Moderna begins testing vaccine on young children, infants

Moderna has begun testing its COVID-19 vaccine on children and infants between the ages of six months and 12 years old in a study, as the pharmaceutical company seeks to expand approval for its vaccine to children. 

Moderna announced on Tuesday that the first participants in the KidCOVE study on pediatric COVID-19 vaccinations had been dosed. Moderna is the first of the companies with vaccines authorized in the U.S. to launch testing among infants. 

The research expects to enroll 6,750 children older than six months and younger than 12 years old in the U.S. and Canada. The National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority will assist in the study.

The study will consist of two parts, with the first aiming to determine the correct dosage for efficacy for those between six months and 2 years old and, separately, for children between 2 years old and 12 years old.

“Children often need lower doses of vaccines than adults and we want to make sure we find the best dose that increases their immunity,” Jacqueline Miller, Moderna’s therapeutic head for infectious diseases, told ABC’s “Good Morning America.”  

The second part of the study will look into the “safety, tolerability, reactogenicity and effectiveness” of vaccine doses given 28 days apart, using interim analysis from the first part to decide on the dosage. The participants will be monitored through 12 months after their second vaccination.

The Moderna vaccine was the second to receive an emergency use authorization from the Food and Drug Administration in December for those at least 18 years and older, following the Pfizer-BioNTech vaccine that was approved for those 16 years and older. 

Both Moderna and Pfizer have already started trials for children 12 and older in the hopes of making vaccines available to the age group this year. 

President Biden told reporters last month that high school students could get the vaccine in the fall, while elementary-aged students will likely have to wait until next year. 

Children are less likely to experience severe illness or death from the coronavirus, with less than 0.2 percent of the total U.S. deaths attributed to those younger than 17, according to government data. 

But children can spread the virus to adults who may be more vulnerable to COVID-19.