Friday, September 21, 2007
Low Dose H5N1 Vaccine: Improving Ability to Stockpile?
Sanofi Pasteur, which developed the first FDA-approved pre-pandemic vaccine in April, recently released results of a clinical trial of a new antigen-sparing, low-dose H5N1 vaccine, which they said produced an immune responses in a significant (70-80%) number of the adults in the trial.
The guidelines for the first vaccine from Sanofi would have recommended a dose of 90ug of antigen to produce an immune response to the virus, whereas annual flu vaccine contains about 45ug of antigen.
This new low-dose vaccine could contain only 1.9 to 3.75ug of anitgen, significantly increasing the number of doses manufacturers could deliver in a shorter time period, which would be particularly important in the event of a pandemic.
The vaccine is still in Phase 1 trials in the United States and Sanofi has not commented on how long they believe it will take before the vaccine is ready for licensure or manufacturing.
Full story available online:
http://www.outsourcing-pharma.com/news/ng.asp?n=79839-sanofi-pasteur-vaccine-h-n-influenza
The guidelines for the first vaccine from Sanofi would have recommended a dose of 90ug of antigen to produce an immune response to the virus, whereas annual flu vaccine contains about 45ug of antigen.
This new low-dose vaccine could contain only 1.9 to 3.75ug of anitgen, significantly increasing the number of doses manufacturers could deliver in a shorter time period, which would be particularly important in the event of a pandemic.
The vaccine is still in Phase 1 trials in the United States and Sanofi has not commented on how long they believe it will take before the vaccine is ready for licensure or manufacturing.
Full story available online:
http://www.outsourcing-pharma.com/news/ng.asp?n=79839-sanofi-pasteur-vaccine-h-n-influenza
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