccine. The information provided in this article pertains to the injectable version of the H1N1 vaccine produced by the three approved manufacturers.
Makers of the Injectable Swine Flu Vaccine
There are three manufacturers approved to formulate injectable swine flu vaccine for use in the United States. CSL Limited, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur, Inc. all received approval for their swine flu vaccine on September 15, 2009. The injected vaccine produced by these companies is inactive, and contains no live virus. In each case, the adverse reaction information in the package inserts is taken from studies based on the seasonal flu vaccine.
H1N1 Vaccine by CSL Limited
The H1N1 vaccine produced by CSL Limited is only intended for the vaccination of individuals age 18 and over. Package insert information of note:
- Single dose formulation contains no thimerosal, a preservative containing mercury
- Multi-dose formulation contains thimerosal
- This vaccine is not intended for use in breastfeeding mothers, children, or pregnant women
- Adults over the age of 65 do not acquire as much immunity from this vaccine as younger adults
- Other ingredients in a dose of H1N1 vaccine include: sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, monobasic potassium phosphate, potassium chloride, and calcium chloride.
Swine Flu Vaccine Produced by Novartis Vaccines and Diagnostics Limited
The swine flu vaccine produced by Novartis is also approved for use in adults and children over the age of four years. Important information to be found in the package insert:
- Single dose formulation contains trace amounts of thimerosal
- Multi-dose formulation contains thimerosal as a preservative
- This vaccine has not been tested in pregnant women, nursing mothers, or children under the age of four years
- Children ages 4-9 may need a second injection after one month
- Other substances present in a dose of the H1N1 vaccine include: ovalbumin, polymyxin, neomycin, betapropiolactone, and nonylphenol ethoxylate.
Sanofi Pasteur, Inc.'s Swine Flu Vaccine
The swine flu vaccine produced by Sanofi Pasteur, Inc. is approved for adults, children, and infants over the age of six months. Pertinent information contained in the package insert:
- Single dose formulation contains no thimerosal
- Multi-dose formulation of this vaccine contains thimerosal
- Infants and children under 10 years of age may need a second injection after one month
- This vaccine has not been tested in pregnant women, nursing mothers, or infants under the age of six months.
- Other ingredients present in a single dose of this vaccine include: gelatin, formaldehyde, polyethylene glycol p-isooctylphenyl ether, and sucrose.
CDC Recommendations
No manufacturer of the swine flu vaccine recommends the use of the vaccine in pregnant women or breastfeeding mothers.The CDC, however, strongly recommends vaccination for both segments of the population based on previous studies of seasonal flu vaccine safety.
References:
Centers for Disease Control and Prevention
U.S. Food and Drug Administration
CSL Limited Influenza A (H1N1) 2009 Monovalent Vaccine
Novartis Vaccines and Diagnostics Limited Influenza A (H1N1) 2009 Monovalent Vaccine
Sanofi Pasteur, Inc. Influenza A (H1N1) 2009 Monovalent Vaccine
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