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Moderna Files for Authorization of Its COVID-19 Vaccine in Young Children Six Months to Under Six Years of Age
Submission to Regulators Globally Is Based on Phase 2/3 Studies of mRNA-1273 in Young ChildrenCAMBRIDGE, MA / ACCESSWIRE / April 28, 2022 / Moderna, Inc.
About this update from Moderna, Inc.
[{"type":"text","content":"Submission to Regulators Globally Is Based on Phase 2/3 Studies of mRNA-1273 in Young ChildrenCAMBRIDGE, MA / ACCESSWIRE / April 28, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a request for emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age to the U.S. Food and Drug Administration and that similar requests are underway with international regulatory authorities. The requests are based on a 25 μg two-dose primary series of mRNA-1273.\"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, Chief Executive Officer 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.\"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","length":2341,"tagName":"div"}]