Moderna Seeks FDA Authorization For COVID-19 Vaccine For Kids Under 6 – CNET

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Moderna is submitting data on its COVID-19 vaccine tests on young children.

Sarah Tew/CNET

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Moderna will seek US Food and Drug Administration and other regulators’ approval to administer its COVID-19 vaccine to children aged 6 months to 6 years of age in the coming weeks, it said Wednesday. Those children would receive two 25 microgram shots, which is a quarter of the amount adults get.

The pharmaceutical company’s tests showed “a robust neutralizing antibody response,” with “a favorable safety profile.” The efficacy was 43.7% in children 6 months to 2 years old, and 37.5% in children from 2 to under 6, with no severe cases of COVID-19 reported.

Doses were given 28 days apart to 2,500 children aged 6 months to 2 years and to 4,200 children aged 2 to 6 years.

“The majority of adverse events were mild or moderate and were more frequently reported after dose two,” Moderna noted.

Last month, Pfizer and its partner BioNTech postponed their rolling FDA application to authorize their COVID-19 vaccine for children ages 6 months to 4 years, to allow for additional data on a third dose for that age group.

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