The U.S. Food and Drug Administration (FDA) approved FluMist (Influenza Virus Vaccine Live, Intranasal), the first influenza vaccine delivered as a nasal mist available in the United States for healthy people. FluMist will be available in physicians' offices and some pharmacies beginning in late summer to early fall, in time for this flu season.
FluMist, indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age, is manufactured and marketed by MedImmune Vaccines Inc, a wholly owned subsidiary of MedImmune Inc, and is co-marketed by Wyeth Vaccines, a business unit of Wyeth Pharmaceuticals, a division of Wyeth.
"The innovative delivery of FluMist is changing the way we think about flu prevention and could increase the number of healthy people who receive a yearly influenza vaccination," said Robert B. Belshe, professor of Internal Medicine, Pediatrics, Molecular Microbiology and Immunology at Saint Louis University, and the lead investigator of key FluMist clinical trials. "There is a strong need for healthy people to get vaccinated against influenza. For example, healthy school-aged children are often the first to be infected by influenza and can infect others in the community."
Each year in the U.S., influenza infects an estimated 17 million to 50 million people, many of whom are otherwise healthy children and adults. 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.
"MedImmune is proud to bring FluMist to market as a new, needle-free option to help reduce the occurrence and impact of the flu," said David Mott, Chief Executive Officer of MedImmune Inc.
"The FDA approval of FluMist brings the public an innovative vaccine delivery system aimed at protecting the health of school-aged children and adults," said Geno Germano, Executive Vice President and General Manager of Wyeth Global Vaccines. "FluMist is cutting-edge technology in influenza vaccine delivery in the U.S."