Table 2. Sponsor’s proposed routine and additional pharmacovigilance activities Objectives Safety Status Date for type concerns (planned, submission addressed started) of reports1 Routine To collect all All Planned PSUR to be AE reports submitted as To be and monitor per regulatory implemented these, along requirement ISCRs, when the QIV with other PSURs/DSURs receives MAA Signal sources of monitoring detection safety safety profile, activities will information to safety signal be conducted detect and detection and as defined in changes in the evaluation the sponsor safety profile signal over time detection SOP Postmarketing To collect the Exposure To be planned ASR from surveillance of missing and safety of and pregnancy the QIV information of the QIV in implemented safety exposure in exposure of pregnancy when MAA is surveillance pregnancy and the QIV in (missing obtained for and final pregnancy pregnant information) the QIV safety report outcomes women from the pregnancy safety surveillance ISCR = Individual Case Safety Report; PSUR = Periodic Safety Update Report; DSUR = Developmental Safety Update Report; MAA = Marketing Authorisation Approval; SOP = Standard Operating Procedure; ASR = Annual Safety Report. 1) Refers to interim or reports (planned or actual). Risk minimisation activities Only routine risk minimisation activities are proposed for all safety concerns in Australia. Reconciliation of issues outlined in the RMP report 3 summarises the TGA’s first round evaluation of the RMP, the sponsor’s responses to issues raised by TGA the in the evaluation of the sponsor’s responses. Table 3. Reconciliation of issues outlined in the RMP report. Recommendation Sponsor’s response (or summary of the RMP in RMP evaluation response) evaluator’s report comment Safety The nonclinical evaluation report suggests The sponsor’s considerations may addition of embryofetal development study response has ‘No be raised by the has been conducted with Afluria Quad’ to the been noted. nonclinical and precautions section of the PI. We accept TGA’s clinical evaluators recommendation and have added this statement through to the PI provided with this response. consolidated TGA The clinical evaluation report provided no questions for the recommendations related to safety. sponsor and/or the
Table 2. Sponsor’s proposed routine and additional pharmacovigilance activities type Objectives Safety concerns addressed Status (planned, started) Date for submission of reports1 Routine ISCRs, PSURs/DSURs monitoring safety profile, safety signal detection and evaluation To collect all AE reports and monitor these, along with other sources of safety information to detect and changes in the safety profile over time All Planned To be implemented when the QIV receives MAA PSUR to be submitted as per regulatory requirement Signal detection activities will be conducted as defined in the sponsor signal detection SOP Postmarketing surveillance of the QIV exposure in pregnancy and pregnancy outcomes To collect the missing information of exposure of the QIV in pregnant women Exposure and safety of the QIV in pregnancy (missing information) To be planned and implemented when MAA is obtained for the QIV ASR from pregnancy safety surveillance and final safety report from the pregnancy safety surveillance ISCR = Individual Case Safety Report; PSUR = Periodic Safety Update Report; DSUR = Developmental Safety Update Report; MAA = Marketing Authorisation Approval; SOP = Standard Operating Procedure; ASR = Annual Safety Report. 1) Refers to interim or reports (planned or actual). Risk minimisation activities Only routine risk minimisation activities are proposed for all safety concerns in Australia. Reconciliation of issues outlined in the RMP report 3 summarises the TGA’s first round evaluation of the RMP, the sponsor’s responses to issues raised by TGA the in the evaluation of the sponsor’s responses. Table 3. Reconciliation of issues outlined in the RMP report. Recommendation in RMP evaluation report Sponsor’s response (or summary of the response) RMP evaluator’s comment Safety considerations may be raised by the nonclinical and clinical evaluators through consolidated TGA questions for the sponsor and/or the The nonclinical evaluation report suggests addition of ‘No embryofetal development study has been conducted with Afluria Quad’ to the precautions section of the PI. We accept TGA’s recommendation and have added this statement to the PI provided with this response. The clinical evaluation report provided no recommendations related to safety. The sponsor’s response has been noted.
auspar-inactivated-quadrivalent-influenza-vaccine-split-virion-170720.docx