>>GAITHERSBURG, Md., and MADISON, N.J., June 17 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) today approved FluMist(TM) (Influenza Virus Vaccine Live, Intranasal), the first influenza vaccine delivered as a nasal mist available in the United States for healthy people. FluMist(TM) will be available in physicians' offices and some pharmacies beginning in late summer to early fall, in time for this flu season.
FluMist(TM), 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. (Nasdaq: MEDI - News), and is co-marketed by Wyeth Vaccines, a business unit of Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News).
"The innovative delivery of FluMist(TM) 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, MD, professor of Internal Medicine, Pediatrics, Molecular Microbiology and Immunology at Saint Louis University, and the lead investigator of key FluMist(TM) 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(TM) 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(TM) 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(TM) is cutting-edge technology in influenza vaccine delivery in the U.S."
Clinical Data
In a clinical trial with adults aged 18 years to 41 years (N=60), the ability of FluMist(TM) to protect adults from influenza illness was 85 percent (95 percent confidence interval [CI]: 28, 100) in those who were intentionally exposed to wild-type virus. In a two-year pediatric field trial, the efficacy of FluMist(TM) in preventing influenza was 87 percent (P less than or equal to 0.05) among healthy children aged 60 months to 84 months (N=544). 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. In placebo- controlled clinical trials, the most common adverse events in healthy adults (n=2,548) included runny nose, headache, sore throat, tiredness/weakness, muscle aches, cough, and chills. In clinical trials, in the indicated population, these events were transient.
FluMist(TM) is 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.
There are risks associated with all vaccines, including FluMist(TM). FluMist(TM) does not protect 100% of individuals vaccinated, or protect against viral strains not represented in the vaccine. FluMist is not indicated for children less than 5 years or for adults 50 years and older. FluMist(TM) 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(TM) have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airway disease; the vaccine should not be administered to these patients. See Prescribing Information for indications and usage, dosage and administration, and safety information.<<
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