Drugmaker Moderna announced on Tuesday it has kicked off a mid-to-late stage COVID-19 vaccine trial for children under the age of 12.
The company said in a press release that the first participants in its Phase 2/3 study, called the KidCOVE study, have been given their first dose. The goal is to test if the vaccine candidate would protect children ages 6 months to less than 12 years from getting sick with COVID-19.
The study is a collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
“We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” said Stéphane Bancel, Chief Executive Officer of Moderna, in a statement.
Moderna said the study will be broken up into two parts, one phase is an open-label, dose-escalation, age de-escalation. The other is a randomized, placebo-controlled expansion study.
Both phases of the study will "evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart" in about 6,750 child participants from the U.S. and Canada.
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