Moderna started clinical trials of its two-dose vaccine in children from six months to 11 years old in the United States and Canada, the company announced Tuesday.
“This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” Moderna CEO Stephane Bancel said.
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The clinical trial will enroll 6,750 children in the U.S. and Canada between the ages of six months and 11 years old. Each child will be given both doses 28 days apart, the same vaccine schedule for adults.
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In part one of the study, infants from six months to younger than two years will be given either a 25, 50, or 100 microgram-level dose. Children between the ages of two and 11 will receive two doses of the vaccine spaced about 28 days apart at either a 50 or 100 microgram level. The dosages will increase once researchers determine the low doses are safe.
Children who receive the first doses will be monitored for adverse reactions before they are given second doses. In part two of the study, some children will receive a placebo shot of saline, which does not do anything.
The “KidCOVE” study will be conducted in cooperation with the National Institutes of Health, the federal government’s largest medical research agency. Moderna has already launched clinical trials in children 12 to 17, but the company did not specify when the studies will be complete.
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Pfizer has also launched trials to determine vaccine safety in children. Johnson & Johnson, meanwhile, expects to have a vaccine safe enough for children under 18 by September, according to CEO Alex Gorsky.
