Kickstarting the approval process with regulators across many countries, Moderna, Inc. has become the second company, after Pfizer, to ask the Food and Drug Administration for emergency use authorization (EUA) for a COVID-19 vaccine in the U.S., according to an official press release.
The breaking news comes following the new trial data showing the vaccine to be 94% effective at preventing the disease and 100% effective at preventing severe COVID-19 cases.
The findings are consistent with earlier data from the Phase 3 clinical trial and across different demographics, including age, gender, and ethnicity, according to the company.
The Phase 3 clinical trial's new findings, which had over 30,000 participants, showed the Moderna's vaccine to be 100% effective at preventing severe COVID-19 cases, Forbes reported.
The press release stated that no serious safety concerns were reported. The only side effects were injection site pain, headaches, and fatigue.
FDA will meet to consider the vaccine on Dec. 17
Moderna has submitted the data to the regulators in the U.S., Europe, and the U.K. to get an emergency permit. It expects the U.S. FDA to consider it at its meeting on December 17, Moderna said in a press release.
The FDA could make its official authorization decision following the meeting.
CEO Stéphane Bancel emphasized the vaccine’s high success rate when talking about the results, and stated, "We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death."