Hyun Jung Kim reported in a November 2020 report for the Bulletin of Atomic Scientists that adopting Emergency Use Authorization (EUA) to speed development of a vaccine for COVID-19 entails risks that have not been adequately understood. While an emergency use authorization “may be the speediest way for public health officials to begin a vaccination campaign, it may not end up shaving that much time off of a more traditional route to government approval,” Kim wrote. Instead, other official paths available to the Food and Drug Administration (FDA)—including fast track, breakthrough therapy, accelerated approval, and priority review—may work “almost as quickly…while providing the public with greater reassurance that those vaccines are safe and effective.”
If a COVID-19 vaccine receives an emergency use authorization, Kim reported, it will be “the first time the FDA has used the process for a novel vaccine.” (Previously, the only other vaccine approved by the FDA for emergency use was the anthrax vaccine, but it was an already licensed vaccine, rather than a novel, investigational vaccine, Kim noted.)
In March 2020, Secretary of Health and Human Services Alex Azar published a declaration to provide liability immunity for activities related to medical and security countermeasures against the pandemic. A 2005 law, the Public Readiness and Emergency Preparedness Act, provides liability protections for drugs, devices, or vaccines approved by the FDA or authorized for emergency use.
“While scientific scrutiny of the vaccine development process in the United States ensures that we can be confident that the vaccine candidates—including those that may receive an emergency use authorization—have been rigorously tested for safety and efficacy,” Kim concluded, the emergency use authorization process is “being stretched too far.” Instead, he argued, new COVID-19 vaccines should be approved through one of the FDA’s four official fast-tracked programs.
Source: Jung Kim, Hyun, “Is Emergency Use Authorization the Best Way to Get a COVID-19 Vaccine to the Public?” Bulletin of the Atomic Scientists, November 23, 2020, thebulletin.org/2020/11/is-emergency-use-authorization-the-best-way-to-get-a-covid-19-vaccine-to-the-public/.
Student Researcher: Joselyn Saavedra (Sonoma State University)
Faculty Evaluator: Peter Phillips (Sonoma State University)