Moderna announced today [Nov 16] that early analysis indicates their Covid-19 vaccine is 94.5% effective, making it the second large company to announce a possible vaccine, as pharmaceutical giant Pfizer already announced that early analysis showed its vaccine candidate was more than 90% effective.
“These are obviously very exciting results,” said Dr. Anthony Fauci, the United States top infectious disease doctor. “It’s just as good as it gets — 94.5% is truly outstanding.”
A statement from the company said that the “independent, NIH-appointed Data Safety Monitoring Board [DSMB] for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
“This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and 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.
“The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% [p <0.0001].
“A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases [as defined in the study protocol] in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.
“The 95 COVID-19 cases included 15 older adults [ages 65+] and 20 participants identifying as being from diverse communities [including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial].
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. 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 Stéphane Bancel, Chief Executive Officer of Moderna.
The company added, “Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization [EUA] with the U.S. Food and Drug Administration [FDA] in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data [with a median duration of at least 2 months]. Moderna also plans to submit applications for authorizations to global regulatory agencies.”
