MedImmune Inc. said Monday that an improved version of its nasal spray flu vaccine vaccine significantly reduced the number of flu cases in an important clinical trial.
MedImmune said a late-stage, or Phase III, study of the vaccine, CAIV-T, showed that 3.9 percent of patients who took the vaccine came down with flu, compared with 8.6 percent of patients receiving conventional flu shots.
CAIV-T is a new version of the company’s nasal spray vaccine FluMist, which is currently approved to prevent flu in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age.
FluMist, however, has to be kept frozen, an inconvenience that has contributed to disappointing sales of the vaccine. CAIV-T can be kept refrigerated, making it easier to handle.
In addition, CAIV-T was tested in children ages 6 months through 59 months. If approved, the company’s ability to sell the vaccine to this population would substantially expand its market.
The company plans to file for marketing approval for the vaccine in the second quarter of 2006 and will ask the agency to give it a priority review. If approved, MedImmune expects to begin selling it as an alternative to the injectable flu vaccine beginning in the 2007 flu season.
A difference in side effects was seen mainly in children under two years of age who had not been previously vaccinated after the first dose. In these children significant wheezing occurred at a rate of 3.2 percent compared to 2 percent in those getting a conventional shot, the company said.
