Children may soon get the jab if things go according to plan. Moderna has started testing a COVID-19 vaccine candidate o
n kids in Canada and the US..
Till now, no COVID-19 vaccine has been administered to children. Also, it is not yet known what effects a vaccine may have on kids. But now things may change soon. US-based Biotechnology company Moderna on Tuesday announced that it is now testing a COVID-19 vaccine designed to be used on children aged between 6 months to less than 12 years old. To begin with, the company intends to enroll approximately 6,750 paediatric participants in the US and Canada. 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). In a statement, the Chief Executive Officer of Moderna, Stephane Bancel, said that the company is pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the US and Canada. In the statement, they also thanked NIAID and BARDA for their collaboration in this. Bancel further added, “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
Participants To Receive One Of Two Dose Levels In Phase 1
This Phase 2/3 two-part and randomised study will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart. In Part 1, each participant ages two years to less than 12 years may receive one of two dose levels (50 microgrammes or 100 microgrammes). Also, in Part 1 clinical Tips, each participant ages six months to less than 2 years may receive one of three dose levels (25 microgrammes, 50 microgrammes and 100 microgrammes).
This Phase 2/3 two-part and randomised study will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart. In Part 1, each participant ages two years to less than 12 years may receive one of two dose levels (50 microgrammes or 100 microgrammes). Also, in Part 1 clinical Tips, each participant ages six months to less than 2 years may receive one of three dose levels (25 microgrammes, 50 microgrammes and 100 microgrammes).
Dosage Yet To Be Decided For Phase 2 Trials
An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination, the company said. 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, it added.
An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination, the company said. 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, it added.
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