Moderna reaches target goal of 30,000 vaccine trial participants, could apply for market in December
The company’s vaccine is one of four in the phase 3 stage or trial.
A Moderna COVID-19 vaccine clinical trial in the U.S. is underway and has reached the 30,000 participant target. The vaccine is one of four U.S vaccines in the phase 3 stage of trial.
The company says it's on track to apply for authorization from the Food and Drug Administration in early December if all requirements are met.
Of the 30,000 participants enrolled in the trial, half of them received the trial vaccine, while the other half received a placebo vaccine of a saline solution that does nothing. The participants receive a second dose four weeks after the first shot.
Moderna President Stephen Hoge says the enrollment of 30,000 participants is "just a milestone – it's not the mission."
Hoge says three things need to happen in the next few weeks to apply for emergency authorization. First, of the 30,000 participants, 53 must come down with the virus, which is expected to happen in late November. Next, of the 53 sick participants, 40 must be patients who received the placebo instead of the real vaccine, which would show a 75% effective rate.
The last step would be to make sure eight weeks have passed to see whether participants develop side effects, a requirement by the FDA.
Johnson and Johnson and AstraZeneca vaccine trials remain paused after participants became sick.
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