First large-scale US COVID-19 vaccine trial reaches target enrollment of 30,000 participants

10/22/2020 10:46:00 PM
First large-scale US COVID-19 vaccine trial reaches target enrollment of 30,000 participants

Moderna, the first company to start US clinical trials of a COVID-19 vaccine, finished enrolling all 30,000 of its participants

Moderna, the first company to start US clinical trials of a COVID-19 vaccine, finished enrolling all 30,000 of its participants.

Moderna, the first company to start US clinical trials of a COVID-19 vaccine, finished enrolling all 30,000 of its participants

(CNN) --Moderna, the first company to start US clinical trials of a COVID-19 vaccine, on Thursday finished enrolling all 30,000 of its participants.All 30,000 have received their first shot, and most of them have also received the required second shot.

The company's president says it's now on track to apply to the US Food and Drug Administration for authorization to put the vaccine on the market in early December"if all the stars align."Dr. Stephen Hoge, Moderna's president, said enrolling 30,000 participants is"just a milestone -- it's not the mission." Half of the participants received the vaccine and half received a placebo, or a shot of saline that does nothing. The participants receive a second shot four weeks later.

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endIndex: (CNN) -- Moderna, the first company to start US clinical trials of a COVID-19 vaccine, on Thursday finished enrolling all 30,000 of its participants.COVID fatigue " and said more restrictions could be on the way if residents don't help bring COVID-19 numbers down.NEW YORK -- Spectators will not be allowed for the 75th US Women's Open in December at Houston, Texas, due to Covid-19 safety concerns, the US Golf Association announced Wednesday.endIndex: Metro Manila (CNN Philippines, October 22) — The clinical trial in the Philippines for anti-viral drug Avigan has hit another snag after the Department of Health revealed that hospitals are having trouble recruiting volunteer patients.

All 30,000 have received their first shot, and most of them have also received the required second shot. The company's president says it's now on track to apply to the US Food and Drug Administration for authorization to put the vaccine on the market in early December"if all the stars align. And as holidays approach , experts worry gatherings will only help drive an already rampant spread." Dr. "While we're disappointed that we won't be able to welcome fans and their unmatched energy at Champions Golf Club, we know this is the right decision for the community and players. Stephen Hoge, Moderna's president, said enrolling 30,000 participants is"just a milestone -- it's not the mission. "If you really want to get together indoors, everybody should quarantine themselves for 14 days, and then get tested which would substantially reduce the risk," emergency physician Dr." Half of the participants received the vaccine and half received a placebo, or a shot of saline that does nothing. There are also other clinical trials conducted in the country so the recruitment of patients is becoming a challenge.

The participants receive a second shot four weeks later. CDC guidelines for safer holidays States take additional measures Illinois Gov. Reduced daylight forced organizers to use both the Jackrabbit and Cypress Creek courses to stage all four rounds of the LPGA major event, which will be staged without traditional qualifying. Moderna is one of four US Phase 3 trials of coronavirus vaccines, each involving tens of thousands of participants. Moderna started its Phase 3 trial July 27, and Pfizer started its trial that evening.B. AstraZeneca started its US trial August 31 and paused it about a week later when a participant fell ill. Johnson & Johnson started its trial September 23 and paused it less than three weeks later for the same reason. The new measures will include no indoor service for bars and restaurants and a closing time of 11 p. The nine-month trial was supposed to start on August 17, but it was postponed several times due to funding and documentary requirements.

Both of those pauses are still in effect. Pfizer has said it could apply for emergency use authorization after the third week in November. for outdoor services. Hoge said three things needs to happen before Moderna applies to the FDA for emergency use authorization. Of the 30,000 participants, 53 need to become sick with COVID-19. "As colder weather approaches and flu season is upon us, we're going to see the rippling effects of these current unfortunate trends," Prtizker said in a news release . The company expects that to happen in the second half of November.

The second milestone is that of the 53 participants who become ill with COVID-19, at least 40 of them need to be participants who received the placebo. There is no easy fix for the effects of this virus on our economy and our public health. That would show the vaccine is 75% effective. The third milestone is a requirement by the FDA to ensure that enough time has passed to see if participants develop side effects. In past weeks, neighboring Wisconsin reported record-high case counts, hospitalizations and daily death toll and Gov. The FDA rule is that at least eight weeks must pass after half the participants have received their second shot before a company can apply for emergency use authorization. So far, 25,650 participants have received their second shot, and Hoge said Moderna expects to hit this safety milestone in the second half of November.

Thursday, Moderna also released the racial breakdown of its study participants. Of the 30,000 participants, 20% are Latino and 10% are Black. Those are higher than the percentages the company was achieving early in its trial, but still lower than the percentages sought by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. This story was first published on CNN.

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