Tue 16 March 2021:
Moderna has begin enrolling children under the age of 12 in a new scientific trials aimed at gauging the safety and effectiveness of its vaccine in the younger-age population, the company said on Tuesday.
“The Company intends to enroll approximately 6,750 pediatric participants in the US and Canada ages 6 months to less than 12 years,” Moderna said in a press release.
The first participants in the trial have already been dosed in the Phase 2/3 study, called the KidCOVE study, of Moderna’s mRNA-1273 vaccine, Moderna said.
The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID and the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services, Moderna added.
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In Part 1 of the study, each participant ages two years to less than 12 years may receive one of two dose levels (50 μg [micrograms] or 100 μg).
Also in Part 1, each participant ages six months to less than 2 years may receive one of three dose levels (25 μg, 50 μg and 100 μg), Moderna said.
Few children under age 18 have died of COVID-19, less than 300. But the group accounted for more than 10 percent of positive tests for coronavirus infection, according to data from the Centers for Disease Control (CDC) and the American academy of Pediatrics.
Studies attempting to gauge how readily children spread the virus to adults have yielded conflicting results. In addition, some infected children develop a related disease known as Multisystem Inflammatory Syndrome which typically requires hospitalization, although most victims recover, researchers say.
Covid-19 vaccine competitor Pfizer announced last month that it had begun a trial of its Covid-19 vaccine in adolescents aged 12-15 (the vaccine is already approved for teens aged 16 and up), but the company hasn’t said anything yet about dosing younger children.
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