In an opinion article for the MIT Technology Review, Bass, Berry & Sims attorney Clint Hermes offered his views about the potential consequences if the Federal Drug Administration’s (FDA) issues an emergency use authorization (EUA) for a COVID-19 vaccine too early in the research process. Clint offered two reasons for his concerns:
- Once a vaccine is authorized in this manner [an EUA], it may be difficult—for ethical and practical reasons—to complete clinical trials involving that vaccine (and thus to collect additional safety data and population-specific data for groups disproportionately affected by COVID-19).
- A vaccine that hasn’t gained enough public trust will therefore have a limited ability to control the pandemic even if it’s highly effective.
Clint concludes by stating, “Not only must the public trust a COVID-19 vaccine enough to seek out the first wave of authorized vaccines, but that trust must be resilient enough to withstand potential setbacks: protection below 100% (and perhaps below 50%), significant side effects (or rumors of them), and possible recalls. That level of trust takes time to rebuild if it has been eroded. And the stakes here are not just the slowing of this pandemic.”
The full article, “COVID-19 Vaccines Shouldn’t Get Emergency-Use Authorization,” was published by MIT Technology Review on November 13 and is available online.