National Influenza Recommendations Updated to Include FluMist, First Intranasal Flu Vaccine in U.S.

GAITHERSBURG, Md., and MADISON, N.J. -- The Advisory Committee on Immunization Practices (ACIP) has issued a supplemental recommendation for the use of Live, Attenuated Influenza Vaccine (LAIV) to its annual Recommendations for the Prevention and Control of Influenza.

The newly licensed LAIV, which is called FluMist, Influenza Virus Vaccine Live, Intranasal, has been incorporated into the influenza vaccine recommendations as an option for the vaccination of healthy people aged 5 to 49 years. This group includes millions of healthy persons who wish to avoid acquiring influenza. The complete updated recommendations appeared in the Sept. 26, 2003 Morbidity and Mortality Weekly Report, published by the U.S. Centers for Disease Control and Prevention. FluMist is manufactured by MedImmune Vaccines, Inc., and co-promoted with Wyeth Vaccines.

"ACIP's inclusion of FluMist in the influenza vaccine recommendations for the upcoming flu season is good news for patients," says Dr. Peter Paradiso, vice president of new business and scientific affairs for Wyeth. "The nasal mist delivery of FluMist may be an attractive option for those healthy people who choose to be vaccinated, and it may help increase vaccination rates among this population."

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. The most effective way to help 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. Children 5 to 9 years of age who are getting FluMist for the first time should get two doses, as with the injectible vaccine. These children should get their first dose in October or earlier, followed by a second dose at least six weeks later.

FluMist 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.

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 percent 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.

Source: Wyeth