HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Tuesday, October 12, 2021

An Institutional Solution to Build Trust in Pandemic Vaccines

Yaniv Heled (Georgia State University), Ana Santos Rutschman (Saint Louis University), Liza Vertinsky (Emory University), An Institutional Solution to Build Trust in Pandemic Vaccines, 31 Harv. Pub. Health Rev. (2021):

As the market gatekeeper for new drugs and vaccines, the U.S. Food and Drug Administration (FDA) plays a fundamental role in the response to public health crises. During the COVID-19 pandemic, FDA’s response has been heavily criticized by public health experts, including current and former advisors to the Agency (Baden et al., 2020). The bulk of criticism has centered around FDA’s use of emergency use authorizations (EUAs) covering unapproved COVID-19 products. In at least two instances—the EUA covering chloroquine and hydroxychloroquine, and the one covering COVID-19 convalescent plasma—experts have pointed out that the data used by the FDA in support of an EUA was not “scientifically sound” (Baden et al., 2020) and that the Agency’s decision-making processes appeared to be driven by political pressure and extra-scientific considerations. While the long-term reputational damage to the FDA stemming from these EUA controversies has been discussed abundantly in the literature (Baden et al., 2020), there is a pressing need for short-term measures designed to lessen the growing levels of FDA mistrust. Timely interventions are critical because the EUA pathway is also being used to bring COVID-19 vaccines to market. We, therefore, propose the adoption of a mechanism designed to improve trust in the FDA emergency authorization process, including in the specific context of COVID-19 vaccines, in the form of an independent review body modeled after the now-defunct Congressional Office of Technology Assessment.

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