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Moderna released summary data Wednesday stating its COVID-19 vaccine for children under 6 years is safe and said it plans to seek emergency use authorization (EUA) in the coming weeks.
The mRNA vaccine produced a “robust neutralizing antibody response,” but efficacy against infection ranged from about 38%-44%, according to a press release. The clinical trial data have not been formally published or peer reviewed.
Moderna’s randomized, placebo-controlled trial in the U.S. and Canada included 2,500 children ages 6 months through 1 year and 4,200 children ages 2 years through 5 years. The children were given two 25-microgram (μg) doses 28 days apart. The dose is one-quarter of the adult primary series dose.
Most adverse events were mild or moderate. About 17% of children 6 months through 1 year and about 15% of those 2 through 5 years experienced a fever greater than 38 degrees Celsius (100.4 Fahrenheit). About 0.2% of each group experienced a fever greater than 40 degrees Celsius (104 Fahrenheit). There were no cases of myocarditis or pericarditis and no deaths.
Both age groups had similar immunogenicity to adults 18 to 25 years, meeting the non-inferiority criteria. However, vaccine efficacy against infection was just under 44% for children under 2 years and 37.5% in those ages 2 through 5 years. Moderna noted omicron was predominant during the study of young children. No cases of severe disease were reported in either age group.
In addition to requesting authorization from the Food and Drug Administration (FDA) in the coming weeks, Moderna said it has started the EUA process for children ages 6-11 years and is updating its EUA submission for children ages 12-17 years. The younger group would receive two 50-μg doses, and the older group would receive two 100-μg doses. In addition, the company plans to study a booster dose for all children and adolescents.
The Pfizer-BioNTech vaccine is the only one authorized in the U.S. for adolescents and children as young as 5 years. The companies have been studying a three-dose series in children under 5 years after finding a two-dose series with a 3-μg dosage did not meet non-inferiority criteria for those ages 2-4 years. They are expected to present new data this spring.