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In a significant first, Moderna Inc has dosed its first participants in a study called KidCOVE that uses its mRNA-1273 vaccine against Covid-19, in children between 6 months and less than 12 years.
“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the US and Canada,” said Stéphane Bancel, Moderna’s Chief Executive Officer. The biotech company intends to enrol approximately 6,750 paediatric participants in the two countries, in the specified age groups, a note from the company said.
The development comes even as Governments grapple with reopening schools without making it a super-spreader in itself and putting the children, their families and teachers at risk of getting the virus.
Moderna’s CEO said that about 53 million doses had been given to people in the US and they were encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above. The paediatric study will help assess the potential safety and immunogenicity of the vaccine candidate in the younger population, she added.
The study is being done in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the United States’ National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
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Trial details
The Phase 2/3 two-part, open label, dose-escalation, age de-escalation (Part 1) and randomised, observer-blind, placebo-controlled expansion study (Part 2) will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart, Moderna said.
In Part 1, each participant aged two years to less than 12 years may receive one of two dose levels (50 μg 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), the note explained.
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An interim analysis will be done to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study, it said, adding that participants would be followed through 12 months after the second vaccination.
Vaccine effectiveness will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (ages 18-25) population, Moderna said.
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