Moderna, Inc. (MRNA) said Monday that preliminary data from the Phase 3 study of its coronavirus vaccine candidate, mRNA-1273, has shown the vaccine to be more than 94 percent effective. Following the news, the company’s stock jumped more than 15 percent in pre-market to trade at $103.
The company said that it was informed by the NIH-appointed Data Safety Monitoring Board or DSMB for the Phase 3 study of mRNA-1273 that the trial met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5 percent.
The Phase 3 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 or NIAID, and the Biomedical Advanced Research and Development Authority or BARDA.
The first interim analysis evaluated 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group. This resulted in an estimated vaccine efficacy of 94.5 percent.
Based on these interim safety and efficacy data, Moderna said it plans to submit for an Emergency Use Authorization or EUA 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 two months.
Moderna also plans to submit applications for authorizations to global regulatory agencies.
By the end of 2020, Moderna expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The company said it remains on track to manufacture 500 million to 1 billion doses of the vaccine globally in 2021.
Last Monday, Pfizer Inc. (PFE) and German biotech firm BioNTech SE (BNTX) said that their mRNA-based coronavirus vaccine candidate, BNT162b2, was found to be more than 90 percent effective in preventing COVID-19 among patients without prior evidence of infection.
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