Moderna’s protocol release coincided with a call Thursday morning with investors to discuss the company’s coronavirus work, research on other vaccines and its plans to begin developing flu vaccines.
The company’s coronavirus vaccine, developed in collaboration with scientists from the National Institutes of Health, was the first to be tested in humans. The Phase 3 study now underway has enrolled more than 25,000 of its intended 30,000 volunteers, and Dr. Zaks said the enrollment should be complete in the next few weeks.
About 28 percent of the participants are Black, Latino or from other populations that have been particularly hard hit by the disease. A diverse enrollment has been considered essential to make sure that the findings apply to people from as many backgrounds as possible.
Half the participants receive the vaccine, and half a placebo shot consisting of salt water, with neither the volunteers nor the doctors treating them knowing who gets which. Two shots are needed, four weeks apart. Then the participants are monitored to see if they develop symptoms of Covid-19 and test positive for the virus.
Side effects of the vaccine are also tracked, with participants recording symptoms in electronic diaries, taking their own temperatures, making clinic visits and receiving periodic phone calls to assess their condition. In earlier studies the vaccine has caused transient reactions like a sore arm, fever, chills, muscle and joint pain, fatigue and headaches.
To determine the vaccine’s efficacy, Covid-19 cases are counted only if they occur two weeks after the second shot. Some patients are already two weeks beyond the second shot, but Dr. Zaks said he did not know if any trial participants had contracted the disease yet.
Source Article from https://www.nytimes.com/2020/09/17/health/covid-moderna-vaccine.html
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