First U.S Vaccine Trial Enrols 30,000 Participants


Moderna, the first company to start clinical trials of the Covid-19 vaccine in the United States, completed registration of all 30,000 participants on Thursday.

All 30,000 received their first shot, and most of them received the second required shot.
The company’s president, Dr. Stephen Hoge said the company would apply for permission with the US Food and Drug Administration to launch a vaccine in early December, when all things go well.

Half of the participants received the vaccine and the other half received a placebo or salt injection that produced nothing. Participants received a second injection four weeks later.
Moderna is one of four Phase 3 trials of the coronavirus vaccine in America, each involving tens of thousands of participants.

Moderna began the Phase 3 studies on July 27, and Pfizer began it’s trial the evening of the same day. AstraZeneca started its trial in the U.S on August 31 and took a break about a week later when a participant fell ill. Johnson & Johnson started its case on September 23 and suspended it for less than three weeks for the same reason. Both pauses are still in effect.

Hoge said three things had to happen before Moderna could apply for an emergency clearance with the FDA.

Of the 30,000 participants, 53 must contract Covid-19. The company expects this in the second half of November.

The second phase is from 53 participants who have Covid-19. At least 40 of these had to be participants who received the placebo. This will show that the vaccine is 75% effective.

The third stage is a requirement at the FDA to ensure that sufficient time has elapsed to determine whether participants develop side effects.

The FDA rule is that at least eight weeks must pass after half of the participants have their second injection before the company can apply for emergency clearance.
So far, 25,650 attendees have had their second shots, and Hoge said Moderna hopes to reach this important stage in the second half of November.

On Thursday, Moderna also released racial details of the study participants. Of the 30,000 participants, 20% were Latin and 10% were black. They are higher than the percentage the company achieved at the start of their study, but still lower than the percentage wanted by Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases.



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