Moderna’s vaccine for kids ages 6 through 11 shows a “robust” immune response in a study of more than 4,500 youths, the Massachusetts-based pharmaceutical company said Monday.
Moderna said it plans to submit the data to the U.S. Food and Drug Administration “in the near term.” The randomized, observer-blind, placebo-controlled expansion study involved a two-dose vaccine. The dosage is half that of the adult vaccine.
The majority of adverse events were mild or moderate in severity, the company said, with the most common ones being fatigue, headache, fever and pain in the injection site.
“We are encouraged by the immunogenicity and safety profile,” said Stéphane Bancel, Moderna’s chief executive officer. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
The FDA has not yet announced a decision on Moderna’s vaccine for youths ages 12 through 17. Moderna submitted results from that study in June.
A panel of FDA advisers will vote this week on whether to authorize the Pfizer-BioNTech COVID-19 vaccine for use in children 5 to 11.