Moderna said Wednesday that it expects to release the first data from the late-stage trial of its coronavirus vaccine in the coming days — which could reveal whether the shot is effective.
A spokesperson for the company, which is working with the National Institutes of Health on the vaccine, said that the independent data safety monitoring board overseeing the study will have the data in "days, not weeks." How long their analysis will take is unclear.
The news comes days after Pfizer revealed that initial data suggest its vaccine is more than 90 percent effective.
Anthony Fauci, the top U.S. infectious disease expert, told a Financial Times conference on Wednesday that the Moderna data would be coming in the "next few days to a week" and that he would "be surprised if we didn’t see a similar degree of efficacy" as the results from Pfizer.
Fast forward: Like other vaccine developers, Moderna designated certain points in the trial when the data board would dip in and review data for signs of safety and effectiveness. The company initially planned for the first analysis to take place when 53 of the 30,000 people in the trial became infected with the virus.
But Moderna said Wednesday that it has seen "a significant increase" in cases over the last week in the areas where the trial is being conducted. Because of this the company it expects the first data release will involve "substantially more" than 53 infections.
Crunching the data: The company will determine the vaccine's effectiveness by comparing the number of infections among those who got the vaccine and those who received a placebo. The greater the proportion of infections among the placebo group, the more effective the vaccine.
After reviewing the data, the data monitoring board will provide Moderna with one of three options. If most infections are in the placebo group, the board could halt the trial and Moderna could apply to FDA for an emergency-use authorization after it collects about a month more of safety data. If the vaccine does not appear to reach the 50 percent efficacy threshold set by FDA, the board could end the trial.
And if the data on the vaccine's effectiveness is inconclusive, the board could recommend continuing the trial to collect more data and get a clearer picture of how well the shot works. Moderna's next scheduled analysis point comes at 106 infections, according to the blueprint for the trial. A full analysis of the trial will take place after 151 infections occur.
What's next: If Moderna's trial proves to be a success, the company could follow a similar timeline as Pfizer and apply for an emergency authorization later this month or in early December.
Moderna said it expects to produce about 20 million doses of its vaccine through the end of the year, and from 500 million to 1 billion doses worldwide in 2021. The U.S. has purchased 100 million doses of the vaccine for about $1.5 billion.
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November 12, 2020 at 05:54AM
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Moderna close to revealing first data on whether its vaccine works - POLITICO
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