older. There is CBER (the Routine consideration by Centre for Biologics Evaluation pharmacovigilance is the Delegate. and Research) guidance that proposed. From a RMP the safety and immunogenicity perspective, the of QIV to children 9 to 17 years proposed routine of age could be inferred from pharmacovigilance the safety profiles of QIV in is acceptable. children 6 months to < 9 years ACSOV advised of age and in adults 18 years of that in age and older. Notwithstanding ‘data this justification, it is aged 9 to 17 recommended that the sponsor years’ should be proposes pharmacovigilance included in the activities for adolescents (˃ 9 RMP as important years of age). missing information. This recommendation is endorsed by the evaluator. Important potential risks in the The sponsor has The sponsor’s RMP include Events advised in their justification is “Adverse of Special Interest” (AESI) response that they are accepted from a which reflect post market not planning to conduct RMP standpoint. experience for the Fluzone any other observational However the (inactivated TIV), which is not studies beyond a acceptability of a currently registered in pregnancy registry postmarketing Australia. The sponsor states in study in Australia. safety profile of the the RMP; quadrivalent The sponsor contends vaccine largely on the available that the safety profile is “Based extrapolated from information from clinical well characterised the trivalent studies GRC43, QIV03 and (according mainly to vaccine is QIV04 and supportive data from data for the trivalent ultimately the the Applicant’s trivalent formulation) and thus decision of the formulation of Fluzone vaccine, no additional activities Delegate. no further risk minimization are required. activities are deemed necessary ACSOV advised at this point. No additional that there should pharmacovigilance activities to be consideration assess effectiveness of risk for class-wide minimization measures are enhanced ongoing or planned”. surveillance of quadrivalent In general terms the rationale influenza vaccines for the studies is appropriate. particularly for the However, the sponsor has not potential risk of provided information for any febrile seizures. Australian specific activities. It is noted that Fluzone is currently not registered in Australia. Adverse event rates observed in the clinical trials of a vaccine also cannot be
older. There is CBER (the Centre for Biologics Evaluation and Research) guidance that the safety and immunogenicity of QIV to children 9 to 17 years of age could be inferred from the safety profiles of QIV in children 6 months to < 9 years of age and in adults 18 years of age and older. Notwithstanding this justification, it is recommended that the sponsor proposes pharmacovigilance activities for adolescents (˃ 9 years of age). Routine pharmacovigilance is proposed. consideration by the Delegate. From a RMP perspective, the proposed routine pharmacovigilance is acceptable. ACSOV advised that ‘data in aged 9 to 17 years’ should be included in the RMP as important missing information. This recommendation is endorsed by the evaluator. Important potential risks in the RMP include “Adverse Events of Special Interest” (AESI) which reflect post market experience for the Fluzone (inactivated TIV), which is not currently registered in Australia. The sponsor states in the RMP; “Based on the available information from clinical studies GRC43, QIV03 and QIV04 and supportive data from the Applicant’s trivalent formulation of Fluzone vaccine, no further risk minimization activities are deemed necessary at this point. No additional pharmacovigilance activities to assess effectiveness of risk minimization measures are ongoing or planned”. In general terms the rationale for the studies is appropriate. However, the sponsor has not provided information for any Australian specific activities. It is noted that Fluzone is currently not registered in Australia. Adverse event rates observed in the clinical trials of a vaccine also cannot be The sponsor has advised in their response that they are not planning to conduct any other observational studies beyond a pregnancy registry study in Australia. The sponsor contends that the safety profile is well characterised (according mainly to data for the trivalent formulation) and thus no additional activities are required. The sponsor’s justification is accepted from a RMP standpoint. However the acceptability of a postmarketing safety profile of the quadrivalent vaccine largely extrapolated from the trivalent vaccine is ultimately the decision of the Delegate. ACSOV advised that there should be consideration for class-wide enhanced surveillance of quadrivalent influenza vaccines particularly for the potential risk of febrile seizures.
auspar-influenza-virus-haemagglutinin-150206.docx