Moderna plans to seek emergency approval of its coronavirus vaccine candidate once data shows it to be at least 70% effective—but that's not likely to occur before November and perhaps not until mid-2021. That's according to the company's 135-page plan for analyzing trial data, released Thursday. Moderna has already recruited more than 25,000 of 30,000 volunteers for its late-stage vaccine trial and expects to compete enrollment in the next few weeks, reports the New York Times. Half of the group will be given the vaccine in two doses four weeks apart, the other half a placebo. Researchers then wait to see who contracts the virus and how they react. An independent safety board will do an initial review of Moderna's data once 53 participants become infected. Moderna expects that will happen in November, perhaps late October, per Reuters.
"The odds of demonstrating 60% effectiveness at the first analysis are not high,” reports the Times. If 70% efficacy is not proven, an independent safety board will review Moderna's data again after 106 cases and 151 cases. Moderna expects these reviews to happen in late December and late May, respectively. But if 70% efficacy is proven, "we can protect a lot of lives in the people at the highest risk," CEO Stephane Bancel tells Reuters. At that point, the company will seek emergency authorization for use on emergency workers and the elderly. It only plans to seek full FDA approval after acquiring much more data. It has millions of doses prepared in case all goes well. But there won’t be enough for everyone. Indeed, "the world is going to be massively supply-constrained" for the first half of 2021 and "maybe until Labor Day next year," Bancel tells the Times. (More coronavirus vaccine stories.)
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