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Moderna announced today that it has submitted to the U.S. Food and Drug Administration a request for emergency use authorization for its COVID-19 vaccine to be given to children from 6 months to under 2 years of age, and for children from ages 2 to under 6. Similar requests are underway with international regulatory authorities.
The EUA submission for children ages 6 months to under 6 years will be complete next week, Moderna said.
WHAT’S THE IMPACT?
Positive interim results from a Phase 2/3 KidCOVE study, announced on March 23, showed a robust neutralizing antibody response in the 6 month to under 6 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody concentration in the 6 month to 23 month and 2 years to under 6 years age subgroups met the statistical criteria for similarity to adults in the COVE study, which satisfied the primary objective of the study, Moderna said.
The results included an efficacy analysis on cases mostly collected during the Omicron wave, including home testing for COVID-19. These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273.
Moderna is also currently studying booster doses for all pediatric cohorts.
THE LARGER TREND
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 (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
BARDA is reimbursing Moderna for 100% of the allowable costs incurred for conducting the program. HHS is supporting the continued research and development of the company’s COVID-19 vaccine development efforts with federal funding.
In February, the FDA gave full approval to Moderna’s COVID-19 vaccine for individuals 18 years of age and older.
Pfizer/BioNTech got full approval for its vaccine in August.
In March, the FDA authorized both Pfizer and Moderna to give a second booster dose of their COVID-19 vaccines to individuals aged 50 and older and to those who are immunocompromised.
ON THE RECORD
“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” said Stéphane Bancel, CEO of Moderna. “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.”
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