Covid-19 vaccine for younger kids showed strong results, says Moderna

Moderna 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 Monday 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 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 US 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.  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 US 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. 

‘Safe for kids’

• Biotech preparing to ask US, EU regulators for clearance
• Children ages 6 through 11 developed strong immune response
• 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