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.