Covid-19 vaccines shouldn’t get emergency-use authorizationon November 13, 2020 at 5:10 pm

Judging from their written and verbal comments to the advisory committee, major vaccine manufacturers recognize the potential disruptions to subsequent clinical trials and are seeking the FDA’s advice to address them. While those considerations are daunting, I suspect that manufacturers and the FDA could create workable responses. But even then, the public trust issues associated with EUAs–which most of the public first heard about through the hydroxychloroquine debacle and again in the context of the convalescent plasma controversy–still make this tool a poor fit for vaccines.

Instead, if vaccine trial data are promising enough to warrant giving some people pre-approval access to a covid-19 vaccine, the FDA should do so using a mechanism called “expanded access.” While the FDA ordinarily uses expanded access to make experimental treatments available to sick patients who have no alternative treatment available, it has been used for vaccines before and could be used now to avoid disrupting ongoing clinical trials or fostering public perceptions that a vaccine was being rushed because of an “emergency.” Expanded-access programs are also overseen by ethics committees and have informed consent requirements for patients that go beyond those associated with products authorized by EUA.

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. As former senior health official Andy Slavitt recently said, “Done right, vaccines end pandemics. Done wrong, pandemics end vaccines.”

Clint Hermes, a former academic medical center general counsel, has advised universities, teaching hospitals, and life sciences companies on global health problems. He has helped set up vaccination, treatment, and surveillance projects for infectious diseases in North and South America, Africa, Asia, and the Middle East. The views expressed here are his own and not those of any organization with which he is affiliated, including his employer. The information presented here should not be construed as legal advice.

Read More