Estabilidade da vacina anti-rábica liofilizada e reconstituída: amostra SAD

Abstract

The stability of SAD rabies vaccine has been studied at various storage time and length. A 10-vial pooled batch of SAD rabies vaccine produced by a brazilian comercial laboratory, grown in BHK²¹ cells, was reconstituted and tested for potency and efliciency after storage at the following temperatures and times: ice bath, 25°C, 37°C, samples taken at each hour past up to four hours from reconstitution. Ice bath and 25°C conservation maintained the mininum requirements for up to four hours post-reconstitution. At 37°C the vaccine did not maintain the minimum requirements within one hour of storage. The same rabies vaccine lyophilized was divided into six aliquots of Eve vials which were submitted to 25°C and 37°C temperatures and tested for potency and eHiciency after IO, 20 and 30 days of storage. Within I0 days at 25°C the vaccine maintained the minimum required titer but did not pass the eHiciency test, whereas within 20 and 30 days at the same temperature, the vaccine did not maintain neither efficiency nor potency. A batch of l0 vials was maintained in a refrigerator and tested after one year of storage, maintaining higher than minimum recommended titer and efficiency.