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Moderna is planning to request approval from the Food and Drug Administration for itsCOVID-19vaccine for children under age 6.
The pharmaceutical companyannouncedWednesday that it will submit a request to the FDA “in the coming weeks” for approval of a low-dose, two-shot vaccine for young children.
Moderna seeks FDA approval after collecting results from its KidCOVE study, which administered two doses of its vaccine to young children 28 days apart. The study observed results in 2,500 children ages 6 months to under 2 years, and to 4,200 children ages 2 to under 6 years, the drugmaker said. In total, approximately 6,700 participants ages 6 months up to 6 years were enrolled in the study.
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While the KidCOVE study also collected data from children ages 6 to 12 years, Moderna reported on the 6 months to under 6 years age groups in the Wednesday press release.
“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age. We now have clinical data on the performance of our vaccine from infants six months of age through older adults,” Stéphane Bancel, Chief Executive Officer of Moderna, said in a statement.
“Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,” Bancel added.
At 25-micrograms each, the two doses of Moderna’s vaccine for children are a quarter of the dose currently given to adults 18 years and older.
Modern reported mild to moderate side effects for majority of the participants in their KidCOVE study ages 6 months up to 6 years.
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The KidCOVE study monitored protection against Omicron, and showed that “vaccine efficacy in children 6 months to 2 years was 43.7%,” while “vaccine efficacy was 37.5% in the 2 to under 6 years age group.”
Moderna reported that “the majority of cases were mild, and no severe COVID-19 disease was observed in either age group.”
source: people.com
