MEDIMMUNE PRESENTS RESULTS OF PEDIATRIC FLU VACCINE STUDY

MedImmune has announced results of a study that demonstrated higher influenza serum antibody responses in children receiving its next-generation, investigational intranasal influenza vaccine, CAIV-T (cold-adapted influenza vaccine, trivalent), than in children who received the traditional injectable trivalent inactivated flu vaccine (TIV). In this study involving 52 children between 6 and 35 months of age, CAIV-T prompted significantly higher seroconversion rates and higher antibody titers than TIV. CAIV-T also demonstrated significantly more cross-reactivity to the mismatched strain that predominantly circulated during the 2004-2005 season.

In the study a group of influenza-vaccine-naive children received two doses of CAIV-T or TIV approximately 35 days apart. The children's immune responses (measured by serum hemagglutination inhibition antibody levels) were evaluated at the time of enrollment, just prior to and approximately 30 days after the second dose. Study results indicated that CAIV-T produced significantly higher antibody responses than TIV against vaccine-like virus strains (matched) as well as against mismatched viruses that were circulating during the 2004-2005 season in seronegative children. Higher antibody responses were seen for CAIV-T after both the first and second doses.

The FDA is currently reviewing a supplemental biologics licensing application (sBLA) submitted by MedImmune to switch formulations from frozen FluMist (influenza virus vaccine live, intranasal), currently approved in healthy individuals 5 to 49 years of age, to the refrigerator-stable CAIV-T formulation for the same population. MedImmune has also submitted a separate sBLA 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 for this sBLA is anticipated in the second quarter of 2007 and, pending positive outcome, MedImmune plans to commercially provide CAIV-T for the 2007-2008 influenza season.