COVID-19 erased the regulatory and trial-related hurdles that Moderna could never surmount before. Yet, how did Moderna know that COVID-19 would create those conditions months before anyone else, and why did they later claim that their vaccine being tested in NIH trials was different than their commercial candidate?
In late 2019, the biopharmaceutical company Moderna was facing a series of challenges that not only threatened its ability to ever take a product to market, and thus turn a profit, but its very existence as a company. There were multiple warning signs that Moderna was essentially another Theranos-style fraud, with many of these signs growing in frequency and severity as the decade drew to a close. Part I of this three-part series explored the disastrous circumstances in which Moderna found itself at that time, with the company’s salvation hinging on the hope of a divine miracle, a “Hail Mary” save of sorts, as stated by one former Moderna employee.
While the COVID-19 crisis that emerged in the first part of 2020 can hardly be described as an act of benevolent divine intervention for most, it certainly can be seen that way from Moderna’s perspective. Key issues for the company, including seemingly insurmountable regulatory hurdles and its inability to advance beyond animal trials with its most promising—and profitable—products, were conveniently wiped away, and not a moment too soon. Since January 2020, the value of Moderna’s stock—which had embarked on a steady decline since its IPO—grew from $18.89 per share to its current value of $339.57 per share, thanks to the success of its COVID-19 vaccine.
Yet, how exactly was Moderna’s “Hail Mary” moment realized, and what were the forces and events that ensured it would make it through the FDA’s emergency use authorization (EUA) process?