PREPARATION AND STANDARDIZATION OF US STANDARD PERTUSSIS-VACCINE, LOTNO-11

The Center for Biologics Evaluation and Research within the U.S. Food and Drug Administration has prepared a new U.S. Standard Pertussis Vac cine. Whole cell pertussis vaccine concentrate was diluted in 5% (w/v) lactose and lyophilized. The preparation was tested for toxicity, ste rility, heterogeneity and residual moisture. Based on data from an int ernational collaborative study involving 11 laboratories, the potency was estimated in relation to the U.S. Master Standard Pertussis Vaccin e, Lot 4 and the international Standard for Pertussis Vaccine, Lot 2. The potency of the preparation was defined to be 90 units per ampoule. When reconstituted and stored according to instructions, no significa nt change in potency was observed in the 14 days following reconstitut ion. This material was shown to be suitable for a pertussis vaccine st andard and accordingly it was designated as U.S. Standad Pertussis Vac cine, Lot 11 on March 22, 1994. (C) 1996 The International Association of Biological Standardization.