MarketVIEW: pre-pandemic vaccines

Experts commonly believe that the next influenza pandemic is imminent. They are particularly concerned about the current avian influenza strain H5N1 (and subclades) which has spread rapidly in bird populations in SE Asia. H5N1 has caused high mortality in poultry and occasionally infects humans in close contact with around 60% of cases (408) so far being fatal. As of February 27th 2009 confirmed H5N1 Avian influenza deaths in humans have reached 256, a significant increase upon 2004. A simultaneous infection of a human influenza virus and H5N1 could cause genetic reassortment forming a new virus that can be spread more rapidly between humans initiating a pandemic. To date H5N1 has not been reported in the Western Hemisphere.

This expert report provides a comprehensive up-to-date review of the current status of H5N1 pre-pandemic vaccines and investigates all of the critical issues with regard to their licensure, technology, safety and eventual use/deployment. The report captures the viewpoints of 5 recognised global opinion leaders, FDA VRBPAC and assesses the strengths/weaknesses of each commercial manufacturer’s progress to date. An emphasis is placed on current expert perceptions with regard to adjuvantation, cell-based systems and the optimal immune response required to provide protection should a pandemic occur.