Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency

Beatrice Brown

​On August 30, FDA Commissioner Stephen Hahn remarked that the FDA is willing to issue an Emergency Use Authorization (EUA) for a vaccine before the completion of Phase III clinical trials, if the benefits outweigh the risks. EUA authority is granted by the Federal Food, Drug, and Cosmetic Act, allowing the FDA to make unapproved products or unapproved uses of an approved product available during a public health emergency in the absence of a suitable, approved alternative.
 
EUAs have been issued for several drugs and products during the pandemic, including convalescent plasma just last week, remdesivir, and hydroxychloroquine (which has since been revoked). However, unlike drugs that are intended to treat unhealthy patients, vaccines are intended to be deployed to millions of healthy citizens, making safety and efficacy even more paramount. But a rushed EUA can undermine both this safety and efficacy.
 
In a recent Viewpoint in JAMA, PORTAL researchers argue that premature rollout of a vaccine from unprecedented political and economic pressures could result in a major public health misstep. The authors explain the various mechanisms that FDA can utilize to expedite access to a vaccine, but they question whether expedited pathways—particularly, the issuance of an EUA—can negatively impact safety and efficacy by undermining randomized trials and public health measures like social distancing, as well as by missing opportunities for learning about the vaccine’s safety early on. Furthermore, current vaccine hesitancy not only makes it less likely that we will attain needed herd immunity, but it also means that any safety and efficacy issues with an expedited vaccine can undermine the public’s already fragile trust in vaccines. In the midst of one of the worst pandemics in recent history, science and data should come before politics and economics—the FDA can ensure the safety and health of the American public by acting on this data and not succumbing to political and economic pressures.