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Moderna Receives FDA Authorization for Emergency Use of Its COVID-19 Vaccine for Children 6 Months of Age and Older
mRNA-1273 was authorized for children and adolescents aged 6 months through 17 years of age, administered as two doses given one month apartmRNA-1273 has been
About this update from Moderna, Inc.
[{"type":"text","content":"mRNA-1273 was authorized for children and adolescents aged 6 months through 17 years of age, administered as two doses given one month apartmRNA-1273 has been administered to millions of children and adolescents over the age of 6 worldwide, with safety and tolerability profiles consistent with other age groupsCAMBRIDGE, MA / ACCESSWIRE / June 17, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine (mRNA-1273) in young children ages 6 months through 5 years of age at a dose level of 25 µg. The company has also received emergency use authorization for a 50 μg two-dose regimen of mRNA-1273 for children ages 6 through 11 years old and a 100 μg two-dose regimen for adolescents aged 12 through 17 years old. The two-dose regimens, with doses tailored for each age group given one month apart, are well-timed to initiate protection for the start of the school year, as children return to higher-risk classroom and daycare settings.\"We are thrilled that the FDA has granted Emergency Use Authorization of Moderna's COVID-19 vaccine for children and adolescents, particularly for our vulnerable, youngest children,\" said Stéphane Bancel, Chief Executive Officer of Moderna. \"Children need to live highly social lives to develop and flourish. With this authorization, caregivers for young children ages 6 months through 5 years of age finally have a way to safeguard against COVID risks in classroom and daycare settings. Our pediatric COVID-19 vaccine is a two-dose regimen for all children 6 months and older, providing protection against COVID-19 two weeks after the second dose.\"mRNA-1273 for children and adolescents showed protection starting 14 days after the second dose. Protection was statistically significant, with data coming from large, well-controlled trials of more than 14,000 children and adolescents and a median follow-up of more than 2 months for 6 months through 5 years of age, 5.6 months for 6 through 11 years of age, and 11.1 months for adolescents.Positive interimresults from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6 months through 5 years of age group c...