Vaccine efficacy/effectiveness None Reconciliation of issues outlined in the RMP report Table 7 summarises the OPR’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the OPR’s evaluation of the sponsor’s responses. Table 7. Reconciliation of issues outlined in the RMP report Recommendation in RMP Sponsor’s response OPR evaluator’s evaluation report comment Safety considerations may be The sponsor confirms This is acceptable. raised by the nonclinical and that the Nonclinical and clinical evaluators through the Clinical Evaluation consolidated request and/or Reports have been the Nonclinical and Clinical reviewed to ensure that Evaluation Reports the any safety respectively. It is important to considerations raised ensure that the information have been considered for provided in response to these relevance to the Risk includes a consideration of the Management Plan and relevance for the Risk addressed accordingly. Management Plan, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. The reason for not calling the Fluzone Quadrivalent This is acceptable. vaccine Fluzone Quadrivalent was initially licensed in (as in USA) is not The the United States but sponsor is requested to clarify Sanofi Pasteur is now the reason behind not expanding licensure to proposing a standard name for several countries in the the vaccine. northern and southern hemispheres. Several health authorities in southern hemisphere countries objected to the use of the trade name “Fluzone”; therefore, Sanofi Pasteur researched the use of another trade name.
Vaccine efficacy/effectiveness None Reconciliation of issues outlined in the RMP report Table 7 summarises the OPR’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the OPR’s evaluation of the sponsor’s responses. Table 7. Reconciliation of issues outlined in the RMP report Recommendation in RMP evaluation report Sponsor’s response OPR evaluator’s comment Safety considerations may be raised by the nonclinical and clinical evaluators through the consolidated request and/or the Nonclinical and Clinical Evaluation Reports respectively. It is important to ensure that the information provided in response to these includes a consideration of the relevance for the Risk Management Plan, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. The sponsor confirms that the Nonclinical and Clinical Evaluation Reports have been reviewed to ensure that the any safety considerations raised have been considered for relevance to the Risk Management Plan and addressed accordingly. This is acceptable. The reason for not calling the vaccine Fluzone Quadrivalent (as in USA) is not The sponsor is requested to clarify the reason behind not proposing a standard name for the vaccine. Fluzone Quadrivalent was initially licensed in the United States but Sanofi Pasteur is now expanding licensure to several countries in the northern and southern hemispheres. Several health authorities in southern hemisphere countries objected to the use of the trade name “Fluzone”; therefore, Sanofi Pasteur researched the use of another trade name. This is acceptable.
auspar-influenza-virus-haemagglutinin-150206.docx