COVID-19 Vaccine for kids?
“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada and we thank NIAID and BARDA for their collaboration,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“It is humbling to know that 53 million doses have been administered to people in the U.S. 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 trial is broken into two phases. Phase one, different dosages of the vaccine are being tested on the children. Children between the ages of 6 months and 1 year old will receive two doses of the vaccine spaced about 28 days apart at either a 25 or a 50 or a 100 microgram level. Children between the ages of 2 and 11 will receive two doses of the vaccine spaced about 28 days apart at either a 50 or a 100 microgram level.
Based on results of phase one, it will determine which dose will be used in part two. For part two, the trial will expand to include children who are given a saline placebo, which does nothing. The children will be followed for 12 months after their second injection.
The Company intends to enroll approximately 6,750 pediatric participants in the U.S. and Canada ages 6 months to less than 12 years.
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