Moderna has announced that it plans to ask the US Food and Drug Administration to authorize a lower-dose version of its SARS-CoV-2 vaccine for children under six years of age, CNN reports.
According to the company, two 25-microgram doses of its mRNA-based vaccine given to children 6 months to 6 years old led to similar immunogenicity profiles as two 100-microgram doses given to adults 18 years old and older. CNBC notes, though, that the two-dose regimen was 44 percent effective in preventing Omicron infections among 6-month to under 2-year olds and 38 percent in preventing Omicron infections among children 2-to-5-years old. None of the 6,700 children in the study developed severe disease.
"Given the need for a vaccine against COVID-19 in infants and young children we are working with the US FDA and regulators globally to submit these data as soon as possible," Moderna CEO Stéphane Bancel says, according to CNN. The Moderna vaccine is currently approved for adults 18 years old and older.
The Washington Post notes that Pfizer and BioNTech also sought authorization for their SARS-CoV-2 vaccine for young children, but the companies found that for 2-to-4 year olds, it did not lead to the needed immune response. Despite initially signaling that it might authorize the vaccine while data on a third dose is collected, the FDA is waiting until that data is available to decide.