Moderna says COVID-19 vaccine works for children under 6 years old

Moderna announced Wednesday its COVID-19 vaccine works in children from 6 months old to under 6 years old. 

The biotech company said that it would ask the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators to authorize two small-dose shots for the kids. 

Moderna is also seeking to have larger-dose shots approved for older children and teenagers in the U.S. 

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According to the company, interim study data was "positive" for children 6 months old to under 2 years old and in those 2 years old to under 6 years old. 

It said the analysis showed a "robust neutralizing antibody response in both age groups" following a 25 microgram two-dose primary series of its vaccine, along with a "favorable safety profile."

The pharmaceutical giant enrolled around 6,900 children in a study of the 25-microgram doses. 

In both of the examined age groups, the majority of adverse events were "mild or moderate" and the "tolerability profile was generally consistent with that observed in children age 6 to under 12, in adolescents age 12 to 17 and in adults."

In addition, two of the 25-microgram doses "provided similar immunogenicity to the [100-microgram] two-dose primary series in adults ages 18 to 25 years."

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While COVID-19 vaccines don't prevent infection with the omicron variant as well as earlier variants, they do still offer strong protection against severe illness.

Moderna reported that same trend in the trial of children under 6, conducted during the omicron surge. While there were no severe illnesses, the vaccine proved 43.7% effective at preventing any infection in babies up to age 2, and 37.5% effective in preschoolers.

Similar to adults, it wrote that it is preparing to evaluate the potential of a booster dose for all pediatric populations and adolescents and is evaluating booster doses of its vaccine and bivalent booster candidate.

"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," Moderna CEO Stéphane Bancel 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. Additionally, after consultation with the U.S. FDA we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data," he added.

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America's 18 million children under 5 are the only age group not yet eligible for vaccination.

While other countries already have allowed Moderna’s shots to be used in children as young as 6, the U.S. has limited its vaccine to adults. A Moderna request to expand its shots to 12- to 17-year-olds has been stalled for months.

Pfizer and BioNTech currently offer kid-sized vaccine doses for school-age children and full-strength shots for those 12 and older.

The Associated Press contributed to this report.