An illustration of the new coronavirus that causes the disease COVID-19. Image courtesy of the Centers for Disease Control.

Cambridge-based Moderna plans on Monday to request emergency use authorization of its COVID-19 vaccine from the U.S. Food and Drug Administration and the European Medicines Agency.

The company reported new vaccine safety and efficacy data and said the continuous review of its Phase 3 study of mRNA-1273 safety data “is ongoing and no new serious safety concerns have been identified by the Company.”

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 percent 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,” said Moderna CEO Stéphane Bancel.

A meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, Dec. 17, Moderna said. It expects that the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) will make a recommendation on immunization priorities, and anticipates the shipping of mRNA-1273 to designated distribution points throughout the U.S. shortly after an emergency use authorization is granted.

Moderna Asking FDA For Emergency Vaccine OK

by State House News Service time to read: 1 min
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