Moderna Asks FDA to Approve COVID-19 Vaccine for Children 6 Months and Older

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Moderna, Inc. announced Thursday that the biotechnology company has submitted a request to the U.S. Food and Drug Administration for emergency use authorization of its COVID-19 vaccine for children between the ages of 6 months and 6 years old.

Officials said Thursday that similar requests are also underway with international regulatory authorities.

The requests are based on a 25 μg two-dose primary series of mRNA-1273, Moderna officials said.

“We are proud to share that we have submitted for authorization for our COVID-19 vaccine for young children,” Stéphane Bancel, Chief Executive Officer of Moderna, said. “We believe mRNA-1273 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.”

According to Moderna officials, positive interim results from the Phases 2 and 3 KidCOVE study, announced on March 23, 2022, showed a "strong neutralizing antibody response in the 6 months to under 6 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile."

The antibody titers in the 6-month to 6-years-old sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the study's primary objective, officials said.

Officials said the results also included a supportive preliminary efficacy analysis on cases mostly collected during the Omicron wave, including home testing for COVID-19.

According to Moderna, the company is also studying booster doses for the two oldest pediatric cohorts, and the company is designing the study to evaluate the potential for vaccine use for children 6 years old and younger.

The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

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