As Moderna prepares to launch a Phase 3 trial of its Covid-19 vaccine in July, the company’s CEO says there’s a high probability that the company’s product could reach distribution in 2021.
“It seems to be possible that we could have efficacy data by, let’s say, Thanksgiving,” Moderna (ticker: MRNA) CEO Stéphane Bancel said during Barron’s Investing in Tech conference Wednesday. That data would potentially allow Moderna to fight for approval either late this year or early in the new year, Bancel said.
The company recently announced it hopes to recruit 30,000 people for its Phase 3 trial—”a lot of people, indeed,” the CEO said. “We are very, very interested in knowing as much as we can about this vaccine and to ensure it is safe,” he said. The Food and Drug Administration has the same objective, emphasizing that the large pool of volunteers has been discussed and agreed upon with the agency.
On the Front Line of Developing a Covid-19 Vaccine
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A large cohort of trial participants is also essential for geographic reasons. “We do not know where exactly outbreaks will happen in the fall,” Bancel said. With volunteers receiving either the active vaccine or a placebo at sites across the country, “wherever outbreaks happen, we’ll be able to see cases,” he said.
As Barron’s previously reported, Moderna is one of several companies using relatively new technology to create a Covid-19 vaccine. FDA approval of the technology, which uses synthetic messenger ribonucleic acid, or RNA, to create a protein that provokes an immune response, could pave the way for the rest of the company’s pipeline.
Bancel said the company’s experience creating vaccines is partially responsible for the speed of Moderna’s Covid-19 vaccine candidate. “This was actually the 10th vaccine that we put in clinical trial,” Bancel said. “We’ve learned a lot over the years: how to optimize the manufacturing process, how to optimize your chemistry, to get the best vaccine we could.”
With the vaccine’s clinical and manufacturing plans addressed, Moderna is now working with several groups to determine the vaccine’s economic value and how much of a share of that value the company thinks is fair to capture, Bancel said. “We need to make sure that the vaccine is affordable so that everybody can be vaccinated, either because it’s paid by a private payer or by the government.”
While Moderna is far from the only company working to produce a Covid-19 vaccine—as of mid-May, there were more than 100 vaccine programs under way—Bancel said he doesn’t see other companies’ vaccine efforts as a negative. “There is no one company in the world who has a manufacturing capacity to supply the planet,” he said, adding his belief that many vaccines will eventually be approved. “And we need those because we have to vaccinate a lot of people to stop this public health emergency.”
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