ID Biomedical’s FluInsure Influenza Vaccine
July 20, 2004 by admin · Leave a Comment
FluInsure™
On July 20 2004, ID Biomedical released preliminary data regarding FluInsure™ from its field efficacy study. Carried out during the 2003-2004 flu season at 28 sites throughout Canada, this study involved 1,349 healthy participants aged 18 to 64. A single dose of the nasally delivered, non-living vaccine had 67% efficacy (3/451 vs. 9/443 placebo) against culture confirmed clinical illness. It is important to note that these results were achieved despite the fact that the vaccine did not match the predominant circulating strain in North America this past flu season (A/Fujian). This Phase III data merits an Efficacy variable score of 80/100.
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