Vaccine quality issues :Sanofi Pasteur

Sanofi Pasteur, which is in the midst of upgrading a Toronto vaccine plant after mold was found in sterile areas, is now recalling several batches of typhoid vaccine that may not meet potency standards. The company said the recall could lead to a shortage of the drug.

Health Canada and the company announced last week that there could be variability in the active ingredient, polysaccharide, in several batches of Salmonella typhi Vi Capsular Polysaccharide Vaccine. It said there may not be sufficient antigen in some syringes and 20-dose vials.

There is no safety concern tied to the recall, the joint announcement says, but the company says it has no information on what might result from having too little antigen and that there is no test to determine if the delivered product meets potency standards. It says it does not recommend revaccination but “currently there is no available commercial kit to easily evaluate the level of anti-Vi serum antibodies of individuals and, furthermore, there is no validated immunological Vi antibody-based surrogate of protection for typhoid fever.” And there is no information on what happens if patients were to be revaccinated with an alternative vaccine.

Sanofi Pasteur, the largest operation devoted to human vaccines in the world, in June recalled four batches of the tuberculosis vaccine BCG and suspended production at a plant in Canada after regulators found problems with sterility. That has led to a shortage of that vaccine. There was some concern that there might also be a shortage of its bladder cancer drug, ImmuCyst, which also is made in the plant, but Canadian regulators cleared that product for sale after it had been on hold because of problems flagged at the plant, which is now idled for an overhaul.

An FDA warning letter from inspections in the spring laid out 24 observations at its plant in Toronto where the mold was found, as well as a few more found during a routine March inspection of a plant in Marcy-l’Étoile, France. Among problems at the Toronto plant, the FDA says, “there have been no less than 58 documented non-conformances relating to the isolation of mold within the BCG aseptic processing areas” since August 2010.