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(CNN) – Moderna, the first company to begin U.S. clinical trials of a COVID-19 vaccine, finished enrolling 30,000 participants on Thursday.
All 30,000 have received their first shot, and most of them have also received the required second shot.
The company president says he is now on his way to petition the US Food and Drug Administration for authorization to put the vaccine on the market in early December “if all the stars align.”
Moderna President Dr. Stephen Hoge said enrolling 30,000 participants is “just a milestone, not the mission.” Half of the participants received the vaccine and the other half received a placebo or a saline injection that does nothing. Participants receive a second injection four weeks later.
Moderna is one of four U.S. Phase 3 trials of coronavirus vaccines, each with tens of thousands of participants.
Moderna began its Phase 3 trial on July 27, and Pfizer began its trial that night. AstraZeneca began its trial in the United States on August 31 and stopped about a week later when one participant became ill. Johnson & Johnson began its trial on September 23 and stopped it less than three weeks later for the same reason. Both breaks are still in effect.
Pfizer has said it could request an emergency use authorization after the third week of November.
Hoge said three things need to happen before Moderna applies to the FDA for emergency use authorization.
Of the 30,000 participants, 53 need to get sick with COVID-19. 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 must be participants who received the placebo. That would show that the vaccine is 75% effective.
The third milestone is a requirement from the FDA to ensure that enough time has passed to see if participants develop side effects. The FDA’s rule is that at least eight weeks must pass after half of the participants have received their second injection before a company can apply for an emergency use authorization.
So far, 25,650 participants have received their second chance, and Hoge said Moderna hopes to reach this safety milestone in the second half of November.
On Thursday, Moderna also released the racial breakdown of study participants. Of the 30,000 participants, 20% are Latino and 10% are Black. Those are higher than the percentages the company was achieving at the beginning of 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.com, “US First Large-Scale COVID-19 Vaccine Trial Reaches Target Enrollment of 30,000 Participants”
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