US Classifies Pandemic Flu Vaccine as a Select Agent
Recombinomics Commentary
January 24, 2005
One of the more interesting facts to emerge from the University of Michigan symposium on Pandemic Influenza: Could History Repeat Itself? was the fact that the US declared the flu virus a select agent because it had been genetically modified to REDUCE its lethality.
Highly pathogenic influenza A virus, including H5N1, have a poly-basic cleavage site in the hemagglutinin protein. To make the virus less lethal and enhance virus production in eggs, several of the basic amino acids are genetically removed,.
However, the removal of these sequences placed the virus in the "select agent" category, requiring background checks and paperwork that would significantly delay development of the vaccine. WHO has been pushing for programs to delay the looming pandemic, saying that each day allows for 5 million more doses of vaccine to be made.
It wasn't clear how long it took to get the designation removed, but the clinical trials scheduled to begin this month are now at least 4-6 weeks away for Aventis. Chiron is stated to begin even later because they built a special testing facility for pandemic flu vaccine development.
Bird flu is looming large as the red tape flows out of Washington.