Gaithersburg, MD (AHN) - MedImmune Inc. announced today that their refrigerated formulation of FluMist has been approved by the Food and Drug Administration (FDA).
Although a frozen formulation of FluMist has been on the market since its approval from the FDA in 2003, MedImmune's latest refrigerated formulation of FluMist will be available to the public in the 2007-2008 vaccination period for the next influenza season.
Both frozen and refrigerated formulations of FluMist are free of preservatives, such as thimerosal, which is a product that causes an allergic reaction in some individuals. Thimerosal is still currently being used to formulate the injectable flu vaccinations.
MedImmune's latest formulation of the FluMist was tested on children as young as 6 weeks old and as old as 98 years of age.
To date there have been 42 clinical trials that involved 60,000 study participants to test the effects of the FluMist product. The latest results of the 2004-2005 influenza season study found that using FluMist demonstrated a significant 55 percent reduction in strains that are included in the FluMist and even those that were not included in the formula in comparison with the injection form of the flu vaccine.
MedImmune is one of several manufacturers approved by the FDA to make the vaccine available to the public.
The nasal spray delivery of Flu-Mist is a well-tolerated influenza prevention option for healthy individuals in the listed age group. Current approved applications of this vaccine apply to healthy children and adults ages 5 to 49 years only as a nasal inhalant.
MedImmune has requested that the FDA expand the age group allowable for FluMist, which is still pending approval. The manufacturer wishes to include children as young as one year of age as long as they do not have any history of asthma or wheezing.
The anticipated future application of MedImmune's latest formulation of FluMist is scheduled for early August 2007.
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