Moderna announced it would request authorization from the Food and Drug Administration to administer a smaller dose of its COVID-19 vaccine to children ages 6 months old to 6 years old.

Clinical trial data showed that children under 6 mounted a robust neutralizing antibody response comparable to young adults when given a dose a quarter as strong, the company said on Wednesday.

“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age," Moderna CEO Stephane Bancel said. "Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible.”

Moderna’s two-dose regimen was found to be safe and protected the study subjects from severe illness and hospitalization. But protection against infection from the omicron variant was low. For children ages 6 months old to 2 years old, the vaccine’s efficacy was 43.7%, while efficacy for children ages 2 to 6 was 37.5%. Moderna said, though, that the lower vaccine efficacy against the mutated omicron variant was consistent with that seen in fully vaccinated adults.


The company said it was already evaluating the need for a booster dose in this age group, as well as an omicron-specific booster. Moderna has also submitted an emergency use authorization application for its vaccines in children 6 to 11 years old.

The study enrolled 6,700 young children to determine the proper dosage of vaccine for that age group, which is the only one remaining that does not have a vaccine available. The Pfizer-BioNTech vaccine has been authorized for children as young as 5, but not younger. The U.S. would be the first country to authorize the shots in children under 5.

Pfizer-BioNTech has requested that the FDA authorize its mRNA vaccine for young children, though the application process was delayed last month when the companies said they would wait for clinical trial results of a third dose.


The news will be a relief for many parents of young children, who were hospitalized due to omicron at five times the rate as last year’s delta variant, according to a recent report from the Centers for Disease Control and Prevention. Yet enthusiasm for the vaccines among parents of children as young as 5 appears low nearly five months after they were granted authorization. Less than 30% of children ages 5 to 11 have completed the two-dose vaccination regimen, according to federal tracking. Young children are far less vulnerable to severe illness and death than older adults and those with underlying health conditions.