American Moderna is urgently applying for emergency registration of a vaccine against COVID-19 after the final data of clinical trials confirmed the high efficiency of the drug (more than 94%) and its safety. The request will be received by the US Food and Drug Administration (FDA).
In Phase 3 clinical trials, Moderna has confirmed 196 cases of coronavirus among 30,000 volunteers. In the placebo group, 185 people became ill with coronavirus compared to 11 in the control group. Thus, the effectiveness of the vaccine was 94.1%.
The researchers stated that the vaccine protects against a severe course of coronavirus infection. Among the 30 participants in the trial who had severe illness, not a single volunteer received the vaccine. One coronavirus death was also reported in the placebo group.
The effectiveness of the vaccine has been proven regardless of age, race and gender, follows from the message. In addition, the absence of serious side effects in all groups was confirmed - they come down to fatigue, muscle and headaches.
The FDA is expected to review Moderna's request within a few weeks. The agency may schedule an advisory committee meeting on 17 December. The company has already requested approval for the use of the vaccine from regulators around the world, including the European Medicines Agency (EMA).
On the news, Moderna was up 12% in premarket trading.
On November 20, an application for the use of a coronavirus vaccine in the United States was submitted by the American Pfizer and the German BioNTech. In early November, they reported that the vaccine they were developing was more than 90% effective, and then raised the estimate to 95%.
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