An Institutional Solution to Build Trust in Pandemic Vaccines

31 Harvard Public Health Review 2021

3 Pages Posted: 21 Jun 2021

See all articles by Yaniv Heled

Yaniv Heled

Georgia State University College of Law

Ana Santos Rutschman

Saint Louis University - School of Law

Liza Vertinsky

Emory University School of Law

Date Written: June 2021

Abstract

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.

Keywords: Vaccines, COVID-19, Food and Drug Administration, FDA, Public Health, Vaccine Hesitancy, Emergency Use Authorization, EUA, chloroquine, hydroxychloroquine, convalescent plasma, coronavirus, pandemic, Office of Technology Assessment, OTA

Suggested Citation

Heled, Yaniv and Santos Rutschman, Ana and Vertinsky, Liza, An Institutional Solution to Build Trust in Pandemic Vaccines (June 2021). 31 Harvard Public Health Review 2021, Available at SSRN: https://ssrn.com/abstract=3866661 or http://dx.doi.org/10.2139/ssrn.3866661

Yaniv Heled (Contact Author)

Georgia State University College of Law ( email )

85 Park Pl NE
Atlanta, GA 30303
United States
404-413-9092 (Phone)

Ana Santos Rutschman

Saint Louis University - School of Law ( email )

100 N. Tucker Blvd.
St. Louis, MO 63101
United States

Liza Vertinsky

Emory University School of Law ( email )

1301 Clifton Road
Atlanta, GA 30322
United States

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