Moderna Inc, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines became the second U.S drugmaker to release data from a large study of its experimental vaccine saying it has proven to be 94.5% effective in preventing the COVID-19 virus. One of the top 9 companies leading the COVID-19 vaccine race, Moderna is closer to the much-needed breakthrough to end this global pandemic.
According to the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
Moderna released early results from a clinical trial that had more than 30,000 participants, after US pharmaceutical company Pfizer and its German partner BioNTech last week said their vaccine was more than 90 percent effective.
The study, also known as the COVE study, is being 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.
“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,” said Moderna CEO Stephane Bancel.
Moderna expects to have enough safety and efficacy data, to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks. It also plans to submit applications for authorizations to global regulatory agencies.
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