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FDA Panel Recommends Expanding Use of FluMist to Children Under 5 Years of Age

GAITHERSBURG, Md., May 16 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of expanding the population for use of FluMist (Influenza Virus Vaccine Live, Intranasal) to include children under 5 years of age. The committee voted that the data demonstrate the efficacy of FluMist in children 6 to 59 months of age. In addition, the committee voted in favor of the risk-benefit profile of FluMist in children 12 to 59 months of age without a history of wheeze, and voted in favor of the risk-benefit profile of FluMist in children 24 to 59 months of age regardless of a history of wheeze.

"We are very pleased with the committee's endorsement to expand the availability of FluMist to children under 5 years of age," said Edward M. Connor, M.D., executive vice president and chief medical officer. "Pending approval, we believe that FluMist will be an important new alternative for helping to protect this group of vulnerable children from influenza. We look forward to continuing discussions with the FDA in its review of our application."

FluMist, a nasal spray vaccine, is currently approved for healthy children and adolescents 5 to 17 years of age and healthy adults 18 to 49 years of age. The FDA is expected to respond to the company's supplemental biologics licensing application (sBLA) requesting an expanded indication for FluMist in children below 5 years of age by May 28, 2007.

During today's FDA advisory meeting, the questions voted on by the committee and the resulting votes are described below:
1. Do the data demonstrate the efficacy of FluMist for prevention of influenza illness in the following:
a. The applicant's proposed population, i.e., children age 12-59 months without history of wheeze? Vote: 15-0 in favor
b. Children in the age strata 6-23 months? Vote: 14-1 in favor
c. Children in the age strata 24-59 months? Vote: 15-0 in favor

2. Do the safety data demonstrate that the benefits will exceed the risks of FluMist for use in:
a. The applicant's proposed population, i.e., children age 12-59 months without history of wheeze? Vote: 9-6 in favor
b. Children in the age strata 6-23 months, regardless of wheezing history? Vote: 3-12 against
c. Children in age strata 24-59 months, regardless of wheezing history? Vote: 15-0 in favor

A third question solicited advice from the panel regarding post-marketing studies and surveillance activities.

About FluMist
FluMist is currently 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. There are risks associated with all vaccines, including FluMist. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine.

Under no circumstances should FluMist be administered as an injection (i.e. parenterally). 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.

In randomized, placebo-controlled clinical trials of FluMist in its refrigerated and frozen formulations, the most common solicited adverse events in the indicated population (n=11,604) included runny nose/nasal congestion, sore throat, cough, irritability, headache, chills, vomiting, muscle aches, decreased appetite, abdominal pain, and decreased activity/feeling of tiredness/weakness.

On January 5, 2007, the FDA approved MedImmune's sBLA for a refrigerated version of FluMist, which will be manufactured for the 2007-2008 influenza season. Prior versions required frozen storage. Due to the seasonal nature of influenza vaccine, full prescribing information for the refrigerated version does not yet contain complete details on vaccine strains to be included for next season's vaccine. However, preliminary prescribing information can be found at https://www.fda.gov/cber/label/inflmed010507LB.pdf.

Source: MedImmune

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