March 23, 2022 – Vaccine maker Moderna says its COVID-19 vaccine produces "robust" antibodies to fight the coronavirus in children 6 months up to 6 years of age – levels similar to those seen in adults.

Vaccine efficacy against infection was 43.7% in children 6 months to 2 years and 37.5% among children 2 years up to 6 years old, the company’s new data shows.

Moderna plans to include this data when it applies to the FDA for emergency use authorization of the vaccine in these younger children in the coming weeks.

The company says the lower efficacy numbers in these younger children was similar to the effectiveness in adults during the Omicron wave.

A majority of COVID-19 cases were mild in the 6,900 children in the study. No severe COVID-19 cases, hospitalizations or deaths were reported.

Childre in the study were given two 25 microgram doses of the vaccine 28 days. Side effects were described as generally mild to moderate. For example, a fever over 100.4 F was reported for 17.0% of the 6 month- 2 years group, for 14.6% of the 2-6 year group. A few children, 0.2% of each group, had a a fever above 104 F.

"We now have clinical data on the performance of our vaccine on infants from 6 months age through older adults," Moderna CEO Stephane Bancel said in a news release. He described the interim results as "good news for parents of children under 6 years of age."

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Moderna: “Moderna Announces its COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to Under 6 Years Has Successfully Met Its Primary Endpoint.”

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