mRNA-1273.222 Targets the BA.4/BA.5 Strains of Omicron Variant
Authorization Is Based Upon Clinical and Pre-Clinical Data for Moderna’s Bivalent Vaccine Candidates
CAMBRIDGE, MA / ACCESSWIRE / October 12, 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 BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, in children and adolescents 6 to 17 years of age. The authorizations are based on a 25 μg booster dose for children ages 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old, each following a completed primary series of any of the authorized COVID-19 vaccines or a previous booster. The booster doses of mRNA-1273.222 each contain 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.
“We are proud to have received authorization for our updated, bivalent COVID-19 booster for children and adolescents 6 to 17 years of age,” said Stéphane Bancel, Chief Executive Officer of Moderna. “With bivalent boosters available for most age groups, families have access to updated tools as they head into the winter months and holiday gatherings. We are grateful for the FDA for their thorough and timely review.”
Last month, mRNA-1273.222, which targets the BA.4/BA.5 subvariants of Omicron, received FDA EUA for adults over the age of 18. The pediatric and adolescent EUA application is based upon clinical trial booster data for Moderna’s original vaccine, Spikevax, which was administered to over a thousand participants in each cohort. 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.
Moderna is currently working to finalize its EUA application for children ages 6 months to 5 years old. The application is expected to be completed later this year.
