Moderna to seek emergency use authorization for vaccine
Photo | Courtesy of Moderna
A biopharma worker
For the second consecutive Monday, people are waking up to promising news about COVID-19 vaccines.
An independent safety board appointed by the National Institutes for Health has notified Cambridge-based Moderna that its vaccine candidate achieved an efficacy rating of 94.5 percent.
"Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups," the company reported, while cautioning that the data are subject to change based on ongoing analysis.
"This is a pivotal moment in the development of our COVID-19 vaccine candidate," Moderna CEO Stéphane Bancel said in a statement. "Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease."
Last Monday, Pfizer and its partner BioNTech announced that its vaccine candidate was more than 90 percent effective in preventing COVID-19, with no serious safety concerns observed. The companies said they planned to submit an emergency use authorization to the U.S. Food and Drug Administration this month.
Moderna intends to request an emergency use authorization with the FDA in the coming weeks, the company announced, and also plans to submit applications for authorizations to global regulatory agencies.
The promising news is fueling projections that a vaccine may reach the general population during the first half of 2021.
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