The study enrolled 4,753 participants ages 6-11. Children were given two 50 microgram doses of Moderna’s vaccine, administered 28 days apart. The dosage is half that of the drugmaker’s vaccine for adults.
Moderna said the vaccine was generally well tolerated, with most adverse events being mild or moderate. The most common side effects were fatigue, headache, fever and injection site pain.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Moderna CEO Stéphane Bancel said in a news release. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
The drugmaker will submit the trial data to the FDA and other regulatory agencies “soon,” according to the release.
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