MedImmune's new flu formulation gets FDA approval
has been approved by the US Food and Drug Administration (FDA). The
new formulation can now be stored in a refrigerator rather than
frozen, which proved a major disadvantage of the company's previous
form of the drug.
"We recognise that the frozen storage presented difficulties for some physician practices as well as for providers who administer vaccines in places like schools, pharmacies and grocery stores, and we are confident that this improvement will enhance access to this important vaccine," said senior vice president of medical and scientific affairs at the company, Frank Malinoski.
Since its approval by the FDA in 2003, FluMist had been marketed in a frozen formulation bringing it under criticism due to the impractical storage requirements. In 2004 were shortages of flu vaccine, exacerbated by a halt in production at UK-based vaccine manufacturer Chiron due to contamination. Chiron, now part of Novartis, was due to provide roughly 50 per cent of the entire US flu vaccine supply, and MedImmune was unable to capitalise on the vaccine shortage at least partly due to difficult storage requirements making their product less attractive.
The company hopes that this new formulation will address these issues, and aims to have stocks of the vaccine available for the 2007-2008 influenza season.
The vaccine itself is administered as a fine mist through the nose, and is indicated for the prevention of disease caused by influenza A and B viruses. A weakened form of the live flu virus, the vaccine is designed to work in the nasal passages to stimulate the body's natural immune response.
The vaccine is currently only approved for the 5 - 49 years age range, and MedImmune's next goal is to gain approval to extend this age indication. Clinical trials with infants as young as 6 weeks and adults up to 98 years have already been conducted, and a study involving children aged 6 - 59 months has been submitted to the FDA to support the company's request to expand the age range of potential FluMist patients.
In the mean time, MedImmune has upped production of the new FluMist formulation, and anticipates shipping the first doses to physicians during 2007 in time to start vaccinating patients in August. In 2006, MedImmune was the first influenza vaccine manufacturer to have product available for the 2006-2007 US flu season.
In the first three quarters of 2006 MedImmune recorded revenues of $18m (€14m) for FluMist, which still places them well behind vaccine market leaders Sanofi-Aventis, Novartis and GSK.
