Moderna said its experimental coronavirus vaccine was nearly 95 percent effective in a pivotal study. The NIH-appointed Data Safety Monitoring Board (DSMB) 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.
“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.
Massachusetts-based Moderna said it will ask the US Food and Drug Administration for emergency approval of the shot “in the coming weeks” after it collects more data on the vaccine’s efficacy and safety. Pfizer has similarly said it could seek an emergency use authorization by the end of the month.
Moderna released the results after an independent safety board examined data from 95 participants in the 30,000-person study who contracted COVID-19. Just five of those 95 patients had received both doses of the vaccine before catching the virus, while the other 90 had gotten a placebo, the company said.
Eleven of those sick participants developed severe cases of coronavirus, but none had received the vaccine, a sign that the shot is effective at preventing serious infections, according to the company.