Evaluation of the quality of trivalent poliomyelitis vaccine produced in 2007

ABSTRACT

Background: Trivalent poliomyelitis vaccine was produced from strains which had been supported by Japan. One of the standards of vaccine quality required by WHO is potency and thermostability. Follow that potency at 370C and within 48 hours is not less effective than potency at -200C exceedingly 0,5 lgCCID50. Objectives: To assess the potency of Trivalent poliomyelitis vaccine and the thermostability of mokey vaccine preserved at 370C within 48 hours. Subjects and method: 12 lots of trivalent poliomyelitis vaccine (included 3 types) produced in January 2007 were evaluated by microneutralization technique. Results: Potency of 12 type I lots were all 106,0 CCID50/0,1ml and the disparity of potency at two temperatures were all < 0,5 lgCCID50/0,1ml. Potency of 12 type II lots were all 105,0 CCID50/0,1ml and the disparity of potency at two temperatures were all < 0,5 lgCCID50/0,1ml. Potency of 12 type III lots were all 105,5 CCID50/0,1ml and the disparity of potency at two temperatures were all < 0,5 lgCCID50/0,1ml. Conclusion: 12 final poliovaccine lots produced in Center for research and production of vaccines and biologicals \ufffd?Ha Noi in 2007 met WHO requirements for potency and thermostability.