Moderna Therapeutics (NASDAQ:MRNA) recently filed a statement with regulators that outlines forward-looking statements its executives recently made in public. Specifically, during a recent interview with investment bank analysts, CEO Stephane Mancel said a COVID-19 vaccine could be available to some people this fall
The special people Bancel had in mind were healthcare professionals, and the experimental coronavirus vaccine he was referring to was the one Moderna has in a phase 1 clinical trial right now -- mRNA-1273.
The pathway that could allow Moderna to provide its experimental vaccine to handfuls of people is an emergency-use authorization (EUA), but the system those are granted under isn't designed to handle thousands of requests all at once. An EUA requires a doctor's note that says you're a good candidate for an experimental drug, but ineligible for any available clinical trials.
Not so fast
While physicians and Moderna might be willing to push the paperwork through as quickly as possible, each case needs to be reviewed individually by an internal review board (IRB). Once an IRB green-lights an application, the FDA needs to give the final go-ahead before a patient can receive the experimental drug.
That process is by necessity so slow that Gilead Sciences (NASDAQ:GILD) on Sunday announced it would stop accepting new EUA requests for its experimental antiviral drug remdesivir. According to Gilead, the IRBs and the FDA won't be able to work through the backlog of applications already waiting for reviews before the treatment finishes two of its five on-going clinical trials in April and gets a decision from the FDA. Instead, that company is looking to develop a streamlined expanded-access program for the drug.
However, 99.99% of Americans will not be able to access mRNA-1273 or remdesivir until (and unless) Moderna and Gilead, respectively, produce more evidence of their safety and efficacy against COVID-19.