Moderna Inc has begun testing its Covid-19 vaccine on children and infants between the ages of six months and 12-year-old in a study, as the pharmaceutical company seeks to expand approval for its vaccine to children, the company said on Tuesday. The phase 2-phase 3 trial is being conducted in conjunction with the National Institute of Allergy and Infectious Diseases.
The vaccine has already been authorized for emergency use in Americans who are aged 18 and older. For adults, Moderna’s vaccine was found to be safe and 94.1% effective at preventing Covid-19, and it appears to work well across demographic groups and in people with underlying medical conditions.
The study will assess the safety and effectiveness of two doses of mRNA-1273 given 28 days apart and intends to enroll about 6,750 children in the United States and Canada.
Each child in Moderna’s study will receive two shots, 28 days apart. The study will have two parts. In the first, children aged 2 years to less than 12 may receive two doses of 50 or 100 micrograms each. Those under 2 years may receive two shots of 25, 50 or 100 micrograms.
In each group, the first children inoculated will receive the lowest doses and will be monitored for reactions before participants are given higher doses in the later stage. 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.
Moderna is doing the tests to see if the vaccine protects children from getting sick if they come into contact with coronavirus, according to the clinical trial’s patient information website.
Moderna is not the only Covid-19 vaccine currently being tested in children, as the Pfizer/BioNTech Covid-19 vaccine is being studied in children as well. Johnson & Johnson has announced plans to study the vaccine in adolescents, ages 12 to 18.
