New Delhi: Biotechnology company Moderna is now testing a Covid-19 vaccine designed to be used on children aged between six months to less than 12 years old, the US-based firm announced on Tuesday.
“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,” IANS quoted Moderna Chief Executive Officer Stephane Bancel as saying in a statement.
Bancel’s remarks came as the trials are being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
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“We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this paediatric study will help us assess the potential safety and immunogenicity of our Covid-19 vaccine candidate in this important younger age population,” he added.
The Phase 2/3 two-part and randomised study will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 to be given 28 days apart.
Each participant aged two years to less than 12 years may receive one of two dose levels (50 microgrammes or 100 microgrammes) in Part 1. In addition, each participant aged six months to less than two years may receive one of three dose levels (25 microgrammes, 50 microgrammes and 100 microgrammes) in Part 1.
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An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study.
The company said the participants will be followed through 12 months after the second vaccination, adding vaccine effectiveness will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (aged 18-25) population.