How Moderna nearly lost the race to develop a Covid-19 vaccine

Moderna Inc. has emerged as a biotech power — and a household name — thanks to its success developing a Covid-19 vaccine. But that outcome hides what happened along the way: The company came perilously close to being the biggest loser in the race for a Covid-19 vaccine.

At one point last year, Moderna CEO Stéphane Bancel was overcome with sadness because he thought he had blown the company’s opportunity to produce vaccines to help stop the pandemic.

I spent 17 months investigating how the Covid-19 vaccines were developed. I spoke with more than three hundred scientists, academics, executives, government officials, investors, and others who made the Covid-19 vaccines possible. Though developing a safe and effective Covid-19 vaccine in a timeline that many called impossible was a monumental effort, the Moderna story is a stark reminder of how thin the line can be between success and failure.

For years, Bancel exuded confidence about his company’s prospects. A 49-year-old native of Marseille, France, Bancel spent the years leading up to 2020 declaring that Moderna was on its way to producing vaccines and drugs using messenger RNA molecules, ignoring rampant skepticism in the biotech world. Well before SARS-CoV-2 emerged, he left rivals slack-jawed with his ability to coax tens of billions of dollars from investors around the globe.

Working with scientists from the National Institutes of Health, Moderna produced a promising Covid-19 vaccine in January 2020, just weeks after the virus’s sequence had been shared by Chinese scientists.

On March 2, Bancel flew to Washington, D.C., to join some of the world’s leading drug-industry executives in a meeting with President Donald Trump. Representatives from Pfizer, Johnson & Johnson, GlaxoSmithKline, Sanofi, and others were there, as were senior members of the Trump administration and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Bancel and the others made their ways through layers of security to enter the West Wing. So many people were invited for the meeting that, at the last moment, it was moved to a large conference room next to the Oval Office. As Bancel and the others found spots around the room, however, even that space began to feel cramped.

Trump asked each of the drug company execs for updates on their progress making vaccines and drugs. Sitting across from Trump and Vice President Mike Pence, Bancel spoke with confidence, saying Moderna would move its vaccine into Phase 2 trials in the coming few months and would then start a final Phase 3 trial. Bancel promised such a lightning-fast pace for his company’s vaccine development that some around the table became uncomfortable, viewing the timetable as unrealistic. Trump became visibly excited, though. He tried to pin down Bancel on a date when he could expect Moderna to deliver a vaccine.

“So you’re talking within a year,” Trump began, before Fauci stepped in. He seemed worried that Bancel was exaggerating the speed of his vaccine program, which was being run with the NIH.

“A year to a year and a half,” Fauci told the president, something Trump didn’t seem thrilled to hear.

A day later, the Food and Drug Administration (FDA) gave Moderna a green light to begin testing its vaccine in humans. The company was moving quickly, just as Bancel promised the president. Bancel oozed confidence, at least publicly.

Privately, however, Bancel and his colleagues were becoming disheartened. Some were even despondent. Although the Moderna team was certain it had a winning formula for a vaccine, it was facing a huge problem: the company barely had money to manufacture any doses.

Moderna had begun the year dealing with financial pressures. In late 2019, executives began cutting back on research and other expenditures. Cash from investors had stopped pouring in and partnerships with some drug makers had been discontinued. In meetings at Moderna, Bancel emphasized the need to stretch every dollar and employees were told to reduce travel and other expenses, a frugality they were advised would last several years.

“We were freaked out about money,” Stephen Hoge, Moderna’s president, told me.

In January 2020, after Covid-19 emerged and Moderna decided to develop a vaccine, the financial issues became even more pressing. In February, the company raised $500 million by selling new shares at a price of $19 apiece. That sounds like a lot of money, but in many ways the sale was an embarrassment, because in late 2018, Moderna had gone public at $23 a share. Over the following year or so, the company made substantial progress on a number of vaccines, including one against cytomegalovirus (CMV). Now it was making headway on a vaccine to halt a virus that held the world in its grip. Yet its stock price had gone down, suggesting that Moderna was less valuable than before.

“It was humbling,” Hoge said.

The worst part about the stock sale was that the Moderna executives didn’t feel they could use the new cash for their Covid-19 work. Some of the big investors who had purchased the shares told Hoge and others they didn’t want the company to become distracted with a coronavirus vaccine. Vaccine development was viewed as a dead-end endeavor with little potential payoff, and potential shots for the new virus seemed to have an uncertain likelihood of success.

Juan Andres, a Madrid-born executive who headed Moderna’s manufacturing effort, was desperate to start making tens of millions of doses of the company’s vaccines, or even hundreds of millions of doses, so they could be ready to be distributed as soon as the shots were authorized by regulators.

Andres had reason for urgency. Back in January, he had warned his family that a pandemic was likely coming. He bought an extra refrigerator to store food and purchased cans of disinfectant and enough toilet paper to last a full year. His family giggled — the tall piles of toilet paper were among the funniest things they had ever seen. In March, when Andres’s mother-in-law died of Covid-19, his family understood his concern.

Now, Andres couldn’t get Moderna’s vaccine-manufacturing process going; he didn’t have enough money to buy the essential ingredients for the shots. The company needed hundreds of millions of dollars, perhaps even more than a billion dollars. Andres didn’t know where the money was going to come from; neither did Bancel and Hoge. Time was ticking, rivals were acting, people were dying, and Moderna was sitting on its hands. It was eating them up.

Throughout February, March, and April, Bancel begged for money. He asked Trevor Mundel, a top leader of the Gates Foundation. He reached out to an arm of the World Health Organization called COVAX. He phoned or scheduled Zoom calls with representatives of other government bodies and charitable foundations. He presented reasons why Moderna deserved financial assistance. Bancel became frustrated by the rejections and his requests became more plaintive.

“Look, if you don’t help us, and this [vaccine] works, it will cost hundreds of thousands of lives, if not hundreds of millions,” Bancel told one person. “It’s a tragedy . . . we need help.”

Each time, Bancel came up empty. Sometimes he swallowed his pride and asked an organization a second time, hoping for a change of heart. The answers remained no. Some of the potential funders deemed mRNA too risky. Some were committed to helping other companies’ vaccine efforts. Still others didn’t have the free cash.

Moderna managed to get some money from the Biomedical Advanced Research and Development Authority (BARDA), an arm of the U.S. government, but it wasn’t enough to manufacture many doses.

At one point, Bancel called Roger Perlmutter, who was then Merck’s R&D chief, suggesting that the companies team up on a Covid-19 vaccine, just like Pfizer and BioNTech were doing. Perlmutter was enthusiastic about the idea. A few years earlier, Merck had worked with Moderna on vaccines against various infectious diseases, so it made sense that they would join forces against SARS-CoV- 2.

But Merck never followed through on Bancel’s pitch. Some at Moderna got the sense that Merck executives, including the company’s head of infectious disease discovery, Daria Hazuda, viewed mRNA-based vaccines as unproven, a stumbling block for an alliance.

In the early years after Moderna had been started in 2010, Bancel was impatient with staffers. They became fearful of letting him down. Now, Bancel was upset with himself. He was convinced that he had failed his company, his shareholders, and the world. He was a master fundraiser but when it truly counted, he had come up short. Lives were at stake and he had blown it. Bancel had risked his company’s reputation pursuing a Covid-19 vaccine but he was losing that bet. He was overcome with sadness.

“I wasn’t good enough to get it done,” Bancel told me later, looking back on that time.

By May 2020, Moderna still couldn’t produce much of its vaccine. AstraZeneca, Pfizer, and J&J were all bulking up their own manufacturing capacities, preparing to produce tens of millions of doses as soon as regulators authorized their shots. Moderna was sitting still, though, and Andres was becoming more frustrated. People were suffering all over the world. He and his company were in a position to help, yet he couldn’t do a thing to pitch in.

“We need to place the orders if we want vaccines,” an exasperated Andres told a colleague. “We need to do it now!”

The spring brought hope for Bancel and his company. On May 15, President Trump stood on the White House lawn to announce the formation of Operation Warp Speed, an effort to hasten the development of a coronavirus vaccine. He picked pharmaceutical veteran Moncef Slaoui to run the effort, a decision that was a mixed blessing for Moderna.

Slaoui, a Moroccan-born Belgian American who once led GlaxoSmithKline’s vaccine division, had been a member of Moderna’s board of directors since 2017. He had long been skeptical of using mRNA molecules for drugs or vaccines, though. Slaoui’s expertise was in vaccines that injected synthesized proteins into the body. While on Moderna’s board, Slaoui routinely questioned the company’s focus on mRNA vaccines. But impressive data in 2019 for Moderna’s CMV shots had convinced him that mRNA could work, suggesting that he now might be open to helping Moderna’s Covid-19 effort.

Right away, however, Operation Warp Speed gave another vaccine maker help, not Moderna. The initiative pledged up to $1.2 billion to help the Oxford/AstraZeneca team develop, produce, and manufacture vaccines. The British effort was furthest along: the team had already planned a trial of 30,000 adults in the United Kingdom and elsewhere, as well as a trial for younger people, so the decision made sense, but it brought more disappointment to the Moderna team.

Time was running out on them. They decided to turn to the one place they were feeling the love: Wall Street. By then, Moderna shares were absolutely soaring. After starting 2020 below $20 a share, the stock topped $66 on May 15 as investors became hopeful that the company’s Covid-19 vaccine could be a big seller. Moderna hired investment banking firm Morgan Stanley to try to sell new shares to investors, this time specifically to pay for vaccine manufacturing.

Three days later, Moderna reported results from its first human study: Eight participants in the Phase 1 study who had been inoculated with the company’s Covid- 19 vaccine had developed neutralizing antibodies comparable to those seen in people who had been infected by the virus and subsequently recovered, and the shots were generally safe and well tolerated. The data were early and based on a tiny number of subjects, but investors were so excited about the prospect of an effective vaccine that they sent the Dow Jones Industrial Average up 912 points that day, or 3.9%, while Moderna’s shares jumped 20%, past $75 a share.

The trial results were good news for the vaccine, less so for the Moderna team. The stock’s climb made it harder for Morgan Stanley to sell a big batch of new shares — who wanted to buy a stock that has already jumped in price? Criticism emerged that Moderna’s results had been revealed with a press release, not with a peer-reviewed study, raising fresh questions about the company.

After some deliberation, Morgan Stanley agreed to purchase $1.34 billion of Moderna’s newly issued shares itself, betting it could sell them to the bank’s customers. The money meant everything to Bancel and his team: They finally had a chance to produce huge numbers of doses and compete with the larger drug companies.

Right away, Andres was told to start spending the money on lipids, glass, steel, and every other kind of material and piece of equipment he needed to make vaccine doses.

Go, go, go!

Bancel, Hoge and Andres breathed deep sighs of relief. They had hope.

The company is worth $135 billion as I write this, more than pharmaceutical giants like GlaxoSmithKline and Sanofi, which failed to deliver effective vaccines. Moderna’s shares are up 320% over the past year, even after a recent slump. An article in the New England Journal of Medicine showed that Moderna’s shots are somewhat more protective than the Pfizer/BioNTech Covid-19 vaccine.

Analysts project that Moderna will record $35 billion of sales from its Covid-19 vaccine through next year. It is using its full coffers and newfound clout to develop new mRNA-based vaccines and drugs and take on other diseases, suggesting more breakthroughs could be ahead.

But Moderna’s executives know how close they came to missing out on a historic opportunity, were it not for a timely piece of data and a willing investment bank.

“We had bet the company on a Covid-19 vaccine, but one misstep last year and Moderna and possibly mRNA vaccines were goners,” Hoge says. “We spent 10 years building the company for the moment, but we needed a lot of luck to survive the year.”

Gregory Zuckerman is a special writer at the Wall Street Journal and author of “A Shot to Save the World: The Inside Story of the Life-or-Death Race for a Covid-19 Vaccine” (Portfolio, Oct. 26, 2021), from which this essay was adapted.