The final version of this Target Product Profile (TPP) will be the result of an extensive consultation process with key stakeholders in public and animal health, scientific research, funding agencies, manufacturer communities and policy making bodies. It is intended that the final version will guide and prioritize the development of vaccines. As new scientific evidence is generated, this TPP may require further review and revision. Target Product Profile Vaccine characteristic Reactive use Preventive use Preferred Critical or Minimal Preferred Critical or Minimal Indication for use For active immunization of at-risk persons in the area of an outbreak to protect against plague; to be used in conjunction with other control measures to curtail or end an outbreak. For active immunization of persons considered potentially at risk to protect against plague. Risk groups will include communities in endemic areas and certain health care workers (HCWs) . Target population All age groups ,, excluding infants. Suitable for administration to pregnant and lactating women and to immunodeficient persons. All age groups 6,7,8 potentially excluding infants, pregnant and lactating women, and immunodeficient persons at the time of initial authorization based on the safety profile of the vaccine in these special populations . All age groups 6,7,8. Suitable for administration to pregnant and lactating women and to immunodeficient persons. All age groups 6,7,8 excluding pregnant and lactating women and immunodeficient persons . Safety/Reactogenicity Safety and reactogenicity sufficient to provide a highly favorable risk-benefit profile, ideally with only mild and transient adverse events related to vaccination and no Safety and reactogenicity whereby vaccine benefit clearly outweighs safety risks. Safety and reactogenicity at least comparable to routine vaccines, ideally with only mild and transient adverse events related to vaccination and no Safety and reactogenicity whereby vaccine benefit clearly outweighs safety risks.
serious adverse events related to vaccination with the vaccine or vaccine-platform, including in individuals with compromised immune function or when administered in pregnancy. serious adverse events related to vaccination with the vaccine or vaccine platform, including in individuals with compromised immune function or when administered in pregnancy. Measures of Efficacy At least 80% efficacy in preventing bubonic and pneumonic forms of plague in the target population. Rapid onset of protective immunity (less than one week). At least 70% efficacy 11 in preventing bubonic and pneumonic form of plague predicted and stop transmission in the affected population. Rapid onset of protective immunity (less than 10 days). At least 80% efficacy 11 in preventing bubonic and pneumonic form of plague in the target population. At least 70% efficacy 11 in preventing bubonic and pneumonic form of plague in the target population. Dose regimen Single-dose regimen highly preferred. Primary series: no more than 2 doses, with preference for less than one-month interval between doses and good protection after the first dose. Single-dose regimen highly preferred. Primary series: no more than 3 doses, and with preference for less than one-month interval between doses. Durability of protection Confers protection of at least 2 years. Confers protection of at least one year. Confers long-lasting protection of 10 years or more following the primary series and can be Confers protection of at least 5 years after primary series and can be maintained
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
mL; or multi-dose (10-20) with a dropper presentation with a maximal dosage volume of 0.05 mL (1 drop) or 0.1 mL (2 drops); with favorable taste (e.g. sweet). If injectable administration, vaccine is provided as a liquid product in 10-dose presentation with a volume of 0.5 mL. Multi-dose presentations should be formulated, managed and discarded in compliance with WHO’s vial policy. multi-dose container with a dropper device with 10-20 doses. If injectable administration, vaccine is provided as a liquid or lyophilized product in mono-dose or multi-dose presentations with a volume of 0.5 mL. Multi-dose presentations should be formulated, managed and discarded in compliance with WHO’s vial policy. If not supplied in a dual-barrel syringe, lyophilized vaccine will need to be accompanied by paired separate vials of the appropriate diluent. taste (e.g. sweet). If injectable administration, vaccine is provided as a liquid product in mono-dose or multi-dose (2) presentations with a maximal dosage volume of 0.5 mL. Multi-dose presentations should be formulated, managed and discarded in compliance with WHO’s vial policy. in plastic tubes. If injectable administration, vaccine is provided as a liquid or lyophilized product in mono-dose or multi-dose presentations with a maximal dosage volume of 0.5 mL. Multi-dose presentations should be formulated, managed and discarded in compliance with WHO’s vial policy. If not supplied in a dual-barrel syringe, lyophilized vaccine will need to be accompanied by paired separate vials of the appropriate diluent. Registration and Prequalification Should be WHO pre-qualified according to the process outlined in Procedures for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. Should be WHO pre-qualified according to the process outlined in Procedures for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies.