Uncomplicated influenza is characterized by the sudden onset of constitutional and respiratory signs and symptoms. In the majority of patients, recovery is complete after several days; however, in certain individuals, influenza can exacerbate underlying medical conditions. Young children with influenza infection can have initial symptoms mimicking bacterial sepsis with high fevers; influenza infection has also been associated with encephalopathy, transverse myelitis, Reye syndrome, myositis, myocarditis, and pericarditis. Estimates of influenza related deaths sit in the 19,000-36,000 per annum range. A study that modeled influenza-related deaths estimated that an average of 92 deaths occurred among children aged <5 years annually during the 1990's. There were 143 laboratory-confirmed pediatric deaths during the 2003–2004 influenza season; 41% were aged <2 years and 45% of did not have an underlying medical condition. We have assigned a 100 point score to the burden of illness variable.

We believe nasally administered vaccines represent true innovation; however, MedImmune’s FluMist is already approved. Of important note, ID Biomedical’s FluInsure is also in Phase 3 testing. CAIV-T merits a 55/100 score for the innovation status variable. Demand/diffusion scoring is difficult as this year’s flu vaccine shortage due to Fluvirin’s withdrawal highlights. Under normal supply/demand circumstances, intranasal vaccines will be significantly more expensive than injectable influenza vaccines. We maintain our demand/diffusion score of 10 here to remain consistent with FluInsure’s scoring resulting in a score of 60 for CAIV-T. Health services delivery clients should assess current influenza immunization programs looking specifically at the planned role for inhaled intranasal vaccines.

Technology Details
Target Disease / Indication: Influenza
Technology Classification: Drug/Vaccine
Body System: Respiratory
Program Area: Medicine/Infectious Disease
Regulatory Status: Phase 3
BioHorizon Impact Score: 60100 – Moderate/High

According to the CDC, every year between 5 and 20% of Americans develop influenza. This results in an estimated 114, 000 influenza-related hospitalizations and 36, 000 influenza-related deaths annually. Influenza receives a 100/100 score for the Burden of Illness variable.

Biohorizon is currently monitoring one other inhaled Influenza vaccine, MedImmune’s FluMist™, a live-attenuated intranasal vaccine. Demand for FluMist during the 2003-2004 season was significantly lower than expected and in June of 2004, MedImmune announced a 50% price reduction (from approximately 46 to 23 dollars per dose). The company also announced a reduction in production from 4 million doses to 1 to 2 million doses. ID Biomedical’s FluInsure is inactivated vs. live and could have an expanded indication. We have assessed the Demand/Diffusion variable to be 10/100. The Innovation variable is currently scored at 60/100.

Several factors should significantly increase influenza vaccine demand in the 2004-2005 season and beyond. These factors include: the higher than expected pediatric mortality associated with the 2003-2004 A/Fujian strain of influenza; concerns regarding Avian Influenza; the availability of intranasal vaccine delivery as an alternative to intramuscular vaccine delivery; and the CDC’s expanded recommendations for routine immunization of infants 6-23 months of age. If FluInsure receives FDA approval and infants and children are included in the indication, this vaccine could have a major impact on immunization costs. We therefore recommend commencement of preliminary assessment activities and have placed FluInsure in the Moderate/High Impact category with an Impact Score of 63.

Technology Details
Target Disease / Indication: Influenza
Technology Classification: Drug
Body System: Respiratory
Program Area: Medicine/Infectious Disease
Regulatory Status: Phase III
BioHorizon Impact Score: 63/100 –Moderate/ High