US FDA clears fridge formula FluMist

US drugmaker MedImmune says that the US Food and Drug Administration has approved its new refrigerated formulation of FluMist (influenza virus vaccine live, intranasal) for use in helping to prevent influenza in healthy children and adults from five years to 49 years of age.

The firm hopes the new formulation will encourage more health care providers to offer the vaccine to their customers and patients, as it can be conveniently stored in a standard refrigerator rather than frozen, as previously required. FluMist has been marketed in a frozen formulation since its original FDA approval in 2003, and millions of doses have been distributed and administered since then. The newly-approved formulation of FluMist, known in clinical studies as CAIV-T (cold adapted influenza vaccine-trivalent), will be available for the 2007-2008 influenza season.

The firm's next goal for the product is expanding its pediatric label. To this end, in a recently completed pivotal Phase III study involving approximately 8,500 children between six and 59 months of age, FluMist demonstrated a statistically significant 55% relative reduction in the incidence of influenza illness caused by any influenza strain, including both matched and mismatched strains, compared to the injectable influenza vaccine. This study was conducted during the 2004-2005 influenza season in the USA, Europe and Asia and was submitted in July 2006 to the FDA as the basis of MedImmune's request to expand the age indication for FluMist to include children as young as one year of age with a history of wheezing or asthma.