Moderna Asks FDA to Authorize Its COVID-19 Vaccine for Children Under 6

THURSDAY, April 28, 2022 (HealthDay News) -- Moderna announced Thursday that it has asked the U.S. Food and Drug Administration to authorize the emergency use of its COVID-19 vaccine for children younger than 6 years old. It is the first vaccine maker to seek U.S. authorization of a COVID-19 shot for that age group.

"We believe mRNA-1273 [the Moderna vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers," Moderna CEO Stéphane Bancel said in a statement.

The two 25-µg doses of the vaccine for children younger than 6 are smaller than the two 100-µg doses for adults, but tests among children ages 6 months to younger than 6 years showed a "robust neutralizing antibody response" and a "favorable safety profile," according to Moderna.

The company also said that preliminary analysis of lab tests during the omicron wave showed the vaccine's efficacy against infection was 51 percent among children younger than 2 years and 37 percent among children aged 2 to 5 years. "These efficacy estimates are similar to vaccine efficacy estimates in adults against omicron after two doses," the company said in its statement.

For now, FDA authorization of the Moderna vaccine is limited to adults. Along with the new request, the company has also asked for authorization of the vaccine for children ages 6 to 17 years.

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