FDA FluMist To Include Children Two To Five Years Of Age
FDA has approved the expanded use of MedImmune's FluMist (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age.
FluMist is now approved for active immunization for the prevention of disease caused by influenza A and B viruses in individuals two to 49 years of age. Only one manufacturer had previously been licensed in the United States to produce influenza vaccine for children under four years of age.
MedImmune anticipates shipping FluMist with the expanded label to health care providers in the coming days so that vaccinations may be offered to eligible individuals ahead of and throughout the upcoming influenza season.
"As a company dedicated to innovative advancements in pediatric medicine, MedImmune is delighted to be able to offer FluMist as an option for children as young as two years old to help protect them from influenza," said James F. Young, Ph.D., president, research and development. "With the new, refrigerated formulation approved in January, the results from our head-to- head study published in the February issue of The New England Journal of Medicine, and the expanded age indication now within the label, it is an exciting time for FluMist."
In a pivotal study that included more than 4,000 children between the ages of two and five years of age during the 2004-2005 influenza season, there was a 54 percent reduction in cases of flu in children who received FluMist compared with those who received the traditional flu shot (4.5 percent vs. 9.8 percent, respectively).(1) In the study, FluMist demonstrated a reduction in influenza rates compared to the inactivated vaccine against strains that were both matched and mismatched to the vaccine.
In 48 completed clinical trials, more than 48,000 subjects ranging in age from six weeks to more than 90 years of age received FluMist. In addition to the clinical trial experience, approximately 60,000 doses of FluMist have been administered in two post-marketing studies, and approximately seven million doses of FluMist have been distributed for use in individuals five to 49 years of age following licensure of the product in 2003 through the 2006-2007 influenza season. FluMist is different from the flu shot in that it uses live, attenuated - or weakened - viruses within the vaccine to help stimulate an immune response that is designed to closely resemble the body's natural response to an influenza infection.
"The FDA approval of FluMist for young children is important because these young kids have very high attack rates for influenza, often require