Proof of feasibility and intent including absence of toxicity. distribution container. to apply a VVM to the primary Vaccine Vial Monitor (VVM): container. Proof of feasibility and intent Vaccines that are not to apply a VVM to the primary damaged by freezing container. temperatures (<0oC) are Vaccines that are not preferred. damaged by freezing Vaccines stable out of cold temperatures (<0oC) are chain are preferred. If not, preferred. vaccines that can be delivered Vaccines stable out of cold via the Controlled chain are preferred. If not, Temperature Chain are vaccines that can be delivered preferred . via the Controlled Temperature Chain are preferred 12. Co-administration The vaccine will be given as a stand-alone product not The vaccine can be The vaccine will be given as a with other vaccines with other vaccines. with other stand-alone product not vaccines. with other vaccines. If oral administration, If oral administration, If oral administration, 2-5 If oral administration, 2-5 Presentation presentation in plastic presentation in glass vial doses with a volume of 1-2 mL doses with a volume of 1-2 mL tubes with a volume of 1-2 with a volume of 1-2 mL or in plastic tubes; with favorable
Proof of feasibility and intent to apply a VVM to the primary container. Vaccines that are not damaged by freezing temperatures (<0oC) are preferred. Vaccines stable out of cold chain are preferred. If not, vaccines that can be delivered via the Controlled Temperature Chain are preferred . including absence of toxicity. Vaccine Vial Monitor (VVM): Proof of feasibility and intent to apply a VVM to the primary container. Vaccines that are not damaged by freezing temperatures (<0oC) are preferred. Vaccines stable out of cold chain are preferred. If not, vaccines that can be delivered via the Controlled Temperature Chain are preferred 12. distribution container. Co-administration with other vaccines The vaccine will be given as a stand-alone product not with other vaccines. The vaccine can be with other vaccines. The vaccine will be given as a stand-alone product not with other vaccines. Presentation If oral administration, presentation in plastic tubes with a volume of 1-2 If oral administration, presentation in glass vial with a volume of 1-2 mL or If oral administration, 2-5 doses with a volume of 1-2 mL in plastic tubes; with favorable If oral administration, 2-5 doses with a volume of 1-2 mL
Plague_Vaccine_TPP_Online_Consultation.docx