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H1N1 vaccine for babies now made by two companies - FDA approves CSL Limited vaccine for infants
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New Swine Flu Shot for Babies Untested Prior to Full Release
The U.S. Food and Drug Administration (FDA) has approved the use of CSL Limited's H1N1 vaccine for babies as young as 6 months old. This vaccine, and the CSL Limited seasonal flu vaccine, were previously only approved for adults age 18 and older.
Fast track approval from the FDA
The FDA has approved swine flu vaccines from 5 manufacturers without the typical extensive testing and review process required in order to approve a vaccine for public use.
Infant swine flu vaccine approval
Swine flu vaccines for use in infants are now available from two manufacturers. Sanofi Pasteur, Inc. is currently conducting tests on the safety of the swine flu vaccine now being used on private citizens down to the age of 6 months. CSL Limited has not tested the swine flu vaccine that has been approved for individuals ages 6 months and up on anyone under the age of 18.
Vaccine shortages cause early approval
The FDA states that the reason for approval is the need for more swine flu vaccines for children, due to the fact that the pediatric population is at a higher risk from H1N1 complications.
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