3: Summary of safety concerns R=routine and A=additional Summary of safety concerns Pharmacovigilance Risk EU-RMP v8.2 with ASA v1.0 R A Routine only No important identified risks Guillain-Barré syndrome Important * § † potential Acute disseminated * - † encephalomyelitis Thrombocytopenia † Vasculitis including Kawasaki * - disease Brachial neuritis - † Facial Paresis - Severe injection site reactions - Systemic reactions (severe), - including febrile convulsion Vaccination failure (lack of - efficacy) Safety during pregnancy or Missing ? lactation information Safety in altered - immunocompetence subjects Safety in bleeding disorder - patients Safety in serious acute, chronic - - or progressive disease patients Safety in subjects with a history - - of Guillain-Barré syndrome Exposure to repeated doses, - ‡ including booster Missing information: and immunogenicity data in elderly subjects (above 65 years of age)’ is ‘Safety included in the EU-RMP and not in the ASA. The following safety concerns (struck through above) are proposed to be removed in the sponsor’s response: Important potential risk: reactions (severe) including febrile convulsion’ ‘Systemic Missing information: to repeated doses, including booster ‘Exposure Key: * targeted follow up questionnaires, § Australian only routine risk minimisation, Completed studies (V59_54OB, V59_34OB) Completed studies (V59_57, V59P20E1) † ‡ ? Pregnancy marketing Surveillance’ Inadequately described. ‘Post – Ongoing pharmacovigilance activities include: Routine pharmacovigilance with limited use of targeted follow-up questionnaires
3: Summary of safety concerns R=routine and A=additional Summary of safety concerns EU-RMP v8.2 with ASA v1.0 Pharmacovigilance Risk R A Routine only No important identified risks Important potential Guillain-Barré syndrome * † § Acute disseminated encephalomyelitis * † - Thrombocytopenia † Vasculitis including Kawasaki disease * - Brachial neuritis † - Facial Paresis - Severe injection site reactions - Systemic reactions (severe), including febrile convulsion - Vaccination failure (lack of efficacy) - Missing information Safety during pregnancy or lactation ? Safety in altered immunocompetence subjects - Safety in bleeding disorder patients - Safety in serious acute, chronic or progressive disease patients - - Safety in subjects with a history of Guillain-Barré syndrome - - Exposure to repeated doses, including booster ‡ - Missing information: ‘Safety and immunogenicity data in elderly subjects (above 65 years of age)’ is included in the EU-RMP and not in the ASA. The following safety concerns (struck through above) are proposed to be removed in the sponsor’s response: Important potential risk: ‘Systemic reactions (severe) including febrile convulsion’ Missing information: ‘Exposure to repeated doses, including booster Key: * targeted follow up questionnaires, § Australian only routine risk minimisation, † Completed studies (V59_54OB, V59_34OB) ‡ Completed studies (V59_57, V59P20E1) ? Pregnancy ‘Post marketing Surveillance’ – Inadequately described. Ongoing pharmacovigilance activities include: Routine pharmacovigilance with limited use of targeted follow-up questionnaires