Moderna to seek authorization for COVID-19 vaccine for kids under six

Moderna on Wednesday said it will soon seek emergency use authorization for its two-dose COVID-19 vaccine in children under six years old, after preliminary data showed kids in that age group had a similar immune response to adolescents and young adults when given a smaller dose of the vaccine.

The company said it will be submitting data to the Food and Drug Administration “in the coming weeks.”

However, Moderna said the vaccine was only about 44 percent effective at preventing symptomatic infection in children 6 months to 2 years old, and 37 percent effective in children aged 2 through 5. 

Children in the trial received two shots of 25 micrograms each, a quarter of the size of an adult dose. 

The trial was conducted while omicron was the predominant variant in the country, a sign of the variant’s ability to evade some of the vaccine’s protection. 

In a statement, the company said the trial of 6,900 kids was designed to study safety and immune response, not effectiveness. No new side effects or safety issues were identified in the study, the company said, and no cases of heart inflammation, a rare side effect linked to mRNA vaccines in adults and teens, were seen. 

There were no severe infections, hospitalizations or deaths in any of the children in the trial, the company said, making it impossible to interpret the results against those outcomes.

But the company said the efficacy results were statistically significant, and lower efficacy against COVID-19 infection due to omicron was expected based on how the vaccine performs in adults. 

Children have largely been spared from the worst consequences of COVID-19, as their infections tend to be milder than those in adults. But even though it’s rare, the virus can still cause severe illness. During the most recent omicron wave, the hospitalization rates of infants and children ages 4 and under spiked to five times the rate of the previous peak during the delta variant wave, according to a Centers for Disease Control and Prevention study.

“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age. We now have clinical data on the performance of our vaccine from infants six months of age through older adults,” Stéphane Bancel, CEO of Moderna, said in a statement.

“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,” Bancel said.

Moderna also said Wednesday it will update its data and ask the FDA to clear larger doses for older children, ages 6 to 11. However, Pfizer’s vaccine is already authorized for that age group.

–Updated 9:11 a.m.