Vaccine-Related Liability: Past Approaches, Current Challenges, and Proposals for Encouraging Future Innovation and More Widespread Vaccine UseOctober 14, 2021 –
Posted with permission from the Food and Drug Law Institute.
"Scientists, governments, and pharmaceutical companies face significant obstacles to global adoption of COVID-19 vaccines. Chief among these challenges are public fear of vaccine-related injury and manufacturers’ fears of liability arising from those injuries. Through the lens of the COVID-19 pandemic, we explore the history and current landscape of liability related to vaccines, and we propose potential solutions to the challenges of ensuring widespread adoption of vaccines.
Part II provides background on vaccine development, discussing the challenges of achieving herd immunity—a situation in which sufficient numbers of a community are vaccinated and thus immune, leading to containment or eradication of an infectious disease—and the history of and obstacles to implementing mandatory vaccination policies in the United States and around the world.
Against this historical backdrop, Part III summarizes and critiques the steps taken in the United States and globally to address liability related to the development and release of vaccines, including for COVID-19. It describes how vaccine-related liability has discouraged pharmaceutical companies from developing vaccines and how various countries have mitigated this risk and spurred innovation by establishing vaccine injury compensation programs. Part III discusses the Vaccine Injury Compensation Program (VICP) in the United States, which compensates people injured by vaccines, and no-fault vaccine compensation regimes that other countries around the world have implemented. And it discusses the invocation of the Public Health Emergency Preparedness Act (PREP Act) and the issuance of Declarations by the Secretary of Health and Human Services in response to the COVID-19 pandemic as a way to provide immunity to vaccine manufacturers. Although PREP provides expansive immunity, it does not prevent litigants from bringing suit, and those invoking PREP will have to litigate their entitlement to its protections. Finally, Part III discusses vaccine liability in the context of three previous pandemics: H1N1, Ebola, and Dengue fever in the Philippines.
Part IV provides an overview of the skepticism about the effectiveness and safety of vaccines, exploring historical examples of vaccine controversy. In particular, it discusses public perceptions of vaccines and the impact of the decision by the Centers for Disease Control and Prevention (CDC) to withdraw its recommendation for the RotaShield vaccine.
Finally, Part V offers recommendations aimed at establishing a more effective injury compensation regime designed to encourage innovation and swift adoption of vaccines and other pandemic responses. In this section, we discuss the importance of global coordination in limiting liability. We propose three strategies for establishing a global vaccine-injury compensation scheme: a global treaty, a third-party intermediary declaration modeled after the PREP Act, and letters of agreement modeled after the response to H1N1. In addition, in the United States, we recommend reforms to the VICP so that this system can accommodate claims related to COVID-19 vaccines. To ensure the prompt adoption of effective vaccines so as to achieve herd immunity, we recommend developing enforceable and near-mandatory vaccination requirements. And we propose strategies for addressing two related hurdles that have previously stymied vaccine development and pandemic preparedness: global amnesia, which describes the collective forgetting of key details of a public health crisis once a situation has resolved, and hindsight bias, which describes the tendency to misjudge, after-the-fact, the challenges and uncertainties experienced during a crisis."
To continue reading John Winter, Camille Fletcher, and Greg Margolis' Food and Drug Law Journal article on this topic, please click here.