The first large-scale US COVID-19 vaccine trial reached a target enrollment of 30,000 participants

Related video above: Coronavirus vaccine timeline impacts everyday life, officials said Moderna, the first company to begin US clinical trials of the COVID-19 vaccine, on Thursday for all 30,000 participants They say they have finished registering. All 30,000 people received the first shot and they also received the required second shot. The company’s president said he plans to apply to the Food and Drug Administration for permission to bring the vaccine to market in early December “when all the stars are together.” Stephen Hoge, president of Moderna, said registering 30,000 participants was “just a milestone, not a mission.” Half of the participants received the vaccine and half received a placebo or a shot of saline that did nothing. Participants will receive a second shot after 4 weeks. Moderna is one of four US Phase 3 trials of the coronavirus vaccine, each with tens of thousands of participants. Moderna began Phase 3 trials on July 27, and Pfizer began trials that night. AstraZeneca began testing in the United States on August 31, and paused about a week later when participants became ill. Johnson & Johnson began the trial on September 23 and suspended the trial within three weeks for the same reason. Pfizer states that it can apply for an emergency license after the third week of November. Hooge said three things were needed before Modana could apply for an emergency license from the FDA. 53 out of 30,000 participants need to get sick with COVID-19. The company expects to occur in the second half of November. The second milestone is that at least 40 of the 53 participants who became ill with COVID-19 must have received a placebo. there is. This shows that the vaccine is 75% effective. The third milestone is the FDA to make sure that enough time has passed to see if participants develop side effects. It is a requirement by. FDA rules require that at least eight weeks have passed since half of the participants received the second shot before the company applied for an emergency license. Milestone in late November. On Thursday, Moderna also released a racial breakdown of study participants. Of the 30,000 participants, 20% are Latin and 10% are black. These are higher than the percentage the company achieved early in the trial, but still lower than the percentage requested by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

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