NEW YORK (BLOOMBERG) – 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 aged six to under 12.
An interim analysis showed a protective antibody response from children in the study, Cambridge, Massachusetts-based Moderna said on Monday (Oct 25) in a statement.
Participants received two 50 microgram doses – half that initially given to adults – spaced 28 days apart.
Health officials are aiming to get immunisations 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 US Covid-19 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 rose 0.4 per cent in early New York trading. The stock has been under pressure of late, sliding about 24 per cent over the past month.
The trial data also showed a favourable safety profile, the company said, consistent with that seen earlier in adults and adolescents.
In reaching the paediatric population, Moderna is following on the heels of the Pfizer-BioNTech vaccine.
The competing messenger RNA regimen was cleared for adolescents’ use in May, and about half of all US children aged 12 through 17 are now fully vaccinated.
Focus on children
An FDA panel is expected to review data on the Pfizer-BioNTech vaccine for five- to 11-year-olds on Tuesday.
Last 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-19 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 Britain, National Health Service chairman 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,” he said last Tuesday evening 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.
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