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Moderna plans to submit new vaccine applications in the US and EU

via:CnBeta     time:2020/12/1 0:05:33     readed:342

Moderna Inc. plans to apply for a new crown vaccine license in the United States and Europe on Monday. The company's vaccine is effective and safe in preventing new crown infections, according to a recent analysis.According to the company's statement, the main analysis of 196 subjects showed that the vaccine was 94.1% effective, consistent with the preliminary analysis released earlier this month. All 30 serious cases observed in the trial were subjects injected with placebo.

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The latest analysis makes Moderna Inc. vaccine one of the first batch of new coronal vaccines approved in the United States. Pfizer and biontech se filed applications for similar vaccines in the United States earlier this month, and will be subject to regulatory review and evaluation before the Moderna vaccine.

Moderna said it plans to apply for emergency use authorization in the United States on Monday and conditional marketing authorization in Europe. The company said consultants from the U.S. Food and drug administration may evaluate the data at a public meeting on December 17. A similar evaluation of Pfizer's vaccine is expected to take place a week earlier.

Stephane Bancel, chief executive of Moderna, said emergency authorization could be obtained as soon as 24-72 hours after the December 17 meeting. If authorized, the full inventory of Moderna will be sent to the federal government. Bancel said it expects to deliver 20 million doses of the vaccine in the United States by the end of this year.

Moderna has reached an agreement to provide 100 million doses of vaccine to the United States and 80 million doses to the European Union.

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