FluMist Nasal Vaccine

June 17 2003 -- The FDA approved FluMist, an influenza vaccine that is the first nasally administered vaccine to be marketed in the United States. It is also the first live virus influenza vaccine approved in the U.S.

FluMist (Influenza Virus Vaccine Live, Intranasal) is approved to prevent influenza illness due to influenza A and B viruses in healthy children and adolescents, ages 5-17 years, and healthy adults, ages 18-49. Children 5-8 years old need two doses at least 6 weeks apart in their first year of influenza vaccination with FluMist, and individuals 9-49 years old need one dose.

According to the Centers for Disease Control and Prevention (CDC), influenza, or "flu," is responsible for an average of approximately 36,000 deaths per year in the United States. Rates of infection are highest among children ages 5-14 years; however the most severe illnesses and deaths occur among individuals with underlying medical conditions, children less than 2 years of age, and those over 65 years old.

"This new vaccine provides another option for protection against influenza and will potentially increase the availability of the injected killed virus vaccine for those people at highest risk," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "Having enough supplies of flu vaccine available has sometimes been a challenge because there are few manufacturers, the vaccine needs to be changed every year, and certain strains of the virus grow slowly during the vaccine development process."

"In addition, for those people who are eligible for the new vaccine and are reluctant to get a shot, such as healthy children over the age of 5, the availability of FluMist will be especially welcome."