Moderna Inc has announced that the trial of its Covid-19 vaccine has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5 per cent.
Plainly speaking, Moderna's vaccine proved 94.5 per cent effective in preventing Covid-19 with symptoms. Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.
Moderna said that a study conducted by an independent, National Institutes of Health-appointed Data Safety Monitoring Board had confirmed the results of the Phase 3 study of mRNA-1273 vaccine. The study, known as the COVE study, enrolled more than 30,000 participants in the U.S.
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 percent.
Stéphane Bancel, Chief Executive Officer of Moderna, said: "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."
Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization with the U.S Food and Drug Administration 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.
By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021.
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