Fueled By $500 Million In Federal Cash, Moderna Races To Make A Billion Doses Of An…

The company’s billionaire CEO has secured huge grants on the promise of a new class of mRNA vaccines, but nobody really knows if they will work.

^From the moment the first case of what would later be called COVID-19 was announced, Moderna CEO Stéphane Bancel started keeping an eye on the virus. He circulated a Wall Street Journal article about the new disease to his staff in early January, telling them to watch it closely. When the genomic sequence of the virus was released online by Chinese scientists on January 11, 2020, the Cambridge, Massachusetts–based Moderna team had a vaccine design ready within 48 hours. It shipped a batch of its first vaccine candidate to the National Institutes of Health for a phase one study just 42 days after that. In early March, Moderna’s mRNA vaccine, which represents an entirely new way to provide immunity to disease, was injected into humans for the first time.

That’s lightning fast. Vaccines typically take years (or in some cases, decades) to develop, but it’s not fast enough for Bancel. “Every day we’re losing lives; we really believe that every day matters,” he says.

The speed is made possible by a new technology: mRNA vaccines, which have the potential to fix many of the pitfalls of traditional vaccines, which take a long time to manufacture, aren’t 100% effective and, if they are made with a live virus, have an outside chance of making you sick. mRNA vaccines work kind of like a computer program: After the mRNA “code” is injected into the body, it instructs the machinery in your cells to produce particular proteins. Your body then becomes a vaccine factory, producing parts of the virus that trigger the immune system. In theory, this makes them safer and quicker to develop and manufacture, which is why Moderna has thrown all its weight behind this new COVID-19 vaccine, pausing enrollment of several of its other clinical trials in the meantime.

It’s a big bet for the ten-year-old company, which currently has 24 products in its pipeline—but nothing yet on the market. The biotech sports a huge market cap of $17.5 billion, but it posted a net loss of $514 million on revenues of just $60 million last year. And most of that incoming cash came from government grants and research collaborations with big pharmaceutical companies.

The prospect that Moderna may have the technology to compress years into a few months and take on a virus that has crippled the global economy has investors salivating. The company’s stock price has jumped from $19.23 on January 2, 2020, to a recent $53.19. That’s made Bancel, who owns roughly 9% of Moderna’s stock, a new billionaire, with a net worth of $1.6 billion.

“If it works, we might have the best vaccine technology in the world,” Bancel says. 

When asked how we know mRNA vaccines will work, Drew Weissman, who’s been researching them for 13 years, bluntly answered: “We don’t.”

But that’s a big “if.” No mRNA vaccine currently exists on the market, and nobody knows for sure if the technology will work, much less against this virus. To date, nobody’s been able to make a vaccine that works against a human coronavirus.

Bancel, 47, himself wasn’t always a believer in the technology. When he first was approached with the idea of building a company around mRNA, he balked. “[I] had a lot of learning to do on the molecule. How do you make it stable? How do you make it not immunogenic? How do you make it pure enough so that you can inject a human safely?” he recalls.

Born in Marseille, France, Bancel was getting his master’s degree in chemical engineering at the University of Minnesota, when he first learned about mRNA in the mid-1990s. mRNA (the “m” stands for “messenger”) transports genetic information from your DNA to ribosomes, the factories in your cell that make the proteins that keep your body working. It’s also highly unstable and quickly degrades within the human body. That notion of mRNA being fragile and difficult to work with stuck with him.

By 2010, Bancel, who also has an M.B.A. from Harvard Business School, was CEO of French biotech company bioMérieux when a venture capitalist named Noubar Afeyan approached him with a plan to create a company that used mRNA to create new disease treatments and vaccines. Bancel was skeptical at first, but Afeyan won him over. “If this is real, this could be a new class of medicine,” Bancel remembers thinking. Bancel joined Afeyan and a team of scientists from MIT and Harvard to start Moderna later that year.

Since then the company has faced a series of setbacks and skepticism. In its early years, Moderna was criticized for being secretive about its data, prompting an editorial in Nature Biotechnology. Several years ago it dropped one of its most-touted drugs it was developing in partnership with pharmaceutical company Alexion, ALXN 1540, a treatment for Crigler-Najjar syndrome, a rare genetic blood disorder, from its pipeline indefinitely. And while some of the vaccines in its pipeline now show promise, that hasn’t always been the case.

“The first Zika vaccine that Moderna was working on had poor efficacy,” says Justin Richner, a microbiologist at the University of Illinois College of Medicine, “but then they were able to retool that vaccine and have a better response.”

Bancel is clear that Moderna needs more data before the company can declare its coronavirus vaccine effective. But he thinks that the nine vaccine candidates that Moderna has already tested in early clinical trials have shown evidence that its platform is solid. “I’m not a betting person, but I’m cautiously optimistic,” he says.

Bancel isn’t the only optimist. In the past 20 years, there’s been an explosion of companies developing mRNA vaccines for a large swathe of diseases, and many have turned their attention towards the COVID-19 pandemic. German company BioNTech is working with Pfizer to develop an mRNA vaccine. Human trials have already begun. Another German company, CureVac, is backed by the Gates Foundation and is expected to begin vaccine trials this summer. Lexington, Massachusetts-based Translate Bio has partnered with French pharmaceutical giant Sanofi to develop its mRNA vaccine, with human trials expected to start later this year.

The federal government is backing mRNA vaccines with serious cash – it’s pledged nearly $500 million to Moderna alone for its COVID-19 vaccine.

All of them are banking on the idea that mRNA vaccines can overturn the way vaccines have been produced for centuries: using weakened or inactive versions of the virus to train your body to produce antibodies, providing immunity against disease. Traditional vaccines have some big drawbacks. One is that there’s a small chance you can get sick from the vaccine if a live virus is used. The second is that making them takes a long time. A seasonal flu vaccine, for example, takes a minimum of six months to produce by growing viruses in chicken eggs. They also aren’t 100% effective—a typical flu shot uses an inactive form of the virus to stimulate your immune system, but is only about 40% to 60% effective.

mRNA vaccines promise to solve both problems. Once the genome of a virus is known, a vaccine can be designed in a matter of days. Because they don’t use a live virus, there’s no risk of them making anyone sick.

But it still all theoretical—there aren’t any mRNA vaccines on the market for any diseases yet. When asked how we know mRNA vaccines will work, Drew Weissman, a researcher at the University of Pennsylvania School of Medicine who has spent 13 years studying the technology, answered bluntly: “We don’t.” There have been only a handful of human trials for any mRNA infectious disease vaccine, all of which have been focused on safety. There’s yet to be a trial showing mRNA vaccines are effective and long-lasting at preventing an infectious disease.

Scientists also don’t know how fast this coronavirus will mutate, which could affect how often a new vaccine will need to be created. If the virus mutates quickly, Weissman says, “We might have to make a new coronavirus vaccine every year or every couple of years.”

Moderna’s partnered with Swiss manufacturing firm Lonza to produce up to 1 billion doses of the new coronavirus vaccine per year.

Nevertheless, the federal government is backing mRNA vaccines with serious cash. It has pledged to give nearly $500 million to Moderna alone for its COVID-19 vaccine. To speed development, the FDA has authorized both Moderna and BioNTech to begin vaccine trials in humans before safety-testing in animals was finished.

Moderna is no stranger to working with the government. For the past two years, the company has been working with the National Institute of Allergy and Infectious Disease, the organization headed by the government’s COVID-19 quarterback Dr. Anthony Fauci, on a vaccine for another coronavirus that causes MERS (Middle East respiratory syndrome).

Moderna’s phase three clinical trial is expected to start early this summer, but Bancel is already preparing to scale up. On May 1, 2020, the company announced a new partnership with Swiss manufacturing company Lonza to produce up to 1 billion doses of the new coronavirus vaccine per year. Manufacturing is supposed to start in July, well before any vaccine would be approved by the FDA, which probably won’t happen until sometime next year.

The time frame may sound ambitious or even foolhardy to the uninitiated. Ten years ago, when the idea for mRNA vaccines was first pitched to him, Bancel felt the same way. “It was a pitch-black, cold February night. I walked across a bridge in Cambridge, and my head was literally spinning,” he recalls. “I ended up thinking, ‘Geez, this is crazy. Most likely it won’t work, but if it does it will change the lives of so many people. I have to do it.’”

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