One of the first large studies of safety and effectiveness of a coronavirus vaccine in the United States began on Monday, according to the National Institutes of Health and the biotech company Moderna, which collaborated to develop the vaccine.
The first shot was given to a person at 6:45 a.m., Dr. Anthony S. Fauci, the nation’s leading infections disease expert, told reporters.
The study, a Phase 3 clinical trial, will enroll 30,000 healthy people at about 89 sites around the country. Half will receive two shots of the vaccine, 28 days apart, and half will receive two shots of a saltwater placebo. Neither the volunteers nor the medical staff giving the injections will know who is getting the real vaccine.
Dr. Fauci estimated that the trial’s full enrollment of 30,000 will be completed by the end of the summer, and that results might be available by November. Even earlier results might be possible, he said, but added that he doubted that would be the case.
At the news briefing, Dr. Francis Collins, the director of the National Institutes of Health, said that at least three other Phase 3 trials would be starting soon, each needing 30,000 patients. Those trials will involve vaccines made by Novavax, by a collaboration of the University of Oxford and AstraZeneca, and by Johnson & Johnson. All are part of the U.S. government’s Operation Warp Speed.
A fourth vaccine, made by Pfizer and BioNTech, is also expected to start Phase 3 this month, but is not part of that program, Dr. Collins said.
Once volunteers are vaccinated, researchers will be looking for side effects and waiting to see if the vaccine significantly lowers cases of Covid-19. The study will also try to find out if it can prevent severe Covid-19 cases and death; if it can prevent infection entirely, based on lab tests; and if just one shot can prevent the illness.