Summary of submissions from prescribed experts, agencies and authorities The Regulator received several submissions from prescribed experts, agencies and authorities on the consultation RARMP. All issues raised in submissions that related to risks to the health and safety of people and the environment were considered in the context of the currently available scientific evidence and were used in finalising the RARMP that formed the basis of the Regulator’s decision to issue the licence. Advice received is summarised below. View (general tone): n = neutral; x = do not support; y = support Abbreviations: EX: Exposure; HGT: Horizontal gene transfer; HREC: Human Research Ethics Committee; LC: Licence conditions R: Risk Assessment and Risk Management Plan (RARMP) ST: Septic tank; TGA: Therapeutic Goods Administration; UE: Unintended effects; WHO: World Health Organisation Sub. View Issue Summary of issues raised Comment No: 1 N - Agrees with the overall conclusion of the Noted RARMP. EX The Regulator should further consider The RARMP has been updated to consider potential exposure of contacts less than 2 likelihood of exposure of children and their years of age. household contacts. LC The Regulator should further consider other The RARMP has been updated to include possible exclusions relating to other discussion of the WHO recommendation vaccinations. regarding simultaneous vaccination with live typhoid vaccine and the potential adverse effects. This information will also be forwarded to the TGA, and the applicant will be advised that they should inform the HRECs overseeing the trial of this information. R The Regulator should consider more The information relating to the method of specificity related to the method of managing managing batch variation was considered by the variation. Regulator. However, this information has been requested to be considered as Confidential Commercial Information (CCI) under section 185 of the Act and so is not included in the RARMP 2 N - Has no comment to put forth in relation to the Noted proposal. 3 Overall finds no real risk with the vaccine and The potential of unintended changes in bacterial support the proposed trail. Suggests that characteristics due to horizontal gene transfer consideration should be given to HGT and was evaluated in detail. The RARMP concludes recombination events as they could lead to that this is not likely to occur and the risk is reversion of vaccine strain to pathogenic negligible. form.
Summary of submissions from prescribed experts, agencies and authorities The Regulator received several submissions from prescribed experts, agencies and authorities on the consultation RARMP. All issues raised in submissions that related to risks to the health and safety of people and the environment were considered in the context of the currently available scientific evidence and were used in finalising the RARMP that formed the basis of the Regulator’s decision to issue the licence. Advice received is summarised below. View (general tone): n = neutral; x = do not support; y = support Abbreviations: EX: Exposure; HGT: Horizontal gene transfer; HREC: Human Research Ethics Committee; LC: Licence conditions R: Risk Assessment and Risk Management Plan (RARMP) ST: Septic tank; TGA: Therapeutic Goods Administration; UE: Unintended effects; WHO: World Health Organisation Sub. No: View Issue Summary of issues raised Comment 1 N - Agrees with the overall conclusion of the RARMP. Noted EX The Regulator should further consider potential exposure of contacts less than 2 years of age. The RARMP has been updated to consider likelihood of exposure of children and their household contacts. LC The Regulator should further consider other possible exclusions relating to other vaccinations. The RARMP has been updated to include discussion of the WHO recommendation regarding simultaneous vaccination with live typhoid vaccine and the potential adverse effects. This information will also be forwarded to the TGA, and the applicant will be advised that they should inform the HRECs overseeing the trial of this information. R The Regulator should consider more specificity related to the method of managing variation. The information relating to the method of managing batch variation was considered by the Regulator. However, this information has been requested to be considered as Confidential Commercial Information (CCI) under section 185 of the Act and so is not included in the RARMP 2 N - Has no comment to put forth in relation to the proposal. Noted 3 Overall finds no real risk with the vaccine and support the proposed trail. Suggests that consideration should be given to HGT and recombination events as they could lead to reversion of vaccine strain to pathogenic form. The potential of unintended changes in bacterial characteristics due to horizontal gene transfer was evaluated in detail. The RARMP concludes that this is not likely to occur and the risk is negligible.