The company will submit a request to the Food and Drug Administration “in the coming weeks” for authorization for a two-dose shot for younger kids.
A Moderna COVID-19 vaccine is prepared during a pop-up vaccine clinic at Cristo Rey Church in East Austin on July 24, 2021.
“Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,” Moderna CEO Stéphane BancelIn tests, the doses were given 28 days apart to 2,500 children ages 6 months to under 2 and to 4,200 children ages 2 to under 6.
Dr. Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University, said the study, while promising, leaves many questions unanswered, such as how long the children were observed after being vaccinated and whether efficacy rates could decline over time. 17% of children from 6 months to under 2 years old had fevers of 100.4 degrees, while 14.6% of children from 2 to under 6 had the same side effect. These results are “consistent with other commonly used and recommended pediatric vaccines,” the release said.
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