maintained indefinitely by indefinitely by booster doses. booster doses. Route of Oral or non-parenteral route. A route enabling rapid mass Oral or non-parenteral route. A route compatible with use in Administration A route enabling rapid mass administration. Where A route compatible with use in routine immunization administration. injection (IM or SC) is routine immunization programs. Where injection required, using standard programs. (IM, ID or SC) is required, using volumes for injection as standard volumes for injection specified in programmatic as specified in programmatic suitability for prequalification. suitability for prequalification. Coverage against all plague Coverage against the most Coverage against all plague Coverage against plague Coverage strains. common outbreak plague strains. strains circulating in the strains. endemic areas. Product Stability and Shelf life of at least 5 years at Shelf life of at least 12 months Ideally: stable at room Shelf life of at least 2 years at Storage 2-8oC. at -20oC and one month at temperature for 2-3 years. and 6 months at 2-8oC. Shelf life of at least 5 years at Preferably thermostable at The need for a preservative is 2-8oC. higher temperatures for The need for a preservative is determined and any issues are several days. The need for a determined and any issues are Preferably thermostable at addressed including absence preservative is determined addressed including absence higher temperatures for of toxicity. and any issues are addressed several days. The need for a of toxicity. Vaccine Vial Monitor (VVM): preservative is determined including absence of toxicity. Proof of feasibility and intent and any issues are addressed Vaccine Vial Monitor (VVM): to apply a VVM to the primary
maintained indefinitely by booster doses. indefinitely by booster doses. Route of Administration Oral or non-parenteral route. A route enabling rapid mass administration. A route enabling rapid mass administration. Where injection (IM or SC) is required, using standard volumes for injection as specified in programmatic suitability for prequalification. Oral or non-parenteral route. A route compatible with use in routine immunization programs. A route compatible with use in routine immunization programs. Where injection (IM, ID or SC) is required, using standard volumes for injection as specified in programmatic suitability for prequalification. Coverage Coverage against all plague strains. Coverage against the most common outbreak plague strains. Coverage against all plague strains. Coverage against plague strains circulating in the endemic areas. Product Stability and Storage Shelf life of at least 5 years at 2-8oC. Preferably thermostable at higher temperatures for several days. The need for a preservative is determined and any issues are addressed including absence of toxicity. Vaccine Vial Monitor (VVM): Shelf life of at least 12 months at -20oC and one month at The need for a preservative is determined and any issues are addressed including absence of toxicity. Ideally: stable at room temperature for 2-3 years. Shelf life of at least 5 years at 2-8oC. Preferably thermostable at higher temperatures for several days. The need for a preservative is determined and any issues are addressed Shelf life of at least 2 years at and 6 months at 2-8oC. The need for a preservative is determined and any issues are addressed including absence of toxicity. Vaccine Vial Monitor (VVM): Proof of feasibility and intent to apply a VVM to the primary