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 For active immunization of at-risk persons in the area of an For active immunization of persons considered potentially at Indication for use outbreak to protect against plague; to be used in risk to protect against plague. conjunction with other control measures to curtail or end an outbreak. Risk groups will include communities in endemic areas and certain health care workers (HCWs) . All age groups ,, excluding All age groups 6,7,8 All age groups 6,7,8 excluding Target population All age groups 6,7,8. potentially excluding infants, pregnant and lactating women infants. Suitable for administration to pregnant and lactating and immunodeficient Suitable for administration to pregnant and lactating women women, and immunodeficient persons . pregnant and lactating women and to immunodeficient persons at the time of initial and to immunodeficient persons. authorization based on the persons. safety profile of the vaccine in these special populations . Safety/Reactogenicity Safety and reactogenicity Safety and reactogenicity Safety and reactogenicity at Safety and reactogenicity whereby vaccine benefit sufficient to provide a highly whereby vaccine benefit least comparable to clearly outweighs safety risks. favorable risk-benefit profile, clearly outweighs safety risks. routine ideally with only mild and vaccines, ideally with only mild transient adverse events and transient adverse events related to vaccination and no related to vaccination and no
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.
Plague_Vaccine_TPP_Online_Consultation.docx