On Monday, the pharmaceutical company Moderna plans to ask the FDA to review new data from its experimental coronavirus vaccine clinical trials.
The new data suggests that the vaccine is 100 percent effective at preventing severe cases of COVID-19 and 94.1 percent effective at preventing the disease in general — results so promising that Moderna Chief Medical Officer Dr. Tal Zaks told CNN he was brought to tears.
“It was the first time I allowed myself to cry,” Zaks said. “We have a full expectation to change the course of this pandemic.”
Moderna is sending the data over to the FDA in order to request emergency use authorization (EUA), or a fast-tracked regulatory approval that circumvents much of the usual, lengthy process. Pfizer already submitted for an EUA earlier this month, CNN reports, and the FDA will review the applications for both experimental vaccines in December.
That means — if one or both of the vaccines is granted an EUA — that vaccinations against COVID-19 could theoretically begin in the U.S. before the end of the year.
As far as the data goes, Moderna injected about 30,000 volunteers — 15,000 with the vaccine and 15,000 with a placebo. There were 185 confirmed COVID cases within the placebo group, 30 of which were considered severe cases and one of which was fatal. However, there were only 11 cases among those who got the vaccine, and none of them were severe.
“The magnitude of this achievement and the implications of what it means to what’s ahead of us in the context of what’s going on around us,” Zaks told CNN, “it’s just overwhelming emotionally.”
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