Moderna's CEO told us we should know if the biotech's coronavirus vaccine works in November
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- Moderna CEO Stephane Bancel said it's likely we'll know if Moderna's experimental coronavirus vaccine works in November.
- The timing depends in part on how effective the shot actually is at preventing disease. The more effective the vaccine is, the quicker a board of independent scientists will be able to conclude that it works.
- Moderna, Pfizer, and AstraZeneca are all leading coronavirus vaccine programs that are aiming to win emergency approval in 2020, if they get positive results for their experimental vaccines.
- Bancel also told BI that Moderna has shut down trial sites that were doing a poor job at recruiting minorities. The company is seeking to boost diversity in its trial.
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One of the three leaders in the quest for a coronavirus vaccine expects to know if his shot works in November, despite slowing down crucial trials to recruit a more diverse group of volunteers.
Stephane Bancel, the CEO of the Massachusetts-based biotech Moderna, told Business Insider we'll probably get data on the coronavirus shot in November, though it's possible it could come next month.
"Base case: November. Best case: October," Bancel said in a Wednesday interview, ahead of the biotech's R&D day. "I think October, as Dr. [Anthony] Fauci has said, is unlikely just in terms of probability and especially as you see the number of cases in the country slowing down."
Moderna, Pfizer, and AstraZeneca are all leading coronavirus vaccine programs that are aiming to achieve emergency approval for their shots this year, if they can prove the injections work. The studies compare rates of COVID-19 between volunteers who got the shot and ones who got a placebo, to see if there's a meaningful difference.
Pfizer's CEO has repeatedly said in recent days that the New York drugmaking giant expects conclusive effectiveness data for its vaccine candidate in October.
AstraZeneca's studies were recently halted as scientists investigated a serious adverse event to see if it was related to the shot. While AstraZeneca's UK-based trial has resumed, the US-based trial remains on hold. Still, its CEO has said data should come before year's end.
Results in November depend on Moderna's vaccine being highly effective
The timeline Bancel shared on Wednesday is similar to the one he laid out shortly after Moderna started the late-stage study in July.
Despite a modest slowdown in new coronavirus cases in the US, from roughly 60,000 per day to 40,000, Bancel said Wednesday that the first look at Moderna's data should happen in November. An independent board of scientists, known as a data safety monitoring board, will conduct this review.
There's a decent chance the board won't find conclusive data that the vaccine works that soon, and will require the study to continue.
As part of its R&D day, Moderna shared Thursday the underlying statistical plans that will drive the study.
If Moderna's vaccine is ultimately 74% effective at preventing disease, that would translate to a 50% probability that there's enough evidence to call the study at this first interim analysis. If the shot winds up being closer to 80% effective, the chances of the interim analysis finding a meaningful difference rise to around 80%.
But if it's less effective — say 60% — the first interim analysis will most likely not produce a conclusive efficacy result.
Bancel said Moderna will probably share the results of each data review publicly.
"Most probably we will decide to communicate whatever the [data safety monitoring board] tells us. If it tells us the efficacy, we will of course communicate that," Bancel said. "If they tell us it is inconclusive, we need to keep going, I also think we will share that with the world so the information is out there."
"No news in November might still lead us to a very high efficacy vaccine at approval," he added.
Moderna shut down some trial sites to boost diversity in participants
As of last Friday, Moderna had enrolled about 24,000 people in its study, which aims to recruit 30,000 volunteers. The company has also intentionally slowed down recruitment recently to boost diversity.
Bancel said the number of Black participants was "a bit too low."
"We said let's slow down by basically shutting down the sites that have not done a good job of recruiting minorities, and let's favor the sites that have done a good job at recruiting minorities," he said.
"We want to make this vaccine so if it works and it is approved, people use it," Bancel added. "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."
from Business Insider https://ift.tt/32Bi4YW
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