A Comparative Approach on Shelf Life Stability of Tetanus Toxoid Vaccine Produced from Imported and Locally Formulated Bulk in Private Sector Facility of Pakistan

Abstract

Tetanus is an acute ailment, pictured by the substantial increase in rigidity and spastic cramps in striated muscle. The substandard tetanus toxoid vaccine might increase the incidence of neonatal tetanus. WHO has taken many steps to help national regulatory authorities and vaccine manufacturers to make sure its quality and efficacy. It has developed international principles of stability analysis of every vaccine that is available in the form of recommendations and guidelines. The aim of the present study was to ensure the efficacy of tetanus vaccine produced by manufacturer of private sector (Amson Vaccine and Pharma (Pvt) LTD. Islamabad, Pakistan). All stability studies performed on final products stored at 2-80C and evaluated at near expiry and even three months after its expiry month. The study gives efficacy comparison between Tetanus vaccine injection filled from imported RTF Bulk and Formulated Tetanus Toxoid Bulk from the private sector. The findings indicate that the formulated tetanus vaccine is equally effective when checked its safety profile in live animals. The study also reveals that the product remains stable till last day of its expiry month provided if the cold chain was maintained between 2 80C till consumed.