COVID-19 Vaccine May Be on Fast Track for Mass Distribution

A COVID-19 vaccine may be authorized for emergency use before its Phase Three trials are complete.

More than 25 million people have been affected by the virus to date, with the U.S. leading among the world's most cases. The U.S. Food and Drug Administration Commissioner Dr. Stephen Hahn told the Financial Times, "It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application. If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination."

Dr. Hahn noted that authorization is different than FDA approval, stating, "Our emergency use authorization is not the same as a full approval," he said. "The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency."

Not all doctors are jumping on board the vaccine bandwagon, suggesting the implementation of an independent panel to review data before a large-scale release.

"We're used to this world where if the FDA or the CDC or the NAS says something is safe and effective, that's enough, but I don't think this time that's sufficient to overturn public skepticism," said bioethicist Arthur Caplan, referring to the U.S. Centers for Disease Control and the National Academy of Sciences. "I think we desperately need an independent national commission."

In addition to the potentially inconclusive data regarding the vaccine's effectiveness without a complete three-phase trial period, recipients will also likely require two doses, further complicating distribution and administration.

"There's no question that this is going to be the most complicated, largest vaccination program in human history," said Dr. Kelly Moore, a health policy professor at Vanderbilt University, to CNN, "and that's going to take a level of effort, a level of sophistication, that we've never tried before."