Moderna Begins First U.S. Late-Stage Vaccine Trial
The study aims to enroll 30,000 people this summer and determine whether the vaccine is safe and effective, possibly by November.
The first major study on the safety and efficacy of a coronavirus vaccine in the U.S. began Monday morning, according to the National Institutes of Health and biotech company Moderna, which have worked together to develop the vaccine.
A volunteer in Savannah, Georgia, received the first shot at 6:45 a.m., Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said at a news conference.
The study, a Phase 3 clinical trial, will involve 30,000 healthy people at about 89 locations across the country this summer. Half receive two vaccinations every 28 days and half two vaccinations with a saltwater placebo. Neither the volunteers nor the medical staff who administered the injections will know who will receive the real vaccine.
The researchers will then monitor the subjects and look for side effects. Their main goal will be to find out whether significantly fewer vaccinated people get Covid-19 to see if the vaccine can prevent the disease. The study will also try to find out whether the vaccine can prevent severe cases of covid and death; if it can completely block the infection, based on laboratory tests; and if only one shot can prevent the disease.
Dr Fauci estimated that the full registration of 30,000 people will be completed by the end of the summer and that the results may be available by November. Findings could emerge even earlier, he said, but added that he doubted it. He said the high transmission rates in some parts of the country, though unhappy, would help speed up the process of determining whether the vaccine works.
In total, 150 to 160 coronavirus infections in the study will be enough to determine whether the vaccine is acceptable – that is, if it protects 60 percent of those who receive it, Dr. Fauci said.
Dr. Francis Collins, the director of the National Institutes of Health, said the U.S. government had reached out to the groups most affected by Covid – the elderly, people with chronic diseases, blacks, Latinos and Native Americans – to participate in the study. He said the pandemic had made the health differences a “sharp relief” and that additional efforts were needed to gain people’s trust in those groups that might not be willing to sign up for a medical experiment.