FDA Approves First U.S. Vaccine vs. H5N1

The sanofi pasteur vaccine, which demonstrated effectiveness for about half of the humans receiving it during test trials, will be stockpiled by the U.S. Government and will not be sold commercially.

FDA Approves First U.S. Vaccine vs. H5N1

Sanofi pasteur: human vaccine specialists

The full press release from the sanofi-aventis group was posted on 17-APR-2007.

Work to improve vaccine effectiveness is ongoing. The FDA press release reports that

"With the support of the FDA, the U.S. National Institutes of Health and other government agencies, sanofi pasteur and other manufacturers are working to develop a next generation of influenza vaccines for enhanced immune responses at lower doses, using technologies intended to boost the immune response."

Prospective simulations must take into account:

  • Lead time for delivery from the stockpile (FDA indicates 12 hours to any state)
  • Supply requirements for intramuscular injections
  • Logistics and tracking requirements for the two-injection regimen
  • As previously mentioned in pandemicsimulation.com, projections must take into account the statistics that effectiveness of the vaccine is no better than 45%
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