COVID-19: Moderna to start vaccine trial for kids under 12, will enroll 6,750 participants

Pharmaceutical firm Moderna Inc. on Tuesday announced that it was starting a COVID-19 RNA (mRNA) vaccine trial for children under the age of 12 for its phase II/III ‘ KidCOVE' study. In an official release, the company informed that it will administer the first doses to the pediatric population aged between 6 months to less than 12 years to evaluate the safety, tolerability, reactogenicity, and effectiveness of two doses of its mRNA-1273 jab in kids when given 28 days apart.

“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,” Chief Executive Officer of Moderna, Stéphane Bancel said in the release. He added, “This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population.”

To enroll 6,750 children

The pharmaceutical company seeks to enroll an additional 6,750 children across both the US and Canada to test the efficacy and safety of the vaccine among the kid's population. In the first phase of the vaccinations, kids aged two years to less than 12 years will receive one of two doses level  (50 μg or 100 μg), Moderna said, adding that children aged six months to less than 2 years may receive only one of three dose levels (25 μg, 50 μg, and 100 μg) due to their reduced tolerability level. 

Scientists will conduct a medical analysis and publish an interim result to determine which doses need to be administered in the second phase of the pediatric trial. For the second part of the trial, children who are administered with saline placebo will receive the additional dose. After the second jab, the kids will be monitored for at least 12 months to note any side effects or adverse reactions to the vaccine. Moderna has collaborated with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) for the study. Apart from Moderna, Pfizer and johnson & Johnson jabs are also being tested on kids aged between 12 to 18 to determine the vaccine’s efficacy against COVID-19 in children.