Moderna said Monday that a final data analysis indicated that their COVID-19 vaccine is 94.1% effective in preventing COVID-19 among trial participants, and 100% effective against severe COVID-19.
With the new analysis Moderna said it will file today with the Food and Drug Administration for Emergency Use Authorization for its vaccine.
The Phase 3 study of the vaccine, mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis, Moderna said.
Known as the COVE study, the Phase 3 study enrolled more than 30,000 participants in the United States and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services.
Moderna noted that efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).
“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. 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 Stéphane Bancel, Moderna CEO.
Moderna's news follows on the heels of Pfizer and BioNTech's final data analysis, which indicated that their coronavirus vaccine is 95% effective in preventing COVID-19 among trial participants.
Moderna said that the FDA’s Vaccines and Related Biological Products Advisory Committee meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Dec. 17.
Moderna is working with the CDC, Operation Warp Speed and McKesson, a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations and approvals. By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 available in the United States.
The company also said it remains on track to manufacture 500 million to 1 billion doses globally in 2021.