In This Article:
CAMBRIDGE, MA / ACCESSWIRE / November 1, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222 (Spikevax Bivalent Original/Omicron BA.4-5) in adults 18 years and older. Spikevax Bivalent Original/Omicron BA.4-5 contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant BA.4-5. mRNA-1273.222 now joins Moderna's BA.1 variant targeting vaccine, mRNA-1273.214, which was approved in Japan in September.
"COVID-19 continues to be a public health threat in Japan, with ongoing rates of infections driven by Omicron subvariants. mRNA-1273.222 is designed to provide broader and more durable immune response against Omicron BA.4-5, which are the main subvariants circulating in Japan," said Rami Suzuki, President & Representative Director of Moderna Japan. "We are grateful for this approval decision and are committed to bringing this vaccine to the people of Japan as soon as possible."
Moderna developed mRNA-1273.222 in accordance with U.S. FDA guidance to develop a BA.4-5-targeting bivalent vaccine. A Phase 2/3 trial for mRNA-1273.222 is currently underway. Takeda Pharmaceutical Co. Ltd. continues to provide distribution support for Spikevax Bivalent Original/Omicron BA.4-5 under the current national vaccination campaign for Moderna COVID-19 vaccines for a transitional period.
Authorized Use
Spikevax Bivalent Original/Omicron BA.4-5 is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. One 0.5 mL dose is provided intramuscularly.
About Moderna
In over 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 vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.