Moderna Inc. said that its COVID-19 vaccine showed a strong immune response in younger children in a late-stage clinical trial, paving the way for submission to regulators for clearance in those ages 6 through 11.
An interim analysis showed a protective antibody response from children in the study, Cambridge, Massachusetts-based Moderna said Monday in a statement. Participants received two 50 microgram doses — half the amount initially given to adults — spaced 28 days apart.
Health officials are aiming to get immunizations to younger children before the holiday season, when travel and indoor activity can bring an increased risk of infection. As more adults are vaccinated, children are now making up a greater proportion of U.S. COVID cases amid the spread of the delta variant.
Moderna said it plans to submit the data to the Food and Drug Administration, the European Medicines Agency and other global regulators in the near term.
Shares of Moderna closed up 7.05% Monday. The stock has been under pressure of late, sliding about 24% over the past month.
The trial data also showed a favorable safety profile, the company said, consistent with that seen earlier in adults and adolescents.
In reaching the pediatric population, Moderna is following on the heels of the Pfizer Inc.-BioNTech SE vaccine. The competing messenger RNA regimen was cleared for adolescents’ use in May, and about half of all U.S. kids aged 12 through 17 are now fully vaccinated.
An FDA panel is expected to review data on the Pfizer-BioNTech vaccine for 5 to 11-year-olds on Tuesday. On Friday evening, the agency’s staff gave a vote of confidence to the vaccine partners, stating that the benefits of Pfizer-BioNTech vaccine for young children likely outweigh its risks.
The focus on childhood vaccination against COVID is growing as governments look for avenues to stop pandemic resurgence. Infection of older people by youth may be helping to fuel mounting cases in the U.K., National Health Service chair David Prior said in an interview last week.
“It’s too early to say, but that’s what we think is the most likely explanation,” Prior said last week at a Boston health conference.
Moderna has already approached regulators for emergency clearance of its shot in those aged 12 through 17, but the FDA has delayed a decision as it further investigates heart-related side effects in the group. Europe’s regulatory body cleared the shot for adolescents in July.
