Sanofi Pasteur, Sanofi-Aventis’ vaccines business, says that the US Food and Drug Administration has given the regulatory green light to a new preservative-free version of the firm’s paediatric influenza vaccine, known as Fluzone. It plans to manufacture around eight million doses for the 2005-2006 season – almost double the amount it supplied for the previous season.
The firm notes that this is the only flu vaccine approved for use in children aged six to 35 months of age, and that it will replace the previously licensed paediatric formulation, which contained trace amounts of the preservative thimerosal. It says it has taken significant steps to reduce or eliminate the amount of preservative in pediatric vaccines in order to support public confidence in vaccines.
Current US recommendations state that all healthy and high-risk children from the age of six through to 23 months of age should receive an annual influenza vaccination. This age group has been shown to be at an increased risk for hospitalisations due to flu-related complications.