MedImmune, Inc.(Nasdaq: MEDI) has submitted to the USFDA a supplemental Biologics License Application (sBLA) for use of CAIV-T (cold adapted influenza vaccine, trivalent) in children age 12 to 59 months who do not have a history of wheezing or asthma.
CAIV-T is the refrigerator-stable formulation of FluMist® (Influenza Virus Vaccine Live, Intranasal); a frozen vaccine approved in the U.S. for the prevention of influenza in individuals age 5 to 49.
MedImmune’s FluMist®, 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) and healthy adults (18 to 49 years), is now available for the 2006-2007 Influenza Season.
More details from MedImmune, Inc."This is a very satisfying moment for MedImmune as it represents the culmination of multi-year clinical, manufacturing and regulatory efforts to improve the profile of our influenza vaccine," said Edward M. Connor, Jr., M.D., executive vice president and chief medical officer.
"Pending FDA review and approval, we believe that our live, attenuated influenza vaccine will be an important new vaccine for many children currently recommended for annual influenza vaccination by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP)."
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