The FDA’s vaccines and related biological products advisory committee (VRBPAC) voted that the data collected demonstrates the efficacy of FluMist in children between six and 59 months of age.
In addition, the committee voted in favor of the risk-benefit profile of FluMist in children aged 12 to 59 months without a history of wheeze, and in children aged 24 to 59 months regardless of a history of wheeze.
Although Reuters reported that a number of committee panelists have recommended that the FDA call for more safety studies on wheezing, asthma and hospitalizations, especially in those under two, the publication said that the company has maintained that if the drug receives approval, it will continue to monitor its effects closely.
MedImmune’s FluMist nasal spray vaccine is currently approved for healthy children and adolescents aged five to 17 years and healthy adults aged 18 to 49 years. The company expects the FDA to respond to its application for an expanded indication for FluMist in children aged below five years by May 28, 2007.
Although VRBPAC has already voted in favor of this move, final approval must also be sought from the FDA itself. However, the body usually follows the recommendations of its advisory committees.
Edward Connor, executive vice president and chief medical officer at MedImmune, said: “Pending approval, we believe that FluMist will be an important new alternative for helping to protect this group of vulnerable children from influenza. We look forward to continuing discussions with the FDA in its review of our application.”