United States pharmaceutical company Moderna on Monday said that it will seek emergency approval for its COVID-19 vaccine in the US and Europe.
The company cited new trial data to assert that its vaccine had been found 94% effective against COVID-19 and 100% effective at preventing severe cases of the viral disease.
Here are more details.
Out of 196 COVID-19 cases, 185 among placebo group
Moderna said primary efficacy analysis from the randomized, 1:1 placebo-controlled Phase III clinical trial showed that the vaccine continues to be well-tolerated and has no serious safety concerns to date.
The trial involved 30,000 participants, among whom, 196 cases of COVID-19 were observed. Thirty of these infections were severe.
Also, 185 of 196 infections were in the placebo group, including all 30 severe cases.
Moderna to seek emergency approval in US
Moderna said it will seek emergency approval on Monday from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for the vaccine will likely be scheduled for December 17, Moderna said.
Our vaccine may change course of pandemic: Moderna CEO
Moderna CEO Stéphane Bancel said, “This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease.”
“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,” Bancel added.