“A robust neutralizing antibody response,” was observed in a recently conducted study of the Moderna mRNA COVID-19 vaccine in children from 6 months old to under 6 years old, the company announced Wednesday.
According to the Massachusetts-based pharmaceutical company, it will “submit a request for authorization of a 25 microgram two-dose primary series of mRNA-1273 for children 6 months to under 6 years of age to the U.S.
Food and Drug Administration,” as well as other agencies as soon as possible.
The study included observation of the vaccine in a 6-month to 2-year-old age group as well as a 2-year-old to 6-year old age group. The “robust” response was found in both groups after a 25 microgram two-dose primary series of the Moderna mRNA-1273. Moderna vaccines for adults have 100 microgram doses.
Approximately 4,200 children ages 2 to under 6 years and approximately 2,500 children ages 6 months to under 2 years participated in the study, which was conducted while the omicron variant of COVID-19 was the most common strain of the virus. Most adverse events were mild or moderate and were more frequently reported after dose two, according to Moderna.
“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age,” said Stéphane Bancel, CEO of Moderna. “We now have clinical data on the performance of our vaccine from infants six months of age through older adults.”
Previously Moderna “reported positive topline data from the 6 to under 12 years old cohort,” the company said. It has started the submission process with the FDA to make a 50-microgram dose available to that age group.
Regulators in Australia, Canada and the European Union have already authorized its use.
Currently, there is no vaccine with FDA approval for children under 5 years old. Pfizer BioNTech manufacturers the vaccine approved for the youngest age group, children ages 5 to 11, which is a lower dose (10 micrograms) of the full vaccine (30 micrograms) approved for people over 12 years old. Moderna currently has FDA approval for vaccines to be administered to adults over 18 years old.
Moderna is also considering a booster dose for child populations, said the company.
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