by Bethany Blankley
Biotech company Moderna announced Monday that its new COVID-19 vaccine has proven to be 94.5 % effective.
The company said it intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than two months.
Known as the COVE study, 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.
Moderna details the criteria used for the analysis of cases evaluated in its statement, including which number of volunteers received the vaccine or a placebo and how many days apart.
The vaccine combines Moderna’s messenger RNA delivery platform with the stabilized SARS-CoV-2 spike immunogen developed by NIAID scientists at NIH.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Stéphane Bancel, CEO of Moderna, said. “Since early January, we have chased this virus with the intent to protect as many people around the world as possible. 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.”
The NIH announced that an independent data and safety monitoring board oversaw the Phase 3 trial of the COVID-19 vaccine mRNA-1273 and found that “the vaccine is safe and effective at preventing symptomatic COVID-19 in adults.”
In its interim analysis of 95 cases of symptomatic COVID-19 volunteers, it found that after they received the vaccine, they tolerated it well. NIH reported “a vaccine efficacy rate of 94.5 percent,” which it says is “statistically significant, meaning they are likely not due to chance.”
Moderna says it expects to ship roughly 20 million doses of the vaccine to the U.S. by the end of the year. Next year, it expects to distribute roughly 500 million to 1 billion doses worldwide.
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