vaccine, clinical trial, data, COVID-19, polio, H1N1, minority representation, FDA, European Medicines Agency, trade secrets, intellectual property
We find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.
While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new vaccines. For decades, these processes have encompassed several phases of vaccine testing – first without and subsequently with the involvement of human subjects – followed by an analysis of the emerging data.
This Essay reflects on the evolution and status quo of the ways in which these data are gathered and disseminated within the context of the development of new vaccines. It treats information stemming from clinical trials as the initial building blocks of our vaccine data infrastructure, and surveys problems related to data collection and disclosure that have long been pervasive in the vaccine R&D ecosystem.
Part I of the Essay situates the discussion of vaccine clinical trial data within historical boundaries. Part I.A travels back in time to the polio vaccine trials of the 1950s in the United States, which were one of the main catalysts of the adoption of the clinical trial structure now in place throughout the world. Part I.B then charts the formalization of the modern vaccine clinical trial model through legislation adopted between the polio and the COVID-19 vaccine races.
Even though this formalization has resulted in a seemingly robust legal framework, there remain multiple problems that affect both the ways in which vaccine clinical trial data is actually generated and then utilized. Using examples from both past vaccine clinical trials and the COVID-19 vaccine race, Part II.A focuses on data collection issues, with an emphasis on the under-representation of minority populations in vaccine clinical trials. Part II.B then considers how imperfectly generated data meet further roadblocks in the form of delayed reporting or lack of reporting of clinical trial results, as well as restrictions to data sharing often attributable to agency interpretations of trade secrecy provisions that have long been disputed by several legal scholars.
These problems affect both the transparency and accountability of vaccine innovation processes, and pose significant hurdles to follow-on R&D. Moreover, and relatedly, they can impair public trust on vaccine innovation processes at a time in which vaccine misinformation is quickly eroding overall levels of trust in vaccination as a public health tool. Part III concludes the Essay by pointing towards emerging ways to enrich the existing vaccine clinical trial data infrastructure. Specifically, it provides a short case study on the COVID-19 data sharing policy implemented in the European Union by its counterpart to the U.S. Food and Drug Administration, the European Medicines Agency. This ad hoc policy quickly expanded the disclosure of information about emerging COVID-19 drugs and vaccines in response to mounting pressure for more transparency about the drug and vaccine approval process. As such, it may be used as a blueprint by regulators elsewhere, as well as by proponents of a more robust system for the disclosure and sharing of clinical trial data.
Santos Rutschman, Ana, Vaccine Clinical Trials and Data Infrastructure. Utah Law Review, Forthcoming, Saint Louis U. Legal Studies Research Paper No. 2021-01.
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