- The Washington Times - Monday, May 14, 2007

MedImmune’s flu vaccine, FluMist, is effective at preventing the virus in infants and should be federally approved for children younger than 5, the company says in new information given to the government.

Based on data released yesterday, the Gaithersburg company is seeking to expand the age group for which FluMist is approved to children younger than 5. FluMist was designed to supplement the infant flu vaccine market and be a boon to MedImmune’s profit margin, but the vaccine was partially derailed when the Food and Drug Administration ruled in 2003 that it is unsafe for the youngest group of children.

The perceived failure of FluMist played a part in MedImmune’s decision last month to be acquired by drug company AstraZeneca for more than $15.5 billion.

A federal advisory committee will meet tomorrow to vote on whether to recommend that FluMist be approved for children younger than 5. Though not obligated to the committee’s recommendation, the FDA generally accepts it.

The FDA said in documents posted on its Web site that MedImmune’s studies show that FluMist protects children as young as 6 months against the flu and showed a higher rate of effectiveness in a direct comparison with the shot.

“FluMist is a highly effective vaccine, with a 55 percent overall better efficacy,” according to the FDA documents.

The new data did not alleviate concerns raised several years ago about an increased rate of asthma and wheezing in children younger than 5. Children younger than 24 months still showed a “statistically significant” increase in wheezing, and children younger than 12 months had an increase in hospitalizations.

“I expect the committee will show some concern regarding the occurrence of asthmalike symptoms after the use of FluMist in children,” said Dr. William Schaffner, professor and chairman of the department of preventive medicine at Vanderbilt University School of Medicine. He also serves on the board of directors for the National Foundation for Infectious Diseases.

The flu kills an estimated 36,000 people in the United States each year, according the Centers for Disease Control and Prevention, and children younger than 5 are at the greatest risk.

Although a record 92 million doses of the vaccine were produced for this year’s flu season, the addition of FluMist for use among infants would be a safeguard against distribution delays or supply shortages that have occurred in the United States in three of the past five flu seasons.

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