'We developed this in one year PLUS the nine years that came before it,' says Moderna CEO Stéphane Bancel
Adam Glanzman/BloombergIn early 2020, the federal government took a gamble on a plucky startup that had never had an approved medication could produce a Covid-19 vaccine. On Friday, it got paid off as Moderna's vaccine got a regulatory signoff and will start being distributed this weekend—on a $3 billion contract.
In April, the federal government’s Biomedical Advanced Research and Development Authority announced a nearly $500 million grant to Cambridge, Mass.-based biotech startup Moderna. This announcement came just a few weeks after Moderna’s Covid-19 vaccine was first injected into a clinical trial patient. In June, the agency ponied up more money for developing and manufacturing the vaccine, bringing the total to nearly a billion dollars. It was a gamble — a lot of money on a biotech company that hadn’t yet produced an approved medication.
On Friday, BARDA’s bet paid off as the U.S. Food and Drug Administration granted Emergency Use Authorization to Moderna’s Covid-19 vaccine, the second vaccine that will be available for public use in the U.S. The decision came after a day-long vaccine advisory meeting, whose members voted almost unanimously to endorse the company’s request for authorization (one committee member abstained from voting). This is the second vaccine authorized to prevent Covid-19 infection in the United States, where the disease has killed more than 300,000, after a vaccine from Pfizer and BioNTech was given the same Emergency Use Authorization designation last week. So far, the United States is the only country that has authorized Moderna’s vaccine, but the government’s contracted with the company to provide enough vaccine for 100 million people, to the tune of $3 billion.
“We will of course be thrilled that we will be able to help make a difference fighting this pandemic,” Moderna CEO Stéphane Bancel says in an email. “We have been ten years developing the mRNA platform, and it is immensely satisfying to see it contributing in this way.”
The Company To Watch
Early in the race for a Covid-19 vaccine, Moderna became a company to watch. It became the first company to begin testing a Covid-19 vaccine on human volunteers, and since then data has supported both the safety and effectiveness of the vaccine. In documents provided to the FDA earlier this week, clinical trials found that the vaccine was 94% effective in preventing Covid-19 after two doses. No participants who were given the vaccine died from Covid-19, unlike in the placebo group.
Like the Pfizer-BioNTech vaccine, Moderna’s vaccine uses mRNA to produce a snapshot of part of the SARS-CoV-2 protein in the body—enough to stimulate the immune system and build resistance before the protein fragment disappears. Moderna has been one of the pioneers of mRNA technology for years; though this is the company’s first vaccine to get an Emergency Use Authorization from the FDA, the company has been studying mRNA vaccines for other illnesses like Zika virus and cancer since its founding in 2010.
Pfizer and Moderna’s vaccines are extremely similar, says Daniel Griffin, an infectious disease physician in New York. “The data is almost identical,” he says. “The only really subtle difference is the handling challenges,” he adds. While Pfizer’s vaccine needs to be stored in ultra-cold temperatures of -70 degrees fahrenheit, Moderna’s vaccine needs to be stored at warmer temperatures of about -4 degrees fahrenheit, which is within the range of a normal freezer. Griffin credits this difference to the amount of time that Moderna has spent studying mRNA vaccines and perfecting the vaccine delivery technology.
The amount of time from designing the vaccine to first testing it with people was less than three months.
Ted Warren/Associated PressWarp Speed Development
Moderna began work on an mRNA vaccine for Covid-19 in January, 48-hours after Chinese researchers released the genomic sequence of the novel SARS-CoV-2 virus. A little over a month later, it shipped the first doses of its vaccine to the National Institutes of Health to begin human clinical trials. In mid-November, the company released data from its Phase 3 clinical trials that found its vaccine was almost 95% effective in preventing Covid-19 in a trial of 30,000 people across the U.S. And even in vaccinated people who did get cases of Covid-19, none of the cases of disease were severe. The effectiveness is similar to that of the Pfizer-BioNTech vaccine, and also has few serious reported side effects.
“The next challenges will be executing on our manufacturing plan and successfully distributing the vaccine.”
“I think that we should be very relieved that we actually have numerous vaccine candidates,” says University of Manitoba virology professor Jason Kindrachuk. “Having multiple licensed vaccines could allow us to have better global coverage,” when it comes to vaccinations, he says.
Unlike Pfizer and BioNTech, Moderna has worked closely with the U.S. government throughout the development of its vaccine, particularly with the Trump Administration’s Operation Warp Speed. NIH scientists helped with vaccine development and clinical trials, and once . manufacturing and distribution agreements are factored in, the U.S. government will have funded Moderna’s Covid-19 vaccine to a tune of about $4 billion.
Last week, the government announced that it has purchased 200 million doses of Moderna’s vaccine, enough to give 100 million Americans the two doses required for immunity. “Operation Warp Speed is handling distribution and roll-out,” says Bancel. “And has stated publicly an expectation to have doses shipped and available within a day or two.”
Science-based Billionaires
The massive influx of cash from government contracts, as well as soaring stock prices, has minted several new billionaires for the company this year. Bancel owns roughly 9% of the company and now has a net worth of $4.5 billion. Two of the company's other investors, MIT scientist Bob Langer and Harvard biology professor Timothy Springer, have also become billionaires thanks to the stock’s pandemic surge.
The stock’s constant up-and-down, however, means that no one’s fortune is completely safe. Even this week, Moderna stock dropped enough to shave almost $2 billion off of the collective net worths of these three billionaires. In the near-term, the stock is likely to remain volatile. According to analysts at Morgan Stanley, revenue from Covid-19 vaccines is likely to be the only driver of the stock for the next 6-12 months.
The Next Step
Now that the vaccine has been authorized for use in the general public, the rollout will be quick. Healthcare workers could begin getting vaccinated as early as next week, with nursing home residents getting the vaccine soon thereafter. “The next challenges will be executing on our manufacturing plan and successfully distributing the vaccine,” says Bancel. “Thankfully we have great partners in the U.S. government and in private industry helping us in both areas.”
In a conversation with Forbes last month, Bancel predicted that the vaccine would be free for Americans. Moderna also has partnerships with other countries, including Japan, Canada and the E.U., to supply doses of the vaccine once authorized by their respective health agencies.
Moderna’s vaccine still has a few bumps in the road. Like the Pfizer vaccine, two doses are required for full protection against Covid-19, which raises some concerns about compliance. “This is an issue we have to be extremely diligent about,” says Esther Krofah, executive director of FasterCures, a center of the Milken Institute which is tracking Covid-19 vaccines and treatments. She notes that a major part of ensuring people comply with the vaccine schedule is how much they trust the science. “We need an aggressive, on the ground education campaign to get people comfortable with the science and then come back for the second dose,” she says.
Now that the vaccine is authorized for use, the next step is getting it to people.
APLight At The End Of The Covid Tunnel
Though Pfizer, and now Moderna, are the first vaccines authorized in the U.S., more vaccines are coming. Last week, Dr. Anthony Fauci said that a vaccine from Johnson & Johnson may be available early next year, while plenty of other companies, including AstraZeneca and Novavax, still have vaccines in development.
This prospect is a relief for stressed and overburdened healthcare workers who are simply excited that they might soon get protection from this deadly virus. “It’s like kids at Christmas,” Griffin says, “I haven’t seen physicians so bright and giddy since this [pandemic] began.”
For Bancel, the authorization of this vaccine is a satisfying milepost on a journey that began 10 years ago when his company first started developing this vaccine technology, and expressed gratitude towards the people who made it possible: “the many hundreds of Moderna employees who have sacrificed so much sleep, so much family time, and so many weekends and vacations to stay steadfastly focused on helping us have this vaccine make a difference in the world.”
