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  • Title
    mRNA Pioneers
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At the beginning of 2020, no vaccine or therapy involving the delivery system known as messenger RNA (mRNA) had ever been approved by regulators for widespread use. Today, two of the world’s most effective and widely used COVID-19 vaccines—developed by Pfizer/BioNTech and Moderna—rely on mRNA, and some 250 million doses have been administered in the U.S. alone, with hundreds of millions more in arms worldwide. But those vaccines might still be stuck on the drawing board if a handful of farsighted leaders hadn’t been ready to bet on mRNA when the odds were long.

mRNA molecules were discovered in the early 1960s, but it wasn’t until the mid-2000s that researchers figured out how to modify the building blocks of those molecules for therapeutic purposes so that mRNA strands could safely interact with the body. Moderna, based in Cambridge, Mass., and BioNTech, based in Mainz, Germany, saw the potential in the breakthrough, and licensed the relevant discoveries.

Each company then spent years in the biotech wilderness, each building up a body of research in which mRNA came up short in treating some diseases but showed promise for others. Both companies frequently encountered a similar problem: mRNA therapies provoked dangerously strong immune reactions when administered in frequent or regular doses. But such results suggested that mRNA might be well suited for vaccines, where just one or two doses are called for.

That long experience meant that both companies were ready to leap into action in early 2020, when news of a terrifying new pandemic began emerging from China. Each company had experimental vaccines ready to test in the early weeks of the pandemic, and each had reached late-stage clinical trials within six months—unprecedented speed in the drug-development world. But as Moderna CEO Stéphane Bancel told Fortune’s Brainstorm Health virtual conference in 2020, its COVID vaccine is “not our first vaccine, it’s our 10th.”

At BioNTech, meanwhile, cofounders Ugur Sahin and Özlem Türeci had begun collaborating in 2018 with multinational pharma giant Pfizer, working together on an experimental mRNA flu vaccine. That meant Pfizer CEO Albert Bourla had the confidence to quickly commit to a partnership with BioNTech on a COVID inoculation. Pfizer also had the deep pockets to put $2 billion into development of that vaccine without having to accept research funding from governments. Bourla wanted to be able to move fast without having to seek approval on every decision from an outside stakeholder, he told Fortune recently: “I couldn’t do that if I was taking government money.”

While it’s already paying off in the fight against COVID, mRNA has only begun to show its potential. Compared with traditional vaccines, mRNA vaccines are both easy to tweak—to react, for example, to variants of a global virus like SARS-CoV-2—and relatively easy to scale up. But wherever its deployment ultimately leads, what may seem like overnight success was the product of years of hard work and calculated risk-taking, by leaders whose place in the pharma pantheon now seems assured.