Moderna to request FDA’s approval for vaccinating children aged under 6

Los Angeles, U.S. | Xinhua | American biotechnology company Moderna said Wednesday it will request the U.S. Food and Drug Administration (FDA) to grant emergency use authorization for its COVID-19 vaccine for children aged under 6.

The company will submit the request to the FDA, as well as the European Medicines Agency and other global regulators “in the coming weeks,” said the company in a statement.

The submission was based on tests of its COVID-19 vaccine, known as mRNA-1273, in children aged 6 months to under 2 years, and 2 years to under 6 years.

The interim analysis showed a robust neutralizing antibody response in both age groups after a 25 microgram two-dose primary series of mRNA-1273 along with a favorable safety profile, according to the company.

In the study, vaccine efficacy in children aged 6 months to 2 years was 43.7 percent, and 37.5 percent in the 2 to under 6 years age group, according to Moderna.

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Xinhua