Moderna seeks COVID-19 vaccine authorization for kids younger than 6 years

Moderna said Wednesday that it will submit a request to the FDA “in the coming weeks” seeking authorization of its COVID-19 vaccine for children aged younger than 6 years.

The company announced findings from a phase 2/3 trial that indicated that a smaller dose of its messenger RNA vaccine induced an antibody response in young children that was similar to the one seen in adults who received a larger dose.

Vaccine efficacy during the trial — which took place during the omicron wave — was reduced but also consistent with adult data, Moderna said.

The study, called KidCOVE, was conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.

Moderna CEO Stéphane Bancel, MSc, MBA, said in a statement that the results 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 6 months of age through older adults," Bancel said.

KidCOVE’s study population was divided into three age groups: 6 to 12 years, 2 to 5 years, and 6 months to younger than 2 years, with data from the latter two being reported Wednesday.

Among approximately 6,700 participants aged 6 months to 6 years, two 25 µg doses in children aged 6 months to 5 years provided similar immunogenicity to the larger 100 µg two-dose primary series in young adults aged 18 to 25 years who were enrolled in the phase 3 COVE study, with geometric mean ratios of 1.3 (95% CI, 1.1-1.5) and 1 (95% CI, 0.9-1.2) for children aged 6 months to younger than 2 years and 2 to 5 years, respectively, Moderna reported.

“This also predicts protection from COVID-19 and severe COVID-19 disease down to 6 months of age,” the company said. (There were no severe cases of COVID-19 or deaths among study participants, so the vaccine could not be measured against those endpoints, the company said.)

Vaccine efficacy — which was not a primary endpoint — was 43.7% among children aged 6 months to 2 years and 37.5% in the 2 to 5 years group — “statistically significant, but lower efficacy against COVID-19 infection as expected during the omicron wave and consistent with adult observational data,” Moderna said.

It said most adverse events in the trial were mild to moderate, with no myocarditis, pericarditis or multisystem inflammatory syndrome in children reported in any patient in the cohort.

“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.

He said that following a consultation with the FDA, Moderna will also be initiating a submission for an emergency use authorization of its COVID-19 vaccine for children aged 6 to 11 years old, and will update its EUA submission for adolescents aged 12 to 17 years with additional follow-up data.

Although Moderna’s vaccine is fully approved for adults, the FDA delayed its review of the vaccine in adolescents aged 12 to 17 years to evaluate heart risks. Moderna said at the time that it was also delaying an EUA submission for a half-dose for children aged 6 to 11 years.

“We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages,” Bancel said.