Full Name
Dr Madhava Ram Balakrishnan
Hospital/Organisation/Company
WHO
Speaker Bio
Dr Madhava Ram Balakrishnan is a medical epidemiologist and vaccine safety expert with extensive experience in immunization safety, pharmacovigilance, public health surveillance and health systems strengthening. He currently serves as Medical Officer in the Pharmacovigilance team at the World Health Organization (WHO) headquarters in Geneva, Switzerland, where his work focuses on global vaccine safety, adverse events following immunization (AEFI), adverse events following maternal immunization (AEFMI), causality assessment, digital tools, guidance development, training and country support.
At WHO headquarters, Dr Balakrishnan has contributed to the development, refinement and implementation of WHO methodologies for AEFI causality assessment, including practical tools, training materials and electronic platforms that support consistent, transparent and evidence-based decision-making by national expert committees. He has played a central role in strengthening digital approaches for vaccine safety, including the WHO AEFI causality assessment software, VigiFlow- and VigiMobile-aligned reporting workflows, and electronic approaches that improve the quality, timeliness and use of safety data across immunization programmes and regulatory systems.
A major current area of his work is maternal immunization safety. He is leading the development of WHO guidance and tools for reporting, investigating and assessing the cause of AEFMI, including a structured methodology and software-assisted approach for evaluating events in pregnant women, foetuses and neonates. This work brings together case-based investigation, standardized data collection, expert causality assessment and risk communication, with technical inputs from international experts and country collaborators.
Dr Balakrishnan has contributed to WHO guidance, manuals and training resources on vaccine safety for priority public health contexts, including COVID-19, Ebola, mpox and maternal immunization. He also contributes to WHO vaccination policy guidance, including inputs to WHO vaccine position papers through the Immunization, Vaccines and Biologicals (IVB) steering processes. His technical support spans National Immunization Programmes, National Regulatory Authorities, WHO regional and country offices, and collaborating centres, with emphasis on practical implementation in diverse settings.
Before joining WHO headquarters, Dr Balakrishnan held technical roles with WHO in India and the WHO South-East Asia Region, where he supported and led surveillance and immunization-related work for vaccine-preventable diseases, including poliomyelitis, measles and Japanese encephalitis, as well as broader public health surveillance activities.
Selected areas of contribution
• WHO AEFI causality assessment methodology, tools, training materials and software-assisted workflows.
• WHO AEFMI reporting, investigation and causality assessment framework for maternal, foetal and neonatal events.
• Vaccine safety guidance and training for COVID-19, Ebola, mpox and other priority immunization contexts.
• Support to Member States, National Immunization Programmes and National Regulatory Authorities on vaccine safety surveillance and pharmacovigilance systems.
• Technical inputs to WHO vaccination policy guidance and vaccine position paper processes.
At WHO headquarters, Dr Balakrishnan has contributed to the development, refinement and implementation of WHO methodologies for AEFI causality assessment, including practical tools, training materials and electronic platforms that support consistent, transparent and evidence-based decision-making by national expert committees. He has played a central role in strengthening digital approaches for vaccine safety, including the WHO AEFI causality assessment software, VigiFlow- and VigiMobile-aligned reporting workflows, and electronic approaches that improve the quality, timeliness and use of safety data across immunization programmes and regulatory systems.
A major current area of his work is maternal immunization safety. He is leading the development of WHO guidance and tools for reporting, investigating and assessing the cause of AEFMI, including a structured methodology and software-assisted approach for evaluating events in pregnant women, foetuses and neonates. This work brings together case-based investigation, standardized data collection, expert causality assessment and risk communication, with technical inputs from international experts and country collaborators.
Dr Balakrishnan has contributed to WHO guidance, manuals and training resources on vaccine safety for priority public health contexts, including COVID-19, Ebola, mpox and maternal immunization. He also contributes to WHO vaccination policy guidance, including inputs to WHO vaccine position papers through the Immunization, Vaccines and Biologicals (IVB) steering processes. His technical support spans National Immunization Programmes, National Regulatory Authorities, WHO regional and country offices, and collaborating centres, with emphasis on practical implementation in diverse settings.
Before joining WHO headquarters, Dr Balakrishnan held technical roles with WHO in India and the WHO South-East Asia Region, where he supported and led surveillance and immunization-related work for vaccine-preventable diseases, including poliomyelitis, measles and Japanese encephalitis, as well as broader public health surveillance activities.
Selected areas of contribution
• WHO AEFI causality assessment methodology, tools, training materials and software-assisted workflows.
• WHO AEFMI reporting, investigation and causality assessment framework for maternal, foetal and neonatal events.
• Vaccine safety guidance and training for COVID-19, Ebola, mpox and other priority immunization contexts.
• Support to Member States, National Immunization Programmes and National Regulatory Authorities on vaccine safety surveillance and pharmacovigilance systems.
• Technical inputs to WHO vaccination policy guidance and vaccine position paper processes.
