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On Friday, December 18, 2020, Carlota Vinals, head of regulatory affairs for infectious diseases at Moderna received a nine-page letter from the US FDA. Ensconced within the arcane sounding communiqué, were fifteen seminal words, “I am authorizing the emergency use of Moderna COVID-19 vaccine for the prevention of COVID-19.” For a start-up that was just into its first decade of operations, this approval culminated a remarkable saga of courage, conviction and chaos. Peter Loftus, a reporter at the Wall Street Journal covering pharmaceuticals, medical devices and healthcare, in his upcoming book, “The Messenger” lays out in riveting and revealing fashion the journey of Moderna from the prosaic to the phenomenal, and its metamorphosis from the unheard to the ubiquitous.
Moderna was incorporated as a company that banked on the success of a technology whose potential was just a tiny blip on the medical horizon. Messenger RNA (mRNA for short) is present in all of the cells in a human body. mRNA interacts with other components in cells thereby aiding and abetting in the creation of proteins. Scientists at Moderna attempted to design each mRNA so that directions could be given to the cells to manufacture a specific kind of protein. mRNA is delivered by either injection or infusion.
Canadian stem cell biologist and entrepreneur, Derrick Rossi; American chemical engineer, scientist, entrepreneur, inventor and a man carrying the formidable moniker, “the Edison of Medicine”, Robert Langer; and Kenneth Chien, a Harvard Medical School faculty member, pioneered the establishment of Moderna. Travails, tribulations and knocking on umpteen doors later, the founders managed to obtain a funding for their venture from Flagship Ventures, a Venture Capital firm headed by a Lebanese immigrant, Noubar Afeyan.
Moderna began operations from a non-descript building in Cambridge, Massachusetts. Jason Schrum, a PhD holder in biological chemistry and molecular pharmacology from Harvard became the first employee and toiled away in solitary fashion from a basement. The hard talking, hard selling and mercurial Stephane Bancel was lured away from his lucrative job as CEO of bioMerieux by Noubar Afeyan. Fluent in Japanese, the Frenchman, was a calculated go getter who brooked no opposition in furthering the ambitions of, and activities at Moderna. When Bancel assumed office at his new company, people were offering the Science of mRNA, a measly 2%-5% chance of working. That was until employee No.1 Jason Schrum hit pseudo-uridine, or in commercial terms, paydirt! Pseudo-uridine minimized inflammatory responses in the cells and caused high protein production, while extending the mRNA half-life to about a week or nine days.
Despite intermittent successes at research, Moderna, even after ten years of operations, did not have a single product based on mRNA against its name. However 2020 and the COVID-19 pandemic changed everything. In tandem with the brilliant Kizzmekia Corbett at NIAID, Bancel and Moderna began a “Stopwatch drill”. Moderna would attempt to race against time in coming out with a vaccine based on mRNA technology that would be used to neutralize the SARS-CoV-2 virus.
An astronomical contrivance of resilience and research led to the development of the Moderna vaccine within an unbelievably short span of time. From Phase I clinical trials where the vaccine was given the plaid name mRNA-1273 to the emergency use authorization by the FDA, it had taken exactly 286 days for Moderna to produce a vaccine that would provide hopes to billions across the globe. The upstart had finally arrived! Laurels started flowing in. The Vatican in May 2021, bestowed upon Stephane Bancel, a “Pontifical Hero Award”; Noubar Afeyan was awarded the Lebanese National Order of Merit, and co-founder Derrick Rossi became the beneficiary of the 2021 Princess of Asturias Award for Technical & Scientific Research. Rossi by this time had parted from Moderna in an acrimonious fashion having taken up cudgels with Bancel and consequently, ousted by the latter.
When COVID-19 first raised its dreaded hood, Moderna had less than $2 billion in cash and 800 employees. The behemoth Pfizer (another contender for the mRNA vaccine) in stark contrast, had a burgeoning treasure chest of $52 billion in annual revenues and a mammoth workforce of 88,000! Just a year and a half later, Moderna would forecast a full year revenue in the range of $15-$18 billion, and in the process barge into the top twenty largest pharmaceutical companies by annual sales in its first full year of having a single commercial product.
The employees and co-founders became overnight billionaires. Stephane Bancel’s stake exceeded $12 billion, Noubar Afeyan’ s VC was richer by $10 billion; and Bob Langer now found himself the custodian of a newly acquired wealth worth $4.5 billion. This prompted some stinging rebuke from people such as Oxfam’s Health Policy Manager, Anna Marriott who viewed such wealth as not only ill gotten but eking mileage out of misery. Moderna tried to get into the good books of altruism by establishing foundations and charities. However the contributions to such charities paled into insignificance before the humongous, jaw dropping profits made by the top brass at Moderna.
More than everything, the success of Moderna represented a new beginning and suffused optimism in the realm of medicine and biotechnology. The proven success of mRNA can only mean hope for patients suffering from cancer and other infectious diseases.
The Messenger – Harbinger of Good tidings!
(The Messenger: Moderna, the Vaccine, and the Business Gamble That Changed the World is published by Harvard Business Review Press, and will be available for sale from the 26th of July 2022 onwards. Thank You, Net Galley for the Advance Reviewer Copy)