New flu vaccine for kids hits the market

Mar 10 2005

A new pediatric influenza vaccine that contains no preservatives - the only influenza vaccine approved for use in children 6 to 35 months of age - has been produced by the sanofi-aventis Group, in time for the 2005-2006 influenza season.

The U.S Food and Drug Administration (FDA) has approved the company's license supplement to market the new formulation of its pediatric influenza vaccine.

"Influenza and its related complications can lead to hospitalizations and even death in children," said Philip Hosbach, vice president, new products and immunization policy at sanofi pasteur. "We are pleased to offer parents and physicians a completely preservative-free pediatric formulation of influenza vaccine for the immunization of infants aged 6 to 35 months."

The new vaccine (trade name: Fluzone®, Influenza Virus Vaccine, No Preservative) is presently the only injectable influenza vaccine approved by the FDA that does not introduce a preservative at any stage in the manufacturing process.

The company will manufacture approximately eight million doses of the new influenza vaccine. This is almost double the number of pediatric doses of influenza vaccine than was supplied in the 2004-2005 season. This newly licensed product will replace the previously licensed pediatric formulation, which contained trace amounts of the preservative thimerosal, and will be available in single-dose, prefilled syringes in both a pediatric dose package and a standard dose package for children ages three years and above. The pediatric dose package will contain 0.25 mL of vaccine and the standard dose package will contain 0.50 mL.

Sanofi pasteur has taken steps to reduce or eliminate the amount of preservative in pediatric vaccines to support public confidence in vaccines.

The Centers for Disease Control and Prevention and the American Academy of Pediatrics, currently recommend that all healthy and high-risk children 6 to 23 months of age should receive an annual influenza vaccination. Children in this age group are at an increased risk for hospitalizations due to influenza-related complications.

Children at risk for influenza-related complications can receive influenza vaccine at the same time they receive other routine vaccinations during the influenza season, according to the CDC. Children younger than 9 years of age receiving influenza vaccine for the first time require two doses, one month apart.

For the 2004-2005 influenza season, the company produced nearly 58 million doses of influenza vaccine and worked closely with the CDC to ensure the vaccine was equitably distributed to high-risk priority groups when a shortfall in the nation's supply occurred early in the influenza season. Sanofi pasteur, the nation's influenza vaccine leader, is the only manufacturer of influenza vaccine approved in the U.S. for all populations from 6 months of age and older.