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- Moderna went from a hot biotech startup to one of the world’s best-known companies, boosted most recently by its coronavirus-vaccine program.
- It says its shot is 94.5% effective at protecting people against COVID-19.
- While those results have yet to be published in a journal and regulators still need to review the data, the scientific feat outlines an exit plan from this pandemic.
- This is the inside story of how Moderna leveraged its speedy technology platform and ongoing research projects with the National Institutes of Health to develop an effective vaccine in record time.
- Now valued at $39 billion, the Massachusetts biotech is at the forefront of a revolution in vaccine research, driven by its promising technology.
- For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.
In January, Stéphane Bancel, the chief executive of Moderna, was skimming through the news on his iPad while vacationing with his family in the south of France. A headline stopped his finger: “Health Officials Work to Solve China’s Mystery Virus Outbreak,” The Wall Street Journal reported on January 6.
The Frenchman, who is 48, wrote an email to Dr. Barney Graham, a vaccine researcher at the US National Institutes of Health, asking him what he knew about these pneumonia cases cropping up in central China.
Graham said he didn’t yet know the identity of the mysterious virus, but within a few days it was identified as a novel coronavirus. Bancel urged the Graham to let him know when government scientists had the virus’ genetic sequence.
His company, Moderna, was ready to get to work.
Now, less than a year later, Moderna and the NIH have developed a vaccine that appears to be highly effective at preventing people from coming down with COVID-19, the disease caused by that new virus. The speed with which Moderna and two other vaccine programs, led by Pfizer with its partner BioNTech and by AstraZeneca with the University of Oxford, have worked to develop vaccines against a new virus is unprecedented.
If Moderna and Pfizer’s vaccines secure emergency-use authorization before year’s end, about 20 million Americans could be immunized in December, leading government scientists say. An emergency OK could mark the beginning of the end of the coronavirus’ hold on the world.
A new era of vaccine research
Beyond the pandemic, Moderna is now among a handful of companies looking to usher in a new era of vaccine research, built around technologies that are far faster than traditional methods. The new approach promises a revolution in how vaccines will be made and, for Moderna, a chance to capture a bigger slice of a $35 billion vaccine market dominated by big pharma companies.
“This is not the same game,” Bancel previously told Business Insider. “We never saw the virus. We don’t need to see the virus. What we need is the genetic instruction of the virus.”
For now the pandemic rages on. The US is seeing surges in new infections, hospitalizations, and deaths. Experts fear the winter could be the bleakest stretch.
Vaccine supplies will be extremely limited for the next several months, though manufacturing is ramping up. People who are particularly vulnerable to the virus, such as older people or those with underlying health conditions, as well as some medical workers, will likely be immunized first.
A shot could be widely available to many more Americans in the spring or early summer, perhaps beginning in April, said Dr. Anthony Fauci, the director of the NIH’s infectious-disease division.
Investors haven’t waited to back Bancel’s vision for Moderna’s potential. The company’s stock has increased by about 400% since the beginning of the year. Moderna commands a $39 billion market value, making it one of the most highly valued biotechs.
Despite being a fraction of their size, Moderna competed toe to toe with pharmaceutical giants in the race for a COVID-19 vaccine, announcing positive efficacy results a week after the team of Pfizer and BioNTech. Here’s how they were able to do it.
Moderna built on an existing research relationship with Fauci’s team
Moderna had a massive head start in crafting a vaccine because of its longstanding relationship with the NIH’s infectious-disease unit, led by Fauci, Graham, and Dr. John Mascola.
“Our collaboration with Moderna has been most extraordinary,” Fauci said on a November 16 call with reporters. “It goes back years and years, and I think that’s one of those things the general public doesn’t fully appreciate when they hear an announcement like this. They think this is something that just happened a few months ago. It did not.”
Graham joined the NIH’s Vaccine Research Center in 2000, when it was founded, with the aim of developing an HIV vaccine, an elusive goal the group is still pursuing. But the 21st century helped shaped the new center’s mission, as a string of pandemic scares emerged with SARS, H1N1, Ebola, MERS, and Zika.
Graham’s team could craft antigens that they believed could neutralize these viruses, but it took too long in practice to use their discoveries to thwart Ebola and Zika outbreaks.
“We decided we need to be more proactive and start getting ahead of the game of pandemic preparedness,” Graham said in an October interview with Business Insider.
Looking for a partner that could help create vaccines more quickly, Graham’s team started working with Moderna in 2017.
Graham’s lab had mapped out 25 virus families that could infect humans and cause massive problems for the world. The plan was to craft a blueprint for each virus type, pinpointing weaknesses and how to exploit them.
At the start of the year, mRNA was a promising but still unproven technology
Moderna and the NIH started early lab work on two vaccines: one against the bat-borne Nipah virus and another against a coronavirus responsible for MERS, or Middle East respiratory syndrome.
Both were built with Moderna’s genetics-based technology, a potentially powerful but unproven way of developing vaccines.
At a basic level, vaccines work by giving cells a taste of a virus, just enough for our bodies to recognize it as an intruder and pump out virus-fighting proteins — called antibodies — to fight future invasions.
For decades, vaccines contained a dead or weakened version of the virus itself. Then, early advances in genetics allowed a vaccine to use just proteins made by the virus. That method was first used in the 1980s to develop a vaccine for hepatitis B.
Moderna aims to go a step further. Instead of using viruses or proteins, the company’s technology needs only the genetic material of the virus. The biotech is focused on messenger RNA, the genetic material that tells cells how to make proteins. The young company was founded in 2010 on the potential that these “information molecules” could form a new class of medicines.
“What you could probably do is make this a whole new way of making drugs, vaccines, almost anything,” Bob Langer, one of Moderna’s founders and a famed MIT professor, told Business Insider.
The grand vision persuaded investors to pump record sums of money into the privately held company: $110 million in 2013; $450 million in a 2015 round; $474 million more the following year; and $500 million in early 2018.
That culminated in an initial public offering, in December 2018, the largest in the biotech industry’s history. Moderna raised $563 million, commanding a valuation of $7.5 billion.
Despite the massive financing and grand ambitions, Moderna’s technology was unproven heading into 2020. There are no federally approved mRNA-based therapeutics or vaccines on the market, and, before this pandemic, there were no late-stage study results that showed the approach worked in humans.
‘Crazy hours, short nights’ marked a flurry of activity in the race to become the first program to begin testing on humans
In November 2019, Graham and NIH officials toured Moderna’s facilities, discussing with company’s executives the plan to start human testing for the Nipah-virus vaccine.
After exchanging emails in early January about the mysterious viral outbreak in China, Graham and Bancel agreed during a phone call that it was time to put their early research into practice.
“We said, ‘Well, instead of working on something that could happen, why don’t we work on something that is happening and do our demonstration project on the coronavirus,'” Graham recalled.
NIH scientists targeted the spike protein, which the virus uses to latch onto healthy cells and infect them. The mRNA vaccine instructs the body to produce this protein. It generates an immune response, which helps protect against the disease.
After the coronavirus’ genetic sequence was published on January 11, it took two days for the teams to finalize the targeted genetic sequence for its vaccine, dubbed mRNA-1273. With traditional vaccine platforms, the process can take years.
In the weeks that followed, the virus spread worldwide, killing thousands of people through February and March and weighing on financial markets. In that same time, about 100 employees at Moderna — one-tenth of the entire workforce — worked around the clock alongside NIH scientists to develop a coronavirus vaccine.
That period was full of “crazy hours, short nights,” Bancel said in an interview in March, adding: “They did what they had to do to get things done.”
In the first lap of a marathon race, Moderna’s technology excelled. Its collaboration with Graham’s team helped it move faster than anyone else. On February 24, the company shipped the first batch of its experimental vaccine to NIH scientists in Bethesda, Maryland.
The first volunteer received the first dose on March 16, in Seattle, and that launched the world’s first clinical trial of any coronavirus-vaccine candidate.
Hype builds, and criticism mounts, as first results show promise
That first trial enrolled 45 healthy volunteers to start, and randomly gave them one of three dosages to begin evaluating the shot.
In May, the biotech released interim results from that study in a press release, saying all participants developed virus-fighting proteins, or antibodies. Even more encouraging, people who got a more potent dose made more antibodies.
Moderna’s results marked an important but early milestone. Researchers still had no idea how many antibodies people actually needed to be protected from the virus, but the results suggested Moderna could be on the right track.
Investors cheered the progress, sending Moderna surging to a $30 billion valuation. But as the company embraced the scientific limelight, its executives also faced criticism.
Within hours of touting these results and seeing its stock surge by 25%, Moderna announced plans to raise $1.3 billion by selling more stock. Some infectious-disease experts criticized the announcement as “science by press release,” wanting to see the underlying data, while industry watchdogs like Lower Drug Prices Now argued that Moderna was profiting from the pandemic and the speculation about its vaccine.
Over the next several months, some of Moderna’s leaders sold some of their own holdings in the company, personally cashing in as Moderna’s stock price soared. A Business Insider analysis found Moderna insiders had sold $236 million in stock through the first nine months of 2020.
Operation Warp Speed launches, with Moderna a key element
Another reason for Moderna’s speedy success was the substantial support it received from the US government, particularly after Operation Warp Speed launched in May to accelerate vaccine development.
The ambitious program spent more than $12 billion to support vaccine development. Overall, the US has committed up to $2.48 billion to Moderna’s vaccine effort, which includes paying for research, manufacturing, and securing 100 million doses.
By footing the bill, Warp Speed removed the typical boardroom calculations that go into drug-development decisions. Without facing as much financial risks, Moderna quickly started additional and larger studies of its shot, even as results were still coming in from earlier research.
Typically, vaccine research happens in three phases, with each study being larger and more costly than the previous one. The US government’s funding allowed that process to happen simultaneously.
On July 27, Moderna and Pfizer both launched 30,000-volunteer studies designed to give a definitive answer about whether their experimental shots would work in humans and stop COVID-19. These definitive studies are known as Phase 3 trials.
Neck and neck with Pfizer, Bancel decides to slow down
Then, in the heat of the vaccine race, Bancel’s team made an unexpected decision to slow down.
Through the final weeks of the summer, Moderna’s Phase 3 study was enrolling volunteers rapidly.
On the outside it looked as if the study was moving along flawlessly. But there was a problem — big enough that Bancel decided to shut down many of the research sites.
By mid-September, Moderna’s trial had enrolled well over 20,000 volunteers. But those participants were disproportionately white, a problem the drug industry has long struggled to address.
Moderna intentionally slowed recruitment to boost diversity, closing sites that had done a poor of job of recruiting members of minority groups.
“We want to make this vaccine so if it works and it is approved, people use it,” Bancel said in September. “It would be really sad if one of the big communities of the country doesn’t have enough representation, that people don’t feel the vaccine is safe for their genetic pool of diversity, and effective.”
Throughout late-September and October, nearly everyone who joined Moderna’s trial was nonwhite. In total, about 11,000 participants were from minority communities, making up 37% of the study.
The vaccine was successful in a late-stage study
November 15 was far from a lazy Sunday morning for Bancel, who was busy pacing his home office, waiting as patiently as he could for the most important data of his professional life.
He knew that a group of independent experts was meeting at 10 a.m. to pore over preliminary results from Moderna’s late-stage trial for the first time. Bancel was not invited to that meeting.
In the early afternoon, his team called him and told him to get on a WebEx videoconference. They had the data, they told their boss.
The independent board reviewed 95 cases of COVID-19 among trial participants. Ninety people who’d received a placebo shot got sick, compared with just five who got Moderna’s vaccine.
That meant the shot was about 95% effective at preventing COVID-19, which ranked it alongside the most potent vaccines in medicine.
“You can imagine how relieved we were, how happy we are for what I hope we will be able to do to help millions of people around the world,” Bancel said.
Even with great scientific success, the pandemic is far from over
Moderna plans to file for emergency-use authorization with US regulators this month or in early December, starting a review process that will take weeks.
Looking ahead, even if the vaccine is authorized, it will take several months for it to be widely available in the US, and even longer for it to reach the entire world.
Even though the pandemic is far from over, having effective vaccines gives society a valuable tool to fight back. But the immediate effects will be limited, meaning people will need to keep wearing masks and socially distancing.
Moderna’s vision has always been years ahead, and 2020 only throws gas on the fire for Bancel’s expectations of what his company can accomplish. The biotech is working on several other vaccine candidates, for Zika, the flu, cytomegalovirus, and respiratory syncytial virus.
Bancel said he anticipates that the COVID-19 success could translate to immunizing against these other diseases just as well.
“It’s copy and paste,” he said. “So the Zika vaccine, the CMV vaccine, if this vaccine shows high efficacy, they are going to have high efficacy. It’s just science.”
This article was published on November 21. It has been updated with AstraZeneca’s vaccine results.