Sonali Kochhar

Clinical Associate Professor, Department of Global Health, University of Washington, Seattle, and Medical Director, Global Healthcare Consulting

Dr Sonali Kochhar, M.D., has over two decades of leadership experience for global Phase I-IV clinical research, safety and epidemiology studies, and implementation research for vaccines conducted in USA, Europe, Africa and Asia in adult, maternal and pediatric populations; vaccine for infectious diseases (including COVID-19, HIV/AIDS, TB, GBS, RSV, influenza, MERS, rift valley fever, lassa, nipah, ebola, zika, malaria, diarrheal, and tropical diseases); maternal immunization (MI); pandemic preparedness and response; introduction of new vaccines; increasing immunization coverage and acceptance; translating research into impactful immunization programs by policy, strategy, advocacy, pharmacovigilance and healthcare systems strengthening; clinical trial data sharing and research with vulnerable and at-risk populations (including pregnant women and immunocompromised). Her work has informed global and country specific vaccine policy recommendations.                                 

Dr Kochhar has led multiple research projects in Kenya, Uganda, Zambia, The Gambia, South Africa, the United States, Belgium, Germany, India, Bangladesh and Nepal. She has led multi-country clinical development programs for vaccines, and the development and management of the clinical development plans, clinical and regulatory strategies, safety assessment and pharmacovigilance including risk management plans and benefit-risk assessment.

She has co-authored internationally accepted guidance, research standards, protocol templates and case definitions for adverse events (AE) for vaccine research, MI and safety. She has led the development of templates for the benefit-risk assessment of vaccines. These are being utilized by vaccine developers. She helped develop 21 novel Maternal and Neonatal case definitions for AE detection and evaluation. The definitions and guidance are being utilized in vaccines clinical research and pharmacovigilance globally.

For vaccine policy development, she is helping lead the development of the Evidence Considerations for Vaccine Policy (ECVP) framework, to help in early (pre-phase 3 trial design) alignment between regulators, policy makers and the national, regional and global stakeholders on the clinical trial and observational data or evidence needed for policy and program decisions for new vaccine classes, and help mitigate delays in post-licensure vaccine implementation. The ECVP for TB vaccines for adolescents and adults has been prepared as a test case for the concept.

She is helping in new vaccines implementation, Pharmacovigilance systems strengthening and setting up a pregnancy registry in LMICs. She has led immunization programs strengthening by policy, strategy and healthcare systems strengthening (including evaluation, capacity building and supply chains strengthening). She has led work on increasing immunization coverage and acceptance in LMICs, and new vaccine introduction, working in close collaboration with the National EPI teams. 

She has led vaccines R&D strategic partnerships, and advocacy with government partners and ministries of health, regulatory bodies (including the FDA, EMA, African and Asian), donors (including the Gates Foundation, USAID, Wellcome Trust, MRC), public health authorities, international organizations (including WHO, NIH, CDC, World Bank), pharmaceutical companies, local communities, and the media.

She serves on several advisory panels including the Chair of the WHO SAGE Working Group (WG) on COVID-19 vaccines; Gavi’s Vaccine investment Strategy (VIS) Steering Committee,  Co-Chair of the WHO Evidence Considerations for Vaccine Policy (ECVP) WG, Co-Chair of the WHO Technical Advisory Group on GBS Vaccine Development, WHO Expert Steering Committee on Safety Surveillance in Pregnancy in LMICs, Advisory Board for Bill and Melinda Gates Medical Research Institute for the TB Vaccine Phase 3 trial, WHO Technical Advisory Group on the development of a roadmap for global Introduction of new TB Vaccines, Co-Chair of the WHO COVID-19 Ethics & Governance WG, Co-Chair of the WHO Ethics and Monkeypox WG, Steering Committee for the International Network of Special Immunization Services (INSIS), Research Committee of the Infectious Diseases Society of America (IDSA) and Chair of the Brighton Collaboration Science Board. She is an Expert Evaluator for the European Commission, Medical Research Council, UK and Canadian Institutes of Health Research.

Kochhar serves as guest faculty for international vaccinology programs, and has published over 144 publications, with over 29,900 citations and a h-index of 42. She has received multiple awards including the Yale World Fellowship for 2011 (Yale University’s International Leadership Program) and the Vaccinology Fellowship Award from Fondation Mérieux and University of Geneva.