Sam F. Halabi


The global rollout of COVID-19 vaccines is underway, and with it the inevitable occurrence of severe side effects that accompany, rarely, even the safest and most effective vaccines. Governments have invested billions of dollars in supporting research, development, logistics, and supply chains, as well as supporting the creation of networks of healthcare providers to deliver vaccines to recipients all over the world. The European Commission and several international organizations have established the COVAX Facility to pool resources in promising vaccine candidates and to subsidize their procurement by low- and middle-income countries. Yet up-front investment in vaccine development and delivery solves only half the problem with respect to vaccine access. Risks of legal liabilities, particularly product liability for severe side effects, will serve as an important, if not decisive, factor in how vaccine manufacturers participate in the response with Emergency Use Authorized and recently-licensed COVID-19 vaccines. If manufacturers do not receive sufficient assurance against legal liability, especially product liability, they will not ship vaccines. There is limited experience with developing coronavirus vaccines, and severe side effects following immunization are inevitable, as evidenced from Phase III trials and strongly suggested by early administration of Emergency Use Authorized vaccines. Therefore, there is a critical need to balance the risk calculations of manufacturers with justice for immunization recipients who become seriously ill or die in order to contribute to herd immunity in the community. This Article outlines the components of a global no-fault liability, indemnification, and compensation system that includes leveraging current no-fault systems in thirty-nine countries, a World Health Organization insurance mechanism, and a combination of insurance and compensation fund construction based on claims-processing precedents from the Deepwater Horizon Oil Spill and Boeing 737 Max crashes—both of which had tens of thousands of claims originating from dozens of countries and processed in at least six languages. The proposed system will be essential for vaccine manufacturer response and to address vaccine hesitancy and injury in populations across the globe.



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