Biotech company Moderna said it will apply with federal regulators Monday for an emergency use permit for its COVID-19 vaccine.
Moderna will become the second company to request authorization from the U.S. Food and Drug Administration after Pfizer applied for its vaccine earlier this month.
In announcing its application, Moderna said Monday that further testing during its Phase 3 study, known as the COVE study, has shown that the vaccine is 94.1% effective and it is also safe.
Moderna enrolled more than 30,000 participants in the U.S. to test the vaccine. The study was conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
The vaccine combines Moderna’s messenger RNA delivery platform with the stabilized SARS-CoV-2 spike immunogen developed by NIAID scientists at NIH.
“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," Stéphane Bancel, chief executive officer of Moderna, said in a statement. "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.”
Moderna says it expects to ship roughly 20 million doses of the vaccine around the U.S. by the end of the year. Next year, it expects to distribute roughly 500 million to 1 billion doses worldwide.
Pfizer's COVID-19 vaccine, which is still awaiting FDA approval, started shipping to the U.S. from Belgium on Friday. Pfizer expects it will receive an emergency use permit by mid-December.
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