Press release
Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children 6 Months Through 5 Years of Age
mRNA-1273.222 Targets the BA.4/BA.5 Strains of Omicron VariantAuthorization Is Based Upon Clinical and Pre-Clinical Data for Moderna's Bivalent
About this update from Moderna, Inc.
[{"type":"text","content":"mRNA-1273.222 Targets the BA.4/BA.5 Strains of Omicron VariantAuthorization Is Based Upon Clinical and Pre-Clinical Data for Moderna's Bivalent VaccinesCAMBRIDGE, MA / ACCESSWIRE / December 8, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, in children 6 months through 5 years of age. The authorization is based on a 10 μg booster dose following a completed primary series of Moderna's original vaccine. The booster dose of mRNA-1273.222 contains mRNA encoding for the spike protein of BA.4/BA.5 as well as mRNA encoding for the original strain of the SARS-CoV-2 virus.\"With the FDA's decision, children and adolescents of all age groups in the U.S. will now be eligible for our updated bivalent COVID-19 booster, providing families with an important protective tool as we continue through the winter months,\" said Stéphane Bancel, Chief Executive Officer of Moderna. \"We appreciate the FDA's timely review.\"mRNA-1273.222, which targets the BA.4/BA.5 subvariants of Omicron, has also received FDA EUA for children and adolescents aged 6 through 17 years old, as well as adults over the age of 18. The pediatric EUA application is based upon clinical trial booster data for Moderna's original vaccine, Spikevax. In addition, the EUA application included pre-clinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying mRNA-1273.214, another Omicron-targeting bivalent booster vaccine developed by Moderna.Last month, Moderna announced results from a Phase 2/3 trial in over 500 adults, which showed mRNA-1273.222 induced significantly higher neutralizing antibody titers against BA.4/BA.5 compared to a booster dose of Moderna's original vaccine. A Phase 2/3 trial evaluating Omicron-targeting bivalent vaccines as booster and primary series in children 6 months through 5 years of age is currently underway, with initial results expected in early 2023.About ModernaIn 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of v...