Moderna Inc. announced it’s begun dosing the first child participants of a mid-to-late stage study of its COVID-19 vaccine.
On Tuesday, the US pharmaceutical company said the KidCOVE study of its mRNA-1273 vaccine has begun the Phase 2/3 trial in children aged six months to less than 12 years.
The study will evaluate the safety and effectiveness of two doses of mRNA-1273 given 28 days apart. The company intends to enroll about 6,750 children in Canada and the US.
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“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the US and Canada, and we thank NIAID and BARDA for their collaboration,” said Moderna CEO Stéphane Bancel in a statement.
“It is humbling to know that 53 million doses have been administered to people in the US. 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.”
The Moderna vaccine was approved by Health Canada on December 23, and two million doses are set to be delivered to Canada by the end of March.
The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health and the Biomedical Advanced Research and Development Authority.
There are currently no COVID-19 vaccines for children and adolescents.
So far in Canada, 2,722,849 people have received at least one dose of the vaccine, with 606,662 fully vaccinated.