Moderna to file EUA for COVID-19 vaccine candidate, which showed 94.1% efficacy

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Moderna Inc. said Monday that it will file for emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine candidate, mRNA-1273. The biotechnology company also said that the primary analysis of its Phase 3 study of mRNA-1273, conducted on 196 cases, demonstrated an efficacy of 94.1%, which compares with the first interim analysis with a total of 95 cases which demonstrated efficacy of 94.5%. Shares of Moderna shot up 11.4% in premarket trading. The company said a continuous review of safety data is ongoing, with no new serious safety concerns identified. “This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Moderna Chief Executive Stephane Bancel. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death.” The stock has rocketed 549.4% year to date through Friday, while the S&P 500 has advanced 12.6%.
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