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Monovalent influenza A (H1N1) vaccine licensure expanded to include children

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The FDA expanded the approved use of an existing 2009 influenza A (H1N1) vaccine to include children aged 6 months and older in efforts to meet the needs of those populations at highest risk.

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children’s vaccines available is an important step in responding to the H1N1 outbreak,” Margaret A. Hamburg, MD, commissioner of food and drugs, said in a press release.

The inactivated, monovalent H1N1 vaccine (CSL Biotherapies) was previously approved for use in adults aged 18 years and older; it received the expanded indication along with the company’s seasonal influenza virus vaccine (Afluria). The decision was made using the FDA’s accelerated approval regulation and was based on immune responses elicited by the seasonal vaccine.

CSL’s H1N1 vaccine is available in two formulations: a thimerosal-free single-dose prefilled syringe and a multidose vial that contains thimerosal as a preservative.