serious adverse events related serious adverse events related to vaccination with the to vaccination with the vaccine or vaccine-platform, vaccine or vaccine platform, including in individuals with including in individuals with compromised immune compromised immune function or when function or when administered in pregnancy. administered in pregnancy. Measures of Efficacy At least 80% efficacy in At least 70% efficacy 11 in At least 80% efficacy 11 in At least 70% efficacy 11 in preventing bubonic and preventing bubonic and preventing bubonic and preventing bubonic and pneumonic forms of plague in pneumonic form of plague pneumonic form of plague in pneumonic form of plague in the target population. predicted and stop the target population. the target population. transmission in the affected Rapid onset of protective population. immunity (less than one week). Rapid onset of protective immunity (less than 10 days). Dose regimen Single-dose regimen highly Primary series: no more than 2 Single-dose regimen highly Primary series: no more than 3 preferred. doses, with preference for less preferred. doses, and with preference for than one-month interval less than one-month interval between doses and good between doses. protection after the first dose. Durability of Confers protection of at least Confers protection of at least Confers long-lasting protection Confers protection of at least protection 2 years. one year. of 10 years or more following 5 years after primary series the primary series and can be and can be maintained
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
Plague_Vaccine_TPP_Online_Consultation.docx