CAIV-T, a cold adapted influenza vaccine produced higher influenza serum antibody responses than an injectable trivalent inactivated flu vaccine (TIV).
“These data are consistent with the results from our phase III study conducted during the 2004-2005 season that demonstrated CAIV-T’s increased efficacy against matched and mismatched strains in children under five years of age compared to TIV,” said Robert Belshe, director of the Center for Vaccine Development at Saint Louis University School of Medicine.
The FDA is currently reviewing a supplemental biologics licensing application submitted by MedImmune to switch formulations from its original vaccine FluMist, to the new CAIV-T formulation, for individuals 5 to 49 years of age.
MedImmune has also submitted a separate biologics application to the FDA seeking an expanded label for CAIV-T for use in children between 12 months and 59 months of age who do not have a history of wheezing or asthma.
A response from the FDA is anticipated in the second quarter of 2007 and MedImmune plans to launch CAIV-T for the 2007-2008 influenza season.