Moderna Will Ask FDA to Approve COVID-19 Vaccine for Young Children

WEDNESDAY, March 23, 2022 (HealthDay News) -- Moderna announced Wednesday that it will ask the U.S. Food and Drug Administration to approve the emergency use of its COVID-19 vaccine for children under 6.

The company said that its request is based on interim results from its clinical trial that showed, even when given a dose that was one-quarter as strong as the adult dose, these youngest children had an immune response that was similar to young adults.

"We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults," Moderna CEO Stéphane Bancel said in a company 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 that Moderna will also ask for emergency approval for its two-shot vaccine for children aged 6 to 11, and was updating a request that it filed last summer for those aged 12 to 17. That request was shelved at the time because the FDA wanted to see more data on the rare side effect myocarditis.

In Moderna's latest trial among young children, there were no cases of serious illness or hospitalizations. But with omicron now the dominant variant in the United States, the vaccine's power in preventing infections dropped to roughly 40 percent overall, and was even slightly lower in children under 2 years of age.

Children in the study received two shots of a 25-microgram dose. The findings, culled from tests on nearly 7,000 children, have not yet been published or peer-reviewed. Moderna said it plans to submit the data to the FDA in the coming weeks.

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