The FDA has approved the company’s license supplement to market the new formulation of its pediatric influenza vaccine – the only influenza vaccine approved for use in children six to 35 months of age.
The new formulation of Fluzone will be the only injectable influenza vaccine approved by the FDA that does not introduce a preservative at any stage in the manufacturing process.
Sanofi Pasteur plans to manufacture approximately eight million doses of the new formulation; almost double the number of pediatric doses of influenza vaccine than was supplied in the 2004-2005 season. This will replace the previously licensed pediatric formulation, which contained trace amounts of the preservative thimerosal, which has been linked to autism.
The new formulation will be available in single-dose, pre-filled syringes in both a pediatric dose package and a standard dose package for children ages three years and above.