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04/28/2022

Moderna seeks EU authorization for COVID-19 vaccine in young children

Moderna's submission to the FDA is based on Phase 2/3 studies of mRNA-1273 in young children.
Sandra Levy
Senior Editor
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Moderna has submitted a request to the Food and Drug Administration for emergency use authorization for its COVID-19 vaccine (mRNA-1273) in children aged 6 months old to under 2 years old and aged 2 years old to under 6 years old.

The company said that similar requests, which are based on a 25 μg two-dose primary series of mRNA-1273, are underway with international regulatory authorities.

"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."

[Read more: FDA authorizes Moderna, J&J COVID-19 booster shots, clears mix-and-match brands]

Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, 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 titers in the pre-specified 6 month to 23 month and 2 years to under 6 years age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study.

The previously announced results included a supportive preliminary efficacy analysis on cases mostly collected during the Omicron wave, including home testing for COVID-19. When the analysis is limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR vaccine efficacy remained significant at 51% (95% CI: 21-69) for 6 months to <2 years and 37% (95% CI: 13-54) for 2 to <6 years. These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273, the company said.

[Read more: Retailers begin offering Moderna, J&J COVID-19 booster shots] 

The EUA submission for children ages 6 months to under 6 years will be complete next week. Moderna also is currently studying booster doses for all pediatric cohorts.

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