Does this mean Sanofi Pasteurs influenza vaccine, Fluzone, will not be available for the 2006 – 2007 flu season?
At this time, the deficiencies noted in the inspection of Sanofi Pasteur’s Swiftwater, PA, manufacturing facility are not expected to significantly affect the availability of Fluzone for the 2006 – 2007 flu season, but we continue to review the progress made by the company. The violations noted in the Warning Letter regarding Fluzone relate to manufacture of the monovalent concentrates. Monovalent concentrates are “intermediates” derived from one of the three influenza strains used to produce final vaccine each year. Though there will be some impact due to the loss of these monovalent concentrates, it is not expected to be significant.
