FluMist, First Intranasal Flu Vaccine in the U.S., Now Available From Healthcare Providers

GAITHERSBURG, Md., and MADISON, N.J. -- MedImmune Vaccines, Inc., and Wyeth Vaccines announced today that FluMist (Influenza Virus Vaccine Live, Intranasal), the first influenza vaccine delivered as a nasal mist approved in the United States for healthy people, is now available in doctors' offices and in some pharmacies nationwide for the 2003-2004 influenza season. FluMist is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age.

"FluMist is the first needle-free option in the U.S. for immunizing healthy children and adults against influenza," said Robert B. Belshe, MD, professor of internal medicine, pediatrics, Molecular Microbiology and Immunology at Saint Louis University, and the lead investigator of key FluMist clinical trials. "Healthy people should consider vaccination against the flu, as the burden of influenza in this population is significant. With the availability of FluMist, more healthy people could get vaccinated against influenza this fall."

The flu is a recurrent epidemic infectious disease that significantly affects and disrupts the lives of healthy children and adults. Each year in the U.S., an estimated 17 million to 50 million people, many of whom are otherwise healthy children and adults, are infected with the influenza virus. Influenza also results in approximately $3 billion to $15 billion annually in direct and indirect costs, including approximately 70 million missed workdays and approximately 38 million missed school days.

Because the influenza virus is airborne, it is easily transmitted, placing nearly everyone at risk for exposure. Areas where people gather, such as schools, homes, and offices, are likely locations for catching the flu. The most effective way to prevent influenza is vaccination.

Many healthcare professionals immunize against the flu between October and November, although vaccination can be beneficial even beyond December. Flu season peaks between December and March; however, many healthcare professionals vaccinate as soon as vaccine is available.

FluMist is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age.

In placebo-controlled clinical trials, the most common solicited adverse events in healthy children (n=214) included runny nose/nasal congestion, cough, irritability, headache, decreased activity, sore throat, fever (oral temperature > 100 degrees F), muscle aches, chills, and vomiting. The most common adverse events in healthy adults (n=2,548) included runny nose, headache, sore throat, tiredness/weakness, muscle aches, cough, and chills.

There are risks associated with all vaccines, including FluMist. FluMist does not protect 100% of individuals vaccinated, or protect against viral strains not represented in the vaccine. FluMist is not indicated for immunization of individuals less than 5 years of age, or 50 years of age and older. FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients. See Prescribing Information for indications and usage, dosage and administration, and safety information.

Source: MedImmune, Inc.; Wyeth Vaccines