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.

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