Instability of Pertussis-Vaccine Component in Quadruple Antigen Vaccine

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Abstract
The potency of pertussis antigen alone or in combination with diphtheria and tetanus toxoids is generally stable throughout its dating period of 18 months. The present investigation revealed that when poliomyelitis vaccine was added to the triple-antigen vaccine, potency of pertussis vaccine was unstable and that the rate of loss was about 6% per month. Loss was more rapid in samples exposed to the normal variable conditions on the market than in those held constantly under refrigeration. To compensate for this loss, the initial potency estimate requirement has been increased, and the dating period has been decreased to 4 months from date of issue. These factors have limited the availability of the product until the cause of deterioration has been removed.

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