Moderna Inc is getting closer to making its COVID-19 vaccine candidate available for distribution, as the biotech company announced on Monday it plans to apply for an emergency permit – “today” from the US. Food and Drug Administration

The announcement comes when Moderna revealed that a primary analysis of the Phase 3 study of mRNA-1273 revealed a 94% efficacy rate, which is consistent with the “high efficacy” of 945% reported two weeks ago from the first Interim analysis known

â ???? This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 941% effectiveness and most importantly its ability to prevent severe COVID-19 disease, ???? Moderna Managing Director Stephane Bancel said We believe our vaccine will provide a new and powerful tool that can transform the course of this pandemic and help prevent serious illness, hospitalization and death ”

shares of Moderna
Up 131% Towards Record Area In Premarket Trading The stock closed Friday at a record $ 12703 after rising 289% over two days. It was up 883% this month through Friday, during the S&P 500 index
won 113%

Moderna said mRNA-1273 continues to be generally well tolerated with no new serious safety concerns identified.The most common side effects of mRNA-1273 were injection site pain, fatigue, headache, muscle pain, joint pain, and injection site redness. The side effects put on weight more often and more heavily after the second dose

The primary efficacy analysis announced on Monday was conducted on 196 cases compared to 95 cases in the first interim analysis. Of the 196 cases, 185 cases of COVID-19 were observed in the placebo group, versus 11 cases in the mRNA-1273 group / p>

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A secondary endpoint of the Phase 3 study included 30 severe cases of COVID-19, all of which occurred in the placebo group. The company said there was one COVID-19 death in the study

Moderna announced it would be filing an Emergency Marketing Authorization (EUA) with the FDA and a conditional marketing authorization application with the European Medicines Agency, the company said it was working with the US. Centers for Disease Control and Prevention, the Executive “Operation Warp Speed” and McKesson Corp.
Prepare for distribution of mRNA-1273 if EUA request is in order Approximately 20 million doses are expected to be available in the U.S. By the end of the year, global production of 500 to 1 billion cans in 2021 is expected to stay on track

According to Moderna, the COVE phase 3 study of mRNA-1273 has more than 30000 participants included and is conducted in collaboration with the National Institute for Allergies and Infectious Diseases, part of the National Institutes of Health, and Biomedical Advanced Research and Development Agency, or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the US. Ministry of Health and Human Services

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Tomi Kilgore is MarketWatch’s assistant editor for investments and corporate news and is based in New York. You can follow him on Twitter @TomiKilgore

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World News – US – Moderna stock is rising amid plan to apply for emergency approval for COVID-19 vaccine candidate